Rekovelle

Helstu upplýsingar

  • Heiti vöru:
  • Rekovelle
  • Lyf við lungum:
  • Mannfólk
  • Lyfjaform:
  • Allópatísk lyf

Skjöl

Staðsetning

  • Fáanlegt í:
  • Rekovelle
    Evrópusambandið
  • Tungumál:
  • enska

Meðferðarupplýsingar

  • Meðferðarhópur:
  • Sex hormones and modulators of the genital system,
  • Lækningarsvæði:
  • Anovulation
  • Ábendingar:
  • Controlled ovarian stimulation for the development of multiple follicles in women undergoing assisted reproductive technologies (ART) such as an in vitro fertilisation (IVF) or intracytoplasmic sperm injection (ICSI) cycle.
  • Vörulýsing:
  • Revision: 1

Staða

  • Heimild:
  • EMA - European Medicines Agency
  • Leyfisstaða:
  • Authorised
  • Leyfisnúmer:
  • EMEA/H/C/003994
  • Leyfisdagur:
  • 11-12-2016
  • EMEA númer:
  • EMEA/H/C/003994
  • Síðasta uppfærsla:
  • 30-03-2019

Opinber matsskýrsla

30 Churchill Place

Canary Wharf

London E14 5EU

United Kingdom

An agency of the European Union

Telephone

+44 (0)20 3660 6000

Facsimile

+44 (0)20 3660 5555

Send a question via our website

www.ema.europa.eu/contact

© European Medicines Agency, 2017. Reproduction is authorised provided the source is acknowledged.

EMA/684112/2016

EMEA/H/C/003994

EPAR summary for the public

Rekovelle

follitropin delta

This is a summary of the European public assessment report (EPAR) for Rekovelle. It explains how the

Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is

not intended to provide practical advice on how to use Rekovelle.

For practical information about using Rekovelle, patients should read the package leaflet or contact

their doctor or pharmacist.

What is Rekovelle and what is it used for?

Rekovelle is a medicine given to women who are having fertility treatments such as in vitro fertilisation

(IVF) or intracytoplasmic sperm injection (ICSI). It is used to stimulate the ovaries to produce several

eggs at the time, which can then be collected and fertilised in the laboratory.

Rekovelle contains the active substance follitropin delta.

How is Rekovelle used?

Rekovelle is available as a solution for injection, contained in a cartridge to be used with Rekovelle

injection pen. The medicine can only be obtained with a prescription and treatment should be started

under the supervision of a doctor who has experience in the treatment of fertility problems.

Rekovelle is given by injection under the skin once a day for several consecutive days during the

woman’s menstrual cycle starting on day 2 or 3 of the cycle and is continued until sufficient eggs have

developed. The starting dose of Rekovelle depends on the woman’s bodyweight and on the blood level

of the anti-Müllerian hormone (a hormone which indicates how well the ovaries will respond to

stimulation). The dose can then be modified in subsequent cycles according to the woman’s response.

After the first injection, the woman or their partner may be able to give the injections themselves, if

they have been trained and have access to expert advice.

Rekovelle

EMA/684112/2016

Page 2/3

For further information, see the package leaflet.

How does Rekovelle work?

The active substance in Rekovelle, follitropin delta, is a copy of the natural hormone called follicle-

stimulating hormone (FSH) which plays a key role in fertility in women by stimulating the production of

eggs in the ovaries. Giving extra stimulation with Rekovelle helps increase the number of eggs

produced in the ovaries, which means that more eggs can then be collected and fertilised in the

laboratory.

What benefits of Rekovelle have been shown in studies?

Rekovelle was compared with GONAL-f (follitropin alfa), another fertility medicine, in one study

involving 1,326 women who were undergoing controlled ovarian stimulation for IVF or ICSI. The main

measure of effectiveness was the rate of implantation and pregnancy.

The study showed that Rekovelle was as effective as GONAL-f at stimulating the ovaries: around 31%

of women (204 out of 665) treated with Rekovelle became pregnant compared with around 32% of

women (209 out of 661) treated with GONAL-f. Implantation rates were also similar: around 35% with

Rekovelle versus around 36% with GONAL-f.

What are the risks associated with Rekovelle?

The most common side effects with Rekovelle (which may affect between 1 and 10 people in 100) are

headache, discomfort and pain in the pelvic area which may arise from the ovaries, nausea (feeling

sick) and tiredness and ovarian hyperstimulation syndrome (OHSS). OHSS is when a woman’s ovaries

over-respond to stimulation, causing symptoms such as vomiting, diarrhoea and pain. In severe cases

OHSS may lead to difficulty breathing and problems with blood clotting. The frequency of side effects

may decrease with repeated treatment cycles. For the full list of all side effects reported with

Rekovelle, see the package leaflet.

Rekovelle must not be used in women with tumours of the pituitary gland or hypothalamus, or cancer

of the breast, womb or ovary. Rekovelle must not be used when there is enlargement of an ovary or a

cyst that is caused by something other than polycystic ovarian syndrome, or when there is unexplained

bleeding from the vagina. For the full list of restrictions, see the package leaflet.

Why is Rekovelle approved?

The Agency’s Committee for Medicinal Products for Human Use (CHMP) decided that Rekovelle’s

benefits are greater than its risks and recommended that it be approved for use in the EU.

The CHMP considered that Rekovelle was effective in obtaining several eggs at the same time following

stimulation in women undergoing fertility treatment. The safety profile of Rekovelle was considered

acceptable and similar to that of GONAL-f.

What measures are being taken to ensure the safe and effective use of

Rekovelle?

Recommendations and precautions to be followed by healthcare professionals and patients for the safe

and effective use of Rekovelle have been included in the summary of product characteristics and the

package leaflet.

Rekovelle

EMA/684112/2016

Page 3/3

Other information about Rekovelle

The European Commission granted a marketing authorisation valid throughout the European Union for

Rekovelle on 12 December 2016.

The full EPAR for Rekovelle can be found on the Agency’s website:

ema.europa.eu/Find

medicine/Human medicines/European public assessment reports. For more information about

treatment with Rekovelle, read the package leaflet (also part of the EPAR) or contact your doctor or

pharmacist.

This summary was last updated in 12-2016.

Upplýsingar um fylgiseðil sjúklinga: samsetning, vísbendingar, aukaverkanir, skammtar, milliverkanir, aukaverkanir, meðgöngu, brjóstagjöf

B. PACKAGE LEAFLET

Package leaflet: Information for the user

REKOVELLE 12 micrograms/0.36 mL solution for injection

follitropin delta

This medicine is subject to additional monitoring. This will allow quick identification of new

safety information. You can help by reporting any side effects you may get. See the end of section 4

for how to report side effects.

Read all of this leaflet carefully before you start using this medicine because it contains

important information for you.

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor or pharmacist.

This medicine has been prescribed for you only. Do not pass it on to others. It may harm them,

even if their signs of illness are the same as yours.

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side

effects not listed in this leaflet. See section 4.

What is in this leaflet

What REKOVELLE is and what it is used for

What you need to know before you use REKOVELLE

How to use REKOVELLE

Possible side effects

How to store REKOVELLE

Contents of the pack and other information

1.

What REKOVELLE is and what it is used for

REKOVELLE contains follitropin delta, a follicle stimulating hormone which belongs to the family of

hormones called gonadotropins. Gonadotropins are involved in reproduction and fertility.

REKOVELLE is used in the treatment of female infertility and in women undergoing assisted

reproduction programmes such as

in vitro

fertilisation (IVF) and intracytoplasmic sperm injection

(ICSI). REKOVELLE stimulates the ovaries to grow and develop many egg sacs (‘follicles’), from

which eggs are collected and fertilised in the laboratory.

2.

What you need to know before you use REKOVELLE

Before starting treatment with this medicine, a doctor should check you and your partner for possible

causes of your fertility problems.

Do not use REKOVELLE if:

you are allergic to follicle stimulating hormone or any of the other ingredients of this medicine

(listed in section 6)

you have a tumour of the uterus, ovaries, breasts, pituitary gland or hypothalamus

you have enlarged ovaries or cysts on your ovaries (unless caused by polycystic ovarian

disease)

you suffer from bleeding from the vagina without any known cause

you have had an early menopause

you have malformations of the sexual organs which make a normal pregnancy impossible

you have fibroids of the uterus which make a normal pregnancy impossible.

Warnings and precautions

Ovarian hyperstimulation syndrome

Gonadotropins like this medicine may cause ovarian hyperstimulation syndrome. This is when your

follicles develop too much and become large cysts.

Talk to your doctor if you:

have abdominal pain, discomfort or swelling

have nausea

are vomiting

get diarrhoea

gain weight

have difficulty in breathing

Your doctor may ask you to stop using this medicine (see section 4).

If the recommended dose and schedule of administration are followed, ovarian hyperstimulation

syndrome is less likely.

Blood clotting problems (thromboembolic events)

Clots in the blood vessels (veins or arteries) are more likely in women who are pregnant. Infertility

treatment can increase the risk of this happening, especially if you are overweight or you or someone

in your family (blood relative) have a known blood clotting disease (thrombophilia). Tell your doctor

if you think this applies to you.

Twisting of ovaries

There have been reports of twisting of ovaries (ovarian torsion) following assisted reproductive

technology treatment. Twisting of the ovary could cut off the blood flow to the ovary.

Multiple pregnancy and birth defects

When undergoing assisted reproductive technology treatment the possibility of having a multiple

pregnancy (such as twins) is mainly related to the number of embryos placed inside your womb, the

quality of the embryos, and your age. Multiple pregnancy may lead to medical complications for you

and your babies. Furthermore, the risk of birth defects may be slightly higher following infertility

treatment, which is thought to be due to characteristics of the parents (such as your age, and your

partner’s sperm characteristics) and multiple pregnancy.

Pregnancy loss

When undergoing assisted reproductive technology treatment, you are more likely to have a

miscarriage than if you conceive naturally.

Pregnancy outside the uterus (ectopic pregnancy)

When undergoing assisted reproductive technology treatment, you are more likely to have a pregnancy

outside the uterus (ectopic pregnancy) than if you conceive naturally. If you have a history of tubal

disease, you have an increased risk of ectopic pregnancy.

Ovarian and other reproductive system tumours

There have been reports of ovarian and other reproductive system tumours in women who had

undergone infertility treatment. It is not known if treatment with fertility medicines increase the risk of

these tumours in infertile women.

Other medical conditions

Before starting to use this medicine, tell your doctor if:

you have been told by another doctor that pregnancy would be dangerous for you

you have kidney or liver disease

Children and adolescents (under 18 years of age)

This medicine is not indicated in children and adolescents.

Other medicines and REKOVELLE

Tell your doctor if you are taking, have recently taken or might take any other medicines, including

medicines obtained without a prescription.

Pregnancy and breast-feeding

Do not use this medicine if you are pregnant or breast-feeding.

Driving and using machines

This medicine does not affect your ability to drive and use machines.

REKOVELLE contains sodium

This medicinal product contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially

“sodium-free”.

3.

How to use REKOVELLE

Always use this medicine exactly as your doctor has told you and at the dose your doctor has told you.

Check with your doctor if you are not sure.

The REKOVELLE dose for your first treatment cycle will be calculated by your doctor using the level

of anti-Müllerian hormone (AMH, a marker of how your ovaries will respond to stimulation with

gonadotropins) in your blood and your body weight. Therefore the AMH result from a blood sample

(taken within the last 12 months) should be available before you start treatment. Your body weight

will also be measured before you start treatment. The REKOVELLE dose is stated in micrograms.

The REKOVELLE dose is fixed for the whole treatment period with no adjustments to increase or

decrease your daily dose. Your doctor will monitor the effect of REKOVELLE treatment, and

treatment is stopped when an appropriate number of egg sacs are present. In general, you will be given

a single injection of a medicine called human chorionic gonadotrophin (hCG) at a dose of

250 micrograms or 5,000 IU for final development of the follicles.

If your body´s response to treatment is too weak or too strong, your doctor may decide to stop

treatment with REKOVELLE. For the next treatment cycle, your doctor will in this case give you

either a higher or a lower daily dose of REKOVELLE than before.

How are injections given

REKOVELLE is developed for use in the REKOVELLE injection pen. The instructions for using the

injection pen supplied with the pen including loading the cartridge must be followed carefully. Do not

use the cartridge if the solution contains particles or if the solution does not look clear.

The first injection of this medicine should be given under the supervision of a doctor or a nurse. Your

doctor will decide if you can give yourself further doses of this medicine at home, but only after

receiving adequate training.

This medicine is to be given by injection just under the skin (subcutaneously) usually in the abdomen.

The cartridge may be used for several injections.

If you use more REKOVELLE than you should

The effects of taking too much of this medicine are unknown. Ovarian hyperstimulation syndrome

may possibly occur, which is described in section 4.

If you forget to use REKOVELLE

Do not take a double dose to make up for a forgotten dose. Please contact your doctor as soon as you

notice that you forgot a dose.

If you have any further questions on the use of this medicine, ask your doctor.

4.

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Serious side effects:

Hormones used in the treatment of infertility such as this medicine may cause a high level of activity

in the ovaries (ovarian hyperstimulation syndrome). Symptoms may include pain, discomfort or

swelling of the abdomen, nausea, vomiting, diarrhoea, weight gain or difficulty breathing. If you have

any of these symptoms you should contact a doctor immediately.

The risk of having a side effect is described by the following categories:

Common (may affect up to 1 in 10 people):

Headache

Nausea

Ovarian hyperstimulation syndrome (see above)

Pelvic pain and discomfort, including of ovarian origin

Tiredness (fatigue)

Uncommon (may affect up to 1 in 100 people):

Mood swings

Sleepiness/drowsiness

Dizziness

Diarrhoea

Vomiting

Constipation

Discomfort of the abdomen

Vaginal bleeding

Breast complaints (include breast pain, breast tenderness)

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects

not listed in this leaflet. You can also report side effects directly via the national reporting system

listed in Appendix V. By reporting side effects you can help provide more information on the safety of

this medicine.

5.

How to store REKOVELLE

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the cartridge label and carton after

EXP. The expiry date refers to the last day of that month.

Store in refrigerator (2 °C - 8 °C). Do not freeze.

Before first use, store in the original package in order to protect from light.

REKOVELLE may be stored at or below 25 °C for up to 3 months including the period after first use.

It must not be refrigerated again and must be discarded if it has not been used after 3 months.

After first use: 28 days when stored at or below 25 °C. Keep the cartidge in the REKOVELLE

injection pen.

At the end of the treatment any unused solution must be discarded.

Do not throw away any medicines via household waste. Ask your pharmacist how to dispose of

medicines you no longer use. These measures will help protect the environment.

6.

Contents of the pack and other information

What REKOVELLE contains

The active substance is follitropin delta.

Each multidose cartridge contains 12 micrograms of follitropin delta in 0.36 millilitre of

solution. One millilitre of solution contains 33.3 micrograms of follitropin delta in each

millilitre of solution.

The other ingredients are phenol, polysorbate 20, L-methionine, sodium sulphate decahydrate,

disodium phosphate dodecahydrate, concentrated phosphoric acid, sodium hydroxide and water

for injections.

What REKOVELLE looks like and contents of the pack

REKOVELLE is a clear and colourless solution for injection (injection). It is available in packs of

1 cartridge and 3 pen injection needles.

Marketing Authorisation Holder

Ferring Pharmaceuticals A/S

Kay Fiskers Plads 11

2300 Copenhagen S

Denmark

Manufacturer

Ferring GmbH

Wittland 11

D-24109 Kiel

Germany

For any information about this medicine, please contact the local representative of the Marketing

Authorisation Holder:

België/Belgique/Belgien

Ferring N.V.

Tel/Tél: +32 53 72 92 00

ferringnvsa@ferring.be

Lietuva

UAB PharmaSwiss

Tel: +370 5 2790762

lithuania.info@pharmaswiss.com

България

Аквaxим АД

Тел: +359 2 807 5022

aquachim@aquachim.bg

Luxembourg/Luxemburg

Ferring N.V.

Belgique/Belgien

Tel/Tél: +32 53 72 92 00

ferringnvsa@ferring.be

Česká republika

Ferring Pharmaceuticals CZ s.r.o.

Tel: +420 234 701 333

cz1-info@ferring.com

Magyarország

Ferring Magyarország Gyógyszerkereskedelmi Kft.

Tel: +36 1 236 3800

ferring@ferring.hu

Danmark

Ferring Lægemidler A/S

Tlf: +45 88 16 88 17

Malta

E.J. Busuttil Ltd.

Tel: +356 21447184

info@ejbusuttil.com

Deutschland

Ferring Arzneimittel GmbH

Tel: +49 431 5852 0

info-service@ferring.de

Nederland

Ferring B.V.

Tel: +31 235680300

infoNL@ferring.com

Eesti

PharmaSwiss Eesti OÜ

Tel: +372 682 7400

estonia.info@pharmaswiss.com

Norge

Ferring Legemidler AS

Tlf: +47 22 02 08 80

mail@oslo.ferring.com

Ελλάδα

Ferring Ελλάς ΜΕΠΕ

Τηλ: +30 210 68 43 449

Österreich

Ferring Arzneimittel Ges.m.b.H

Tel: +43 1 60 8080

office@ferring.at

España

Ferring S.A.U.

Tel: +34 91 387 70 00

Registros@ferring.com

Polska

Ferring Pharmaceuticals Poland Sp. z o.o.

Tel: +48 22 246 06 80

ferring@ferring.pl

France

Ferring S.A.S.

Tél: +33 1 49 08 67 60

information.medicale@ferring.com

Portugal

Ferring Portuguesa – Produtos Farmacêuticos,

Sociedade Unipessoal, Lda.Tel: +351 21 940 51 90

geral@ferring.com

Hrvatska

Clinres farmacija d.o.o.

Tel: +385 1 2396 900

România

Ferring Pharmaceuticals Romania SRL

Tel: +40 356 113 270

Ireland

Ferring Ireland Ltd.

Tel: +353 1 4637355

enquiries.ireland@ferring.com

Slovenija

SALUS, Veletrgovina, d.o.o.

Tel: +386 1 5899 179

regulatory@salus.si

Ísland

Vistor hf.

Sími: +354 535 70 00

Slovenská republika

Ferring Slovakia s.r.o.

Tel: +421 2 54 416 010

SK0-Recepcia@ferring.com

Italia

Ferring S.p.A.

Tel: +39 02 640 00 11

Suomi/Finland

Ferring Lääkkeet Oy

Puh/Tel: +358 207 401 440

info@ferring.fi

Κύπρος

A.Potamitis Medicare Ltd

Τηλ: +357 22583333

a.potamitismedicare@cytanet.com.cy

Sverige

Ferring Läkemedel AB

Tel: +46 40 691 69 00

info@ferring.se

Latvija

SIA PharmaSwiss Latvia

Tālr: +371 6 750 2185

latvia.info@pharmaswiss.com

United Kingdom

Ferring Pharmaceuticals Ltd.

Tel: +44 844 931 0050

contact2@ferring.com

This leaflet was last revised in

Detailed information on this medicine is available on the European Medicines Agency web site:

http://www.ema.europa.eu.

Package leaflet: Information for the user

REKOVELLE 36 micrograms/1.08 mL solution for injection

follitropin delta

This medicine is subject to additional monitoring. This will allow quick identification of new

safety information. You can help by reporting any side effects you may get. See the end of section 4

for how to report side effects.

Read all of this leaflet carefully before you start using this medicine because it contains

important information for you.

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor or pharmacist.

This medicine has been prescribed for you only. Do not pass it on to others. It may harm them,

even if their signs of illness are the same as yours.

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side

effects not listed in this leaflet. See section 4.

What is in this leaflet

What REKOVELLE is and what it is used for

What you need to know before you use REKOVELLE

How to use REKOVELLE

Possible side effects

How to store REKOVELLE

Contents of the pack and other information

1.

What REKOVELLE is and what it is used for

REKOVELLE contains follitropin delta, a follicle stimulating hormone which belongs to the family of

hormones called gonadotropins. Gonadotropins are involved in reproduction and fertility.

REKOVELLE is used in the treatment of female infertility and in women undergoing assisted

reproduction programmes such as

in vitro

fertilisation (IVF) and intracytoplasmic sperm injection

(ICSI). REKOVELLE stimulates the ovaries to grow and develop many egg sacs (‘follicles’), from

which eggs are collected and fertilised in the laboratory.

2.

What you need to know before you use REKOVELLE

Before starting treatment with this medicine, a doctor should check you and your partner for possible

causes of your fertility problems.

Do not use REKOVELLE if:

you are allergic to follicle stimulating hormone or any of the other ingredients of this medicine

(listed in section 6)

you have a tumour of the uterus, ovaries, breasts, pituitary gland or hypothalamus

you have enlarged ovaries or cysts on your ovaries (unless caused by polycystic ovarian

disease)

you suffer from bleeding from the vagina without any known cause

you have had an early menopause

you have malformations of the sexual organs which make a normal pregnancy impossible

you have fibroids of the uterus which make a normal pregnancy impossible.

Warnings and precautions

Ovarian hyperstimulation syndrome

Gonadotropins like this medicine may cause ovarian hyperstimulation syndrome. This is when your

follicles develop too much and become large cysts.

Talk to your doctor if you:

have abdominal pain, discomfort or swelling

have nausea

are vomiting

get diarrhoea

gain weight

have difficulty in breathing

Your doctor may ask you to stop using this medicine (see section 4).

If the recommended dose and schedule of administration are followed, ovarian hyperstimulation

syndrome is less likely.

Blood clotting problems (thromboembolic events)

Clots in the blood vessels (veins or arteries) are more likely in women who are pregnant. Infertility

treatment can increase the risk of this happening, especially if you are overweight or you or someone

in your family (blood relative) have a known blood clotting disease (thrombophilia). Tell your doctor

if you think this applies to you.

Twisting of ovaries

There have been reports of twisting of ovaries (ovarian torsion) following assisted reproductive

technology treatment. Twisting of the ovary could cut off the blood flow to the ovary.

Multiple pregnancy and birth defects

When undergoing assisted reproductive technology treatment the possibility of having a multiple

pregnancy (such as twins) is mainly related to the number of embryos placed inside your womb, the

quality of the embryos, and your age. Multiple pregnancy may lead to medical complications for you

and your babies. Furthermore, the risk of birth defects may be slightly higher following infertility

treatment, which is thought to be due to characteristics of the parents (such as your age, and your

partner’s sperm characteristics) and multiple pregnancy.

Pregnancy loss

When undergoing assisted reproductive technology treatment, you are more likely to have a

miscarriage than if you conceive naturally.

Pregnancy outside the uterus (ectopic pregnancy)

When undergoing assisted reproductive technology treatment, you are more likely to have a pregnancy

outside the uterus (ectopic pregnancy) than if you conceive naturally. If you have a history of tubal

disease, you have an increased risk of ectopic pregnancy.

Ovarian and other reproductive system tumours

There have been reports of ovarian and other reproductive system tumours in women who had

undergone infertility treatment. It is not known if treatment with fertility medicines increase the risk of

these tumours in infertile women.

Other medical conditions

Before starting to use this medicine, tell your doctor if:

you have been told by another doctor that pregnancy would be dangerous for you

you have kidney or liver disease

Children and adolescents (under 18 years of age)

This medicine is not indicated in children and adolescents.

Other medicines and REKOVELLE

Tell your doctor if you are taking, have recently taken or might take any other medicines, including

medicines obtained without a prescription.

Pregnancy and breast-feeding

Do not use this medicine if you are pregnant or breast-feeding.

Driving and using machines

This medicine does not affect your ability to drive and use machines.

REKOVELLE contains sodium

This medicinal product contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially

“sodium-free”.

3.

How to use REKOVELLE

Always use this medicine exactly as your doctor has told you and at the dose your doctor has told you.

Check with your doctor if you are not sure.

The REKOVELLE dose for your first treatment cycle will be calculated by your doctor using the level

of anti-Müllerian hormone (AMH, a marker of how your ovaries will respond to stimulation with

gonadotropins) in your blood and your body weight. Therefore the AMH result from a blood sample

(taken within the last 12 months) should be available before you start treatment. Your body weight

will also be measured before you start treatment. The REKOVELLE dose is stated in micrograms.

The REKOVELLE dose is fixed for the whole treatment period with no adjustments to increase or

decrease your daily dose. Your doctor will monitor the effect of REKOVELLE treatment, and

treatment is stopped when an appropriate number of egg sacs are present. In general, you will be given

a single injection of a medicine called human chorionic gonadotrophin (hCG) at a dose of

250 micrograms or 5,000 IU for final development of the follicles.

If your body´s response to treatment is too weak or too strong, your doctor may decide to stop

treatment with REKOVELLE. For the next treatment cycle, your doctor will in this case give you

either a higher or a lower daily dose of REKOVELLE than before.

How are injections given

REKOVELLE is developed for use in the REKOVELLE injection pen. The instructions for using the

injection pen supplied with the pen including loading the cartridge must be followed carefully. Do not

use the cartridge if the solution contains particles or if the solution does not look clear.

The first injection of this medicine should be given under the supervision of a doctor or a nurse. Your

doctor will decide if you can give yourself further doses of this medicine at home, but only after

receiving adequate training.

This medicine is to be given by injection just under the skin (subcutaneously) usually in the abdomen.

The cartridge may be used for several injections.

If you use more REKOVELLE than you should

The effects of taking too much of this medicine are unknown. Ovarian hyperstimulation syndrome

may possibly occur, which is described in section 4.

If you forget to use REKOVELLE

Do not take a double dose to make up for a forgotten dose. Please contact your doctor as soon as you

notice that you forgot a dose.

If you have any further questions on the use of this medicine, ask your doctor.

4.

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Serious side effects:

Hormones used in the treatment of infertility such as this medicine may cause a high level of activity

in the ovaries (ovarian hyperstimulation syndrome). Symptoms may include pain, discomfort or

swelling of the abdomen, nausea, vomiting, diarrhoea, weight gain or difficulty breathing. If you have

any of these symptoms you should contact a doctor immediately.

The risk of having a side effect is described by the following categories:

Common (may affect up to 1 in 10 people):

Headache

Nausea

Ovarian hyperstimulation syndrome (see above)

Pelvic pain and discomfort, including of ovarian origin

Tiredness (fatigue)

Uncommon (may affect up to 1 in 100 people):

Mood swings

Sleepiness/drowsiness

Dizziness

Diarrhoea

Vomiting

Constipation

Discomfort of the abdomen

Vaginal bleeding

Breast complaints (include breast pain, breast tenderness)

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects

not listed in this leaflet. You can also report side effects directly via the national reporting system

listed in Appendix V. By reporting side effects you can help provide more information on the safety of

this medicine.

5.

How to store REKOVELLE

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the cartridge label and carton after

EXP. The expiry date refers to the last day of that month.

Store in refrigerator (2 °C - 8 °C). Do not freeze.

Before first use, store in the original package in order to protect from light.

REKOVELLE may be stored at or below 25 °C for up to 3 months including the period after first use.

It must not be refrigerated again and must be discarded if it has not been used after 3 months.

After first use: 28 days when stored at or below 25 °C. Keep the cartidge in the REKOVELLE

injection pen.

At the end of the treatment any unused solution must be discarded.

Do not throw away any medicines via household waste. Ask your pharmacist how to dispose of

medicines you no longer use. These measures will help protect the environment.

6.

Contents of the pack and other information

What REKOVELLE contains

The active substance is follitropin delta.

Each multidose cartridge contains 36 micrograms of follitropin delta in 1.08 millilitre of

solution. One millilitre of solution contains 33.3 micrograms of follitropin delta in each

millilitre of solution.

The other ingredients are phenol, polysorbate 20, L-methionine, sodium sulphate decahydrate,

disodium phosphate dodecahydrate, concentrated phosphoric acid, sodium hydroxide and water

for injections.

What REKOVELLE looks like and contents of the pack

REKOVELLE is a clear and colourless solution for injection (injection). It is available in packs of

1 cartridge and 6 pen injection needles.

Marketing Authorisation Holder

Ferring Pharmaceuticals A/S

Kay Fiskers Plads 11

2300 Copenhagen S

Denmark

Manufacturer

Ferring GmbH

Wittland 11

D-24109 Kiel

Germany

For any information about this medicine, please contact the local representative of the Marketing

Authorisation Holder:

België/Belgique/Belgien

Ferring N.V.

Tel/Tél: +32 53 72 92 00

ferringnvsa@ferring.be

Lietuva

UAB PharmaSwiss

Tel: +370 5 2790762

lithuania.info@pharmaswiss.com

България

Аквaxим АД

Тел: +359 2 807 5022

aquachim@aquachim.bg

Luxembourg/Luxemburg

Ferring N.V.

Belgique/Belgien

Tel/Tél: +32 53 72 92 00

ferringnvsa@ferring.be

Česká republika

Ferring Pharmaceuticals CZ s.r.o.

Tel: +420 234 701 333

cz1-info@ferring.com

Magyarország

Ferring Magyarország Gyógyszerkereskedelmi Kft.

Tel: +36 1 236 3800

ferring@ferring.hu

Danmark

Ferring Lægemidler A/S

Tlf: +45 88 16 88 17

Malta

E.J. Busuttil Ltd.

Tel: +356 21447184

info@ejbusuttil.com

Deutschland

Ferring Arzneimittel GmbH

Tel: +49 431 5852 0

info-service@ferring.de

Nederland

Ferring B.V.

Tel: +31 235680300

infoNL@ferring.com

Eesti

PharmaSwiss Eesti OÜ

Tel: +372 682 7400

estonia.info@pharmaswiss.com

Norge

Ferring Legemidler AS

Tlf: +47 22 02 08 80

mail@oslo.ferring.com

Ελλάδα

Ferring Ελλάς ΜΕΠΕ

Τηλ: +30 210 68 43 449

Österreich

Ferring Arzneimittel Ges.m.b.H

Tel: +43 1 60 8080

office@ferring.at

España

Ferring S.A.U.

Tel: +34 91 387 70 00

Registros@ferring.com

Polska

Ferring Pharmaceuticals Poland Sp. z o.o.

Tel: +48 22 246 06 80

ferring@ferring.pl

France

Ferring S.A.S.

Tél: +33 1 49 08 67 60

information.medicale@ferring.com

Portugal

Ferring Portuguesa – Produtos Farmacêuticos,

Sociedade Unipessoal, Lda.Tel: +351 21 940 51 90

geral@ferring.com

Hrvatska

Clinres farmacija d.o.o.

Tel: +385 1 2396 900

România

Ferring Pharmaceuticals Romania SRL

Tel: +40 356 113 270

Ireland

Ferring Ireland Ltd.

Tel: +353 1 4637355

enquiries.ireland@ferring.com

Slovenija

SALUS, Veletrgovina, d.o.o.

Tel: +386 1 5899 179

regulatory@salus.si

Ísland

Vistor hf.

Sími: +354 535 70 00

Slovenská republika

Ferring Slovakia s.r.o.

Tel: +421 2 54 416 010

SK0-Recepcia@ferring.com

Italia

Ferring S.p.A.

Tel: +39 02 640 00 11

Suomi/Finland

Ferring Lääkkeet Oy

Puh/Tel: +358 207 401 440

info@ferring.fi

Κύπρος

A.Potamitis Medicare Ltd

Τηλ: +357 22583333

a.potamitismedicare@cytanet.com.cy

Sverige

Ferring Läkemedel AB

Tel: +46 40 691 69 00

info@ferring.se

Latvija

SIA PharmaSwiss Latvia

Tālr: +371 6 750 2185

latvia.info@pharmaswiss.com

United Kingdom

Ferring Pharmaceuticals Ltd.

Tel: +44 844 931 0050

contact2@ferring.com

This leaflet was last revised in

Detailed information on this medicine is available on the European Medicines Agency web site:

http://www.ema.europa.eu.

Package leaflet: Information for the user

REKOVELLE 72 micrograms/2.16 mL solution for injection

follitropin delta

This medicine is subject to additional monitoring. This will allow quick identification of new

safety information. You can help by reporting any side effects you may get. See the end of section 4

for how to report side effects.

Read all of this leaflet carefully before you start using this medicine because it contains

important information for you.

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor or pharmacist.

This medicine has been prescribed for you only. Do not pass it on to others. It may harm them,

even if their signs of illness are the same as yours.

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side

effects not listed in this leaflet. See section 4.

What is in this leaflet

What REKOVELLE is and what it is used for

What you need to know before you use REKOVELLE

How to use REKOVELLE

Possible side effects

How to store REKOVELLE

Contents of the pack and other information

1.

What REKOVELLE is and what it is used for

REKOVELLE contains follitropin delta, a follicle stimulating hormone which belongs to the family of

hormones called gonadotropins. Gonadotropins are involved in reproduction and fertility.

REKOVELLE is used in the treatment of female infertility and in women undergoing assisted

reproduction programmes such as

in vitro

fertilisation (IVF) and intracytoplasmic sperm injection

(ICSI). REKOVELLE stimulates the ovaries to grow and develop many egg sacs (‘follicles’), from

which eggs are collected and fertilised in the laboratory.

2.

What you need to know before you use REKOVELLE

Before starting treatment with this medicine, a doctor should check you and your partner for possible

causes of your fertility problems.

Do not use REKOVELLE if:

you are allergic to follicle stimulating hormone or any of the other ingredients of this medicine

(listed in section 6)

you have a tumour of the uterus, ovaries, breasts, pituitary gland or hypothalamus

you have enlarged ovaries or cysts on your ovaries (unless caused by polycystic ovarian

disease)

you suffer from bleeding from the vagina without any known cause

you have had an early menopause

you have malformations of the sexual organs which make a normal pregnancy impossible

you have fibroids of the uterus which make a normal pregnancy impossible.

Warnings and precautions

Ovarian hyperstimulation syndrome

Gonadotropins like this medicine may cause ovarian hyperstimulation syndrome. This is when your

follicles develop too much and become large cysts.

Talk to your doctor if you:

have abdominal pain, discomfort or swelling

have nausea

are vomiting

get diarrhoea

gain weight

have difficulty in breathing

Your doctor may ask you to stop using this medicine (see section 4).

If the recommended dose and schedule of administration are followed, ovarian hyperstimulation

syndrome is less likely.

Blood clotting problems (thromboembolic events)

Clots in the blood vessels (veins or arteries) are more likely in women who are pregnant. Infertility

treatment can increase the risk of this happening, especially if you are overweight or you or someone

in your family (blood relative) have a known blood clotting disease (thrombophilia). Tell your doctor

if you think this applies to you.

Twisting of ovaries

There have been reports of twisting of ovaries (ovarian torsion) following assisted reproductive

technology treatment. Twisting of the ovary could cut off the blood flow to the ovary.

Multiple pregnancy and birth defects

When undergoing assisted reproductive technology treatment the possibility of having a multiple

pregnancy (such as twins) is mainly related to the number of embryos placed inside your womb, the

quality of the embryos, and your age. Multiple pregnancy may lead to medical complications for you

and your babies. Furthermore, the risk of birth defects may be slightly higher following infertility

treatment, which is thought to be due to characteristics of the parents (such as your age, and your

partner’s sperm characteristics) and multiple pregnancy.

Pregnancy loss

When undergoing assisted reproductive technology treatment, you are more likely to have a

miscarriage than if you conceive naturally.

Pregnancy outside the uterus (ectopic pregnancy)

When undergoing assisted reproductive technology treatment, you are more likely to have a pregnancy

outside the uterus (ectopic pregnancy) than if you conceive naturally. If you have a history of tubal

disease, you have an increased risk of ectopic pregnancy.

Ovarian and other reproductive system tumours

There have been reports of ovarian and other reproductive system tumours in women who had

undergone infertility treatment. It is not known if treatment with fertility medicines increase the risk of

these tumours in infertile women.

Other medical conditions

Before starting to use this medicine, tell your doctor if:

you have been told by another doctor that pregnancy would be dangerous for you

you have kidney or liver disease

Children and adolescents (under 18 years of age)

This medicine is not indicated in children and adolescents.

Other medicines and REKOVELLE

Tell your doctor if you are taking, have recently taken or might take any other medicines, including

medicines obtained without a prescription.

Pregnancy and breast-feeding

Do not use this medicine if you are pregnant or breast-feeding.

Driving and using machines

This medicine does not affect your ability to drive and use machines.

REKOVELLE contains sodium

This medicinal product contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially

“sodium-free”.

3.

How to use REKOVELLE

Always use this medicine exactly as your doctor has told you and at the dose your doctor has told you.

Check with your doctor if you are not sure.

The REKOVELLE dose for your first treatment cycle will be calculated by your doctor using the level

of anti-Müllerian hormone (AMH, a marker of how your ovaries will respond to stimulation with

gonadotropins) in your blood and your body weight. Therefore the AMH result from a blood sample

(taken within the last 12 months) should be available before you start treatment. Your body weight

will also be measured before you start treatment. The REKOVELLE dose is stated in micrograms.

The REKOVELLE dose is fixed for the whole treatment period with no adjustments to increase or

decrease your daily dose. Your doctor will monitor the effect of REKOVELLE treatment, and

treatment is stopped when an appropriate number of egg sacs are present. In general, you will be given

a single injection of a medicine called human chorionic gonadotrophin (hCG) at a dose of

250 micrograms or 5,000 IU for final development of the follicles.

If your body´s response to treatment is too weak or too strong, your doctor may decide to stop

treatment with REKOVELLE. For the next treatment cycle, your doctor will in this case give you

either a higher or a lower daily dose of REKOVELLE than before.

How are injections given

REKOVELLE is developed for use in the REKOVELLE injection pen. The instructions for using the

injection pen supplied with the pen including loading the cartridge must be followed carefully. Do not

use the cartridge if the solution contains particles or if the solution does not look clear.

The first injection of this medicine should be given under the supervision of a doctor or a nurse. Your

doctor will decide if you can give yourself further doses of this medicine at home, but only after

receiving adequate training.

This medicine is to be given by injection just under the skin (subcutaneously) usually in the abdomen.

The cartridge may be used for several injections.

If you use more REKOVELLE than you should

The effects of taking too much of this medicine are unknown. Ovarian hyperstimulation syndrome

may possibly occur, which is described in section 4.

If you forget to use REKOVELLE

Do not take a double dose to make up for a forgotten dose. Please contact your doctor as soon as you

notice that you forgot a dose.

If you have any further questions on the use of this medicine, ask your doctor.

4.

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Serious side effects:

Hormones used in the treatment of infertility such as this medicine may cause a high level of activity

in the ovaries (ovarian hyperstimulation syndrome). Symptoms may include pain, discomfort or

swelling of the abdomen, nausea, vomiting, diarrhoea, weight gain or difficulty breathing. If you have

any of these symptoms you should contact a doctor immediately.

The risk of having a side effect is described by the following categories:

Common (may affect up to 1 in 10 people):

Headache

Nausea

Ovarian hyperstimulation syndrome (see above)

Pelvic pain and discomfort, including of ovarian origin

Tiredness (fatigue)

Uncommon (may affect up to 1 in 100 people):

Mood swings

Sleepiness/drowsiness

Dizziness

Diarrhoea

Vomiting

Constipation

Discomfort of the abdomen

Vaginal bleeding

Breast complaints (include breast pain, breast tenderness)

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects

not listed in this leaflet. You can also report side effects directly via the national reporting system

listed in Appendix V. By reporting side effects you can help provide more information on the safety of

this medicine.

5.

How to store REKOVELLE

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the cartridge label and carton after

EXP. The expiry date refers to the last day of that month.

Store in refrigerator (2 °C - 8 °C). Do not freeze.

Before first use, store in the original package in order to protect from light.

REKOVELLE may be stored at or below 25 °C for up to 3 months including the period after first use.

It must not be refrigerated again and must be discarded if it has not been used after 3 months.

After first use: 28 days when stored at or below 25 °C. Keep the cartidge in the REKOVELLE

injection pen.

At the end of the treatment any unused solution must be discarded.

Do not throw away any medicines via household waste. Ask your pharmacist how to dispose of

medicines you no longer use. These measures will help protect the environment.

6.

Contents of the pack and other information

What REKOVELLE contains

The active substance is follitropin delta.

Each multidose cartridge contains 72 micrograms of follitropin delta in 2.16 millilitre of

solution. One millilitre of solution contains 33.3 micrograms of follitropin delta in each

millilitre of solution.

The other ingredients are phenol, polysorbate 20, L-methionine, sodium sulphate decahydrate,

disodium phosphate dodecahydrate, concentrated phosphoric acid, sodium hydroxide and water

for injections.

What REKOVELLE looks like and contents of the pack

REKOVELLE is a clear and colourless solution for injection (injection). It is available in packs of

1 cartridge and 9 pen injection needles.

Marketing Authorisation Holder

Ferring Pharmaceuticals A/S

Kay Fiskers Plads 11

2300 Copenhagen S

Denmark

Manufacturer

Ferring GmbH

Wittland 11

D-24109 Kiel

Germany

For any information about this medicine, please contact the local representative of the Marketing

Authorisation Holder:

België/Belgique/Belgien

Ferring N.V.

Tel/Tél: +32 53 72 92 00

ferringnvsa@ferring.be

Lietuva

UAB PharmaSwiss

Tel: +370 5 2790762

lithuania.info@pharmaswiss.com

България

Аквaxим АД

Тел: +359 2 807 5022

aquachim@aquachim.bg

Luxembourg/Luxemburg

Ferring N.V.

Belgique/Belgien

Tel/Tél: +32 53 72 92 00

ferringnvsa@ferring.be

Česká republika

Ferring Pharmaceuticals CZ s.r.o.

Tel: +420 234 701 333

cz1-info@ferring.com

Magyarország

Ferring Magyarország Gyógyszerkereskedelmi Kft.

Tel: +36 1 236 3800

ferring@ferring.hu

Danmark

Ferring Lægemidler A/S

Tlf: +45 88 16 88 17

Malta

E.J. Busuttil Ltd.

Tel: +356 21447184

info@ejbusuttil.com

Deutschland

Ferring Arzneimittel GmbH

Tel: +49 431 5852 0

info-service@ferring.de

Nederland

Ferring B.V.

Tel: +31 235680300

infoNL@ferring.com

Eesti

PharmaSwiss Eesti OÜ

Tel: +372 682 7400

estonia.info@pharmaswiss.com

Norge

Ferring Legemidler AS

Tlf: +47 22 02 08 80

mail@oslo.ferring.com

Ελλάδα

Ferring Ελλάς ΜΕΠΕ

Τηλ: +30 210 68 43 449

Österreich

Ferring Arzneimittel Ges.m.b.H

Tel: +43 1 60 8080

office@ferring.at

España

Ferring S.A.U.

Tel: +34 91 387 70 00

Registros@ferring.com

Polska

Ferring Pharmaceuticals Poland Sp. z o.o.

Tel: +48 22 246 06 80

ferring@ferring.pl

France

Ferring S.A.S.

Tél: +33 1 49 08 67 60

information.medicale@ferring.com

Portugal

Ferring Portuguesa – Produtos Farmacêuticos,

Sociedade Unipessoal, Lda.Tel: +351 21 940 51 90

geral@ferring.com

Hrvatska

Clinres farmacija d.o.o.

Tel: +385 1 2396 900

România

Ferring Pharmaceuticals Romania SRL

Tel: +40 356 113 270

Ireland

Ferring Ireland Ltd.

Tel: +353 1 4637355

enquiries.ireland@ferring.com

Slovenija

SALUS, Veletrgovina, d.o.o.

Tel: +386 1 5899 179

regulatory@salus.si

Ísland

Vistor hf.

Sími: +354 535 70 00

Slovenská republika

Ferring Slovakia s.r.o.

Tel: +421 2 54 416 010

SK0-Recepcia@ferring.com

Italia

Ferring S.p.A.

Tel: +39 02 640 00 11

Suomi/Finland

Ferring Lääkkeet Oy

Puh/Tel: +358 207 401 440

info@ferring.fi

Κύπρος

A.Potamitis Medicare Ltd

Τηλ: +357 22583333

a.potamitismedicare@cytanet.com.cy

Sverige

Ferring Läkemedel AB

Tel: +46 40 691 69 00

info@ferring.se

Latvija

SIA PharmaSwiss Latvia

Tālr: +371 6 750 2185

latvia.info@pharmaswiss.com

United Kingdom

Ferring Pharmaceuticals Ltd.

Tel: +44 844 931 0050

contact2@ferring.com

This leaflet was last revised in

Detailed information on this medicine is available on the European Medicines Agency web site:

http://www.ema.europa.eu.

Package leaflet: Information for the user

REKOVELLE 12 micrograms/0.36 mL solution for injection in a pre-filled pen

follitropin delta

This medicine is subject to additional monitoring. This will allow quick identification of new

safety information. You can help by reporting any side effects you may get. See the end of section 4

for how to report side effects.

Read all of this leaflet carefully before you start using this medicine because it contains

important information for you.

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor or pharmacist.

This medicine has been prescribed for you only. Do not pass it on to others. It may harm them,

even if their signs of illness are the same as yours.

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side

effects not listed in this leaflet. See section 4.

What is in this leaflet

What REKOVELLE is and what it is used for

What you need to know before you use REKOVELLE

How to use REKOVELLE

Possible side effects

How to store REKOVELLE

Contents of the pack and other information

1.

What REKOVELLE is and what it is used for

REKOVELLE contains follitropin delta, a follicle stimulating hormone which belongs to the family of

hormones called gonadotropins. Gonadotropins are involved in reproduction and fertility.

REKOVELLE is used in the treatment of female infertility and in women undergoing assisted

reproduction programmes such as

in vitro

fertilisation (IVF) and intracytoplasmic sperm injection

(ICSI). REKOVELLE stimulates the ovaries to grow and develop many egg sacs (‘follicles’), from

which eggs are collected and fertilised in the laboratory.

2.

What you need to know before you use REKOVELLE

Before starting treatment with this medicine, a doctor should check you and your partner for possible

causes of your fertility problems.

Do not use REKOVELLE if:

you are allergic to follicle stimulating hormone or any of the other ingredients of this medicine

(listed in section 6)

you have a tumour of the uterus, ovaries, breasts, pituitary gland or hypothalamus

you have enlarged ovaries or cysts on your ovaries (unless caused by polycystic ovarian

disease)

you suffer from bleeding from the vagina without any known cause

you have had an early menopause

you have malformations of the sexual organs which make a normal pregnancy impossible

you have fibroids of the uterus which make a normal pregnancy impossible.

Warnings and precautions

Ovarian hyperstimulation syndrome

Gonadotropins like this medicine may cause ovarian hyperstimulation syndrome. This is when your

follicles develop too much and become large cysts.

Talk to your doctor if you:

have abdominal pain, discomfort or swelling

have nausea

are vomiting

get diarrhoea

gain weight

have difficulty in breathing

Your doctor may ask you to stop using this medicine (see section 4).

If the recommended dose and schedule of administration are followed, ovarian hyperstimulation

syndrome is less likely.

Blood clotting problems (thromboembolic events)

Clots in the blood vessels (veins or arteries) are more likely in women who are pregnant. Infertility

treatment can increase the risk of this happening, especially if you are overweight or you or someone

in your family (blood relative) have a known blood clotting disease (thrombophilia). Tell your doctor

if you think this applies to you.

Twisting of ovaries

There have been reports of twisting of ovaries (ovarian torsion) following assisted reproductive

technology treatment. Twisting of the ovary could cut off the blood flow to the ovary.

Multiple pregnancy and birth defects

When undergoing assisted reproductive technology treatment the possibility of having a multiple

pregnancy (such as twins) is mainly related to the number of embryos placed inside your womb, the

quality of the embryos, and your age. Multiple pregnancy may lead to medical complications for you

and your babies. Furthermore, the risk of birth defects may be slightly higher following infertility

treatment, which is thought to be due to characteristics of the parents (such as your age, and your

partner’s sperm characteristics) and multiple pregnancy.

Pregnancy loss

When undergoing assisted reproductive technology treatment, you are more likely to have a

miscarriage than if you conceive naturally.

Pregnancy outside the uterus (ectopic pregnancy)

When undergoing assisted reproductive technology treatment, you are more likely to have a pregnancy

outside the uterus (ectopic pregnancy) than if you conceive naturally. If you have a history of tubal

disease, you have an increased risk of ectopic pregnancy.

Ovarian and other reproductive system tumours

There have been reports of ovarian and other reproductive system tumours in women who had

undergone infertility treatment. It is not known if treatment with fertility medicines increase the risk of

these tumours in infertile women.

Other medical conditions

Before starting to use this medicine, tell your doctor if:

you have been told by another doctor that pregnancy would be dangerous for you

you have kidney or liver disease

Children and adolescents (under 18 years of age)

This medicine is not indicated in children and adolescents.

Other medicines and REKOVELLE

Tell your doctor if you are taking, have recently taken or might take any other medicines, including

medicines obtained without a prescription.

Pregnancy and breast-feeding

Do not use this medicine if you are pregnant or breast-feeding.

Driving and using machines

This medicine does not affect your ability to drive and use machines.

REKOVELLE contains sodium

This medicinal product contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially

“sodium-free”.

3.

How to use REKOVELLE

Always use this medicine exactly as your doctor has told you and at the dose your doctor has told you.

Check with your doctor if you are not sure.

The REKOVELLE dose for your first treatment cycle will be calculated by your doctor using the level

of anti-Müllerian hormone (AMH, a marker of how your ovaries will respond to stimulation with

gonadotropins) in your blood and your body weight. Therefore the AMH result from a blood sample

(taken within the last 12 months) should be available before you start treatment. Your body weight

will also be measured before you start treatment. The REKOVELLE dose is stated in micrograms.

The REKOVELLE dose is fixed for the whole treatment period with no adjustments to increase or

decrease your daily dose. Your doctor will monitor the effect of REKOVELLE treatment, and

treatment is stopped when an appropriate number of egg sacs are present. In general, you will be given

a single injection of a medicine called human chorionic gonadotrophin (hCG) at a dose of

250 micrograms or 5,000 IU for final development of the follicles.

If your body´s response to treatment is too weak or too strong, your doctor may decide to stop

treatment with REKOVELLE. For the next treatment cycle, your doctor will in this case give you

either a higher or a lower daily dose of REKOVELLE than before.

How are injections given

The instructions for using the pre-filled pen must be followed carefully. Do not use the pre-filled pen

if the solution contains particles or if the solution does not look clear.

The first injection of this medicine should be given under the supervision of a doctor or a nurse. Your

doctor will decide if you can give yourself further doses of this medicine at home, but only after

receiving adequate training.

This medicine is to be given by injection just under the skin (subcutaneously) usually in the abdomen.

The pre-filled pen may be used for several injections.

If you use more REKOVELLE than you should

The effects of taking too much of this medicine are unknown. Ovarian hyperstimulation syndrome

may possibly occur, which is described in section 4.

If you forget to use REKOVELLE

Do not take a double dose to make up for a forgotten dose. Please contact your doctor as soon as you

notice that you forgot a dose.

If you have any further questions on the use of this medicine, ask your doctor.

4.

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Serious side effects:

Hormones used in the treatment of infertility such as this medicine may cause a high level of activity

in the ovaries (ovarian hyperstimulation syndrome). Symptoms may include pain, discomfort or

swelling of the abdomen, nausea, vomiting, diarrhoea, weight gain or difficulty breathing. If you have

any of these symptoms you should contact a doctor immediately.

The risk of having a side effect is described by the following categories:

Common (may affect up to 1 in 10 people):

Headache

Nausea

Ovarian hyperstimulation syndrome (see above)

Pelvic pain and discomfort, including of ovarian origin

Tiredness (fatigue)

Uncommon (may affect up to 1 in 100 people):

Mood swings

Sleepiness/drowsiness

Dizziness

Diarrhoea

Vomiting

Constipation

Discomfort of the abdomen

Vaginal bleeding

Breast complaints (include breast pain, breast tenderness)

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects

not listed in this leaflet. You can also report side effects directly via the national reporting system

listed in Appendix V. By reporting side effects you can help provide more information on the safety of

this medicine.

5.

How to store REKOVELLE

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the pre-filled pen label and carton

after EXP. The expiry date refers to the last day of that month.

Store in refrigerator (2 °C - 8 °C). Do not freeze.

Before first use, store in the original package in order to protect from light.

REKOVELLE may be stored at or below 25 °C for up to 3 months including the period after first use.

It must not be refrigerated again and must be discarded if it has not been used after 3 months.

After first use: 28 days when stored at or below 25 °C.

At the end of the treatment any unused solution must be discarded.

Do not throw away any medicines via household waste. Ask your pharmacist how to dispose of

medicines you no longer use. These measures will help protect the environment.

6.

Contents of the pack and other information

What REKOVELLE contains

The active substance is follitropin delta.

Each pre-filled pen with multidose cartridge contains 12 micrograms of follitropin delta in

0.36 millilitre of solution. One millilitre of solution contains 33.3 micrograms of follitropin

delta in each millilitre of solution.

The other ingredients are phenol, polysorbate 20, L-methionine, sodium sulphate decahydrate,

disodium phosphate dodecahydrate, concentrated phosphoric acid, sodium hydroxide and water

for injections.

What REKOVELLE looks like and contents of the pack

REKOVELLE is a clear and colourless solution for injection in a pre-filled pen (injection). It is

available in packs of 1 pre-filled pen and 3 pen injection needles.

Marketing Authorisation Holder

Ferring Pharmaceuticals A/S

Kay Fiskers Plads 11

2300 Copenhagen S

Denmark

Manufacturer

Ferring GmbH

Wittland 11

D-24109 Kiel

Germany

Ferring Controlled Therapeutics Limited

1 Redwood Place

Peel Park Campus

East Kilbride

Glasgow G74 5PB

United Kingdom

For any information about this medicine, please contact the local representative of the Marketing

Authorisation Holder:

België/Belgique/Belgien

Ferring N.V.

Tel/Tél: +32 53 72 92 00

ferringnvsa@ferring.be

Lietuva

UAB PharmaSwiss

Tel: +370 5 2790762

lithuania.info@pharmaswiss.com

България

Аквaxим АД

Тел: +359 2 807 5022

aquachim@aquachim.bg

Luxembourg/Luxemburg

Ferring N.V.

Belgique/Belgien

Tel/Tél: +32 53 72 92 00

ferringnvsa@ferring.be

Česká republika

Ferring Pharmaceuticals CZ s.r.o.

Tel: +420 234 701 333

cz1-info@ferring.com

Magyarország

Ferring Magyarország Gyógyszerkereskedelmi Kft.

Tel: +36 1 236 3800

ferring@ferring.hu

Danmark

Ferring Lægemidler A/S

Tlf: +45 88 16 88 17

Malta

E.J. Busuttil Ltd.

Tel: +356 21447184

info@ejbusuttil.com

Deutschland

Ferring Arzneimittel GmbH

Tel: +49 431 5852 0

info-service@ferring.de

Nederland

Ferring B.V.

Tel: +31 235680300

infoNL@ferring.com

Eesti

PharmaSwiss Eesti OÜ

Tel: +372 682 7400

estonia.info@pharmaswiss.com

Norge

Ferring Legemidler AS

Tlf: +47 22 02 08 80

mail@oslo.ferring.com

Ελλάδα

Ferring Ελλάς ΜΕΠΕ

Τηλ: +30 210 68 43 449

Österreich

Ferring Arzneimittel Ges.m.b.H

Tel: +43 1 60 8080

office@ferring.at

España

Ferring S.A.U.

Tel: +34 91 387 70 00

Registros@ferring.com

Polska

Ferring Pharmaceuticals Poland Sp. z o.o.

Tel: +48 22 246 06 80

ferring@ferring.pl

France

Ferring S.A.S.

Tél: +33 1 49 08 67 60

information.medicale@ferring.com

Portugal

Ferring Portuguesa – Produtos Farmacêuticos,

Sociedade Unipessoal, Lda.Tel: +351 21 940 51 90

geral@ferring.com

Hrvatska

Clinres farmacija d.o.o.

Tel: +385 1 2396 900

România

Ferring Pharmaceuticals Romania SRL

Tel: +40 356 113 270

Ireland

Ferring Ireland Ltd.

Tel: +353 1 4637355

enquiries.ireland@ferring.com

Slovenija

SALUS, Veletrgovina, d.o.o.

Tel: +386 1 5899 179

regulatory@salus.si

Ísland

Vistor hf.

Sími: +354 535 70 00

Slovenská republika

Ferring Slovakia s.r.o.

Tel: +421 2 54 416 010

SK0-Recepcia@ferring.com

Italia

Ferring S.p.A.

Tel: +39 02 640 00 11

Suomi/Finland

Ferring Lääkkeet Oy

Puh/Tel: +358 207 401 440

info@ferring.fi

Κύπρος

A.Potamitis Medicare Ltd

Τηλ: +357 22583333

a.potamitismedicare@cytanet.com.cy

Sverige

Ferring Läkemedel AB

Tel: +46 40 691 69 00

info@ferring.se

Latvija

SIA PharmaSwiss Latvia

Tālr: +371 6 750 2185

latvia.info@pharmaswiss.com

United Kingdom

Ferring Pharmaceuticals Ltd.

Tel: +44 844 931 0050

contact2@ferring.com

This leaflet was last revised in

Detailed information on this medicine is available on the European Medicines Agency web site:

http://www.ema.europa.eu.

Instructions For Use

REKOVELLE pre-filled pen

follitropin delta

Your healthcare provider should show you how to prepare and inject REKOVELLE the right way

before you inject it for the first time.

Do not try to inject yourself until you have been shown the right way to give your injections by your

healthcare provider.

Read this booklet completely before using your REKOVELLE pre-filled pen and each time you get a

new pen. There may be new information. Follow the instructions carefully even if you have used a

similar injection pen before. Using the pen incorrectly could result in receiving an incorrect dose of

medicine.

Call your healthcare provider (doctor, nurse or pharmacist) if you have any questions about how to

give your REKOVELLE injection.

The REKOVELLE pre-filled pen is a disposable, dial-a-dose pen that can be used to give more than

1 dose of REKOVELLE. The pen is available in 3 different strengths:

12 micrograms/0.36 mL

36 micrograms/1.08 mL

72 micrograms/2.16 mL

REKOVELLE pre-filled pen and its parts

Instructions for use – REKOVELLE (follitropin delta) pre-filled pen

Important information

The REKOVELLE pre-filled pen and the needles are for use by only one person and should not

be shared with others.

Use the pen only for the medical condition it is prescribed for and as directed by your healthcare

provider.

If you are blind or have poor eyesight and cannot read the dose scale on the pen, do not use this

pen without help. Get help from a person with good eyesight who is trained to use the pen.

Call your healthcare provider or local representative of the marketing authorisation holder

(please refer to pa-tient information leaflet for contact details) before giving your REKOVELLE

injection if you have questions.

Information about your REKOVELLE pre-filled pen

The pen can be dialed to give doses from 0.33 micrograms to 20 micrograms of REKOVELLE in

marked increments of 0.33 micrograms. See “Examples of how to dial a dose” at Page 20 to 21

The dose scale of the pen is numbered from 0 to 20 micrograms.

Each number is separated by two lines, each line is equal to one increment of 0.33 micrograms.

When turning the dial to your dose, you will hear a click sound and feel resistance on the dial

for each increment to help you dial the correct dose.

Cleaning

If needed, the outside of your pen may be cleaned with a cloth moistened with water.

Do not put the pen in water or any other liquid.

Storage

Always store the pen with the pen cap on and without a needle attached.

Do not use the pen after the month of expiration (EXP) printed on the pen label.

Do not store the pen in extreme temperatures, direct sunlight or very cold conditions, such as in

a car or freezer.

Store the pen out of the reach of children and anyone who has not been trained to use the pen.

Before use:

Store the pen in a refrigerator at 2 °C to 8 °C. Do not freeze.

If stored outside the refrigerator (at 2 °C to 25 °C), the pen will last up to 3 months

including the in-use period. Throw away (dispose of) the pen if it has not been used after

3 months.

After first use (in-use period):

The pen may be stored for up to 28 days at 2°C to 25°C.

Supplies you will need to give your REKOVELLE injection

Before use – (Step 1)

Step 1:

Wash your hands.

Check the pen to see that it is not damaged. Do not use the pen if it is damaged.

Check the pen (cartridge) to see that the medicine is clear and does not contain particles. Do not

use a pen with particles or unclear medicine in the cartridge.

Make sure you have the correct pen with correct strength.

Check the expiration on the pen label.

Attaching needle – (Step 2 to 6)

Important:

Always use a new needle for each injection.

Only use the single-use click-on needles supplied with the pen.

Step 2:

Pull off the pen cap.

Step 3:

Pull off the protective foil from the needle.

Step 4:

Click on the needle.

You will hear or feel a click when the needle is safely on.

You may also screw on the needle. When you feel a light resistance it is safely on.

Step 5:

Pull off the outer needle cap.

Do not throw the outer needle cap away. You will need it to throw away (dispose of) the needle

after injecting the medicine.

Step 6:

Pull off the inner needle cap and throw it away.

Priming – (Step 7 to 9)

Before using the pen for the first time, you need to remove air bubbles from the cartridge

(Priming) to receive the correct dose of medicine.

Only prime your pen the first time you use it.

Perform Step 7 to 9 even if you do not see air bubbles.

If the pen has already been used proceed directly to Step 10.

Step 7:

Turn the dose knob clockwise until a symbol of a droplet lines up with the dose indicator.

If you dial the incorrect priming dose, the priming dose can be corrected either up or down

without loss of medicine by turning the dose knob in either direction until the symbol of a

droplet lines up with the dose indicator.

Step 8:

Hold the pen with the needle pointing upwards.

Tap with your finger on the cartridge holder to make any air bubbles in the cartridge rise to the

top of the cartridge.

Step 9:

With the needle still pointing upwards (away from the face) press in the injection button all the

way in until you see the number ‘0’ lined up with the dose indicator.

Check that a droplet of liquid appears at the tip of the needle.

If no droplet(s) appear repeat Steps 7 to 9 (Priming) until a droplet appears.

If no droplet appears after 5 tries, remove the needle (See Step 13), attach a new needle

(See Steps 3 to 6), and repeat priming (See Steps 7 to 9).

Dialing the dose – (Step 10)

See “Examples of how to dial a dose” at Page 20 to 21

Step 10:

Turn the dose knob clockwise until the prescribed dose lines up with the dose indicator in the

dose display window.

The dose can be corrected either up or down without loss of medicine by turning the dose knob

in either direction until the correct dose lines up with the dose indicator.

Do not press the injection button when dialing the dose to avoid loss of medicine.

Split-dosing:

You may need more than one pen to complete your prescribed dose.

If you are not able to dial your complete dose, this means there is not enough medicine left in

the pen. You will need to give a split-dose injection or throw away (dispose of) your current pen

and use a new pen for your injection.

See “Giving a split-dose of REKOVELLE“ at Page 22 to 23

for examples of how to calculate and

record your split dose.

Injecting the dose – (Step 11 to 12)

Important:

Do not use the pen if the medicine contains particles or if the medicine is not clear.

Read Step 11 and 12 at Page 14 to 15

before giving your injection.

This medicine should be given by injection just under the skin (subcutaneously) in the

stomach-area (abdomen).

Use a new injection site for each injection to lower the risk of skin reactions as redness and

irritation.

Do not inject into an area that is sore (tender), bruised, red, hard, scarred or where you have

stretch marks.

Step 11 and 12:

Wipe the skin of your injection site with an alcohol swab to clean it. Do not touch this area

again before you give your injection.

Hold the pen so the dose display window is visible during injection.

Pinch your skin and insert the needle straight into your skin as shown by your healthcare

provider. Do not touch the injection button yet.

After the needle is inserted, place your thumb on the injection button.

Press the injection button all the way in and hold.

Keep pressing the injection button in and when you see the number ‘0’ lined up with the dose

indicator, wait for 5 seconds (slowly count to 5). This will make sure you get your full dose.

After pressing in the injection button for 5 seconds, release the injection button. Then slowly

remove the needle from the injection site by pulling it straight out of the skin.

If blood appears at the injection site, press a gauze pad or cotton ball lightly to the injection site.

Note:

Do not tilt the pen during injection and removal from skin.

Tilting the pen can cause the needle to bend or break off.

If a broken needle remains stuck in the body or remains under the skin, get medical help right

away.

Disposal of Needle – (Step 13)

Step 13:

Carefully replace the outer needle cap over the needle with a firm push (A).

Unscrew the needle in counter-clockwise direction to remove the needle from the pen (B+C).

Throw away (dispose of) the used needle carefully (D).

See “Disposal” at Page 18

Note:

Always remove the needle after every use. The needles are for single-use only.

Do not store the pen with the needle attached.

Replace pen cap – (Step 14)

Step 14:

Firmly replace the pen cap on the pen for protection between injections.

Note:

The pen cap will not fit over a needle.

If you will give a split-dose injection, only throw away (dispose of) the pen when it is empty.

If you will use a new pen to give your full prescribed dose instead of giving a split-dose

injection, throw away (dispose of) your pen when there is not enough medicine in the pen for a

full dose.

Keep the pen cap on the pen when it is not in use.

Disposal

Needles:

Put your used needles in a puncture-resistant container, such as a sharps disposal container right away

after use. Do not throw away (dispose of) your used sharps disposal container in your household trash.

If you do not have a sharps disposal container, you may use a household container that is:

made of a heavy-duty plastic,

can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out,

upright and stable during use,

leak-resistant, and

properly labeled to warn of hazardous waste inside the container.

When your sharps disposal container is almost full, you will need to follow your community

guidelines for the right way to dispose of your sharps disposal container. There may be state or local

laws about how you should throw away used needles.

REKOVELLE pre-filled pens:

Throw away (dispose of) your used pens in accordance with local waste regulations.

Examples of how to dial a dose

Examples of how to dial a dose using your REKOVELLE pre-filled pen

The chart below shows examples of prescribed doses, how to dial the examples of prescribed doses,

and what the dose display window looks like for the prescribed doses.

Examples of

prescribed dose

(in micrograms)

Dose to dial on pen

Dose display window for example of prescribed dose

0.33

0 and 1 line

(Dial to 0 plus 1 click)

0.66 (priming dose)

0 and 2 lines

(Dial to 0 plus 2 clicks)

2.33

2 and 1 line

(Dial to 2 plus 1 click)

11.00

(Dial to 11)

12.33

12 and 1 line

(Dial to 12 plus 1 click)

18.66

18 and 2 lines

(Dial to 18 plus 2 clicks)

20.00

20 (Dial to 20)

Giving a split-dose of REKOVELLE

If you are not able to dial the full prescribed dose in your pen, this means that there is not enough

medicine left in the pen to give the full dose. You will need to give part of your prescribed dose using

your current pen and the remainder of the dose using a new pen (split-dose injection) or you may

throw away (dispose of) the pen you are using and use a new pen to give your full prescribed dose in

1 injection. If you decide to give a split-dose injection, follow these instructions and write down how

much medicine to give using the split-dose diary on Page 23

Column A shows an example of a prescribed dose. Write down your prescribed dose in column

Column B shows an example of the dose that is left in the pen (this is equal to what you are able

to dial).

Write down the dose that is left in your pen in column B. Give the injection using the rest of the

medicine that is left in your pen.

Prepare and prime a new pen (Step 1 to 9).

Calculate and write down the remaining dose to inject in column C by subtracting the number in

column B from the number in column A. Use a calculator to check your math if needed.

See “Examples of how to dial a dose” at Page 20 to 21

if needed.

Doses should be rounded off to nearest increment, X.00, X.33 or X.66 micrograms. For

example, if the number in column C is 5.34, round your remaining dose to 5.33. If the number

in column C is 9.67, round your remaining dose to 9.66.

Call your healthcare provider if you have questions about how to calculate your split-dose.

Inject the remaining dose of medicine (the number in column C) using your new pen to

complete your prescribed dose.

Split-dose diary

Frequently Asked Questions (FAQ)

Is the priming step necessary before each injection?

No. Priming must be performed only before giving the first injection with a new pen.

How do I know that the injection is complete?

The injection button is firmly pushed in all the way until it stops.

The number ‘0’ is lined up with the dose indicator.

You have slowly counted to 5 while you are still holding the injection button in and the

needle is still in your skin.

Why do I have to count to 5 while holding the injection button?

Holding the injection button for 5 seconds allows for the full dose to be injected and

absorbed under your skin.

What if the dose knob cannot be turned to the required dose?

The cartridge in the pen may not have enough medicine left to deliver the prescribed

dose.

The pen does not allow you to dial a larger dose than the dose that is left in the cartridge.

You can inject the medicine left in the pen and complete the prescribed dose with a new

pen (split-dose) or use a new pen to give the full prescribed dose.

Warnings

Do not use a pen if it has been dropped or hit against hard surfaces.

If the injection button is not easy to push in, do not use force. Change the needle. If the injection

button still is not easy to push in after changing the needle, use a new pen.

Do not try to repair a damaged pen. If a pen is damaged, contact your healthcare provider or

local representative of the marketing authorisation holder (please refer to patient information

leaflet for contact details).

Additional information

Needles

Needles are supplied with your pen. If you need additional needles contact your healthcare provider.

Use only needles that come with your REKOVELLE pre-filled pen or that your healthcare provider

prescribes.

Contact

If you have any questions or problems related to the pen, contact your healthcare provider or local

representative of the marketing authorisation holder (please refer to patient information leaflet for

contact details).

Page numbers refer to the printed Instructions For Use booklet and not to actual page numbers in this document.

Package leaflet: Information for the user

REKOVELLE 36 micrograms/1.08 mL solution for injection in a pre-filled pen

follitropin delta

This medicine is subject to additional monitoring. This will allow quick identification of new

safety information. You can help by reporting any side effects you may get. See the end of section 4

for how to report side effects.

Read all of this leaflet carefully before you start using this medicine because it contains

important information for you.

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor or pharmacist.

This medicine has been prescribed for you only. Do not pass it on to others. It may harm them,

even if their signs of illness are the same as yours.

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side

effects not listed in this leaflet. See section 4.

What is in this leaflet

What REKOVELLE is and what it is used for

What you need to know before you use REKOVELLE

How to use REKOVELLE

Possible side effects

How to store REKOVELLE

Contents of the pack and other information

1.

What REKOVELLE is and what it is used for

REKOVELLE contains follitropin delta, a follicle stimulating hormone which belongs to the family of

hormones called gonadotropins. Gonadotropins are involved in reproduction and fertility.

REKOVELLE is used in the treatment of female infertility and in women undergoing assisted

reproduction programmes such as

in vitro

fertilisation (IVF) and intracytoplasmic sperm injection

(ICSI). REKOVELLE stimulates the ovaries to grow and develop many egg sacs (‘follicles’), from

which eggs are collected and fertilised in the laboratory.

2.

What you need to know before you use REKOVELLE

Before starting treatment with this medicine, a doctor should check you and your partner for possible

causes of your fertility problems.

Do not use REKOVELLE if:

you are allergic to follicle stimulating hormone or any of the other ingredients of this medicine

(listed in section 6)

you have a tumour of the uterus, ovaries, breasts, pituitary gland or hypothalamus

you have enlarged ovaries or cysts on your ovaries (unless caused by polycystic ovarian

disease)

you suffer from bleeding from the vagina without any known cause

you have had an early menopause

you have malformations of the sexual organs which make a normal pregnancy impossible

you have fibroids of the uterus which make a normal pregnancy impossible.

Warnings and precautions

Ovarian hyperstimulation syndrome

Gonadotropins like this medicine may cause ovarian hyperstimulation syndrome. This is when your

follicles develop too much and become large cysts.

Talk to your doctor if you:

have abdominal pain, discomfort or swelling

have nausea

are vomiting

get diarrhoea

gain weight

have difficulty in breathing

Your doctor may ask you to stop using this medicine (see section 4).

If the recommended dose and schedule of administration are followed, ovarian hyperstimulation

syndrome is less likely.

Blood clotting problems (thromboembolic events)

Clots in the blood vessels (veins or arteries) are more likely in women who are pregnant. Infertility

treatment can increase the risk of this happening, especially if you are overweight or you or someone

in your family (blood relative) have a known blood clotting disease (thrombophilia). Tell your doctor

if you think this applies to you.

Twisting of ovaries

There have been reports of twisting of ovaries (ovarian torsion) following assisted reproductive

technology treatment. Twisting of the ovary could cut off the blood flow to the ovary.

Multiple pregnancy and birth defects

When undergoing assisted reproductive technology treatment the possibility of having a multiple

pregnancy (such as twins) is mainly related to the number of embryos placed inside your womb, the

quality of the embryos, and your age. Multiple pregnancy may lead to medical complications for you

and your babies. Furthermore, the risk of birth defects may be slightly higher following infertility

treatment, which is thought to be due to characteristics of the parents (such as your age, and your

partner’s sperm characteristics) and multiple pregnancy.

Pregnancy loss

When undergoing assisted reproductive technology treatment, you are more likely to have a

miscarriage than if you conceive naturally.

Pregnancy outside the uterus (ectopic pregnancy)

When undergoing assisted reproductive technology treatment, you are more likely to have a pregnancy

outside the uterus (ectopic pregnancy) than if you conceive naturally. If you have a history of tubal

disease, you have an increased risk of ectopic pregnancy.

Ovarian and other reproductive system tumours

There have been reports of ovarian and other reproductive system tumours in women who had

undergone infertility treatment. It is not known if treatment with fertility medicines increase the risk of

these tumours in infertile women.

Other medical conditions

Before starting to use this medicine, tell your doctor if:

you have been told by another doctor that pregnancy would be dangerous for you

you have kidney or liver disease

Children and adolescents (under 18 years of age)

This medicine is not indicated in children and adolescents.

Other medicines and REKOVELLE

Tell your doctor if you are taking, have recently taken or might take any other medicines, including

medicines obtained without a prescription.

Pregnancy and breast-feeding

Do not use this medicine if you are pregnant or breast-feeding.

Driving and using machines

This medicine does not affect you’re ability to drive and use machines.

REKOVELLE contains sodium

This medicinal product contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially

“sodium-free”.

3.

How to use REKOVELLE

Always use this medicine exactly as your doctor has told you and at the dose your doctor has told you.

Check with your doctor if you are not sure.

The REKOVELLE dose for your first treatment cycle will be calculated by your doctor using the level

of anti-Müllerian hormone (AMH, a marker of how your ovaries will respond to stimulation with

gonadotropins) in your blood and your body weight. Therefore the AMH result from a blood sample

(taken within the last 12 months) should be available before you start treatment. Your body weight

will also be measured before you start treatment. The REKOVELLE dose is stated in micrograms.

The REKOVELLE dose is fixed for the whole treatment period with no adjustments to increase or

decrease your daily dose. Your doctor will monitor the effect of REKOVELLE treatment, and

treatment is stopped when an appropriate number of egg sacs are present. In general, you will be given

a single injection of a medicine called human chorionic gonadotrophin (hCG) at a dose of

250 micrograms or 5,000 IU for final development of the follicles.

If your body´s response to treatment is too weak or too strong, your doctor may decide to stop

treatment with REKOVELLE. For the next treatment cycle, your doctor will in this case give you

either a higher or a lower daily dose of REKOVELLE than before.

How are injections given

The instructions for using the pre-filled pen must be followed carefully. Do not use the pre-filled pen

if the solution contains particles or if the solution does not look clear.

The first injection of this medicine should be given under the supervision of a doctor or a nurse. Your

doctor will decide if you can give yourself further doses of this medicine at home, but only after

receiving adequate training.

This medicine is to be given by injection just under the skin (subcutaneously) usually in the abdomen.

The pre-filled pen may be used for several injections.

If you use more REKOVELLE than you should

The effects of taking too much of this medicine are unknown. Ovarian hyperstimulation syndrome

may possibly occur, which is described in section 4.

If you forget to use REKOVELLE

Do not take a double dose to make up for a forgotten dose. Please contact your doctor as soon as you

notice that you forgot a dose.

If you have any further questions on the use of this medicine, ask your doctor.

4.

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Serious side effects:

Hormones used in the treatment of infertility such as this medicine may cause a high level of activity

in the ovaries (ovarian hyperstimulation syndrome). Symptoms may include pain, discomfort or

swelling of the abdomen, nausea, vomiting, diarrhoea, weight gain or difficulty breathing. If you have

any of these symptoms you should contact a doctor immediately.

The risk of having a side effect is described by the following categories:

Common (may affect up to 1 in 10 people):

Headache

Nausea

Ovarian hyperstimulation syndrome (see above)

Pelvic pain and discomfort, including of ovarian origin

Tiredness (fatigue)

Uncommon (may affect up to 1 in 100 people):

Mood swings

Sleepiness/drowsiness

Dizziness

Diarrhoea

Vomiting

Constipation

Discomfort of the abdomen

Vaginal bleeding

Breast complaints (include breast pain, breast tenderness)

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects

not listed in this leaflet. You can also report side effects directly via the national reporting system

listed in Appendix V. By reporting side effects you can help provide more information on the safety of

this medicine.

5.

How to store REKOVELLE

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the pre-filled pen label and carton

after EXP. The expiry date refers to the last day of that month.

Store in refrigerator (2 °C - 8 °C). Do not freeze.

Before first use, store in the original package in order to protect from light.

REKOVELLE may be stored at or below 25 °C for up to 3 months including the period after first use.

It must not be refrigerated again and must be discarded if it has not been used after 3 months.

After first use: 28 days when stored at or below 25 °C.

At the end of the treatment any unused solution must be discarded.

Do not throw away any medicines via household waste. Ask your pharmacist how to dispose of

medicines you no longer use. These measures will help protect the environment.

6.

Contents of the pack and other information

What REKOVELLE contains

The active substance is follitropin delta.

Each pre-filled pen with multidose cartridge contains 36 micrograms of follitropin delta in

1.08 millilitre of solution. One millilitre of solution contains 33.3 micrograms of follitropin

delta in each millilitre of solution.

The other ingredients are phenol, polysorbate 20, L-methionine, sodium sulphate decahydrate,

disodium phosphate dodecahydrate, concentrated phosphoric acid, sodium hydroxide and water

for injections.

What REKOVELLE looks like and contents of the pack

REKOVELLE is a clear and colourless solution for injection in a pre-filled pen (injection). It is

available in packs of 1 pre-filled pen and 6 pen injection needles.

Marketing Authorisation Holder

Ferring Pharmaceuticals A/S

Kay Fiskers Plads 11

2300 Copenhagen S

Denmark

Manufacturer

Ferring GmbH

Wittland 11

D-24109 Kiel

Germany

Ferring Controlled Therapeutics Limited

1 Redwood Place

Peel Park Campus

East Kilbride

Glasgow G74 5PB

United Kingdom

For any information about this medicine, please contact the local representative of the Marketing

Authorisation Holder:

België/Belgique/Belgien

Ferring N.V.

Tel/Tél: +32 53 72 92 00

ferringnvsa@ferring.be

Lietuva

UAB PharmaSwiss

Tel: +370 5 2790762

lithuania.info@pharmaswiss.com

България

Аквaxим АД

Тел: +359 2 807 5022

aquachim@aquachim.bg

Luxembourg/Luxemburg

Ferring N.V.

Belgique/Belgien

Tel/Tél: +32 53 72 92 00

ferringnvsa@ferring.be

Česká republika

Ferring Pharmaceuticals CZ s.r.o.

Tel: +420 234 701 333

cz1-info@ferring.com

Magyarország

Ferring Magyarország Gyógyszerkereskedelmi Kft.

Tel: +36 1 236 3800

ferring@ferring.hu

Danmark

Ferring Lægemidler A/S

Tlf: +45 88 16 88 17

Malta

E.J. Busuttil Ltd.

Tel: +356 21447184

info@ejbusuttil.com

Deutschland

Ferring Arzneimittel GmbH

Tel: +49 431 5852 0

info-service@ferring.de

Nederland

Ferring B.V.

Tel: +31 235680300

infoNL@ferring.com

Eesti

PharmaSwiss Eesti OÜ

Tel: +372 682 7400

estonia.info@pharmaswiss.com

Norge

Ferring Legemidler AS

Tlf: +47 22 02 08 80

mail@oslo.ferring.com

Ελλάδα

Ferring Ελλάς ΜΕΠΕ

Τηλ: +30 210 68 43 449

Österreich

Ferring Arzneimittel Ges.m.b.H

Tel: +43 1 60 8080

office@ferring.at

España

Ferring S.A.U.

Tel: +34 91 387 70 00

Registros@ferring.com

Polska

Ferring Pharmaceuticals Poland Sp. z o.o.

Tel: +48 22 246 06 80

ferring@ferring.pl

France

Ferring S.A.S.

Tél: +33 1 49 08 67 60

information.medicale@ferring.com

Portugal

Ferring Portuguesa – Produtos Farmacêuticos,

Sociedade Unipessoal, Lda.Tel: +351 21 940 51 90

geral@ferring.com

Hrvatska

Clinres farmacija d.o.o.

Tel: +385 1 2396 900

România

Ferring Pharmaceuticals Romania SRL

Tel: +40 356 113 270

Ireland

Ferring Ireland Ltd.

Tel: +353 1 4637355

enquiries.ireland@ferring.com

Slovenija

SALUS, Veletrgovina, d.o.o.

Tel: +386 1 5899 179

regulatory@salus.si

Ísland

Vistor hf.

Sími: +354 535 70 00

Slovenská republika

Ferring Slovakia s.r.o.

Tel: +421 2 54 416 010

SK0-Recepcia@ferring.com

Italia

Ferring S.p.A.

Suomi/Finland

Ferring Lääkkeet Oy

Tel: +39 02 640 00 11

Puh/Tel: +358 207 401 440

info@ferring.fi

Κύπρος

A.Potamitis Medicare Ltd

Τηλ: +357 22583333

a.potamitismedicare@cytanet.com.cy

Sverige

Ferring Läkemedel AB

Tel: +46 40 691 69 00

info@ferring.se

Latvija

SIA PharmaSwiss Latvia

Tālr: +371 6 750 2185

latvia.info@pharmaswiss.com

United Kingdom

Ferring Pharmaceuticals Ltd.

Tel: +44 844 931 0050

contact2@ferring.com

This leaflet was last revised in

Detailed information on this medicine is available on the European Medicines Agency web site:

http://www.ema.europa.eu.

Instructions For Use

REKOVELLE pre-filled pen

follitropin delta

Your healthcare provider should show you how to prepare and inject REKOVELLE the right way

before you inject it for the first time.

Do not try to inject yourself until you have been shown the right way to give your injections by your

healthcare provider.

Read this booklet completely before using your REKOVELLE pre-filled pen and each time you get a

new pen. There may be new information. Follow the instructions carefully even if you have used a

similar injection pen before. Using the pen incorrectly could result in receiving an incorrect dose of

medicine.

Call your healthcare provider (doctor, nurse or pharmacist) if you have any questions about how to

give your REKOVELLE injection.

The REKOVELLE pre-filled pen is a disposable, dial-a-dose pen that can be used to give more than

1 dose of REKOVELLE. The pen is available in 3 different strengths:

12 micrograms/0.36 mL

36 micrograms/1.08 mL

72 micrograms/2.16 mL

REKOVELLE pre-filled pen and its parts

Instructions for use – REKOVELLE (follitropin delta) pre-filled pen

Important information

The REKOVELLE pre-filled pen and the needles are for use by only one person and should not

be shared with others.

Use the pen only for the medical condition it is prescribed for and as directed by your healthcare

provider.

If you are blind or have poor eyesight and cannot read the dose scale on the pen, do not use this

pen without help. Get help from a person with good eyesight who is trained to use the pen.

Call your healthcare provider or local representative of the marketing authorisation holder

(please refer to pa-tient information leaflet for contact details) before giving your REKOVELLE

injection if you have questions.

Information about your REKOVELLE pre-filled pen

The pen can be dialed to give doses from 0.33 micrograms to 20 micrograms of REKOVELLE in

marked increments of 0.33 micrograms. See “Examples of how to dial a dose” at Page 20 to 21

The dose scale of the pen is numbered from 0 to 20 micrograms.

Each number is separated by two lines, each line is equal to one increment of 0.33 micrograms.

When turning the dial to your dose, you will hear a click sound and feel resistance on the dial

for each increment to help you dial the correct dose.

Cleaning

If needed, the outside of your pen may be cleaned with a cloth moistened with water.

Do not put the pen in water or any other liquid.

Storage

Always store the pen with the pen cap on and without a needle attached.

Do not use the pen after the month of expiration (EXP) printed on the pen label.

Do not store the pen in extreme temperatures, direct sunlight or very cold conditions, such as in

a car or freezer.

Store the pen out of the reach of children and anyone who has not been trained to use the pen.

Before use:

Store the pen in a refrigerator at 2 °C to 8 °C. Do not freeze.

If stored outside the refrigerator (at 2 °C to 25 °C), the pen will last up to 3 months

including the in-use period. Throw away (dispose of) the pen if it has not been used after

3 months.

After first use (in-use period):

The pen may be stored for up to 28 days at 2°C to 25°C.

Supplies you will need to give your REKOVELLE injection

Before use – (Step 1)

Step 1:

Wash your hands.

Check the pen to see that it is not damaged. Do not use the pen if it is damaged.

Check the pen (cartridge) to see that the medicine is clear and does not contain particles. Do not

use a pen with particles or unclear medicine in the cartridge.

Make sure you have the correct pen with correct strength.

Check the expiration on the pen label.

Attaching needle – (Step 2 to 6)

Important:

Always use a new needle for each injection.

Only use the single-use click-on needles supplied with the pen.

Step 2:

Pull off the pen cap.

Step 3:

Pull off the protective foil from the needle.

Step 4:

Click on the needle.

You will hear or feel a click when the needle is safely on.

You may also screw on the needle. When you feel a light resistance it is safely on.

Step 5:

Pull off the outer needle cap.

Do not throw the outer needle cap away. You will need it to throw away (dispose of) the needle

after injecting the medicine.

Step 6:

Pull off the inner needle cap and throw it away.

Priming – (Step 7 to 9)

Before using the pen for the first time, you need to remove air bubbles from the cartridge

(Priming) to receive the correct dose of medicine.

Only prime your pen the first time you use it.

Perform Step 7 to 9 even if you do not see air bubbles.

If the pen has already been used proceed directly to Step 10.

Step 7:

Turn the dose knob clockwise until a symbol of a droplet lines up with the dose indicator.

If you dial the incorrect priming dose, the priming dose can be corrected either up or down

without loss of medicine by turning the dose knob in either direction until the symbol of a

droplet lines up with the dose indicator.

Step 8:

Hold the pen with the needle pointing upwards.

Tap with your finger on the cartridge holder to make any air bubbles in the cartridge rise to the

top of the cartridge.

Step 9:

With the needle still pointing upwards (away from the face) press in the injection button all the

way in until you see the number ‘0’ lined up with the dose indicator.

Check that a droplet of liquid appears at the tip of the needle.

If no droplet(s) appear repeat Steps 7 to 9 (Priming) until a droplet appears.

If no droplet appears after 5 tries, remove the needle (See Step 13), attach a new needle

(See Steps 3 to 6), and repeat priming (See Steps 7 to 9).

Dialing the dose – (Step 10)

See “Examples of how to dial a dose” at Page 20 to 21

Step 10:

Turn the dose knob clockwise until the prescribed dose lines up with the dose indicator in the

dose display window.

The dose can be corrected either up or down without loss of medicine by turning the dose knob

in either direction until the correct dose lines up with the dose indicator.

Do not press the injection button when dialing the dose to avoid loss of medicine.

Split-dosing:

You may need more than one pen to complete your prescribed dose.

If you are not able to dial your complete dose, this means there is not enough medicine left in

the pen. You will need to give a split-dose injection or throw away (dispose of) your current pen

and use a new pen for your injection.

See “Giving a split-dose of REKOVELLE“ at Page 22 to 23

for examples of how to calculate and

record your split dose.

Injecting the dose – (Step 11 to 12)

Important:

Do not use the pen if the medicine contains particles or if the medicine is not clear.

Read Step 11 and 12 at Page 14 to 15

before giving your injection.

This medicine should be given by injection just under the skin (subcutaneously) in the

stomach-area (abdomen).

Use a new injection site for each injection to lower the risk of skin reactions as redness and

irritation.

Do not inject into an area that is sore (tender), bruised, red, hard, scarred or where you have

stretch marks.

Step 11 and 12:

Wipe the skin of your injection site with an alcohol swab to clean it. Do not touch this area

again before you give your injection.

Hold the pen so the dose display window is visible during injection.

Pinch your skin and insert the needle straight into your skin as shown by your healthcare

provider. Do not touch the injection button yet.

After the needle is inserted, place your thumb on the injection button.

Press the injection button all the way in and hold.

Keep pressing the injection button in and when you see the number ‘0’ lined up with the dose

indicator, wait for 5 seconds (slowly count to 5). This will make sure you get your full dose.

After pressing in the injection button for 5 seconds, release the injection button. Then slowly

remove the needle from the injection site by pulling it straight out of the skin.

If blood appears at the injection site, press a gauze pad or cotton ball lightly to the injection site.

Note:

Do not tilt the pen during injection and removal from skin.

Tilting the pen can cause the needle to bend or break off.

If a broken needle remains stuck in the body or remains under the skin, get medical help right

away.

Disposal of Needle – (Step 13)

Step 13:

Carefully replace the outer needle cap over the needle with a firm push (A).

Unscrew the needle in counter-clockwise direction to remove the needle from the pen (B+C).

Throw away (dispose of) the used needle carefully (D).

See “Disposal” at Page 18

Note:

Always remove the needle after every use. The needles are for single-use only.

Do not store the pen with the needle attached.

Replace pen cap – (Step 14)

Step 14:

Firmly replace the pen cap on the pen for protection between injections.

Note:

The pen cap will not fit over a needle.

If you will give a split-dose injection, only throw away (dispose of) the pen when it is empty.

If you will use a new pen to give your full prescribed dose instead of giving a split-dose

injection, throw away (dispose of) your pen when there is not enough medicine in the pen for a

full dose.

Keep the pen cap on the pen when it is not in use.

Disposal

Needles:

Put your used needles in a puncture-resistant container, such as a sharps disposal container right away

after use. Do not throw away (dispose of) your used sharps disposal container in your household trash.

If you do not have a sharps disposal container, you may use a household container that is:

made of a heavy-duty plastic,

can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out,

upright and stable during use,

leak-resistant, and

properly labeled to warn of hazardous waste inside the container.

When your sharps disposal container is almost full, you will need to follow your community

guidelines for the right way to dispose of your sharps disposal container. There may be state or local

laws about how you should throw away used needles.

REKOVELLE pre-filled pens:

Throw away (dispose of) your used pens in accordance with local waste regulations.

Examples of how to dial a dose

Examples of how to dial a dose using your REKOVELLE pre-filled pen

The chart below shows examples of prescribed doses, how to dial the examples of prescribed doses,

and what the dose display window looks like for the prescribed doses.

Examples of

prescribed dose

(in micrograms)

Dose to dial on pen

Dose display window for example of prescribed dose

0.33

0 and 1 line

(Dial to 0 plus 1 click)

0.66 (priming dose)

0 and 2 lines

(Dial to 0 plus 2 clicks)

2.33

2 and 1 line

(Dial to 2 plus 1 click)

11.00

(Dial to 11)

12.33

12 and 1 line

(Dial to 12 plus 1 click)

18.66

18 and 2 lines

(Dial to 18 plus 2 clicks)

20.00

20 (Dial to 20)

Giving a split-dose of REKOVELLE

If you are not able to dial the full prescribed dose in your pen, this means that there is not enough

medicine left in the pen to give the full dose. You will need to give part of your prescribed dose using

your current pen and the remainder of the dose using a new pen (split-dose injection) or you may

throw away (dispose of) the pen you are using and use a new pen to give your full prescribed dose in

1 injection. If you decide to give a split-dose injection, follow these instructions and write down how

much medicine to give using the split-dose diary on Page 23

Column A shows an example of a prescribed dose. Write down your prescribed dose in column

Column B shows an example of the dose that is left in the pen (this is equal to what you are able

to dial).

Write down the dose that is left in your pen in column B. Give the injection using the rest of the

medicine that is left in your pen.

Prepare and prime a new pen (Step 1 to 9).

Calculate and write down the remaining dose to inject in column C by subtracting the number in

column B from the number in column A. Use a calculator to check your math if needed.

See “Examples of how to dial a dose” at Page 20 to 21

if needed.

Doses should be rounded off to nearest increment, X.00, X.33 or X.66 micrograms. For

example, if the number in column C is 5.34, round your remaining dose to 5.33. If the number

in column C is 9.67, round your remaining dose to 9.66.

Call your healthcare provider if you have questions about how to calculate your split-dose.

Inject the remaining dose of medicine (the number in column C) using your new pen to

complete your prescribed dose.

Split-dose diary

Frequently Asked Questions (FAQ)

Is the priming step necessary before each injection?

No. Priming must be performed only before giving the first injection with a new pen.

How do I know that the injection is complete?

The injection button is firmly pushed in all the way until it stops.

The number ‘0’ is lined up with the dose indicator.

You have slowly counted to 5 while you are still holding the injection button in and the

needle is still in your skin.

Why do I have to count to 5 while holding the injection button?

Holding the injection button for 5 seconds allows for the full dose to be injected and

absorbed under your skin.

What if the dose knob cannot be turned to the required dose?

The cartridge in the pen may not have enough medicine left to deliver the prescribed

dose.

The pen does not allow you to dial a larger dose than the dose that is left in the cartridge.

You can inject the medicine left in the pen and complete the prescribed dose with a new

pen (split-dose) or use a new pen to give the full prescribed dose.

Warnings

Do not use a pen if it has been dropped or hit against hard surfaces.

If the injection button is not easy to push in, do not use force. Change the needle. If the injection

button still is not easy to push in after changing the needle, use a new pen.

Do not try to repair a damaged pen. If a pen is damaged, contact your healthcare provider or

local representative of the marketing authorisation holder (please refer to patient information

leaflet for contact details).

Additional information

Needles

Needles are supplied with your pen. If you need additional needles contact your healthcare provider.

Use only needles that come with your REKOVELLE pre-filled pen or that your healthcare provider

prescribes.

Contact

If you have any questions or problems related to the pen, contact your healthcare provider or local

representative of the marketing authorisation holder (please refer to patient information leaflet for

contact details).

Page numbers refer to the printed Instructions For Use booklet and not to actual page numbers in this document.

Package leaflet: Information for the user

REKOVELLE 72 micrograms/2.16 mL solution for injection in a pre-filled pen

follitropin delta

This medicine is subject to additional monitoring. This will allow quick identification of new

safety information. You can help by reporting any side effects you may get. See the end of section 4

for how to report side effects.

Read all of this leaflet carefully before you start using this medicine because it contains

important information for you.

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor or pharmacist.

This medicine has been prescribed for you only. Do not pass it on to others. It may harm them,

even if their signs of illness are the same as yours.

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side

effects not listed in this leaflet. See section 4.

What is in this leaflet

What REKOVELLE is and what it is used for

What you need to know before you use REKOVELLE

How to use REKOVELLE

Possible side effects

How to store REKOVELLE

Contents of the pack and other information

1.

What REKOVELLE is and what it is used for

REKOVELLE contains follitropin delta, a follicle stimulating hormone which belongs to the family of

hormones called gonadotropins. Gonadotropins are involved in reproduction and fertility.

REKOVELLE is used in the treatment of female infertility and in women undergoing assisted

reproduction programmes such as

in vitro

fertilisation (IVF) and intracytoplasmic sperm injection

(ICSI). REKOVELLE stimulates the ovaries to grow and develop many egg sacs (‘follicles’), from

which eggs are collected and fertilised in the laboratory.

2.

What you need to know before you use REKOVELLE

Before starting treatment with this medicine, a doctor should check you and your partner for possible

causes of your fertility problems.

Do not use REKOVELLE if:

you are allergic to follicle stimulating hormone or any of the other ingredients of this medicine

(listed in section 6)

you have a tumour of the uterus, ovaries, breasts, pituitary gland or hypothalamus

you have enlarged ovaries or cysts on your ovaries (unless caused by polycystic ovarian

disease)

you suffer from bleeding from the vagina without any known cause

you have had an early menopause

you have malformations of the sexual organs which make a normal pregnancy impossible

you have fibroids of the uterus which make a normal pregnancy impossible.

Warnings and precautions

Ovarian hyperstimulation syndrome

Gonadotropins like this medicine may cause ovarian hyperstimulation syndrome. This is when your

follicles develop too much and become large cysts.

Talk to your doctor if you:

have abdominal pain, discomfort or swelling

have nausea

are vomiting

get diarrhoea

gain weight

have difficulty in breathing

Your doctor may ask you to stop using this medicine (see section 4).

If the recommended dose and schedule of administration are followed, ovarian hyperstimulation

syndrome is less likely.

Blood clotting problems (thromboembolic events)

Clots in the blood vessels (veins or arteries) are more likely in women who are pregnant. Infertility

treatment can increase the risk of this happening, especially if you are overweight or you or someone

in your family (blood relative) have a known blood clotting disease (thrombophilia). Tell your doctor

if you think this applies to you.

Twisting of ovaries

There have been reports of twisting of ovaries (ovarian torsion) following assisted reproductive

technology treatment. Twisting of the ovary could cut off the blood flow to the ovary.

Multiple pregnancy and birth defects

When undergoing assisted reproductive technology treatment the possibility of having a multiple

pregnancy (such as twins) is mainly related to the number of embryos placed inside your womb, the

quality of the embryos, and your age. Multiple pregnancy may lead to medical complications for you

and your babies. Furthermore, the risk of birth defects may be slightly higher following infertility

treatment, which is thought to be due to characteristics of the parents (such as your age, and your

partner’s sperm characteristics) and multiple pregnancy.

Pregnancy loss

When undergoing assisted reproductive technology treatment, you are more likely to have a

miscarriage than if you conceive naturally.

Pregnancy outside the uterus (ectopic pregnancy)

When undergoing assisted reproductive technology treatment, you are more likely to have a pregnancy

outside the uterus (ectopic pregnancy) than if you conceive naturally. If you have a history of tubal

disease, you have an increased risk of ectopic pregnancy.

Ovarian and other reproductive system tumours

There have been reports of ovarian and other reproductive system tumours in women who had

undergone infertility treatment. It is not known if treatment with fertility medicines increase the risk of

these tumours in infertile women.

Other medical conditions

Before starting to use this medicine, tell your doctor if:

you have been told by another doctor that pregnancy would be dangerous for you

you have kidney or liver disease

Children and adolescents (under 18 years of age)

This medicine is not indicated in children and adolescents.

Other medicines and REKOVELLE

Tell your doctor if you are taking, have recently taken or might take any other medicines, including

medicines obtained without a prescription.

Pregnancy and breast-feeding

Do not use this medicine if you are pregnant or breast-feeding.

Driving and using machines

This medicine does not affect your ability to drive and use machines.

REKOVELLE contains sodium

This medicinal product contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially

“sodium-free”.

3.

How to use REKOVELLE

Always use this medicine exactly as your doctor has told you and at the dose your doctor has told you.

Check with your doctor if you are not sure.

The REKOVELLE dose for your first treatment cycle will be calculated by your doctor using the level

of anti-Müllerian hormone (AMH, a marker of how your ovaries will respond to stimulation with

gonadotropins) in your blood and your body weight. Therefore the AMH result from a blood sample

(taken within the last 12 months) should be available before you start treatment. Your body weight

will also be measured before you start treatment. The REKOVELLE dose is stated in micrograms.

The REKOVELLE dose is fixed for the whole treatment period with no adjustments to increase or

decrease your daily dose. Your doctor will monitor the effect of REKOVELLE treatment, and

treatment is stopped when an appropriate number of egg sacs are present. In general, you will be given

a single injection of a medicine called human chorionic gonadotrophin (hCG) at a dose of

250 micrograms or 5,000 IU for final development of the follicles.

If your body´s response to treatment is too weak or too strong, your doctor may decide to stop

treatment with REKOVELLE. For the next treatment cycle, your doctor will in this case give you

either a higher or a lower daily dose of REKOVELLE than before.

How are injections given

The instructions for using the pre-filled pen must be followed carefully. Do not use the pre-filled pen

if the solution contains particles or if the solution does not look clear.

The first injection of this medicine should be given under the supervision of a doctor or a nurse. Your

doctor will decide if you can give yourself further doses of this medicine at home, but only after

receiving adequate training.

This medicine is to be given by injection just under the skin (subcutaneously) usually in the abdomen.

The pre-filled pen may be used for several injections.

If you use more REKOVELLE than you should

The effects of taking too much of this medicine are unknown. Ovarian hyperstimulation syndrome

may possibly occur, which is described in section 4.

If you forget to use REKOVELLE

Do not take a double dose to make up for a forgotten dose. Please contact your doctor as soon as you

notice that you forgot a dose.

If you have any further questions on the use of this medicine, ask your doctor.

4.

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Serious side effects:

Hormones used in the treatment of infertility such as this medicine may cause a high level of activity

in the ovaries (ovarian hyperstimulation syndrome). Symptoms may include pain, discomfort or

swelling of the abdomen, nausea, vomiting, diarrhoea, weight gain or difficulty breathing. If you have

any of these symptoms you should contact a doctor immediately.

The risk of having a side effect is described by the following categories:

Common (may affect up to 1 in 10 people):

Headache

Nausea

Ovarian hyperstimulation syndrome (see above)

Pelvic pain and discomfort, including of ovarian origin

Tiredness (fatigue)

Uncommon (may affect up to 1 in 100 people):

Mood swings

Sleepiness/drowsiness

Dizziness

Diarrhoea

Vomiting

Constipation

Discomfort of the abdomen

Vaginal bleeding

Breast complaints (include breast pain, breast tenderness)

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects

not listed in this leaflet. You can also report side effects directly via the national reporting system

listed in Appendix V. By reporting side effects you can help provide more information on the safety of

this medicine.

5.

How to store REKOVELLE

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the pre-filled pen label and carton

after EXP. The expiry date refers to the last day of that month.

Store in refrigerator (2 °C - 8 °C). Do not freeze.

Before first use, store in the original package in order to protect from light.

REKOVELLE may be stored at or below 25 °C for up to 3 months including the period after first use.

It must not be refrigerated again and must be discarded if it has not been used after 3 months.

After first use: 28 days when stored at or below 25 °C.

At the end of the treatment any unused solution must be discarded.

Do not throw away any medicines via household waste. Ask your pharmacist how to dispose of

medicines you no longer use. These measures will help protect the environment.

6.

Contents of the pack and other information

What REKOVELLE contains

The active substance is follitropin delta.

Each pre-filled pen with multidose cartridge contains 72 micrograms of follitropin delta in

2.16 millilitre of solution. One millilitre of solution contains 33.3 micrograms of follitropin

delta in each millilitre of solution.

The other ingredients are phenol, polysorbate 20, L-methionine, sodium sulphate decahydrate,

disodium phosphate dodecahydrate, concentrated phosphoric acid, sodium hydroxide and water

for injections.

What REKOVELLE looks like and contents of the pack

REKOVELLE is a clear and colourless solution for injection in a pre-filled pen (injection). It is

available in packs of 1 pre-filled pen and 9 pen injection needles.

Marketing Authorisation Holder

Ferring Pharmaceuticals A/S

Kay Fiskers Plads 11

2300 Copenhagen S

Denmark

Manufacturer

Ferring GmbH

Wittland 11

D-24109 Kiel

Germany

Ferring Controlled Therapeutics Limited

1 Redwood Place

Peel Park Campus

East Kilbride

Glasgow G74 5PB

United Kingdom

For any information about this medicine, please contact the local representative of the Marketing

Authorisation Holder:

België/Belgique/Belgien

Ferring N.V.

Tel/Tél: +32 53 72 92 00

ferringnvsa@ferring.be

Lietuva

UAB PharmaSwiss

Tel: +370 5 2790762

lithuania.info@pharmaswiss.com

България

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This leaflet was last revised in

Detailed information on this medicine is available on the European Medicines Agency web site:

http://www.ema.europa.eu.

Instructions For Use

REKOVELLE pre-filled pen

follitropin delta

Your healthcare provider should show you how to prepare and inject REKOVELLE the right way

before you inject it for the first time.

Do not try to inject yourself until you have been shown the right way to give your injections by your

healthcare provider.

Read this booklet completely before using your REKOVELLE pre-filled pen and each time you get a

new pen. There may be new information. Follow the instructions carefully even if you have used a

similar injection pen before. Using the pen incorrectly could result in receiving an incorrect dose of

medicine.

Call your healthcare provider (doctor, nurse or pharmacist) if you have any questions about how to

give your REKOVELLE injection.

The REKOVELLE pre-filled pen is a disposable, dial-a-dose pen that can be used to give more than

1 dose of REKOVELLE. The pen is available in 3 different strengths:

12 micrograms/0.36 mL

36 micrograms/1.08 mL

72 micrograms/2.16 mL

REKOVELLE pre-filled pen and its parts

Instructions for use – REKOVELLE (follitropin delta) pre-filled pen

Important information

The REKOVELLE pre-filled pen and the needles are for use by only one person and should not

be shared with others.

Use the pen only for the medical condition it is prescribed for and as directed by your healthcare

provider.

If you are blind or have poor eyesight and cannot read the dose scale on the pen, do not use this

pen without help. Get help from a person with good eyesight who is trained to use the pen.

Call your healthcare provider or local representative of the marketing authorisation holder

(please refer to pa-tient information leaflet for contact details) before giving your REKOVELLE

injection if you have questions.

Information about your REKOVELLE pre-filled pen

The pen can be dialed to give doses from 0.33 micrograms to 20 micrograms of REKOVELLE in

marked increments of 0.33 micrograms. See “Examples of how to dial a dose” at Page 20 to 21

The dose scale of the pen is numbered from 0 to 20 micrograms.

Each number is separated by two lines, each line is equal to one increment of 0.33 micrograms.

When turning the dial to your dose, you will hear a click sound and feel resistance on the dial

for each increment to help you dial the correct dose.

Cleaning

If needed, the outside of your pen may be cleaned with a cloth moistened with water.

Do not put the pen in water or any other liquid.

Storage

Always store the pen with the pen cap on and without a needle attached.

Do not use the pen after the month of expiration (EXP) printed on the pen label.

Do not store the pen in extreme temperatures, direct sunlight or very cold conditions, such as in

a car or freezer.

Store the pen out of the reach of children and anyone who has not been trained to use the pen.

Before use:

Store the pen in a refrigerator at 2 °C to 8 °C. Do not freeze.

If stored outside the refrigerator (at 2 °C to 25 °C), the pen will last up to 3 months

including the in-use period. Throw away (dispose of) the pen if it has not been used after

3 months.

After first use (in-use period):

The pen may be stored for up to 28 days at 2°C to 25°C.

Supplies you will need to give your REKOVELLE injection

Before use – (Step 1)

Step 1:

Wash your hands.

Check the pen to see that it is not damaged. Do not use the pen if it is damaged.

Check the pen (cartridge) to see that the medicine is clear and does not contain particles. Do not

use a pen with particles or unclear medicine in the cartridge.

Make sure you have the correct pen with correct strength.

Check the expiration on the pen label.

Attaching needle – (Step 2 to 6)

Important:

Always use a new needle for each injection.

Only use the single-use click-on needles supplied with the pen.

Step 2:

Pull off the pen cap.

Step 3:

Pull off the protective foil from the needle.

Step 4:

Click on the needle.

You will hear or feel a click when the needle is safely on.

You may also screw on the needle. When you feel a light resistance it is safely on.

Step 5:

Pull off the outer needle cap.

Do not throw the outer needle cap away. You will need it to throw away (dispose of) the needle

after injecting the medicine.

Step 6:

Pull off the inner needle cap and throw it away.

Priming – (Step 7 to 9)

Before using the pen for the first time, you need to remove air bubbles from the cartridge

(Priming) to receive the correct dose of medicine.

Only prime your pen the first time you use it.

Perform Step 7 to 9 even if you do not see air bubbles.

If the pen has already been used proceed directly to Step 10.

Step 7:

Turn the dose knob clockwise until a symbol of a droplet lines up with the dose indicator.

If you dial the incorrect priming dose, the priming dose can be corrected either up or down

without loss of medicine by turning the dose knob in either direction until the symbol of a

droplet lines up with the dose indicator.

Step 8:

Hold the pen with the needle pointing upwards.

Tap with your finger on the cartridge holder to make any air bubbles in the cartridge rise to the

top of the cartridge.

Step 9:

With the needle still pointing upwards (away from the face) press in the injection button all the

way in until you see the number ‘0’ lined up with the dose indicator.

Check that a droplet of liquid appears at the tip of the needle.

If no droplet(s) appear repeat Steps 7 to 9 (Priming) until a droplet appears.

If no droplet appears after 5 tries, remove the needle (See Step 13), attach a new needle

(See Steps 3 to 6), and repeat priming (See Steps 7 to 9).

Dialing the dose – (Step 10)

See “Examples of how to dial a dose” at Page 20 to 21

Step 10:

Turn the dose knob clockwise until the prescribed dose lines up with the dose indicator in the

dose display window.

The dose can be corrected either up or down without loss of medicine by turning the dose knob

in either direction until the correct dose lines up with the dose indicator.

Do not press the injection button when dialing the dose to avoid loss of medicine.

Split-dosing:

You may need more than one pen to complete your prescribed dose.

If you are not able to dial your complete dose, this means there is not enough medicine left in

the pen. You will need to give a split-dose injection or throw away (dispose of) your current pen

and use a new pen for your injection.

See “Giving a split-dose of REKOVELLE“ at Page 22 to 23

for examples of how to calculate and

record your split dose.

Injecting the dose – (Step 11 to 12)

Important:

Do not use the pen if the medicine contains particles or if the medicine is not clear.

Read Step 11 and 12 at Page 14 to 15

before giving your injection.

This medicine should be given by injection just under the skin (subcutaneously) in the

stomach-area (abdomen).

Use a new injection site for each injection to lower the risk of skin reactions as redness and

irritation.

Do not inject into an area that is sore (tender), bruised, red, hard, scarred or where you have

stretch marks.

Step 11 and 12:

Wipe the skin of your injection site with an alcohol swab to clean it. Do not touch this area

again before you give your injection.

Hold the pen so the dose display window is visible during injection.

Pinch your skin and insert the needle straight into your skin as shown by your healthcare

provider. Do not touch the injection button yet.

After the needle is inserted, place your thumb on the injection button.

Press the injection button all the way in and hold.

Keep pressing the injection button in and when you see the number ‘0’ lined up with the dose

indicator, wait for 5 seconds (slowly count to 5). This will make sure you get your full dose.

After pressing in the injection button for 5 seconds, release the injection button. Then slowly

remove the needle from the injection site by pulling it straight out of the skin.

If blood appears at the injection site, press a gauze pad or cotton ball lightly to the injection site.

Note:

Do not tilt the pen during injection and removal from skin.

Tilting the pen can cause the needle to bend or break off.

If a broken needle remains stuck in the body or remains under the skin, get medical help right

away.

Disposal of Needle – (Step 13)

Step 13:

Carefully replace the outer needle cap over the needle with a firm push (A).

Unscrew the needle in counter-clockwise direction to remove the needle from the pen (B+C).

Throw away (dispose of) the used needle carefully (D).

See “Disposal” at Page 18

Note:

Always remove the needle after every use. The needles are for single-use only.

Do not store the pen with the needle attached.

Replace pen cap – (Step 14)

Step 14:

Firmly replace the pen cap on the pen for protection between injections.

Note:

The pen cap will not fit over a needle.

If you will give a split-dose injection, only throw away (dispose of) the pen when it is empty.

If you will use a new pen to give your full prescribed dose instead of giving a split-dose

injection, throw away (dispose of) your pen when there is not enough medicine in the pen for a

full dose.

Keep the pen cap on the pen when it is not in use.

Disposal

Needles:

Put your used needles in a puncture-resistant container, such as a sharps disposal container right away

after use. Do not throw away (dispose of) your used sharps disposal container in your household trash.

If you do not have a sharps disposal container, you may use a household container that is:

made of a heavy-duty plastic,

can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out,

upright and stable during use,

leak-resistant, and

properly labeled to warn of hazardous waste inside the container.

When your sharps disposal container is almost full, you will need to follow your community

guidelines for the right way to dispose of your sharps disposal container. There may be state or local

laws about how you should throw away used needles.

REKOVELLE pre-filled pens:

Throw away (dispose of) your used pens in accordance with local waste regulations.

Examples of how to dial a dose

Examples of how to dial a dose using your REKOVELLE pre-filled pen

The chart below shows examples of prescribed doses, how to dial the examples of prescribed doses,

and what the dose display window looks like for the prescribed doses.

Examples of

prescribed dose

(in micrograms)

Dose to dial on pen

Dose display window for example of prescribed dose

0.33

0 and 1 line

(Dial to 0 plus 1 click)

0.66 (priming dose)

0 and 2 lines

(Dial to 0 plus 2 clicks)

2.33

2 and 1 line

(Dial to 2 plus 1 click)

11.00

(Dial to 11)

12.33

12 and 1 line

(Dial to 12 plus 1 click)

18.66

18 and 2 lines

(Dial to 18 plus 2 clicks)

20.00

20 (Dial to 20)

Giving a split-dose of REKOVELLE

If you are not able to dial the full prescribed dose in your pen, this means that there is not enough

medicine left in the pen to give the full dose. You will need to give part of your prescribed dose using

your current pen and the remainder of the dose using a new pen (split-dose injection) or you may

throw away (dispose of) the pen you are using and use a new pen to give your full prescribed dose in

1 injection. If you decide to give a split-dose injection, follow these instructions and write down how

much medicine to give using the split-dose diary on Page 23

Column A shows an example of a prescribed dose. Write down your prescribed dose in column

Column B shows an example of the dose that is left in the pen (this is equal to what you are able

to dial).

Write down the dose that is left in your pen in column B. Give the injection using the rest of the

medicine that is left in your pen.

Prepare and prime a new pen (Step 1 to 9).

Calculate and write down the remaining dose to inject in column C by subtracting the number in

column B from the number in column A. Use a calculator to check your math if needed.

See “Examples of how to dial a dose” at Page 20 to 21

if needed.

Doses should be rounded off to nearest increment, X.00, X.33 or X.66 micrograms. For

example, if the number in column C is 5.34, round your remaining dose to 5.33. If the number

in column C is 9.67, round your remaining dose to 9.66.

Call your healthcare provider if you have questions about how to calculate your split-dose.

Inject the remaining dose of medicine (the number in column C) using your new pen to

complete your prescribed dose.

Split-dose diary

Frequently Asked Questions (FAQ)

Is the priming step necessary before each injection?

No. Priming must be performed only before giving the first injection with a new pen.

How do I know that the injection is complete?

The injection button is firmly pushed in all the way until it stops.

The number ‘0’ is lined up with the dose indicator.

You have slowly counted to 5 while you are still holding the injection button in and the

needle is still in your skin.

Why do I have to count to 5 while holding the injection button?

Holding the injection button for 5 seconds allows for the full dose to be injected and

absorbed under your skin.

What if the dose knob cannot be turned to the required dose?

The cartridge in the pen may not have enough medicine left to deliver the prescribed

dose.

The pen does not allow you to dial a larger dose than the dose that is left in the cartridge.

You can inject the medicine left in the pen and complete the prescribed dose with a new

pen (split-dose) or use a new pen to give the full prescribed dose.

Warnings

Do not use a pen if it has been dropped or hit against hard surfaces.

If the injection button is not easy to push in, do not use force. Change the needle. If the injection

button still is not easy to push in after changing the needle, use a new pen.

Do not try to repair a damaged pen. If a pen is damaged, contact your healthcare provider or

local representative of the marketing authorisation holder (please refer to patient information

leaflet for contact details).

Additional information

Needles

Needles are supplied with your pen. If you need additional needles contact your healthcare provider.

Use only needles that come with your REKOVELLE pre-filled pen or that your healthcare provider

prescribes.

Contact

If you have any questions or problems related to the pen, contact your healthcare provider or local

representative of the marketing authorisation holder (please refer to patient information leaflet for

contact details).

Page numbers refer to the printed Instructions For Use booklet and not to actual page numbers in this document.