Nuwiq

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  • Heiti vöru:
  • Nuwiq
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  • Mannfólk
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  • Allópatísk lyf

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Staðsetning

  • Fáanlegt í:
  • Nuwiq
    Evrópusambandið
  • Tungumál:
  • enska

Meðferðarupplýsingar

  • Meðferðarhópur:
  • Blood coagulation factors
  • Lækningarsvæði:
  • Hemophilia A
  • Ábendingar:
  • Treatment and prophylaxis of bleeding in patients with haemophilia A (congenital factor VIII deficiency). Nuwiq can be used for all age groups.,
  • Vörulýsing:
  • Revision: 6

Staða

  • Heimild:
  • EMA - European Medicines Agency
  • Leyfisstaða:
  • Authorised
  • Leyfisnúmer:
  • EMEA/H/C/002813
  • Leyfisdagur:
  • 21-07-2014
  • EMEA númer:
  • EMEA/H/C/002813
  • Síðasta uppfærsla:
  • 23-05-2019

Opinber matsskýrsla

7 Westferry Circus

Canary Wharf

London E14 4HB

United Kingdom

An agency of the European Union

Telephone

+44 (0)20 7418 8400

Facsimile

+44 (0)20 7418 8416

E-mail

info@ema.europa.eu

Website

www.ema.europa.eu

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

EMA/653987/2017

EMEA/H/C/002813

EPAR summary for the public

Nuwiq

simoctocog alfa

This is a summary of the European public assessment report (EPAR) for Nuwiq. 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 Nuwiq.

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

doctor or pharmacist.

What is Nuwiq and what is it used for?

Nuwiq is a medicine used for the treatment and prevention of bleeding in patients of all ages with

haemophilia A (an inherited bleeding disorder caused by lack of factor VIII). It contains the active

substance simoctocog alfa (human coagulation factor VIII).

How is Nuwiq used?

Nuwiq can only be obtained with a prescription and treatment should be started under the supervision

of a doctor experienced in the treatment of haemophilia.

Nuwiq is available as a powder and solvent that are mixed together to make a solution for injection

into a vein. The dose and duration of treatment depend on whether Nuwiq is used to treat or prevent

bleeding, or during surgery, as well as on the patient’s factor VIII levels, the seriousness of the

haemophilia, the extent and location of the bleeding and the patient’s condition and bodyweight. Nuwiq

is intended for either short-term or long-term use.

Patients or their carers may be able to administer Nuwiq themselves at home once they have been

trained appropriately. For full details, see the package leaflet.

Nuwiq

EMA/653987/2017

Page 2/3

How does Nuwiq work?

The active substance in Nuwiq, simoctocog alfa (human coagulation factor VIII), is a substance that

helps the blood to clot. Patients with haemophilia A lack factor VIII, and this causes blood clotting

problems, such as bleeding in the joints, muscles or internal organs. Nuwiq is used to correct the factor

VIII deficiency by replacing the missing factor VIII, giving temporary control of the bleeding disorder.

Simoctocog alfa is made by a method known as ‘recombinant DNA technology’: it is made by cells into

which a gene (DNA) has been introduced that makes them able to produce it.

What benefits of Nuwiq have been shown in studies?

Nuwiq has been shown to be effective at preventing and treating bleeding episodes in three main

studies involving 113 patients with haemophilia A.

The first study involved 22 patients aged 12 years and above, who were given Nuwiq for the treatment

of bleeding episodes or to prevent bleeding during surgery. A total of 986 bleeding episodes were

recorded, the majority of which resolved with one injection of Nuwiq. The main measure of

effectiveness was based on patients’ assessment of how well treatment worked. Treatment with Nuwiq

was rated as ‘excellent’ or ‘good’ for 94% of bleeding episodes. In the two surgeries that occurred

during the study, Nuwiq was rated as excellent in preventing bleeding episodes.

The second study involved 32 patients aged 12 years and above who were given Nuwiq to prevent and

treat bleeding events as well as to prevent bleeding during surgery. When used to prevent bleeding, an

average of 0.19 bleeds per month was recorded for each patient. When used for the treatment of

bleeding episodes, Nuwiq was mainly rated as ‘excellent’ or ‘good’ at treating major bleeding episodes

and most bleeding episodes resolved following one or more injections of Nuwiq. In the five surgeries

that occurred during the study, Nuwiq was rated as excellent in preventing bleeding episodes for four

surgeries and as moderate to prevent bleeding during one surgical intervention.

The third study involved 59 children aged two to 12 years. When Nuwiq was used to prevent bleeding,

an average of 0.34 bleeds per month was recorded for each child. When used for treatment, bleeding

episodes resolved in 81% of cases following one or two injections with Nuwiq.

What are the risks associated with Nuwiq?

Hypersensitivity (allergic) reactions have been reported with factor VIII medicines and may in some

cases become severe.

There is a risk with factor VIII medicines that some patients will develop inhibitors (antibodies) against

factor VIII, causing the medicine to stop working and resulting in a loss of bleeding control. In such

cases, a specialised haemophilia centre should be contacted.

For the full list of all side effects and restrictions with Nuwiq, see the package leaflet.

Why is Nuwiq approved?

The Agency decided that Nuwiq’s benefits are greater than its risks and recommended that it be

approved for use in the EU. The Agency concluded that Nuwiq has been shown to be effective at

treating and preventing bleeding in patients with haemophilia A and has an acceptable safety profile.

Nuwiq

EMA/653987/2017

Page 3/3

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

Nuwiq?

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

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

package leaflet.

Other information about Nuwiq

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

Nuwiq on 24 July 2014.

The full EPAR for Nuwiq 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 Nuwiq,

read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

This summary was last updated in 10-2017.

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

B. PACKAGE LEAFLET

Package leaflet: Information for the user

Nuwiq 250 IU powder and solvent for solution for injection

Nuwiq 500 IU powder and solvent for solution for injection

Nuwiq 1000 IU powder and solvent for solution for injection

Nuwiq 2000 IU powder and solvent for solution for injection

Nuwiq 2500 IU powder and solvent for solution for injection

Nuwiq 3000 IU powder and solvent for solution for injection

Nuwiq 4000 IU powder and solvent for solution for injection

simoctocog alfa (recombinant human coagulation factor VIII)

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.

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. This includes any possible side effects not listed

in this leaflet. See section 4.

What is in this leaflet

What Nuwiq is and what it is used for

What you need to know before you use Nuwiq

How to use Nuwiq

Possible side effects

How to store Nuwiq

Contents of the pack and other information

1.

What Nuwiq is and what it is used for

Nuwiq contains the active substance human recombinant coagulation factor VIII (simoctocog alfa).

Factor VIII is necessary for the blood to form clots and stop bleeding. In patients with haemophilia A

(inborn factor VIII deficiency), factor VIII is missing or not working properly.

Nuwiq replaces the missing factor VIII and is used for treatment and prevention of bleeding in patients

with haemophilia A and can be used for all age groups.

2.

What you need to know before you use Nuwiq

Do not use Nuwiq:

if you are allergic to the active substance simoctocog alfa or any of the other ingredients of

this medicine (listed in section 6).

If you are unsure about this, ask your doctor.

Warnings and precautions

Talk to your doctor before using Nuwiq.

There is a rare chance that you may experience an anaphylactic reaction (a severe, sudden allergic

reaction) to Nuwiq. You should be aware of the early signs of allergic reactions as they are listed in

section 4 “Allergic reactions”.

If any of these symptoms occur, stop the injection immediately and contact your doctor.

The formation of inhibitors (antibodies) is a known complication that can occur during treatment with

all factor VIII medicines. These inhibitors, especially at high levels, stop the treatment working

properly and you or your child will be monitored carefully for the development of these inhibitors. If

you or your child´s bleeding is not being controlled with Nuwiq, tell your doctor immediately.

Cardiovascular events

In patients with existing cardiovascular risk factors, substitution therapy with FVIII may increase the

cardiovascular risk.

Catheter-related complications

If you require a central venous access device (CVAD), risk of CVAD-related complications including

local infections, presence of bacteria in the blood and catheter site thrombosis should be considered.

It is strongly recommended that every time that Nuwiq is administered, the name and batch number of

the product are recorded in order to maintain a link between you and the batch of the medicinal

product.

Other medicines and Nuwiq

Tell your doctor if you are using, have recently used or might use any other medicines.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask

your doctor for advice before using this medicine.

Driving and using machines

Nuwiq has no influence on your ability to drive and use machines.

Nuwiq contains sodium

This medicine contains less than 1 mmol sodium (23 mg) per vial, that is to say essentially ‘sodium-

free’.

However, depending on your body weight and your dose of Nuwiq, you could receive more than one

vial. This should be taken into consideration if you are on a controlled sodium diet.

3.

How to use Nuwiq

Treatment with Nuwiq will be started by a doctor who is experienced in the care of patients with

haemophilia A. Always use this medicine exactly as your doctor or nurse has told you. Check with

your doctor or nurse if you are not sure.

Nuwiq is usually injected into a vein (intravenously) by your doctor or a nurse who are experienced in

the care of patients with haemophilia A. You or someone else might also give your Nuwiq injection,

but only after receiving adequate training.

Your doctor will calculate your dose of Nuwiq (in international units = IU) depending on your

condition and body weight, and on whether it is used for prevention or treatment of bleeding. How

often you need an injection will depend on how well Nuwiq is working for you. Usually, treatment for

haemophilia A is a life-long treatment.

Prevention of bleeding

The usual dose of Nuwiq is 20 to 40 IU per kg body weight, given every 2 to 3 days. However, in

some cases, especially in younger patients, more frequent injections or higher doses may be necessary.

Treatment of bleeding

The dose of Nuwiq is calculated depending on your body weight and the factor VIII levels to be

achieved. The target factor VIII levels will depend on the severity and location of the bleeding.

If you have the impression that the effect of Nuwiq is insufficient, talk to your doctor. Your doctor

will perform appropriate laboratory tests to make sure that you have adequate factor VIII levels. This

is particularly important if you are having major surgery.

Patients developing factor VIII inhibitors

If your plasma factor VIII fails to reach expected levels with Nuwiq, or if bleeding is not adequately

controlled, it could be due to the development of factor VIII inhibitors. This will be checked by your

doctor. You might need a higher dose of Nuwiq or a different product to control bleedings. Do not

increase the total dose of Nuwiq to control your bleeding without consulting your doctor.

Use in children and adolescents

The way Nuwiq is used in children and adolescents does not differ from the way it is used in adults.

Because factor VIII products may have to be given more often in children and adolescents, a central

venous access device (CVAD) may need to be fitted. A CVAD is an external connector that allows

access to the bloodstream through a catheter without injection through the skin.

If you use more Nuwiq than you should

No symptoms of overdose have been reported. If you have injected more Nuwiq than you should,

please inform your doctor.

If you forget to use Nuwiq

Do not take a double dose to make up for a forgotten dose. Proceed with the next dose immediately

and continue as advised by your doctor.

If you stop using Nuwiq

Do not stop using Nuwiq without consulting your doctor.

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.

Allergic reactions

You should be aware of the early signs of allergic reactions. If severe, sudden allergic reactions

(anaphylactic) occur (very rare: may affect up to 1 in 10,000 people), the injection must be stopped

immediately. You must contact your doctor immediately if you notice any of the following symptoms:

rash, hives, wheals, generalised itching,

swelling of lips and tongue,

difficulty in breathing, wheezing, tightness in the chest,

general feeling of being unwell,

dizziness and loss of consciousness.

These symptoms can be early symptoms of an anaphylactic shock. If any of these symptoms occur,

stop the injection immediately and contact your doctor. Severe symptoms require prompt emergency

treatment.

Very common side effects may affect more than 1 in 10 people

Factor VIII inhibition in previously untreated patients.

For children and adolescents not previously treated with factor VIII medicines, inhibitor antibodies

(see section 2) may form very commonly (more than 1 in 10 patients).

However for patients who have received previous treatment with factor VIII (more than 150 days of

treatment) the risk is uncommon (less than 1 in 100 patients). If this happens, your or your child´s

medicines may stop working properly and you or your child may experience persistent bleeding. If this

happens, you should contact your doctor immediately.

Common side effects may affect up to 1 in 10 people

Hypersensitivity, fever.

Uncommon side effects may affect up to 1 in 100 people

Tingling or numbness (paraesthesia), headache, injection site inflammation, injection site pain, back

pain, vertigo, dry mouth, haemorrhagic anaemia, non-neutralising antibody positive (in PTPs).

Reporting of side effects

If you get any side effects, talk to your doctor. 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 Nuwiq

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 carton and vial label after EXP.

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

Store in a refrigerator (2°C – 8°C). Do not freeze. Store vial in the original package in order to protect

from light.

Before the Nuwiq powder is reconstituted, it may be kept at room temperature (up to 25°C) for a

single period not exceeding 1 month. Record the date from when you start to store Nuwiq at room

temperature on the product carton. Do not store Nuwiq in the refrigerator again after it has been stored

at room temperature.

Use the reconstituted solution immediately after reconstitution.

Do not use the medicine in case you notice visible signs of deterioration of the tamper proof of

packaging especially of the syringe and/or the vial.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to

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

6.

Contents of the pack and other information

What Nuwiq contains

Powder:

The active substance is recombinant human coagulation factor VIII (simoctocog alfa).

Each powder vial contains 250, 500, 1000, 2000, 2500, 3000 or 4000 IU of simoctocog alfa.

Each reconstituted solution contains approximately 100, 200, 400, 800, 1000, 1200 or

1600 IU/mL of simoctocog alfa.

The other ingredients are sucrose, sodium chloride, calcium chloride dihydrate, arginine

hydrochloride, sodium citrate dihydrate and poloxamer 188. See section 2, “Nuwiq contains

sodium”.

Solvent:

Water for injections

What Nuwiq looks like and contents of the pack

Nuwiq is provided as powder and solvent for solution for injection. The powder is a white to off-white

powder in a glass vial. The solvent is water for injections in a glass pre-filled syringe.

After reconstitution, the solution is clear, colourless and free from foreign particles.

Each pack of Nuwiq contains:

1 powder vial with 250, 500, 1000, 2000, 2500, 3000 or 4000 IU simoctocog alfa

1 pre-filled syringe with 2.5 mL water for injections

1 vial adapter

1 butterfly needle

2 alcohol swabs

Marketing Authorisation Holder and Manufacturer

Octapharma AB, Lars Forssells gata 23, 112 75 Stockholm, Sweden

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

Authorisation Holder:

België/Belgique/Belgien

Octapharma Benelux (Belgium)

Tél/Tel: +32 2 3730890

Lietuva

Octapharma Nordic AB (Sweden)

Tel: +46 8 56643000

България

Octapharma Nordic AB (Sweden)

Teл.: +46 8 56643000

Luxembourg/Luxemburg

Octapharma Benelux (Belgium)

Tél/Tel: +32 2 3730890

Česká republika

Octapharma CZ s.r.o.

Tel: +420 266 793 510

Magyarország

Octapharma Nordic AB (Sweden)

Tel: +46 8 56643000

Danmark

Octapharma Nordic AB (Sweden)

Tlf: +46 8 56643000

Malta

Octapharma Nordic AB (Sweden)

Tel: +46 8 56643000

Deutschland

Octapharma GmbH

Tel: +49 2173 9170

Nederland

Octapharma Benelux (Belgium)

Tel: +32 2 3730890

Eesti

Octapharma Nordic AB (Sweden)

Tel: +46 8 56643000

Norge

Octapharma AS

Tlf: +47 63988860

Ελλάδα

Octapharma Hellas SA

Τηλ: +30 210 8986500

Österreich

Octapharma Handelsgesellschaft m.b.H.

Tel: +43 1 610321222

España

Octapharma S.A.

Tel: +34 91 6487298

Polska

Octapharma Poland Sp. z o.o.

Tel: +48 22 2082734

France

Octapharma France

Tél: +33 1 41318000

Portugal

Octapharma Produtos Farmacêuticos Lda.

Tel: +351 21 8160820

Hrvatska

Octapharma Nordic AB (Sweden)

Tel: +46 8 56643000

România

Octapharma Nordic AB (Sweden)

Tel: +46 8 56643000

Ireland

Octapharma AB (Sweden)

Tel: +46 8 56643000

Slovenija

Octapharma Nordic AB (Sweden)

Tel: +46 8 56643000

Ísland

Octapharma AS (Norway)

Sími: +47 63988860

Slovenská republika

Octapharma AG, o.z.z.o.

Tel: +421 2 54646701

Italia

Kedrion S.p.A.

Tel: +39 0583 767507

Suomi/Finland

Octapharma Nordic AB

Puh/Tel: +358 9 85202710

Κύπρος

Octapharma Nordic AB (Sweden)

Τηλ: +46 8 56643000

Sverige

Octapharma Nordic AB

Tel: +46 8 56643000

Latvija

Octapharma Nordic AB (Sweden)

Tel: +46 8 56643000

United Kingdom

Octapharma Limited

Tel: +44 161 8373770

This leaflet was last revised in

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

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

---------------------------------------------------------------------------------------------------------------------------

The following information is intended for healthcare professionals only:

On-demand treatment

The amount to be administered and the frequency of administration should always be oriented to the

clinical effectiveness in the individual case.

In the case of the following haemorrhagic events, factor VIII activity should not fall below the given

plasma activity level (in % of normal or IU/dL) in the corresponding period. The following table can

be used to guide dosing in bleeding episodes and surgery.

Degree of haemorrhage/

Type of surgical procedure

Factor VIII level

required (%) (IU/dL)

Frequency of doses (hours)/

Duration of therapy (days)

Haemorrhage

Early haemarthrosis, muscle

bleeding or oral bleeding

20–40

Repeat every 12 to 24 hours. At least 1

day, until the bleeding episode as

indicated by pain is resolved or healing

is achieved.

More extensive haemarthrosis,

muscle bleeding or haematoma

30–60

Repeat infusion every 12 to 24 hours

for 3 to 4 days or more until pain and

acute disability are resolved.

Life threatening haemorrhages

60–100

Repeat infusion every 8 to 24 hours

until threat is resolved.

Surgery

Minor surgery

including tooth extraction

30–60

Every 24 hours, at least 1 day, until

healing is achieved.

Major surgery

80–100

(pre- and

postoperative)

Repeat infusion every 8–24 hours until

adequate wound healing, then therapy

for at least another 7 days to maintain a

factor VIII activity of 30% to

60% (IU/dL).

INSTRUCTIONS FOR PREPARATION AND ADMINISTRATION

Allow the solvent syringe (water for injections) and the powder in the closed vial to reach

room temperature. You can do this by holding them in your hands until they feel as warm as

your hands. Do not use any other way to heat the vial and pre-filled syringe. This temperature

should be maintained during reconstitution.

Remove the plastic flip-off cap from the powder vial to expose the central portions of the

rubber stopper. Do not remove the gray stopper or metal ring around the top of the vial.

Wipe the top of the vial with an alcohol swab. Allow the alcohol to dry.

Peel back the paper cover from the vial adapter package. Do not remove the adapter from the

package.

Place the powder vial on an even surface and hold it. Take the adapter package and place the

vial adapter over the centre of the rubber stopper of the powder vial. Press down firmly the

adapter package until the adapter spike penetrates the rubber stopper. The adapter snaps to the

vial when done.

Peel back the paper cover from the pre-filled syringe package. Hold the plunger rod at the end

and do not touch the shaft. Attach the threaded end of the plunger rod to the solvent syringe

plunger. Turn the plunger rod clockwise until a slight resistance is felt.

Break off the tamper-proof plastic tip from the solvent syringe by snapping the perforation of

the cap. Do not touch the inside of the cap or the syringe tip. In case the solution is not used

immediately close the filled syringe with the tamper-proof plastic tip for storage.

Remove the adapter packaging and discard.

Firmly connect the solvent syringe to the vial adapter by turning clockwise until resistance is

felt.

Slowly inject all solvent into the powder vial by pressing down the plunger rod.

Without removing the syringe, gently move or swirl the vial in circles a few times to dissolve

the powder. Do not shake. Wait until all the powder dissolves completely.

Visually inspect the final solution for particles before administration. The solution should be

clear and colourless, practically free from visible particles. Do not use solutions that are

cloudy or have deposits.

Turn the vial attached to the syringe upside down, and slowly draw the final solution into the

syringe. Make sure that the entire content of the vial is transferred to the syringe.

Detach the filled syringe from the vial adapter by turning counter clockwise and discard the

empty vial.

The solution is now prepared for immediate use. Do not refrigerate.

Clean the chosen injection site with one of the provided alcohol swabs.

Attach the provided infusion set to the syringe.

Insert the needle of the infusion set into the chosen vein. If you have used a tourniquet to make

the vein easier to see, this tourniquet should be released before you start injecting the solution.

No blood must flow into the syringe due to the risk of formation of fibrin clots.

Inject the solution into the vein at a slow speed, not faster than 4 mL per minute.

If you use more than one vial of powder for one treatment, you may use the same injection needle

again. The vial adapter and the syringe are for single use only.