Cosentyx

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  • Heiti vöru:
  • Cosentyx
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  • Mannfólk
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  • Allópatísk lyf

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Staðsetning

  • Fáanlegt í:
  • Cosentyx
    Evrópusambandið
  • Tungumál:
  • enska

Meðferðarupplýsingar

  • Meðferðarhópur:
  • Immunosuppressants,
  • Lækningarsvæði:
  • Arthritis, Psoriatic, Psoriasis, Spondylitis, Ankylosing
  • Ábendingar:
  • Cosentyx is indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy. Psoriatic arthritis Cosentyx, alone or in combination with methotrexate (MTX), is indicated for the treatment of active psoriatic arthritis in adult patients when the response to previous disease‑modifying anti‑rheumatic drug (DMARD) therapy has been inadequate. Ankylosing spondylitis Cosentyx is indicated for the treatment of active ankylosing spondylitis in adults who have responded inadequately to conventional therapy.,
  • Vörulýsing:
  • Revision: 11

Staða

  • Heimild:
  • EMA - European Medicines Agency
  • Leyfisstaða:
  • Authorised
  • Leyfisnúmer:
  • EMEA/H/C/003729
  • Leyfisdagur:
  • 14-01-2015
  • EMEA númer:
  • EMEA/H/C/003729
  • Síðasta uppfærsla:
  • 25-12-2018

Opinber matsskýrsla

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© European Medicines Agency, 2016. Reproduction is authorised provided the source is acknowledged.

EMA/780949/2015

EMEA/H/C/003729

EPAR summary for the public

Cosentyx

secukinumab

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

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

their doctor or pharmacist.

What is Cosentyx and what is it used for?

Cosentyx is an anti-inflammatory medicine used to treat adult patients with:

moderate to severe plaque psoriasis (a disease causing red, scaly patches on the skin) when the

patient needs systemic (whole body) treatment;

psoriatic arthritis (inflammation of the joints associated with psoriasis) when disease-modifying

anti-rheumatic drugs (DMARDs) do not work well enough;

ankylosing spondylitis (a disease causing inflammation and pain in the joints of the spine) when

conventional treatments do not work well enough.

It contains the active substance secukinumab.

How is Cosentyx used?

Cosentyx can only be obtained with a prescription and treatment should only be given under the

supervision of a doctor with experienced in diagnosing and treating the conditions for which Cosentyx

is used.

The medicine is available as a powder used to make a solution for injection, or as a ready-to-use

solution in a pre-filled syringe or pen injector. Cosentyx is given by injection under the skin as four

Cosentyx

EMA/780949/2015

Page 2/3

weekly injections followed by monthly maintenance injections. The dose to be used depends on the

disease to be treated. An improvement is usually seen within 16 weeks of treatment. The doctor

should consider stopping treatment if no improvement has been seen during this time. Some patients

with an initial partial improvement may see further improvements with continued treatment beyond 16

weeks. For further information, see the package leaflet.

How does Cosentyx work?

The active substance in Cosentyx, secukinumab, is a monoclonal antibody, a type of protein, designed

to recognise and attach to a messenger molecule in the immune system called interleukin 17A. This

molecule is involved in the inflammation and other immune system processes that cause psoriasis and

are involved in psoriatic arthritis and ankylosing spondylitis. By attaching to and blocking the action of

interleukin 17A, secukinumab reduces the activity of the immune system and the symptoms of the

disease.

What benefits of Cosentyx have been shown in studies?

Studies showed that Cosentyx is effective in treating psoriasis, psoriatic arthritis and ankylosing

spondylitis, with patients showing greater improvements with Cosentyx than with placebo (a dummy

treatment) or with a comparator medicine, etanercept.

In 4 psoriasis studies involving 2,403 patients, 79% of those on Cosentyx achieved a 75% reduction in

their PASI scores (a measure of disease severity and area of skin affected) after 12 weeks of

treatment. This compares with 44% of those on a comparator medicine etanercept and 4% of those on

placebo. In addition, 65% of patients given Cosentyx had clear or nearly clear skin, compared with

27% of patients given etanercept and 2% of those given placebo.

In a study of 397 patients with psoriatic arthritis, between 51% and 54% of patients on the approved

doses of Cosentyx achieved a 20% reduction in ACR scores (painful, swollen joints and other

symptoms) after 24 weeks. This compares with 15% of patients on placebo.

Finally, in a study of 219 patients with ankylosing spondylitis, 61% of patients given the approved dose

of Cosentyx achieved a 20% reduction in ASAS scores (back pain, morning stiffness and other

symptoms) after 16 weeks, compared with 28% of patients on with placebo.

What are the risks associated with Cosentyx?

The most common side effects with Cosentyx (which may affect more than 1 in 10 people) are upper

respiratory tract infections (colds) with inflammation of the nose and throat (nasopharyngitis) and

blocked or runny nose (rhinitis). Most of the side effects are mild to moderate in severity. Because

Cosentyx may increase the risk of infection, it must not be given to patients with serious active

infections such as tuberculosis.

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

Why is Cosentyx approved?

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

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

medicine has been shown to be of substantial clinical benefit in patients with psoriasis, psoriatic

arthritis and ankylosing spondylitis. The safety profile was considered reassuring, with the main

concern related to mild infections.

Cosentyx

EMA/780949/2015

Page 3/3

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

Cosentyx?

A risk management plan has been developed to ensure that Cosentyx is used as safely as possible.

Based on this plan, safety information has been included in the summary of product characteristics and

the package leaflet for Cosentyx, including the appropriate precautions to be followed by healthcare

professionals and patients.

Further information can be found in the summary of the risk management plan.

Other information about Cosentyx

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

Cosentyx on 15 January 2015.

The full EPAR and risk management plan summary for Cosentyx 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 Cosentyx, read the package leaflet (also part of the EPAR) or contact

your doctor or pharmacist.

This summary was last updated in 11-2015.

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

B. PACKAGE LEAFLET

Package leaflet: Information for the patient

Cosentyx 150 mg powder for solution for injection

Secukinumab

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, pharmacist or nurse.

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, pharmacist or nurse. This includes any possible

side effects not listed in this leaflet. See section 4.

What is in this leaflet

What Cosentyx is and what it is used for

What you need to know before you use Cosentyx

How to use Cosentyx

Possible side effects

How to store Cosentyx

Contents of the pack and other information

1.

What Cosentyx is and what it is used for

Cosentyx contains the active substance secukinumab. Secukinumab is a monoclonal antibody.

Monoclonal antibodies are proteins that recognise and bind specifically to certain proteins in the body.

Cosentyx belongs to a group of medicines called interleukin (IL) inhibitors. This medicine works by

neutralising the activity of a protein called IL-17A, which is present at increased levels in diseases

such as psoriasis, psoriatic arthritis and ankylosing spondylitis.

Cosentyx is used for the treatment of the following inflammatory diseases:

Plaque psoriasis

Psoriatic arthritis

Ankylosing spondylitis

Plaque psoriasis

Cosentyx is used to treat a skin condition called “plaque psoriasis”, which causes inflammation

affecting the skin. Cosentyx reduces the inflammation and other symptoms of the disease. Cosentyx is

used in adults with moderate to severe plaque psoriasis.

Using Cosentyx in plaque psoriasis will benefit you by leading to improvements of skin clearance and

reducing your symptoms such as scaling, itching and pain.

Psoriatic arthritis

Cosentyx is used to treat a condition called “psoriatic arthritis”. The condition is an inflammatory

disease of the joints, often accompanied by psoriasis. If you have active psoriatic arthritis you will first

be given other medicines. If you do not respond well enough to these medicines, you will be given

Cosentyx to reduce the signs and symptoms of active psoriatic arthritis, improve physical function and

slow down the damage to the cartilage and bone of the joints involved in the disease.

Cosentyx is used in adults with active psoriatic arthritis and can be used alone or with another

medicine called methotrexate.

Using Cosentyx in psoriatic arthritis will benefit you by reducing the signs and symptoms of the

disease, slowing down the damage to the cartilage and bone of the joints and improving your ability to

do normal daily activities.

Ankylosing spondylitis

Cosentyx is used to treat a condition called “ankylosing spondylitis”. The condition is an

inflammatory disease primarily affecting the spine which causes inflammation of the spinal joints. If

you have ankylosing spondylitis you will first be given other medicines. If you do not respond well

enough to these medicines, you will be given Cosentyx to reduce the signs and symptoms of the

disease, reduce inflammation and improve your physical function.

Cosentyx is used in adults with active ankylosing spondylitis.

Using Cosentyx in ankylosing spondylitis will benefit you by reducing the signs and symptoms of

your disease and improving your physical function.

2.

What you need to know before you use Cosentyx

Do not use Cosentyx:

if you are allergic to secukinumab or any of the other ingredients of this medicine (listed in

section 6).

If you think you may be allergic, ask your doctor for advice before using Cosentyx.

if you have an active infection which your doctor thinks is important.

Warnings and precautions

Tell your doctor or pharmacist before using Cosentyx:

if you currently have an infection

if you have long-term or repeated infections.

if you have tuberculosis.

if you have Crohn’s disease.

if you have ulcerative colitis.

if you have recently had a vaccination or if you are due to have a vaccination during treatment

with Cosentyx.

if you are receiving any other treatment for psoriasis, such as another immunosuppressant or

phototherapy with ultraviolet (UV) light.

Look out for infections and allergic reactions

Cosentyx can potentially cause serious side effects, including infections and allergic reactions. You

must look out for signs of these conditions while you are taking Cosentyx.

Stop using Cosentyx and tell your doctor or seek medical help immediately if you notice any signs

indicating a possible serious infection or an allergic reaction. Such signs are listed under “Serious side

effects” in section 4.

Children and adolescents

Cosentyx is not recommended for children and adolescents (under 18 years of age) because it has not

been studied in this age group.

Other medicines and Cosentyx

Tell your doctor or pharmacist:

if you are taking, have recently taken or might take any other medicines.

if you have recently had or are due to have a vaccination. You should not be given certain types

of vaccines (live vaccines) while using Cosentyx.

Pregnancy, breast-feeding and fertility

It is preferable to avoid the use of Cosentyx in pregnancy. The effects of this medicine in

pregnant women are not known. If you are a woman of childbearing potential, you are advised

to avoid becoming pregnant and must use adequate contraception while using Cosentyx and for

at least 20 weeks after the last Cosentyx dose. Talk to your doctor if you are pregnant, think you

may be pregnant or are planning to have a baby.

Talk to your doctor if you are breast-feeding or are planning to breast-feed. You and your doctor

should decide if you will breast-feed or use Cosentyx. You should not do both. After using

Cosentyx you should not breast-feed for at least 20 weeks after the last dose.

Driving and using machines

Cosentyx has no or negligible influence on the ability to drive and use machines.

3.

How to use Cosentyx

Cosentyx is given via injection under your skin (known as a subcutaneous injection) by a healthcare

professional.

Make sure you discuss with your doctor when you will have your injections and your follow-up

appointments.

For detailed instructions on how to reconstitute and inject Cosentyx, see “Instructions for use of

Cosentyx powder for solution for injection” at the end of this leaflet.

How much Cosentyx is given and for how long

Your doctor will decide how much Cosentyx you need and for how long.

Plaque psoriasis

The recommended dose is 300 mg by subcutaneous injection.

Each 300 mg dose is given as two injections of 150 mg.

After the first dose you will receive further weekly injections at Weeks 1, 2, 3 and 4 followed by

monthly injections. At each timepoint you will receive a 300 mg dose given as two injections of

150 mg.

Psoriatic arthritis

For psoriatic arthritis patients who also have moderate to severe plaque psoriasis or patients who did

not respond well to medicines called tumour necrosis factor (TNF) blockers:

The recommended dose is 300 mg by subcutaneous injection.

Each 300 mg dose is given as two injections of 150 mg.

After the first dose you will receive further weekly injections at Weeks 1, 2, 3 and 4 followed by

monthly injections. At each timepoint you will receive a 300 mg dose given as two injections of

150 mg.

For other psoriatic arthritis patients:

The recommended dose is 150 mg by subcutaneous injection.

After the first dose you will receive further weekly injections at Weeks 1, 2, 3 and 4 followed by

monthly injections.

Based on your response, your doctor may increase your dose to 300 mg.

Ankylosing spondylitis

The recommended dose is 150 mg by subcutaneous injection.

After the first dose you will receive further weekly injections at Weeks 1, 2, 3 and 4 followed by

monthly injections.

Cosentyx is for long-term treatment. Your doctor will regularly monitor your condition to check that

the treatment is having the desired effect.

If you use more Cosentyx than you should

If you have received more Cosentyx than you should or the dose has been administered sooner than

according to your doctor’s prescription, inform your doctor.

If you forget to use Cosentyx

If you have missed a Cosentyx injection, talk to your doctor.

If you stop using Cosentyx

It is not dangerous to stop using Cosentyx. However, if you stop, your psoriasis, psoriatic arthritis or

ankylosing spondylitis symptoms may come back.

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

4.

Possible side effects

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

Serious side effects

Stop using Cosentyx and tell your doctor or seek medical help immediately if you get any of the

following side effects:

Possible serious infection - the signs may include:

fever, flu-like symptoms, night sweats

feeling tired or short of breath, cough which will not go away

warm, red and painful skin, or a painful skin rash with blisters

burning sensation when passing urine.

Serious allergic reaction - the signs may include:

difficulty breathing or swallowing

low blood pressure, which can cause dizziness or light-headedness

swelling of the face, lips, tongue or throat

severe itching of the skin, with a red rash or raised bumps.

Your doctor will decide if and when you may restart the treatment.

Other side effects

Most of the following side effects are mild to moderate. If any of these side effects becomes severe,

tell your doctor, pharmacist or nurse.

Very common (may affect more than 1 in 10 people):

upper respiratory tract infections with symptoms such as sore throat and stuffy nose

(nasopharyngitis, rhinitis)

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

cold sores (oral herpes)

diarrhoea

runny nose (rhinorrhoea)

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

oral thrush (oral candidiasis)

signs of low levels of white blood cells, such as fever, sore throat or mouth ulcers due to

infections (neutropenia)

athlete’s foot (tinea pedis)

infection of the external ear (otitis externa)

discharge from the eye with itching, redness and swelling (conjunctivitis)

itchy rash (urticaria)

Rare (may affect up to 1 in 1,000 people):

severe allergic reaction with shock (anaphylactic reaction)

Not known (frequency cannot be estimated from the available data):

fungal infections of the skin and mucous membranes (including oesophageal candidiasis)

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. 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 Cosentyx

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 outer box or vial after “EXP”.

Before reconstitution: Store the vial in the refrigerator between 2°C and 8°C.

After reconstitution: The solution can be used immediately or can be stored at 2°C to 8°C for up to

24 hours. Do not freeze. The solution should be administered within one hour after removal from 2°C

to 8°C storage.

This medicine is for single use only. Ask your pharmacist how to dispose of medicines no longer

required.

6.

Contents of the pack and other information

What Cosentyx contains

The active substance is secukinumab. Each vial of powder for solution for injection contains

150 mg secukinumab. After reconstitution, 1 ml of solution contains 150 mg secukinumab.

The other ingredients are sucrose, L-histidine, L-histidine hydrochloride monohydrate and

polysorbate 80.

What Cosentyx looks like and contents of the pack

Cosentyx powder for solution for injection is a white solid powder in a glass vial. Do not use if the

lyophilised powder has not fully dissolved or if the liquid contains easily visible particles, is cloudy or

is distinctly brown. Cosentyx is supplied in a pack containing one vial.

Marketing Authorisation Holder

Novartis Europharm Limited

Vista Building

Elm Park, Merrion Road

Dublin 4

Ireland

Manufacturer

Novartis Pharma GmbH

Roonstraße 25

D-90429 Nuremberg

Germany

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

Authorisation Holder:

België/Belgique/Belgien

Novartis Pharma N.V.

Tél/Tel: +32 2 246 16 11

Lietuva

SIA „Novartis Baltics“ Lietuvos filialas

Tel: +370 5 269 16 50

България

Novartis Bulgaria EOOD

Тел: +359 2 489 98 28

Luxembourg/Luxemburg

Novartis Pharma N.V.

Tél/Tel: +32 2 246 16 11

Česká republika

Novartis s.r.o.

Tel: +420 225 775 111

Magyarország

Novartis Hungária Kft.

Tel.: +36 1 457 65 00

Danmark

Novartis Healthcare A/S

Tlf: +45 39 16 84 00

Malta

Novartis Pharma Services Inc.

Tel: +356 2122 2872

Deutschland

Novartis Pharma GmbH

Tel: +49 911 273 0

Nederland

Novartis Pharma B.V.

Tel: +31 26 37 82 111

Eesti

SIA Novartis Baltics Eesti filiaal

Tel: +372 66 30 810

Norge

Novartis Norge AS

Tlf: +47 23 05 20 00

Ελλάδα

Novartis (Hellas) A.E.B.E.

Τηλ: +30 210 281 17 12

Österreich

Novartis Pharma GmbH

Tel: +43 1 86 6570

España

Novartis Farmacéutica, S.A.

Tel: +34 93 306 42 00

Polska

Novartis Poland Sp. z o.o.

Tel.: +48 22 375 4888

France

Novartis Pharma S.A.S.

Tél: +33 1 55 47 66 00

Portugal

Novartis Farma - Produtos Farmacêuticos, S.A.

Tel: +351 21 000 8600

Hrvatska

Novartis Hrvatska d.o.o.

Tel. +385 1 6274 220

România

Novartis Pharma Services Romania SRL

Tel: +40 21 31299 01

Ireland

Novartis Ireland Limited

Tel: +353 1 260 12 55

Slovenija

Novartis Pharma Services Inc.

Tel: +386 1 300 75 50

Ísland

Vistor hf.

Sími: +354 535 7000

Slovenská republika

Novartis Slovakia s.r.o.

Tel: +421 2 5542 5439

Italia

Novartis Farma S.p.A.

Tel: +39 02 96 54 1

Suomi/Finland

Novartis Finland Oy

Puh/Tel: +358 (0)10 6133 200

Κύπρος

Novartis Pharma Services Inc.

Τηλ: +357 22 690 690

Sverige

Novartis Sverige AB

Tel: +46 8 732 32 00

Latvija

SIA “Novartis Baltics”

Tel: +371 67 887 070

United Kingdom

Novartis Pharmaceuticals UK Ltd.

Tel: +44 1276 698370

This leaflet was last revised in

Other sources of information

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

http://www.ema.europa.eu

Instructions for use of Cosentyx powder for solution for injection

The following information is intended for medical or healthcare professionals only.

Store the vial of powder in the refrigerator between 2°C to 8°C.

The single-use vial contains 150 mg secukinumab for reconstitution with sterile water for injections.

Do not use the vial after the expiry date shown on the outer box or vial. If it has expired, return the

entire pack to the pharmacy.

The preparation of the solution for subcutaneous injection must be done without interruption and

ensuring that aseptic technique is used. The preparation time from piercing the stopper until end of

reconstitution takes 20 minutes on average and should not exceed 90 minutes.

To prepare Cosentyx 150 mg powder for solution for injection, please adhere to the following

instructions:

Instructions for reconstitution of Cosentyx 150 mg powder for solution for injection:

Bring the vial of powder to room temperature and ensure that the sterile water for injections is at

room temperature.

Withdraw slightly more than 1.0 ml sterile water for injections into a 1 ml graduated disposable

syringe and adjust to 1.0 ml.

Remove the plastic cap from the vial.

Insert the syringe needle into the vial containing the powder through the centre of the rubber

stopper and reconstitute the powder by slowly injecting 1.0 ml of sterile water for injections into

the vial. The stream of sterile water for injections should be directed onto the powder.

Tilt the vial to an angle of approx. 45° and gently rotate between the fingertips for approx.

1 minute. Do not shake or invert the vial.

Keep the vial standing at room temperature for a minimum of 10 minutes to allow for

dissolution. Note that foaming of the solution may occur.

Tilt the vial to an angle of approx. 45° and gently rotate between the fingertips for approx.

1 minute. Do not shake or invert the vial.

Allow the vial to stand undisturbed at room temperature for approximately 5 minutes. The

resulting solution should be clear. Its colour may vary from colourless to slightly yellow. Do not

use if the lyophilised powder has not fully dissolved or if the liquid contains easily visible

particles, is cloudy or is distinctly brown.

Prepare the required number of vials (2 vials for the 300 mg dose).

After preparation, the solution for subcutaneous injection can be used immediately or can be stored at

2°C to 8°C for up to 24 hours. Do not freeze. After storage at 2°C to 8°C, the solution should be

allowed to come to room temperature for approximately 20 minutes before administration. The

solution should be administered within one hour after removal from the 2°C to 8°C storage.

Instructions for administration of Cosentyx solution

Tilt the vial to an angle of approximately 45° and position the needle tip at the very bottom of

the solution in the vial when drawing the solution into the syringe. DO NOT invert the vial.

Carefully withdraw slightly more than 1.0 ml of the solution for subcutaneous injection from the

vial into a 1 ml graduated disposable syringe using a suitable needle (e.g. 21G x 2″). This needle

will only be used for withdrawing Cosentyx into the disposable syringe. Prepare the required

number of syringes (2 syringes for the 300 mg dose).

With the needle pointing upward, gently tap the syringe to move any air bubbles to the top.

Replace the attached needle with a 27G x ½″ needle.

Expel the air bubbles and advance the plunger to the 1.0 ml mark.

Clean the injection site with an alcohol swab.

Inject the Cosentyx solution subcutaneously into the front of thighs, lower abdomen (but not the

area 5 centimetres around the navel) or outer upper arms. Choose a different site each time an

injection is administered. Do not inject into areas where the skin is tender, bruised, red, scaly or

hard. Avoid areas with scars or stretch marks.

Any remaining solution in the vial must not be used and should be discarded in accordance with

local requirements. Vials are for single use only. Dispose of the used syringe in a sharps

container (closable, puncture-resistant container). For the safety and health of you and others,

needles and used syringes must never be re-used.

Package leaflet: Information for the patient

Cosentyx 150 mg solution for injection in pre-filled syringe

Secukinumab

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, pharmacist or nurse.

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, pharmacist or nurse. This includes any possible

side effects not listed in this leaflet. See section 4.

What is in this leaflet

What Cosentyx is and what it is used for

What you need to know before you use Cosentyx

How to use Cosentyx

Possible side effects

How to store Cosentyx

Contents of the pack and other information

1.

What Cosentyx is and what it is used for

Cosentyx contains the active substance secukinumab. Secukinumab is a monoclonal antibody.

Monoclonal antibodies are proteins that recognise and bind specifically to certain proteins in the body.

Cosentyx belongs to a group of medicines called interleukin (IL) inhibitors. This medicine works by

neutralising the activity of a protein called IL-17A, which is present at increased levels in diseases

such as psoriasis, psoriatic arthritis and ankylosing spondylitis.

Cosentyx is used for the treatment of the following inflammatory diseases:

Plaque psoriasis

Psoriatic arthritis

Ankylosing spondylitis

Plaque psoriasis

Cosentyx is used to treat a skin condition called “plaque psoriasis”, which causes inflammation

affecting the skin. Cosentyx reduces the inflammation and other symptoms of the disease. Cosentyx is

used in adults with moderate to severe plaque psoriasis.

Using Cosentyx in plaque psoriasis will benefit you by leading to improvements of skin clearance and

reducing your symptoms such as scaling, itching and pain.

Psoriatic arthritis

Cosentyx is used to treat a condition called “psoriatic arthritis”. The condition is an inflammatory

disease of the joints, often accompanied by psoriasis. If you have active psoriatic arthritis you will first

be given other medicines. If you do not respond well enough to these medicines, you will be given

Cosentyx to reduce the signs and symptoms of active psoriatic arthritis, improve physical function and

slow down the damage to the cartilage and bone of the joints involved in the disease.

Cosentyx is used in adults with active psoriatic arthritis and can be used alone or with another

medicine called methotrexate.

Using Cosentyx in psoriatic arthritis will benefit you by reducing the signs and symptoms of the

disease, slowing down the damage to the cartilage and bone of the joints and improving your ability to

do normal daily activities.

Ankylosing spondylitis

Cosentyx is used to treat a condition called “ankylosing spondylitis”. The condition is an

inflammatory disease primarily affecting the spine which causes inflammation of the spinal joints. If

you have ankylosing spondylitis you will first be given other medicines. If you do not respond well

enough to these medicines, you will be given Cosentyx to reduce the signs and symptoms of the

disease, reduce inflammation and improve your physical function.

Cosentyx is used in adults with active ankylosing spondylitis.

Using Cosentyx in ankylosing spondylitis will benefit you by reducing the signs and symptoms of

your disease and improving your physical function.

2.

What you need to know before you use Cosentyx

Do not use Cosentyx:

if you are allergic to secukinumab or any of the other ingredients of this medicine (listed in

section 6).

If you think you may be allergic, ask your doctor for advice before using Cosentyx.

if you have an active infection which your doctor thinks is important.

Warnings and precautions

Tell your doctor or pharmacist before using Cosentyx:

if you currently have an infection

if you have long-term or repeated infections.

if you have tuberculosis.

if you have ever had an allergic reaction to latex.

if you have Crohn’s disease.

if you have ulcerative colitis.

if you have recently had a vaccination or if you are due to have a vaccination during treatment

with Cosentyx.

if you are receiving any other treatment for psoriasis, such as another immunosuppressant or

phototherapy with ultraviolet (UV) light.

Look out for infections and allergic reactions

Cosentyx can potentially cause serious side effects, including infections and allergic reactions. You

must look out for signs of these conditions while you are taking Cosentyx.

Stop using Cosentyx and tell your doctor or seek medical help immediately if you notice any signs

indicating a possible serious infection or an allergic reaction. Such signs are listed under “Serious side

effects” in section 4.

Children and adolescents

Cosentyx is not recommended for children and adolescents (under 18 years of age) because it has not

been studied in this age group.

Other medicines and Cosentyx

Tell your doctor or pharmacist:

if you are taking, have recently taken or might take any other medicines.

if you have recently had or are due to have a vaccination. You should not be given certain types

of vaccines (live vaccines) while using Cosentyx.

Pregnancy, breast-feeding and fertility

It is preferable to avoid the use of Cosentyx in pregnancy. The effects of this medicine in

pregnant women are not known. If you are a woman of childbearing potential, you are advised

to avoid becoming pregnant and must use adequate contraception while using Cosentyx and for

at least 20 weeks after the last Cosentyx dose. Talk to your doctor if you are pregnant, think you

may be pregnant or are planning to have a baby.

Talk to your doctor if you are breast-feeding or are planning to breast-feed. You and your doctor

should decide if you will breast-feed or use Cosentyx. You should not do both. After using

Cosentyx you should not breast-feed for at least 20 weeks after the last dose.

Driving and using machines

Cosentyx has no or negligible influence on the ability to drive and use machines.

3.

How to use Cosentyx

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

pharmacist if you are not sure.

Cosentyx is given via injection under your skin (known as a subcutaneous injection). You and your

doctor should decide if you should inject Cosentyx yourself.

It is important not to try to inject yourself until you have been trained by your doctor, nurse or

pharmacist. A caregiver may also give you your Cosentyx injection after proper training.

For detailed instructions on how to inject Cosentyx, see “Instructions for use of Cosentyx pre-filled

syringe” at the end of this leaflet.

How much Cosentyx is given and for how long

Your doctor will decide how much Cosentyx you need and for how long.

Plaque psoriasis

The recommended dose is 300 mg by subcutaneous injection.

Each 300 mg dose is given as two injections of 150 mg.

After the first dose you will receive further weekly injections at Weeks 1, 2, 3 and 4 followed by

monthly injections. At each timepoint you will receive a 300 mg dose given as two injections of

150 mg.

Psoriatic arthritis

For psoriatic arthritis patients who also have moderate to severe plaque psoriasis or patients who did

not respond well to medicines called tumour necrosis factor (TNF) blockers:

The recommended dose is 300 mg by subcutaneous injection.

Each 300 mg dose is given as two injections of 150 mg.

After the first dose you will receive further weekly injections at Weeks 1, 2, 3 and 4 followed by

monthly injections. At each timepoint you will receive a 300 mg dose given as two injections of

150 mg.

For other psoriatic arthritis patients:

The recommended dose is 150 mg by subcutaneous injection.

After the first dose you will receive further weekly injections at Weeks 1, 2, 3 and 4 followed by

monthly injections.

Based on your response, your doctor may increase your dose to 300 mg.

Ankylosing spondylitis

The recommended dose is 150 mg by subcutaneous injection.

After the first dose you will receive further weekly injections at Weeks 1, 2, 3 and 4 followed by

monthly injections.

Cosentyx is for long-term treatment. Your doctor will regularly monitor your condition to check that

the treatment is having the desired effect.

If you use more Cosentyx than you should

If you have received more Cosentyx than you should or the dose has been administered sooner than

according to your doctor’s prescription, inform your doctor.

If you forget to use Cosentyx

If you have forgotten to inject a dose of Cosentyx, inject the next dose as soon as you remember. Then

talk to your doctor to discuss when you should inject the next dose.

If you stop using Cosentyx

It is not dangerous to stop using Cosentyx. However, if you stop, your psoriasis, psoriatic arthritis or

ankylosing spondylitis symptoms may come back.

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

4.

Possible side effects

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

Serious side effects

Stop using Cosentyx and tell your doctor or seek medical help immediately if you get any of the

following side effects:

Possible serious infection - the signs may include:

fever, flu-like symptoms, night sweats

feeling tired or short of breath, cough which will not go away

warm, red and painful skin, or a painful skin rash with blisters

burning sensation when passing urine.

Serious allergic reaction - the signs may include:

difficulty breathing or swallowing

low blood pressure, which can cause dizziness or light-headedness

swelling of the face, lips, tongue or throat

severe itching of the skin, with a red rash or raised bumps.

Your doctor will decide if and when you may restart the treatment.

Other side effects

Most of the following side effects are mild to moderate. If any of these side effects becomes severe,

tell your doctor, pharmacist or nurse.

Very common (may affect more than 1 in 10 people):

upper respiratory tract infections with symptoms such as sore throat and stuffy nose

(nasopharyngitis, rhinitis)

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

cold sores (oral herpes)

diarrhoea

runny nose (rhinorrhoea)

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

oral thrush (oral candidiasis)

signs of low levels of white blood cells, such as fever, sore throat or mouth ulcers due to

infections (neutropenia)

athlete’s foot (tinea pedis)

infection of the external ear (otitis externa)

discharge from the eye with itching, redness and swelling (conjunctivitis)

itchy rash (urticaria)

Rare (may affect up to 1 in 1,000 people):

severe allergic reaction with shock (anaphylactic reaction)

Not known (frequency cannot be estimated from the available data):

fungal infections of the skin and mucous membranes (including oesophageal candidiasis)

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. 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 Cosentyx

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 outer box or the label on the syringe after “EXP”.

if the liquid contains easily visible particles, is cloudy or is distinctly brown.

Store the syringe sealed in its box to protect from light. Store in the refrigerator between 2°C and 8°C.

Do not freeze. Do not shake.

If necessary, Cosentyx can be left out of the refrigerator for a single period of up to 4 days at room

temperature, not above 30°C.

This medicine is for single use only. Ask your pharmacist how to dispose of medicines no longer

required.

6.

Contents of the pack and other information

What Cosentyx contains

The active substance is secukinumab. Each pre-filled syringe contains 150 mg secukinumab.

The other ingredients are trehalose dihydrate, L-histidine, L-histidine hydrochloride

monohydrate, L-methionine, polysorbate 80 and water for injections.

What Cosentyx looks like and contents of the pack

Cosentyx solution for injection is a clear liquid. Its colour may vary from colourless to slightly yellow.

Do not use if the liquid contains easily visible particles, is cloudy or is distinctly brown. Cosentyx is

available in unit packs containing 1 or 2 pre-filled syringe(s) and in multipacks containing 6 (3 packs

of 2) pre-filled syringes. Not all pack sizes may be marketed.

Marketing Authorisation Holder

Novartis Europharm Limited

Vista Building

Elm Park, Merrion Road

Dublin 4

Ireland

Manufacturer

Novartis Pharma GmbH

Roonstraße 25

D-90429 Nuremberg

Germany

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

Authorisation Holder:

België/Belgique/Belgien

Novartis Pharma N.V.

Tél/Tel: +32 2 246 16 11

Lietuva

SIA „Novartis Baltics“ Lietuvos filialas

Tel: +370 5 269 16 50

България

Novartis Bulgaria EOOD

Тел: +359 2 489 98 28

Luxembourg/Luxemburg

Novartis Pharma N.V.

Tél/Tel: +32 2 246 16 11

Česká republika

Novartis s.r.o.

Tel: +420 225 775 111

Magyarország

Novartis Hungária Kft.

Tel.: +36 1 457 65 00

Danmark

Novartis Healthcare A/S

Tlf: +45 39 16 84 00

Malta

Novartis Pharma Services Inc.

Tel: +356 2122 2872

Deutschland

Novartis Pharma GmbH

Tel: +49 911 273 0

Nederland

Novartis Pharma B.V.

Tel: +31 26 37 82 111

Eesti

SIA Novartis Baltics Eesti filiaal

Tel: +372 66 30 810

Norge

Novartis Norge AS

Tlf: +47 23 05 20 00

Ελλάδα

Novartis (Hellas) A.E.B.E.

Τηλ: +30 210 281 17 12

Österreich

Novartis Pharma GmbH

Tel: +43 1 86 6570

España

Novartis Farmacéutica, S.A.

Tel: +34 93 306 42 00

Polska

Novartis Poland Sp. z o.o.

Tel.: +48 22 375 4888

France

Novartis Pharma S.A.S.

Tél: +33 1 55 47 66 00

Portugal

Novartis Farma - Produtos Farmacêuticos, S.A.

Tel: +351 21 000 8600

Hrvatska

Novartis Hrvatska d.o.o.

Tel. +385 1 6274 220

România

Novartis Pharma Services Romania SRL

Tel: +40 21 31299 01

Ireland

Novartis Ireland Limited

Tel: +353 1 260 12 55

Slovenija

Novartis Pharma Services Inc.

Tel: +386 1 300 75 50

Ísland

Vistor hf.

Sími: +354 535 7000

Slovenská republika

Novartis Slovakia s.r.o.

Tel: +421 2 5542 5439

Italia

Novartis Farma S.p.A.

Tel: +39 02 96 54 1

Suomi/Finland

Novartis Finland Oy

Puh/Tel: +358 (0)10 6133 200

Κύπρος

Novartis Pharma Services Inc.

Τηλ: +357 22 690 690

Sverige

Novartis Sverige AB

Tel: +46 8 732 32 00

Latvija

SIA “Novartis Baltics”

Tel: +371 67 887 070

United Kingdom

Novartis Pharmaceuticals UK Ltd.

Tel: +44 1276 698370

This leaflet was last revised in

Other sources of information

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

http://www.ema.europa.eu

Instructions for use of Cosentyx pre-filled syringe

Read ALL the way through these instructions before injecting. It is important not to try to inject

yourself until you have been trained by your doctor, nurse or pharmacist. The box contains Cosentyx

pre-filled syringe(s) individually sealed in a plastic blister.

Your Cosentyx pre-filled syringe

After the medicine has been injected the syringe guard will be activated to cover the needle. This is

intended to aid in the protection of healthcare professionals, patients who self-inject doctor-prescribed

medicines, and individuals who assist self-injecting patients from accidental needlestick injuries.

What you additionally need for

your injection:

Alcohol swab.

Cotton ball or gauze.

Sharps disposal container.

Important safety information

Caution: Keep the syringe out of the sight and reach of children.

The needle cap of the syringe may contain dry rubber (latex), which should not be handled by

persons sensitive to this substance.

Do not open the sealed outer box until you are ready to use this medicine.

Do not use this medicine if either the seal on the outer box or the seal of the blister is broken, as

it may not be safe for you to use.

Never leave the syringe lying around where others might tamper with it.

Do not shake the syringe.

Be careful not to touch the syringe guard wings before use. By touching them, the syringe guard

may be activated too early.

Do not remove the needle cap until just before you give the injection.

The syringe cannot be re-used. Dispose of the used syringe immediately after use in a sharps

container.

Storage of the Cosentyx pre-filled syringe

Store this medicine sealed in its outer box to protect it from light. Store in the refrigerator

between 2°C and 8°C. DO NOT FREEZE.

Remember to take the syringe out of the refrigerator and allow it to reach room temperature

before preparing it for injection (15-30 minutes).

Needle cap

Syringe guard

Viewing window, label &

expiry date

Finger grips

Syringe guard

wings

Plunger

Plunger

head

Do not use the syringe after the expiry date which is stated on the outer box or syringe label

after “EXP”. If it has expired, return the entire pack to the pharmacy.

The injection site

The injection site is the place on the body where you are

going to use the syringe.

The recommended site is the front of your thighs. You

may also use the lower abdomen, but not the area

5 centimetres around the navel (belly button).

Choose a different site each time you give yourself an

injection.

Do not inject into areas where the skin is tender,

bruised, red, scaly or hard. Avoid areas with scars or

stretch marks.

If a caregiver is giving you the injection, the outer upper

arms may also be used.

Preparing the Cosentyx pre-filled syringe ready for use

Note: For a 300 mg dose, prepare 2 pre-filled syringes and inject the contents of both.

Take the box containing the syringe out of the refrigerator and leave it unopened for about

15-30 minutes so that it reaches room temperature.

When you are ready to use the syringe, wash your hands thoroughly with soap and water.

Clean the injection site with an alcohol swab.

Remove the syringe from the outer box and take it out of the blister.

Inspect the syringe. The liquid should be clear. Its colour may vary from colourless to slightly

yellow. You may see a small air bubble, which is normal. DO NOT USE if the liquid contains

easily visible particles, is cloudy or is distinctly brown. DO NOT USE if the syringe is broken.

In all these cases, return the entire product pack to the pharmacy.

How to use the Cosentyx pre-filled syringe

Carefully remove the needle cap from the syringe.

Discard the needle cap. You may see a drop of

liquid at the end of the needle. This is normal.

Gently pinch the skin at the injection site and

insert the needle as shown. Push the needle all the

way in to ensure that the medicine can be fully

administered.

Hold the syringe as shown. Slowly depress the

plunger as far as it will go so that the plunger

head is completely between the syringe guard

wings.

Keep the plunger pressed fully down while you

hold the syringe in place for 5 seconds.

Keep the plunger fully depressed while you

carefully lift the needle straight out from the

injection site.

Slowly release the plunger and allow the syringe

guard to automatically cover the exposed needle.

There may be a small amount of blood at the

injection site. You can press a cotton ball or gauze

over the injection site and hold it for 10 seconds.

Do not rub the injection site. You may cover the

injection site with a small adhesive bandage, if

needed.

Disposal instructions

Dispose of the used syringe in a sharps container

(closable, puncture resistant container). For the

safety and health of you and others, needles and

used syringes must never be re-used.

Package leaflet: Information for the patient

Cosentyx 150 mg solution for injection in pre-filled pen

Secukinumab

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, pharmacist or nurse.

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, pharmacist or nurse. This includes any possible

side effects not listed in this leaflet. See section 4.

What is in this leaflet

What Cosentyx is and what it is used for

What you need to know before you use Cosentyx

How to use Cosentyx

Possible side effects

How to store Cosentyx

Contents of the pack and other information

1.

What Cosentyx is and what it is used for

Cosentyx contains the active substance secukinumab. Secukinumab is a monoclonal antibody.

Monoclonal antibodies are proteins that recognise and bind specifically to certain proteins in the body.

Cosentyx belongs to a group of medicines called interleukin (IL) inhibitors. This medicine works by

neutralising the activity of a protein called IL-17A, which is present at increased levels in diseases

such as psoriasis, psoriatic arthritis and ankylosing spondylitis.

Cosentyx is used for the treatment of the following inflammatory diseases:

Plaque psoriasis

Psoriatic arthritis

Ankylosing spondylitis

Plaque psoriasis

Cosentyx is used to treat a skin condition called “plaque psoriasis”, which causes inflammation

affecting the skin. Cosentyx reduces the inflammation and other symptoms of the disease. Cosentyx is

used in adults with moderate to severe plaque psoriasis.

Using Cosentyx in plaque psoriasis will benefit you by leading to improvements of skin clearance and

reducing your symptoms such as scaling, itching and pain.

Psoriatic arthritis

Cosentyx is used to treat a condition called “psoriatic arthritis”. The condition is an inflammatory

disease of the joints, often accompanied by psoriasis. If you have active psoriatic arthritis you will first

be given other medicines. If you do not respond well enough to these medicines, you will be given

Cosentyx to reduce the signs and symptoms of active psoriatic arthritis, improve physical function and

slow down the damage to the cartilage and bone of the joints involved in the disease.

Cosentyx is used in adults with active psoriatic arthritis and can be used alone or with another

medicine called methotrexate.

Using Cosentyx in psoriatic arthritis will benefit you by reducing the signs and symptoms of the

disease, slowing down the damage to the cartilage and bone of the joints and improving your ability to

do normal daily activities.

Ankylosing spondylitis

Cosentyx is used to treat a condition called “ankylosing spondylitis”. The condition is an

inflammatory disease primarily affecting the spine which causes inflammation of the spinal joints. If

you have ankylosing spondylitis you will first be given other medicines. If you do not respond well

enough to these medicines, you will be given Cosentyx to reduce the signs and symptoms of the

disease, reduce inflammation and improve your physical function.

Cosentyx is used in adults with active ankylosing spondylitis.

Using Cosentyx in ankylosing spondylitis will benefit you by reducing the signs and symptoms of

your disease and improving your physical function.

2.

What you need to know before you use Cosentyx

Do not use Cosentyx:

if you are allergic to secukinumab or any of the other ingredients of this medicine (listed in

section 6).

If you think you may be allergic, ask your doctor for advice before using Cosentyx.

if you have an active infection which your doctor thinks is important.

Warnings and precautions

Tell your doctor or pharmacist before using Cosentyx:

if you currently have an infection

if you have long-term or repeated infections.

if you have tuberculosis.

if you have ever had an allergic reaction to latex.

if you have Crohn’s disease.

if you have ulcerative colitis.

if you have recently had a vaccination or if you are due to have a vaccination during treatment

with Cosentyx.

if you are receiving any other treatment for psoriasis, such as another immunosuppressant or

phototherapy with ultraviolet (UV) light.

Look out for infections and allergic reactions

Cosentyx can potentially cause serious side effects, including infections and allergic reactions. You

must look out for signs of these conditions while you are taking Cosentyx.

Stop using Cosentyx and tell your doctor or seek medical help immediately if you notice any signs

indicating a possible serious infection or an allergic reaction. Such signs are listed under “Serious side

effects” in section 4.

Children and adolescents

Cosentyx is not recommended for children and adolescents (under 18 years of age) because it has not

been studied in this age group.

Other medicines and Cosentyx

Tell your doctor or pharmacist:

if you are taking, have recently taken or might take any other medicines.

if you have recently had or are due to have a vaccination. You should not be given certain types

of vaccines (live vaccines) while using Cosentyx.

Pregnancy, breast-feeding and fertility

It is preferable to avoid the use of Cosentyx in pregnancy. The effects of this medicine in

pregnant women are not known. If you are a woman of childbearing potential, you are advised

to avoid becoming pregnant and must use adequate contraception while using Cosentyx and for

at least 20 weeks after the last Cosentyx dose. Talk to your doctor if you are pregnant, think you

may be pregnant or are planning to have a baby.

Talk to your doctor if you are breast-feeding or are planning to breast-feed. You and your doctor

should decide if you will breast-feed or use Cosentyx. You should not do both. After using

Cosentyx you should not breast-feed for at least 20 weeks after the last dose.

Driving and using machines

Cosentyx has no or negligible influence on the ability to drive and use machines.

3.

How to use Cosentyx

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

pharmacist if you are not sure.

Cosentyx is given via injection under your skin (known as a subcutaneous injection). You and your

doctor should decide if you should inject Cosentyx yourself.

It is important not to try to inject yourself until you have been trained by your doctor, nurse or

pharmacist. A caregiver may also give you your Cosentyx injection after proper training.

For detailed instructions on how to inject Cosentyx, see “Instructions for use of the Cosentyx

SensoReady pen” at the end of this leaflet.

How much Cosentyx is given and for how long

Your doctor will decide how much Cosentyx you need and for how long.

Plaque psoriasis

The recommended dose is 300 mg by subcutaneous injection.

Each 300 mg dose is given as two injections of 150 mg.

After the first dose you will receive further weekly injections at Weeks 1, 2, 3 and 4 followed by

monthly injections. At each timepoint you will receive a 300 mg dose given as two injections of

150 mg.

Psoriatic arthritis

For psoriatic arthritis patients who also have moderate to severe plaque psoriasis or patients who did

not respond well to medicines called tumour necrosis factor (TNF) blockers:

The recommended dose is 300 mg by subcutaneous injection.

Each 300 mg dose is given as two injections of 150 mg.

After the first dose you will receive further weekly injections at Weeks 1, 2, 3 and 4 followed by

monthly injections. At each timepoint you will receive a 300 mg dose given as two injections of

150 mg.

For other psoriatic arthritis patients:

The recommended dose is 150 mg by subcutaneous injection.

After the first dose you will receive further weekly injections at Weeks 1, 2, 3 and 4 followed by

monthly injections.

Based on your response, your doctor may increase your dose to 300 mg.

Ankylosing spondylitis

The recommended dose is 150 mg by subcutaneous injection.

After the first dose you will receive further weekly injections at Weeks 1, 2, 3 and 4 followed by

monthly injections.

Cosentyx is for long-term treatment. Your doctor will regularly monitor your condition to check that

the treatment is having the desired effect.

If you use more Cosentyx than you should

If you have received more Cosentyx than you should or the dose has been administered sooner than

according to your doctor’s prescription, inform your doctor.

If you forget to use Cosentyx

If you have forgotten to inject a dose of Cosentyx, inject the next dose as soon as you remember. Then

talk to your doctor to discuss when you should inject the next dose.

If you stop using Cosentyx

It is not dangerous to stop using Cosentyx. However, if you stop, your psoriasis, psoriatic arthritis or

ankylosing spondylitis symptoms may come back.

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

4.

Possible side effects

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

Serious side effects

Stop using Cosentyx and tell your doctor or seek medical help immediately if you get any of the

following side effects:

Possible serious infection - the signs may include:

fever, flu-like symptoms, night sweats

feeling tired or short of breath, cough which will not go away

warm, red and painful skin, or a painful skin rash with blisters

burning sensation when passing urine.

Serious allergic reaction - the signs may include:

difficulty breathing or swallowing

low blood pressure, which can cause dizziness or light-headedness

swelling of the face, lips, tongue or throat

severe itching of the skin, with a red rash or raised bumps.

Your doctor will decide if and when you may restart the treatment.

Other side effects

Most of the following side effects are mild to moderate. If any of these side effects becomes severe,

tell your doctor, pharmacist or nurse.

Very common (may affect more than 1 in 10 people):

upper respiratory tract infections with symptoms such as sore throat and stuffy nose

(nasopharyngitis, rhinitis)

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

cold sores (oral herpes)

diarrhoea

runny nose (rhinorrhoea)

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

oral thrush (oral candidiasis)

signs of low levels of white blood cells, such as fever, sore throat or mouth ulcers due to

infections (neutropenia)

athlete’s foot (tinea pedis)

infection of the external ear (otitis externa)

discharge from the eye with itching, redness and swelling (conjunctivitis)

itchy rash (urticaria)

Rare (may affect up to 1 in 1,000 people):

severe allergic reaction with shock (anaphylactic reaction)

Not known (frequency cannot be estimated from the available data):

fungal infections of the skin and mucous membranes (including oesophageal candidiasis)

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. 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 Cosentyx

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 outer box or the label on the pen after “EXP”.

if the liquid contains easily visible particles, is cloudy or is distinctly brown.

Store the pen sealed in its box to protect from light. Store in the refrigerator between 2°C and 8°C. Do

not freeze. Do not shake.

If necessary, Cosentyx can be left out of the refrigerator for a single period of up to 4 days at room

temperature, not above 30°C.

This medicine is for single use only. Ask your pharmacist how to dispose of medicines no longer

required.

6.

Contents of the pack and other information

What Cosentyx contains

The active substance is secukinumab. Each pre-filled pen contains 150 mg secukinumab.

The other ingredients are trehalose dihydrate, L-histidine, L-histidine hydrochloride

monohydrate, L-methionine, polysorbate 80 and water for injections.

What Cosentyx looks like and contents of the pack

Cosentyx solution for injection is a clear liquid. Its colour may vary from colourless to slightly yellow.

Do not use if the liquid contains easily visible particles, is cloudy or is distinctly brown. Cosentyx is

available in unit packs containing 1 or 2 pre-filled pen(s) and in multipacks containing 6 (3 packs of 2)

pre-filled pens. Not all pack sizes may be marketed.

Marketing Authorisation Holder

Novartis Europharm Limited

Vista Building

Elm Park, Merrion Road

Dublin 4

Ireland

Manufacturer

Novartis Pharma GmbH

Roonstraße 25

D-90429 Nuremberg

Germany

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

Authorisation Holder:

België/Belgique/Belgien

Novartis Pharma N.V.

Tél/Tel: +32 2 246 16 11

Lietuva

SIA „Novartis Baltics“ Lietuvos filialas

Tel: +370 5 269 16 50

България

Novartis Bulgaria EOOD

Тел: +359 2 489 98 28

Luxembourg/Luxemburg

Novartis Pharma N.V.

Tél/Tel: +32 2 246 16 11

Česká republika

Novartis s.r.o.

Tel: +420 225 775 111

Magyarország

Novartis Hungária Kft.

Tel.: +36 1 457 65 00

Danmark

Novartis Healthcare A/S

Tlf: +45 39 16 84 00

Malta

Novartis Pharma Services Inc.

Tel: +356 2122 2872

Deutschland

Novartis Pharma GmbH

Tel: +49 911 273 0

Nederland

Novartis Pharma B.V.

Tel: +31 26 37 82 111

Eesti

SIA Novartis Baltics Eesti filiaal

Tel: +372 66 30 810

Norge

Novartis Norge AS

Tlf: +47 23 05 20 00

Ελλάδα

Novartis (Hellas) A.E.B.E.

Τηλ: +30 210 281 17 12

Österreich

Novartis Pharma GmbH

Tel: +43 1 86 6570

España

Novartis Farmacéutica, S.A.

Tel: +34 93 306 42 00

Polska

Novartis Poland Sp. z o.o.

Tel.: +48 22 375 4888

France

Novartis Pharma S.A.S.

Tél: +33 1 55 47 66 00

Portugal

Novartis Farma - Produtos Farmacêuticos, S.A.

Tel: +351 21 000 8600

Hrvatska

Novartis Hrvatska d.o.o.

Tel. +385 1 6274 220

România

Novartis Pharma Services Romania SRL

Tel: +40 21 31299 01

Ireland

Novartis Ireland Limited

Tel: +353 1 260 12 55

Slovenija

Novartis Pharma Services Inc.

Tel: +386 1 300 75 50

Ísland

Vistor hf.

Sími: +354 535 7000

Slovenská republika

Novartis Slovakia s.r.o.

Tel: +421 2 5542 5439

Italia

Novartis Farma S.p.A.

Tel: +39 02 96 54 1

Suomi/Finland

Novartis Finland Oy

Puh/Tel: +358 (0)10 6133 200

Κύπρος

Novartis Pharma Services Inc.

Τηλ: +357 22 690 690

Sverige

Novartis Sverige AB

Tel: +46 8 732 32 00

Latvija

SIA “Novartis Baltics”

Tel: +371 67 887 070

United Kingdom

Novartis Pharmaceuticals UK Ltd.

Tel: +44 1276 698370

This leaflet was last revised in

Other sources of information

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

http://www.ema.europa.eu

Instructions for use of the Cosentyx SensoReady pen

Cosentyx SensoReady pen 150 mg

Solution for injection in a pre-filled pen

Secukinumab

Patient Instructions for Use

Read ALL the way through these instructions before injecting.

These instructions are to help you to inject correctly using the Cosentyx

SensoReady pen.

It is important not to try to inject yourself until you have been trained by

your doctor, nurse or pharmacist.

Your Cosentyx SensoReady pen:

Cosentyx SensoReady pen shown with the

cap removed. Do not remove the cap until

you are ready to inject.

Store your boxed pen in a refrigerator between 2°C

and 8°C and out of the reach of children.

Do not freeze the pen.

Do not shake the pen.

Do not use the pen if it has been dropped with the

cap removed.

For a more comfortable injection, take the pen out of

the refrigerator 15-30 minutes before injecting to

allow it to reach room temperature.

What you need for your injection:

Included in the carton:

A new and unused Cosentyx

SensoReady pen (2 pens are

needed for a 300 mg dose).

Not included in the carton:

Alcohol swab.

Cotton ball or gauze.

Sharps disposal

container

Needle

Needle guard

Cap

Inspection

window

Internal needle

cover

Before your injection:

1. Important safety checks before you inject:

The liquid should be clear. Its colour may vary from colourless to slightly

yellow.

Do not use if the liquid contains easily visible particles, is cloudy or is

distinctly brown. You may see a small air bubble, which is normal.

Do not use the pen if the expiry date has passed.

Do not use if the safety seal has been broken.

Contact your pharmacist if the pen fails any of these checks.

2a. Choose your injection site:

The recommended site is the front of the thighs. You may also use the

lower abdomen, but not the area 5 centimetres around the navel (belly

button).

Choose a different site each time you give yourself an injection.

Do not inject into areas where the skin is tender, bruised, red, scaly or

hard. Avoid areas with scars or stretch marks.

2b. Caregivers and healthcare professionals only:

If a caregiver or healthcare professional is giving you your

injection, they may also inject into your outer upper arm.

3. Cleaning your injection site:

Wash your hands with soap and hot water.

Using a circular motion, clean the injection site with the alcohol swab.

Leave it to dry before injecting.

Do not touch the cleaned area again before injecting.

Your injection:

4. Removing the cap:

Only remove the cap when you are ready to use the pen.

Twist off the cap in the direction of the arrows.

Once removed, throw away the cap. Do not try to re-attach the

cap.

Use the pen within 5 minutes of removing the cap.

5. Holding your pen:

Hold the pen at 90 degrees to the cleaned injection site.

Correct

Incorrect

YOU MUST READ THIS BEFORE INJECTING.

During the injection you will hear 2 loud clicks.

The 1st click indicates that the injection has started. Several seconds

later a 2nd click will indicate that the injection is almost finished.

You must keep holding the pen firmly against your skin until you see a

green indicator fill the window and stop moving.

6. Starting your injection:

Press the pen firmly against the skin to start the injection.

The 1st click indicates the injection has started.

Keep holding the pen firmly against your skin.

The green indicator shows the progress of the injection.

7. Completing your injection:

Listen for the 2nd click. This indicates the injection is almost

complete.

Check the green indicator fills the window and has stopped

moving.

The pen can now be removed.

After your injection:

8. Check the green indicator fills the window:

This means the medicine has been delivered. Contact your doctor if

the green indicator is not visible.

There may be a small amount of blood at the injection site. You can

press a cotton ball or gauze over the injection site and hold it for

10 seconds. Do not rub the injection site. You may cover the

injection site with a small adhesive bandage, if needed.

9. Disposing of your Cosentyx SensoReady pen:

Dispose of the used pen in a sharps disposal container (i.e. a

puncture-resistant closable container, or similar).

Never try to reuse your pen.