Cosentyx
secukinumab
secukinumab
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 (or your child) only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours (or your child’s).
If you (or your child) 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 Cosentyx is and what it is used for
What you need to know before you (or your child) use Cosentyx
How to use Cosentyx
Possible side effects
How to store Cosentyx
Contents of the pack and other information
Cosentyx contains the active substance secukinumab. Secukinumab is a monoclonal antibody which 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 axial spondyloarthritis.
Cosentyx is used for the treatment of the following inflammatory diseases:
Paediatric plaque psoriasis
Juvenile idiopathic arthritis, including enthesitis-related arthritis and juvenile psoriatic arthritis
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 adolescents and children (6 years of age and older) with moderate to severe plaque psoriasis.
Using Cosentyx in plaque psoriasis will benefit you (or your child) by leading to improvements of skin clearance and reducing symptoms such as scaling, itching and pain.
Using Cosentyx in enthesitis-related arthritis and juvenile psoriatic arthritis will benefit you (or your child) by reducing the symptoms and improving your (or your child’s) physical function.
If you think you (or your child) may be allergic, ask your doctor for advice before using
Cosentyx.
Talk to your doctor, nurse or pharmacist before using Cosentyx:
if you (or your child) currently have an infection
if you (or your child) have long-term or repeated infections.
if you (or your child) have tuberculosis.
if you (or your child) have ever had an allergic reaction to latex.
if you (or your child) have an inflammatory disease affecting the gut called Crohn’s disease.
if you (or your child) have an inflammation of the large intestine called ulcerative colitis.
if you (or your child) have recently had a vaccination or are due to have a vaccination during treatment with Cosentyx.
if you (or your child) are receiving any other treatment for psoriasis, such as another immunosuppressant or phototherapy with ultraviolet (UV) light.
Stop using Cosentyx and tell your doctor or seek medical help immediately if you (or your child) notice abdominal cramps and pain, diarrhoea, weight loss, blood in the stool or any other signs of bowel problems.
Cosentyx can potentially cause serious side effects, including infections and allergic reactions. You must look out for signs of these conditions while you (or your child) are taking Cosentyx.
Stop using Cosentyx and tell your doctor or seek medical help immediately if you (or your child) notice any signs indicating a possible serious infection or an allergic reaction. Such signs are listed under “Serious side effects” in section 4.
Cosentyx is not recommended for children younger than 6 years of age with plaque psoriasis because it has not been studied in this age group.
Cosentyx is not recommended for children younger than 6 years of age with juvenile idiopathic arthritis (enthesitis-related arthritis and juvenile psoriatic arthritis).
Cosentyx is not recommended for children and adolescents (under 18 years of age) in other indications because it has not been studied in this age group.
Tell your doctor or pharmacist:
if you (or your child) are taking, have recently taken or might take any other medicines.
if you (or your child) have recently had or are due to have a vaccination. You (or your child) should not be given certain types of vaccines (live vaccines) while using Cosentyx.
It is preferable to avoid the use of Cosentyx in pregnancy. The effects of this medicine in pregnant women are not known. If you (or your child) are of childbearing potential, you (or your child) 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 (or your child) are pregnant, may be pregnant or are planning to have a baby.
Talk to your doctor if you (or your child) are breast-feeding or are planning to breast-feed. You and your doctor should decide if you (or your child) will breast-feed or use Cosentyx. You (or your child) should not do both. After using Cosentyx you (or your child) should not breast-feed for at least 20 weeks after the last dose.
Cosentyx is unlikely to influence your ability to drive and use machines.
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 the skin (known as a subcutaneous injection). You and the doctor should decide if, after proper training, you should inject Cosentyx yourself or a caregiver should give the injection.
It is important not to try to inject Cosentyx before being trained by your doctor, nurse or pharmacist.
For detailed instructions on how to inject Cosentyx, see “Instructions for use of Cosentyx 75 mg pre-filled syringe” at the end of this leaflet.
Instructions for use can also be found via the following QR code and web site: ‘QRcodetobeincluded’
Your doctor will decide how much Cosentyx you (or your child) need and for how long.
Paediatric plaque psoriasis (children aged 6 years and older)
The recommended dose is based on body weight as follows:
Weight below 25 kg: 75 mg by subcutaneous injection.
Weight 25 kg or above and below 50 kg: 75 mg by subcutaneous injection.
Weight 50 kg or above: 150 mg by subcutaneous injection.
Your doctor may increase the dose to 300 mg.
Each 75 mg dose is given as one injection of 75 mg. Other dosage forms/strengths may be available for administration of the 150 mg and 300 mg doses.
After the first dose you (or your child) will receive further weekly injections at weeks 1, 2, 3 and 4 followed by monthly injections.
Juvenile idiopathic arthritis (enthesitis-related arthritis and juvenile psoriatic arthritis)
The recommended dose is based on body weight as follows:
Weight below 50 kg: 75 mg by subcutaneous injection.
Weight 50 kg or above: 150 mg by subcutaneous injection.
Each 75 mg dose is given as one injection of 75 mg. Other dosage forms/strengths may be available for administration of the 150 mg dose.
After the first dose you (or your child) 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 (or your child’s) condition to check that the treatment is having the desired effect.
If you (or your child) have received more Cosentyx than you (they) should or the dose has been administered sooner than according to your doctor’s prescription, inform your doctor.
If you have forgotten to inject a dose of Cosentyx, inject the next dose as soon as you (or your child) remember. Then talk to your doctor to discuss when you should inject the next dose.
It is not dangerous to stop using Cosentyx. However, if you stop, your (or your child’s) psoriasis symptoms may come back.
If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop using Cosentyx and tell your doctor or seek medical help immediately if you (or you child) get any of the following side effects:
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.
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 (or your child) may restart the treatment.
Most of the following side effects are mild to moderate. If any of these side effects becomes severe, tell your doctor, pharmacist or nurse.
upper respiratory tract infections with symptoms such as sore throat and stuffy nose (nasopharyngitis, rhinitis)
cold sores (oral herpes)
diarrhoea
runny nose (rhinorrhoea)
athlete’s foot (tinea pedis)
headache
nausea
fatigue
oral thrush (oral candidiasis)
signs of low levels of white blood cells, such as fever, sore throat or mouth ulcers due to infections (neutropenia)
infection of the external ear (otitis externa)
discharge from the eye with itching, redness and swelling (conjunctivitis)
itchy rash (urticaria)
lower respiratory tract infections
abdominal cramps and pain, diarrhoea, weight loss or blood in the stool (signs of bowel problems)
small, itchy blisters on the palms of hands, soles of feet and edges of the fingers and toes (dyshidrotic eczema)
severe allergic reaction with shock (anaphylactic reaction)
redness and shedding of skin over a larger area of the body, which may be itchy or painful (exfoliative dermatitis)
inflammation of small blood vessels, which can lead to a skin rash with small red or purple bumps (vasculitis)
fungal infections of the skin and mucous membranes (including oesophageal candidiasis)
If you (or your child) 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.
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.
Do not throw away any medicines via wastewater. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
The active substance is secukinumab. Each pre-filled syringe contains 75 mg secukinumab.
The other ingredients are trehalose dihydrate, histidine, histidine hydrochloride monohydrate, methionine, polysorbate 80 and water for injections.
Cosentyx solution for injection is a clear liquid. Its colour may vary from colourless to slightly yellow. Cosentyx 75 mg solution for injection in pre-filled syringe is available in unit packs containing
1 pre-filled syringe and in multipacks containing 3 (3 packs of 1) pre-filled syringes.
Not all pack sizes may be marketed.
Novartis Europharm Limited Vista Building
Elm Park, Merrion Road
Dublin 4 Ireland
90429 Nuremberg Germany
Sandoz GmbH | ||
Biochemiestrasse 10 | ||
6336 Langkampfen | ||
Austria |
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
SIA Novartis Baltics Lietuvos filialas Tel: +370 5 269 16 50
Novartis Bulgaria EOOD Тел: +359 2 489 98 28
Novartis s.r.o.
Tel: +420 225 775 111
Novartis Healthcare A/S Tlf: +45 39 16 84 00
Novartis Pharma Services Inc. Tel: +356 2122 2872
Novartis Pharma GmbH Tel: +49 911 273 0
Novartis Pharma B.V. Tel: +31 88 04 52 111
SIA Novartis Baltics Eesti filiaal Tel: +372 66 30 810
Novartis Norge AS Tlf: +47 23 05 20 00
Novartis (Hellas) A.E.B.E. Τηλ: +30 210 281 17 12
Novartis Pharma GmbH Tel: +43 1 86 6570
Novartis Farmacéutica, S.A. Tel: +34 93 306 42 00
Novartis Poland Sp. z o.o. Tel.: +48 22 375 4888
Novartis Pharma S.A.S. Tél: +33 1 55 47 66 00
Novartis Farma - Produtos Farmacêuticos, S.A. Tel: +351 21 000 8600
Novartis Hrvatska d.o.o. Tel. +385 1 6274 220
Novartis Pharma Services Romania SRL Tel: +40 21 31299 01
Novartis Ireland Limited Tel: +353 1 260 12 55
Novartis Pharma Services Inc. Tel: +386 1 300 75 50
Vistor hf.
Sími: +354 535 7000
Novartis Farma S.p.A. Tel: +39 02 96 54 1
Novartis Finland Oy
Puh/Tel: +358 (0)10 6133 200
Novartis Pharma Services Inc. Τηλ: +357 22 690 690
Novartis Sverige AB Tel: +46 8 732 32 00
SIA Novartis Baltics Tel: +371 67 887 070
Novartis Ireland Limited Tel: +44 1276 698370
Read ALL the way through these instructions before injecting. It is important not to try to inject yourself or a person in your care until you have been trained by your doctor, nurse or pharmacist. The box contains one Cosentyx 75 mg pre-filled syringe individually sealed in a plastic blister.
Syringe Guard
Finger grips Plunger
Needle cap Viewing window Label &
expiry date
Syringe guard wings
Plunger head
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.
Alcohol swab.
Cotton ball or gauze.
Sharps disposal container.
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.
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).
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 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.
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 by holding the syringe guard body.
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.
Carefully remove the needle cap from the syringe by holding the syringe guard body. 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 at an angle of approximately
45 degrees 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.
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.
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.