InfoCons Consumer Protection informs you – Cosentyx – Package Leaflet

Before anything else

Read all of this leaflet carefully before you (or your child ) start using this medicine because it contains important information.

• 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.

ℹ️ 1. What Cosentyx is and what it is used for

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, hidradenitis suppurativa, psoriatic arthritis and axial spondyloarthritis.

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

• Plaque psoriasis
• Hidradenitis suppurativa
• Psoriatic arthritis
• Axial spondyloarthritis, including ankylosing spondylitis (radiographic axial spondyloarthritis) and non -radiographic axial spondyloarthritis
• Juvenile idiopathic arthritis, including enthesitis -related arthritis and juvenile psoriatic arthritis 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, adolescents and children (6 years of age an d older) 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.

Hidradenitis suppurativa Cosentyx is used to treat a condition called hidradenitis suppurativa, also sometimes called acne inversa or Verneuil’s disease. This condition is a chronic and painful inflammatory skin disease.

Symptoms may include tender nodules (lumps) and abscesses (boils) that m ay leak pus. It commonly affects specific areas of the skin, such as under the breasts, the armpits, inner thighs, groin and buttocks. Scarring may also occur in affected areas.

204 Cosentyx can reduce the number of nodules and abscesses you have and the pain that is often associated with the disease. If you have hidradenitis suppurativa you will first be given other medicines. If you do not respond well enough to these medicines, you will be given Cosentyx.

Cosentyx is used in adults with hidradenitis suppurativa and can be used alone or with antibiotics.

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.

Axial spondyloarthritis, including ankylosing spondylitis (radiographic axial spondyloarthritis) and non -radiographic axial spondyloarthritis Cosentyx is used to treat conditions called “ankylosing spondylitis” and “non -radiographic axial spondyloarthritis”. These conditions are inflammatory diseases primarily affecting the spine which cause inflammation of the spinal joints. If you have ankylos ing spondylitis or non -radiographic axial spondyloarthritis 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 i mprove your physical function.

Cosentyx is used in adults with active ankylosing spondylitis and active non -radiographic axial spondyloarthritis.

Using Cosentyx in ankylosing spondylitis and non -radiographic axial spondyloarthritis will benefit you by reducing the signs and symptoms of your disease and improving your physical function.

Juvenile idiopathic arthritis, including enthesitis -related arthritis and juvenile psoriatic arthritis Cosentyx is used in patients (6 years of age and older) to treat conditions of the juvenile idiopathic arthritis categories called “enthesitis -related arthritis” and “juvenile psoriatic arthritis”. These conditions are inflammatory diseases affecting the joints and the places where tendons join the bone.

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.

⚠️ 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 (for example, active tuberculosis) .

205 Warnings and precautions Talk to your doctor, nurse or pharmacist before using Cosentyx:

• if you currently have an infection .
• if you have long -term or repeated infections.
• if you have an inflammatory disease affecting your gut called Crohn’s disease.
• if you have an inflammation of your large intestine called 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.

Tuberculosis Talk to your doctor if you have or previously had tuberculosis. Also tell your doctor if you have recently been in close contact with someone who has tuberculosis. Your doctor will evaluate you and may do a test for tuberculosis before you use Cosentyx. If your doctor thinks you are at risk of tuberculosis, you may be given medicines to treat it. If symptoms of tuberculosis (such as persistent cough, weight loss, listlessness or mild fever) appear during treatment with Cosentyx , tell your doctor immediately.

Hepatitis B Talk to your doctor if you have or previously had a hepatitis B infection. This medicine may cause a reactivation of the infection. Before and during secukinumab treatment, your doctor may check you for signs of infection. Tell your doctor if you notice an y of the following symptoms: worsening tiredness, yellowing of the skin or white part of the eyes, dark urine, loss of appetite, nausea and/or pain in the upper right side of the stomach area.

Inflammatory bowel disease (Crohn’s disease or ulcerative colitis) Stop using Cosentyx and tell your doctor or seek medical help immediately if you notice abdominal cramps and pain, diarrhoea, weight loss, blood in the stool or any other signs of bowel problems.

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 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.

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.

206 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 l ast 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 is unlikely to influence your 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.

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

Plaque psoriasis Adult

• 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. Based on your response, further adjustments to your dose may be recommended by your doctor. At each timepoint you will receive a 300 mg dose given as two injections of 150 mg.

Children aged 6 years and older

• The recommended dose is based on body weight as follows: o Weight below 25 kg: 75 mg by subcutaneous injection . o Weight 25 kg or above and below 50 kg: 75 mg by subcutaneous injection . o Weight 50 kg or above: 150 mg by subcutaneous injection .

Your doctor may increase the dose to 300 mg.

• Each 150 mg dose is given as one injection of 150 mg. Other dosage forms/strengths may be available for administration of the 75 mg and 300 mg doses.

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

Hidradenitis suppurativa

• 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. Based on your response, further adjustments to your dose may be recommended by your doctor.

207 Psoriatic arthritis If you have both psoriatic arthritis and also moderate to severe plaque psoriasis , your doctor may adjust the dose recommendation as needed.

For 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 (Radiographic axial spondyloarthritis)

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

Non-radiographic axial spondyloarthritis

• 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.

Juvenile idiopathic arthritis (enthesitis -related arthritis and juvenile psoriatic arthritis)

• The recommended dose is based on body weight as follows: o Weight below 50 kg: 75 mg by subcutaneous injection. o Weight 50 kg or above: 150 mg by subcutaneous injection.
• Each 150 mg dose is given as one injection of 150 mg. Other dosage forms/strengths may be available for administration of the 75 mg dose.

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.

208 If you stop using Cosentyx It is not dangerous to stop using Cosentyx. However, if you stop, your psoriasis, psoriatic arthritis or axial spondyloarthritis 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)
• headache
• nausea
• fatigue
• itchy, red and dry skin (eczema)

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)
• 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) 209 • small, itchy blisters on the palms of hands, soles of feet and edges of the fingers and toes (dyshidrotic eczema)
• athlete’s foot (tinea pedis)

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

• 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)
• swelling of the neck, face, mouth or throat which may lead to difficulty swallowing or breathing (angioedema)

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

• fungal infections of the skin and mucous membranes (including oesophageal candidiasis)
• painful swelling and skin ulceration (pyoderma gangrenosum)

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.

Do not use this medicine if you notice that the powder has not fully dissolved or if the liquid contains easily visible particles, is cloudy or is distinctly brown.

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.

📦 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, histidine, 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.

Cosentyx is supplied in a pack containing one vial.

210 Marketing Authorisation Holder Novartis Europharm Limited Vista Building Elm Park, Merrion Road Dublin 4 Ireland

Manufacturer

Lek Pharmaceuticals d.d.

Verovškova ulica 57 Ljubljana, 1526 Slovenia Novartis Farmacéutica, S.A.

Gran Vía de les Corts Catalanes, 764 08013 Barcelona Spain Novartis Pharma GmbH Sophie -Germain -Strasse 10 90443 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 88 04 52 111 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 211 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

This leaflet was last revised in

Other sources of information Detailed information on this medicine is available on the European Medicines Agency web site: https://www.ema.europa.eu 212 Instructions for use of Cosentyx powder for solution for injection The following information is intended for medical or healthcare professionals only.

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:

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

2. Withdraw slightly more than 1.0 ml sterile water for injections into a 1 ml graduated disposable syringe and adjust to 1.0 ml.

3. Remove the plastic cap from the vial.

4. 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.

5. 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.

6. 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.

7. 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.

8. 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 liq uid contains easily visible particles, is cloudy or is distinctly brown.

9. Prepare the required number of vials (1 vial for the 75 mg dose, 1 vial for the 150 mg dose, 2 vials for the 300 mg dose).

After storage at 2°C to 8°C, the solution should be allowed to come to room temperature for approximately 20 minutes before administration.

Instructions for administration of Cosentyx solution 1. 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.

2. For the 150 mg and 300 mg doses, 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 with drawing Cosentyx into the disposable syringe. Prepare the required number of syringes (2 syringes for the 300 mg dose).

For a child receiving the 75 mg dose, carefully withdraw slightly more than 0.5 ml of the solution for subcutaneous injection and discard the rest immediately.

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

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

5. Expel the air bubbles and advance the plunger to the 1.0 ml mark for the 150 mg dose.

Expel the air bubbles and advance the plunger to the 0.5 ml mark for the 75 mg dose.

6. Clean the injection site with an alcohol swab.

214 7. 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 s kin is tender, bruised, red, scaly or hard. Avoid areas with scars or stretch marks.

8. 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 an d health of you and others, needles and used syringes must never be re -used.

📄 Package Leaflet – official source

This article reproduces the information in the official package leaflet, as authorised in the European Union. You can consult the original document here: Product information Cosentyx (PDF, ec.europa.eu).

You can check this medicine at any time in the Union Register of medicinal products (EU number EU/1/14/980).

⚠️ Important: This article is for information purposes only and does not replace medical advice or the package leaflet inside the medicine box. Read the leaflet carefully before use. For any questions about your treatment, talk to your doctor or pharmacist. If you experience side effects, tell your doctor or pharmacist and report them through your national reporting system.