COSENTYX 75 mg SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE

2. What you need to know before you (or your child) start using Cosentyx

Do not use Cosentyx:

• to secukinumab or any of the other ingredients of this medicine (listed in section 6).

If you suspect that you (or your child) are allergic, consult your doctor before using Cosentyx.

• that your doctor thinks is important (for example, active tuberculosis).

Warnings and precautions

Talk to your doctor, nurse, or pharmacist before using Cosentyx:

• if you (or your child) have had an infection.
• if you (or your child) have had repeated or long-lasting infections.
• if you (or your child) have ever had an allergic reaction to latex.
• if you (or your child) have a gut condition called Crohn's disease.
• if you (or your child) have a condition that causes inflammation of the large intestine (ulcerative colitis).
• if you (or your child) have been recently vaccinated or are going to be vaccinated during treatment with Cosentyx.
• if you (or your child) are taking any other treatment for psoriasis, such as other immunosuppressants or light therapy with ultraviolet (UV) light.

Tuberculosis

Tell your doctor if you (or your child) have or have had tuberculosis in the past and if you (or your child) know that you have recently been in close contact with someone who has tuberculosis. Your doctor will examine you (or your child) and may do a tuberculosis test before you (or your child) start Cosentyx. If your doctor thinks that you (or your child) are at risk of getting tuberculosis, you (or your child) may be given medicine to treat it. If you (or your child) get symptoms of tuberculosis (such as a persistent cough, weight loss, lack of energy, or a low-grade fever) while taking Cosentyx, tell your doctor right away.

Hepatitis B

Tell your doctor if you (or your child) have or have had a hepatitis B infection. This medicine may cause the infection to come back. Before and during treatment with secukinumab, your doctor may check you (or your child) for signs of infection. Tell your doctor if you notice any of the following symptoms: worsening tiredness, yellowing of the skin or the white part of the eyes, dark urine, loss of appetite, nausea, and/or pain in the upper right part of the stomach.

Inflammatory bowel disease (Crohn's disease or ulcerative colitis)

Stop using Cosentyx and tell your doctor or seek medical help right away if you (or your child) notice stomach cramps and pain, diarrhea, weight loss, blood in the stool, or any other sign of bowel problems.

Watch for signs of infection and allergic reactions

Cosentyx may cause serious side effects, including infections and allergic reactions. You should watch for signs of these conditions while you (or your child) are using Cosentyx.

Stop using Cosentyx and tell your doctor or seek medical help right away if you (or your child) notice any of the signs of a possible serious infection or allergic reaction. These signs are listed in section 4 "Possible side effects".

Children and adolescents

Cosentyx is not recommended for use in children under 6 years of age with plaque psoriasis because it has not been studied in this age group.

Cosentyx is not recommended for use in children under 6 years of age with juvenile idiopathic arthritis (enthesitis-related arthritis and juvenile psoriatic arthritis).

Cosentyx is not recommended for use in children and adolescents (under 18 years of age) for other indications because it has not been studied in this age group.

Other medicines and Cosentyx

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 been recently vaccinated or are going to be vaccinated soon. You (or your child) should not be given certain types of vaccines (live vaccines) while using Cosentyx.

Pregnancy, breastfeeding, and fertility

• It is recommended that you avoid using Cosentyx during pregnancy. The effect of this medicine on pregnant women is not known. If you (or your daughter) are of childbearing age, it is recommended that you avoid becoming pregnant and use adequate contraception while using Cosentyx and for at least 20 weeks after the last dose of Cosentyx. Talk to your doctor if you (or your daughter) are pregnant, think you may be pregnant, or plan to become pregnant.
• Talk to your doctor if you (or your daughter) are breastfeeding or plan to breastfeed. You and your doctor will decide if you (or your daughter) should breastfeed or use Cosentyx. You (or your daughter) cannot do both. After using Cosentyx, you (or your daughter) should not breastfeed for at least 20 weeks after the last dose.

Driving and using machines

Cosentyx is unlikely to affect your ability to drive or use machines.

3. How to use Cosentyx

Follow the instructions for administration of this medicine exactly as your doctor has told you. If you are not sure, ask your doctor, pharmacist, or nurse again.

Cosentyx is given by injection under the skin (i.e., subcutaneously). You and your doctor will decide if, after proper training, you should inject Cosentyx yourself or have a caregiver give the injection.

It is important that you do not try to inject Cosentyx until your doctor, nurse, or pharmacist has shown you how to do it.

Detailed instructions on how to administer Cosentyx can be found in the "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 website:

'QR code to be included'

www.cosentyx.eu

How much Cosentyx to use and for how long

Your doctor will decide how much Cosentyx you (or your child) need and for how long.

Pediatric plaque psoriasis(children from 6 years of age)

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

Your doctor may increase the dose to 300 mg.

• Each 75 mg dose is given as a 75mginjection. For the administration of 150 mg and 300 mg doses, other formulations/concentrations may be available.

After the first dose, you (or your child) will receive injections every week for 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 and above: 150 mg by subcutaneous injection.
• Each 75 mg dose is given as a 75 mg injection. For the administration of the 150 mg dose, other formulations/concentrations may be available.

After the first dose, you (or your child) will receive injections every week for weeks 1, 2, 3, and 4, followed by monthly injections.

Cosentyx is a long-term treatment. Your doctor will regularly check the condition of your (or your child's) disease to see if the treatment is working.

If you use more Cosentyx than you should

If you (or your child) receive more Cosentyx than you should or the dose has been given before the time indicated by your doctor, tell 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 (or your child) remember. Then talk to your doctor to find out when you should inject the next dose.

If you (or your child) stop using Cosentyx

It is not dangerous to stop using Cosentyx. However, if you do, it is possible that the symptoms of your (or your child's) psoriasis may come back.

If you have any other questions about 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 right away if you (or your child) notice any of the following side effects:

Possible serious infection– the signs may include:

• fever, flu-like symptoms, night sweats
• feeling tired or having trouble breathing, persistent cough
• hot, red, and painful skin, or a painful rash with blisters
• burning when urinating.

Severe allergic reaction– the signs may include:

• difficulty breathing or swallowing
• low blood pressure, which can cause dizziness or fainting
• swelling of the face, lips, tongue, or throat
• intense itching of the skin with a rash or blisters.

Your doctor will decide if you (or your child) should and when to restart treatment.

Other side effects

Most of the following side effects are mild or moderate. If they become 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 nasal congestion (pharyngitis, rhinitis).

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

• mouth ulcers (oral herpes)
• diarrhea
• nasal discharge (rhinorrhea)
• headache
• nausea
• fatigue
• itching, redness, and dryness of the skin (eczema)

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

• mouth thrush (oral candidiasis)
• signs of low white blood cell count, such as fever, sore throat, or mouth ulcers due to infections (neutropenia)
• infection of the outer ear (otitis externa)
• eye discharge with itching, redness, and swelling (conjunctivitis)
• itchy rash (urticaria)
• lower respiratory tract infections
• stomach cramps, abdominal pain, diarrhea, weight loss, or blood in the stool (signs of bowel problems)
• small, itchy blisters on the palms of the hands, soles of the 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 peeling of the skin over a large area of the body, which may be itchy or painful (exfoliative dermatitis)
• inflammation of the small blood vessels, which can cause a skin rash with small red or purple bumps (vasculitis)
• swelling of the neck, face, mouth, or throat that can cause difficulty swallowing or breathing (angioedema)

Frequency not known(cannot be estimated from the available data):

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

Reporting of side effects

If you (or your child) experience 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. Storing 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 carton or on the label of the pre-filled syringe after "EXP".
• if the liquid contains easily visible particles, is cloudy, or has a clearly brown color.

Store the pre-filled syringe in its original carton to protect it from light. Store in a refrigerator at 2°C to 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.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Container Contents and Additional Information

Cosentyx Composition

• The active ingredient is secukinumab. Each pre-filled syringe contains 75 mg of secukinumab.
• The other components are trehalose dihydrate, histidine, histidine hydrochloride monohydrate, methionine, polysorbate 80, and water for injectable preparations.

Appearance of Cosentyx and Container Contents

Cosentyx injectable solution is a clear liquid. Its color varies from colorless to slightly yellow.

Cosentyx 75 mg solution for injection in a pre-filled syringe is available in single-unit packs of 1 pre-filled syringe and in multi-packs containing 3 (3 packs of 1) pre-filled syringes.

Not all pack sizes may be marketed.

Marketing Authorization Holder

Novartis Europharm Limited

Vista Building

Elm Park, Merrion Road

Dublin 4

Ireland

Manufacturer

Novartis Pharma GmbH

Roonstraße 25

90429 Nuremberg

Germany

Sandoz GmbH

Biochemiestrasse 10

6336 Langkampfen

Austria

Novartis Pharmaceutical Manufacturing GmbH

Biochemiestrasse 10

6336 Langkampfen

Austria

Novartis Pharma GmbH

Sophie-Germain-Strasse 10

90443 Nürnberg

Germany

For further information, please contact the local representative of the marketing authorization holder:

Date of Last Revision of this Leaflet:11/2024

Other Sources of Information

Detailed information on this medicinal product is available on the European Medicines Agency website: http://www.ema.europa.eu

Instructions for Use of Cosentyx 75 mg Pre-filled Syringe

Read ALL the instructions before injecting the medicine. It is important that you do not attempt to inject the medicine or a person under your care until a doctor, nurse, or pharmacist has taught you how to do it. The box contains a pre-filled syringe of Cosentyx 75 mg inside a plastic blister.

Your Cosentyx 75 mg Pre-filled Syringe

Once the medicine has been injected, the needle shield will be activated. This is designed to protect against accidental needlestick injuries to healthcare professionals, patients who self-inject the prescribed medicine, and individuals who assist patients with self-injection.

Important Safety Information

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

1. The needle cap of the syringe may contain dry natural rubber (latex) that should not be touched by people sensitive to it.
2. Do not open the box until you are ready to use the syringe.
3. Do not use this medicine if the box seal or blister is broken, as it may not be safe to use.
4. Do not use the syringe if it has been dropped onto a hard surface or if it has been dropped after removing the needle cap.
5. Never leave the syringe in places where others may touch it.
6. Do not shake the syringe.
7. Be very careful not to touch the activation clips before use. If you do, the needle shield will trigger prematurely.
8. Do not remove the needle cap until just before injecting.
9. The syringe cannot be reused. Once used, dispose of the syringe in a sharps disposal container.

Storage of Cosentyx 75 mg Pre-filled Syringe

1. Store this medicine in its sealed box to protect it from light. Store in a refrigerator at 2°C to 8°C. DO NOT FREEZE.
2. Remember to remove the syringe from the refrigerator to allow it to reach room temperature before preparing the injection (15-30 minutes).
3. Do not use the syringe after the expiration date shown on the box or on the syringe label after “EXP”. If it has expired, return the complete package to the pharmacy.

Injection Sites

Preparing Cosentyx 75 mg Pre-filled Syringe for Use

1. Remove the box with the syringe from the refrigerator and let it unopenedfor 15-30 minutes to reach room temperature.
2. When you are ready to use the syringe, wash your hands well with soap and water.
3. Disinfect the injection site well with an alcohol wipe.
4. Remove the syringe from the box and take it out of the blister by holding the protective body of the syringe.
5. Inspect the syringe. The liquid should be clear. Its color may vary from colorless to slightly yellowish. There may be a small air bubble, which is normal. DO NOT USE if the liquid contains particles, is cloudy, or has a clearly brown color. DO NOT USE if the syringe is broken. In all these cases, return the complete package to the pharmacy.

How to Use the Cosentyx 75 mg Pre-filled Syringe

Disposal Instructions