Cosentyx 75 mg solucion inyectable en jeringa precargada

Prospecto: information for the user

Cosentyx 75mg injectable solution in pre-filled syringe

secukinumab

Read this prospect carefully before you (or your child) start using this medicine, because it contains important information.

• Keep this prospect, as you may need to read it again.
• If you have any questions, consult your doctor, pharmacist, or nurse.

‑This medicine has been prescribed only for you (or your child), and you must not give it to other people even if they have the same symptoms as you (or your child), as it may harm them.

• If you (or your child) experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this prospect. See section4.

1.What is Cosentyx and for what it is used

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

3.How to use Cosentyx

4.Possible adverse effects

5.Storage of Cosentyx

6.Contents of the package and additional information

Cosentyx contains the active ingredient secukinumab. Secukinumab is a monoclonal antibody that belongs to a group of medications known as “interleukin inhibitors”. It acts by neutralizing the activity of a protein called IL-17A, which is present in high amounts in diseases such as psoriasis, psoriatic arthritis, and axial spondyloarthritis.

Cosentyx is used to treat the following inflammatory diseases:

• Plaque psoriasispediatric

Plaque psoriasis pediatric

Cosentyx is used to treat a skin disorder known as “plaque psoriasis” that causes inflammation in the skin. Cosentyx reduces inflammation and other symptoms of the disease. Cosentyx is used in adolescents and children (from 6 years of age) who suffer from moderate to severe plaque psoriasis.

Using Cosentyx for plaque psoriasis will benefit you (or your child) as it produces improvements in skin appearance and a decrease in symptoms such as scaling, itching, and pain.

Juvenile idiopathic arthritis, including enthesitis-related arthritis and juvenile psoriatic arthritis

Cosentyx is used in patients (from 6 years of age) to treat juvenile idiopathic arthritis in the categories known as “enthesitis-related arthritis” and “juvenile psoriatic arthritis”. These are inflammatory diseases that affect the joints and the places where tendons attach to bone.

Using Cosentyx in enthesitis-related arthritis and juvenile psoriatic arthritis will benefit you (or your child) by reducing symptoms and improving physical function (or that of your child).

You should not use Cosentyx:

• ifyou (or your child)are allergicto secukinumab or any of the other ingredients in this medicine (listed in section6).

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

• ifyou (or your child)have any infectionthat your doctor considers important.

Warnings and precautions

Consult your doctor, nurse or pharmacist before using Cosentyx:

• ifyou (or your child)have contracted an infection.
• ifyou (or your child)have recurring or prolonged infections.
• ifyou (or your child)have tuberculosis.
• ifyou (or your child)have had any latex allergy reaction.
• ifyou (or your child)have an inflammatory bowel disease called Crohn's disease.
• ifyou (or your child)have an inflammatory bowel disease called ulcerative colitis.
• ifyou (or your child)have been recently vaccinated or are to be vaccinated during treatment with Cosentyx.
• ifyou (or your child)are taking other treatments for psoriasis, such as other immunosuppressants or ultraviolet (UV) light therapy.

Hepatitis B

Consult your doctor if you (or your child) have or have had hepatitis B infection. This medicine may cause reactivation of the infection. Before and during treatment with secukinumab, your doctor may examine you (or your child) for signs of infection. Inform your doctor if you notice any of the following symptoms: worsening fatigue, yellowing of the skin or white part of the eyes, dark urine, loss of appetite, nausea and/or upper right abdominal pain.

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

Stop using Cosentyx and inform your doctor or seek medical help immediately ifyou (or your child)notice abdominal cramps and pain, diarrhea, weight loss, blood in the stool or any other signs of intestinal problems.

Watch for signs of infections and allergic reactions

Cosentyx may potentially cause severe side effects, including infections and allergic reactions. You must watch for signs of these diseases whileyou (or your child)areusingCosentyx.

Interrupt treatment with Cosentyx and inform your doctor or seek medical help immediately ifyou (or your child)notice any of the signs indicating a possible severe infection or allergic reaction. These signs are listed in section4 “Possible side effects”.

Children and adolescents

Cosentyx is not recommended for children under 6years of age with plaque psoriasissince the medicine has not been studied in people of this age.

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

Cosentyx is not recommended for children and adolescents (under 18years) in other indications since the medicine has not been studied in people of this age.

Other medicines and Cosentyx

Inform your doctor or pharmacist:

• ifyou (or your child)are taking, have taken or may need to take any other medicine.
• ifyou (or your child)have been recently vaccinated or are to be vaccinated soon. Do not administer certain types of vaccines (live vaccines) while using Cosentyx.

Pregnancy, breastfeeding and fertility

• It is preferable to avoid using Cosentyx during pregnancy. The effect of this medicine on pregnant women is unknown. If you (or your daughter) are fertile, it is recommended that you avoid becoming pregnant and use an appropriate contraceptive while using Cosentyx and for at least 20weeks after the last dose of Cosentyx. Consult your doctor if you (or your daughter) are pregnant, may be pregnant or intend to become pregnant.
• Consult your doctor if you (or your daughter) are breastfeeding or plan to breastfeed. You and your doctor must decide whether you (or your daughter) will breastfeed or use Cosentyx. You (or your daughter) cannot do both. After using Cosentyx, you (or your daughter) must not breastfeed for at least 20weeks after the last dose.

Driving and operating machinery

Cosentyx is unlikely to affect your ability to drive or operate machinery.

Follow exactly the administration instructions of this medication as indicated by your doctor. In case of doubt, consult your doctor, pharmacist, or nurse again.

Cosentyx is administered through a subcutaneous injection under the skin. You and your doctor must decide whether, after proper training, you should administer Cosentyx yourself or have a caregiver administer the injection.

It is essential that you do not attempt to inject Cosentyx before the doctor, nurse, or pharmacist has taught you how to do it.

Instructions for use of Cosentyx 75 mg in pre-filled syringe are provided in the "Instructions for use of Cosentyx 75 mg in pre-filled syringe" section at the end of this leaflet.

Instructions for use can also be found through the following QR code and website:

‘QR code to include’

www.cosentyx.eu

How much Cosentyx should be administered and for how long

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

Psoriasis in plaquespediatric(children aged 6 years and above)

• The recommended dose is based on the following body weight:
• • Body weight less than 25 kg: 75 mg by subcutaneous injection.
  • Body weight between 25 kg and below 50 kg: 75 mg by subcutaneous injection.
  • Body weight 50 kg or above: 150 mg by subcutaneous injection.

Your doctor may increase the dose to 300 mg.

• Each dose of 75 mg is administered as a 75 mg injection. For the administration of 150 mg and 300 mg doses, other forms of dosing/concentrations may be available.

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

Idiopathic juvenile arthritis (arthritis associated with enthesitis and juvenile psoriatic arthritis)

• The recommended dose is based on the following body weight:
• • Body weight less than 50 kg: 75 mg by subcutaneous injection.
  • Body weight 50 kg or above: 150 mg by subcutaneous injection.
• Each dose of 75 mg is administered as a 75 mg injection. For the administration of the 150 mg dose, other forms of dosing/concentrations may be available.

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

Cosentyx is a long-term treatment. Your doctor will monitor your condition (or your child's) periodically to check if the treatment is effective.

If you use more Cosentyx than you should

If you (or your child) receive more Cosentyx than you should or the dose has been administered before the time indicated by your doctor, inform your doctor.

If you forgot 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 to inject the next dose.

If you (or your child) stop using Cosentyx

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

If you have any other questions about the use of this medication, ask your doctor, pharmacist, or nurse.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Severe side effects

Stop treatment with Cosentyx and inform your doctor or seek immediate medical assistance if you (or your child) notice any of the following side effects:

Possible severe infection– the signs may include:

• fever, flu-like symptoms, night sweats
• feeling tired or difficulty breathing, persistent cough
• hot, red, and painful skin to the touch, or painful rash with blisters
• burning sensation while urinating.

Severe allergic reaction– the signs may include:

• difficulty breathing or swallowing
• low blood pressure, which may cause dizziness or lightheadedness
• swelling of the face, lips, tongue, or throat
• intense itching of the skin accompanied by 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, inform your doctor, pharmacist, or nurse.

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

• upper respiratory tract infections with symptoms such as sore throat and nasal congestion (rhinopharyngitis, rhinitis).

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

• 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 100people):

• oral thrush (candidiasis oral)
• signs of low white blood cell count, such as fever, sore throat, or mouth ulcers due to infections (neutropenia)
• outer ear infection (otitis externa)
• suppurative conjunctivitis with itching, redness, and swelling
• urticaria (hives)
• lower respiratory tract infections
• abdominal cramps, abdominal pain, diarrhea, weight loss, or blood in the stool (signs of intestinal problems)
• small blisters with itching on the palms of the hands, soles of the feet, and edges of the fingers and toes (eczema dishidrotic)
• athlete's foot (tinea pedis)

Rare(may affect up to 1 in 10,000people):

• severe allergic reaction with shock (anaphylactic reaction)
• redness and peeling of the skin of a large area of the body, which may be itchy or painful (dermatitis exfoliativa)
• inflammation of small blood vessels, which may lead to a skin rash with small red or purple bumps (vasculitis)
• swelling of the neck, face, mouth, or throat that may lead to difficulty swallowing or breathing (angioedema)

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

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

Reporting side effects

If you (or your child) experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this leaflet.You can also report them directlythroughthenational reporting system included in theAppendix V. By reporting side effects, you can contribute to providing more information about the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not use this medication:

• after the expiration date that appears on the box or on the syringe label after “CAD”/”EXP”.
• if the liquid contains easily visible particles, is cloudy or has a clearly brown color.

Store the syringe sealed in its box to protect it 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 4días at room temperature, not exceeding 30°C.

This medication is for single use only.

Medications should not be disposed of through drains. Ask your pharmacist how to dispose of medications that are no longer needed. This will help protect the environment.

Composition of Cosentyx

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

Appearance of Cosentyx and contents of the pack

Cosentyx injectable solution is a transparent liquid. Its color may vary from colorless to slightly yellow.

Cosentyx 75 mg injectable solution in pre-filled syringe is presented in single unit packs of 1 pre-filled syringe and in multiple 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 about this medicinal product, please consult the representative of the marketing authorisation holder in your country:

Last update of this leaflet:11/2024

Other sources of information

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

Instructions for use of Cosentyx 75 mg in pre-filled syringe

Read all the instructions before injecting the medicinal product. It is essential that you do not attempt to inject the medicinal product or to administer it to someone under your care until a doctor, nurse or pharmacist has taught you how to do it. The pack contains a pre-filled syringe of Cosentyx 75 mg in a plastic blister.

Your Cosentyx 75 mg in pre-filled syringe

Once the medicinal product has been injected, the needle guard will activate. This is designed to protect healthcare professionals, patients who self-administer the medicinal product prescribed by a doctor, and individuals who help patients to self-administer the medicinal product from needlestick injuries.

Important safety information

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

1.The needle cap of the syringe may contain dry rubber (latex) that should not be touched by people sensitive to it.

2.Do not open the pack until you are ready to administer the medicinal product.

3.Do not use the medicinal product if the pack or the blister is damaged, as it may not be safe to use.

4.Do not use the syringe if it has fallen onto a hard surface or if it has fallen after removing the needle cap.

5.Never leave the syringe in places where other people 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 guard will activate prematurely.

8.Do not remove the needle cap until just before administering the injection.

9.The syringe cannot be reused. Once used, dispose of the syringe in a needle disposal container.

Storage of Cosentyx 75 mg in pre-filled syringe

1.Store this medicinal product in its sealed pack to protect it from light. Store in a refrigerator at 2°C to 8°C. DO NOT FREEZE.

2.Remember to take the syringe out of the refrigerator to allow it to come to room temperature before preparing the injection (15‑30minutes).

3.Do not use the syringe after the expiry date shown on the pack or on the syringe label after “CAD”/”EXP”. If it has expired, return the pack to the pharmacy.

Injection sites

Preparing Cosentyx 75 mg in pre-filled syringe ready for use

1.Take the pack with the syringe out of the refrigerator and leave itunopenedfor 15‑30minutes to allow it to come to room temperature.

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

3.Disinfect the injection site thoroughly with a wet wipe in alcohol.

4.Remove the syringe from the pack and take it out of the blister by holding the syringe body.

5.Inspect the syringe. The liquid should be transparent. Its color may vary from colorless to slightly yellow. 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 damaged. In all these cases, return the pack to the pharmacy.

How to use the pre-filled syringe of Cosentyx 75 mg

Disposal instructions