Cosentyx 150 mg solucion inyectable en jeringa precargada

Prospect: information for the user

Cosentyx 150mg injectable solution in pre-filled syringe

secukinumab

Read this prospect carefully before starting to use this medication, because it contains important information for you.

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

‑This medication has been prescribed only to you, and you should not give it to other people even if they have the same symptoms as you, as it may harm them.

• If you experience adverse effects, consult your doctor, pharmacist, or nurse, even if they do not appear in this prospect. See section4.

1.What is Cosentyx and for what it is used

2.What you need to know before starting to use 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 medicines 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, hidradenitis suppurativa, psoriatic arthritis, and axial spondyloarthritis.

Cosentyx is used to treat the following inflammatory diseases:

• Plaque psoriasis
• Hidradenitis supurativa
• Psoriatic arthritis
• Axial spondyloarthritis, including ankylosing spondylitis (radiographic axial spondyloarthritis) and non-radiographic axial spondyloarthritis
• Idiopathic juvenile arthritis, including enthesitis-related arthritis and psoriatic arthritis in children

Plaque psoriasis

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 adults, adolescents, and children (aged 6 years and older) who suffer from moderate to severe plaque psoriasis.

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

Hidradenitis supurativa

Cosentyx is used to treat a disease known as hidradenitis supurativa, also referred to as inverse acne or Verneuil's disease. This pathology is a chronic and painful inflammatory skin disease. Symptoms may include painful nodules (bumps) and abscesses (boils) from which pus may drain. It commonly affects specific areas of the skin, such as under the breasts, armpits, the inner thighs, groin, and buttocks. Scarring may also occur in affected areas.

Cosentyx may reduce the number of nodules and abscesses you have and the pain often associated with the disease. If you have hidradenitis suppurativa, you will first be given other medications. If you do not respond well enough to these medications, 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 disorder known as “psoriatic arthritis”. It is an inflammatory joint disease, often accompanied by psoriasis. If you have active psoriatic arthritis, you will first be given other medications. If you do not respond well enough to these medications, you will be given Cosentyx to reduce the signs and symptoms of active psoriatic arthritis, improve physical function, and slow down damage to the cartilage and bones of the joints involved in the disease.

Cosentyx is used in adults with active psoriatic arthritis and can be used alone or with another medication called methotrexate.

Using Cosentyx for psoriatic arthritis will benefit you as it reduces the signs and symptoms of the disease, slows down damage to the cartilage and bones of the joints, and improves your ability to perform daily normal activities.

Axial spondyloarthritis, including ankylosing spondylitis (radiographic axial spondyloarthritis) and non-radiographic axial spondyloarthritis

Cosentyx is used to treat disorders known as “ankylosing spondylitis” and “non-radiographic axial spondyloarthritis”. These are inflammatory diseases that primarily affect the spine, causing inflammation of the spine joints. If you have ankylosing spondylitis or non-radiographic axial spondyloarthritis, you will first be given other medications. If you do not respond well enough to these medications, 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 and non-radiographic axial spondyloarthritis.

Using Cosentyx for ankylosing spondylitis and non-radiographic axial spondyloarthritis will benefit you as it reduces the signs and symptoms of the disease and improves physical function.

Idiopathic juvenile arthritis, including enthesitis-related arthritis and psoriatic arthritis in children

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

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

Do not use Cosentyx:

• if you are allergicto secukinumab or to any of the other ingredients of this medicine (listed in section6).

If you suspect you are allergic, consult your doctor before using Cosentyx.

• if you have any infectionthat your doctor considers important.

Warnings and precautions

Consult your doctor, nurse or pharmacist before using Cosentyx:

• if you have contracted an infection.
• if you have repeated or prolonged infections.
• if you have tuberculosis.
• if you have ever had an allergic reaction to latex.
• if you havea chronic inflammatory bowel disease called Crohn's disease.
• if you havean inflammatory bowel disease called ulcerative colitis.
• if you have been recently vaccinated or are to be vaccinated during treatment with Cosentyx.
• if you are taking any other treatment for psoriasis, such as other immunosuppressants or ultraviolet (UV) light therapy.

Hepatitis B

Consult your doctor if you have or have had a hepatitis B infection. This medicine may cause reactivation of the infection. Before and during treatment with secukinumab, your doctor may examine you 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 pain in the upper right area of the stomach.

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

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

Watch for the appearance of infections and allergic reactions

Cosentyx may potentially cause severe side effects, including infections and allergic reactions. You must watch for the signs of these diseases while usingCosentyx.

Interrupt treatment with Cosentyx and inform your doctor or seek medical help immediately if you 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 use in children under 6years of age with plaque psoriasissince the medicine has not been studied in people of this age.

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

Cosentyx is not recommended for use in 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:

• if you are taking, have taken or may need to take any other medicine.
• if you have been recently vaccinated or are to be vaccinated soon. Do not receive 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 are a fertile woman, 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 are pregnant, think you may be pregnant or intend to become pregnant.
• Consult your doctor if you are breastfeeding or plan to breastfeed. You and your doctor must decide whether to breastfeed or use Cosentyx. You cannot do both. After using Cosentyx, do 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 an injection under the skin (i.e., subcutaneously). You and your doctor must decide whether you will administer Cosentyx yourself.

It is essential that you do not attempt to inject the medication until your doctor, nurse, or pharmacist has taught you how to do it. The person caring for you can also administer the Cosentyx injection after receiving the necessary training.

Instructions for use can be found in the "Instructions for use of Cosentyx 150 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 need and for how long.

Psoriasis plaques

Adults

• The recommended dose is 300 mg per subcutaneous injection.
• A dose of 300 mg is administered through two injections of 150 mg each.

After the first dose, you will receive weekly injections in weeks 1, 2, 3, and 4, followed by monthly injections. According to your response, your doctor may recommend additional dose adjustments. At each visit, you will receive a dose of 300 mg divided into two injections of 150 mg each.

Children aged 6 years and older

• The recommended dose is based on the following body weight:
• • Weight less than 25 kg: 75 mg through subcutaneous injection.
  • Weight between 25 kg and less than 50 kg: 75 mg through subcutaneous injection.
  • Weight 50 kg or more: 150 mg through subcutaneous injection.

Your doctor may increase the dose to 300 mg.

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

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

Hidradenitis supurativa

• The recommended dose is 300 mg per subcutaneous injection.
• Each dose of 300 mg is administered as two injections of 150 mg each.

After the first dose, you will receive weekly injections in weeks 1, 2, 3, and 4, followed by monthly injections. According to your response, your doctor may recommend additional dose adjustments.

Psoriatic arthritis

If you have psoriatic arthritis and moderate to severe plaque psoriasis, your doctor may adjust the recommended dose as needed.

For patients who did not respond well to known tumor necrosis factor (TNF) blockers:

• The recommended dose is 300 mg per subcutaneous injection.
• Each dose of 300 mg is administered through two injections of 150 mg each.

After the first dose, you will receive weekly injections in weeks 1, 2, 3, and 4, followed by monthly injections. At each visit, you will receive a dose of 300 mg divided into two injections of 150 mg each.

For the rest of patients with psoriatic arthritis:

• The recommended dose is 150 mg per subcutaneous injection.

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

According to your response, your doctor may increase your dose to 300 mg.

Ankylosing spondylitis (Radiographic axial spondyloarthritis)

• The recommended dose is 150 mg per subcutaneous injection.

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

According to your response, your doctor may increase your dose to 300 mg. Each dose of 300 mg is administered through two injections of 150 mg each.

Non-radiographic axial spondyloarthritis

• The recommended dose is 150 mg per subcutaneous injection.

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

Juvenile idiopathic arthritis (Arthritis associated with enthesitis and juvenile psoriatic arthritis)

• The recommended dose is based on the following body weight:
• • Weight less than 50 kg: 75 mg through subcutaneous injection.
  • Weight 50 kg or more: 150 mg through subcutaneous injection.
• Each dose of 150 mg is administered as a 150 mg injection. For the administration of the 75 mg dose, other dosing/concentration forms 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 disease state periodically to check if the treatment is effective.

If you use more Cosentyx than you should

If you receive more Cosentyx than you should or the dose was administered before the time indicated by your doctor, inform your doctor.

If you forgot to use Cosentyx

If you have forgotten to inject Cosentyx, inject the next dose as soon as you remember. Then, talk to your doctor to tell you when to inject the next dose.

If you interrupt Cosentyx treatment

It is not hazardous to stop using Cosentyx. However, if you do, it is possible that the symptoms of psoriasis, psoriatic arthritis, or axial spondyloarthritis may reappear.

If you have any other questions about 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 notice any of the following side effects:

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 a rash or blisters.

Your doctor will decide whether you should and when you should 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 anaphylaxis
• 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 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 directly through the national notification 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.

Medicines should not be disposed of through drains. Ask your pharmacist how to dispose of the medicines that you no longer need. This will help protect the environment.

Composition of Cosentyx

• The active ingredient is secukinumab. Each pre-filled syringe contains 150 mg of secukinumab.
• The other components are trehalose dihydrate, histidine, hydrochloride monohydrate of histidine, 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 150 mg injectable solution in pre-filled syringe is presented in single unit packs of 1 or 2 pre-filled syringes and in multiple packs containing 6 (3 packs of 2) 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 contact the local representative of the marketing authorization holder:

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 150 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 a person under your care until the doctor, nurse or pharmacist has taught you how to do it. The pack contains the pre-filled syringe(s) of Cosentyx 150 mg inside a plastic blister.

Your Cosentyx 150 mg in pre-filled syringe

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

Important safety information

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

1. The needle cover of the syringe may contain dry rubber (latex) that should not be touched by individuals sensitive to it.
2. Do not open the pack until you are ready to administer this medicinal product.
3. Do not use this medicinal product if the pack or 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 cover.
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 cover will activate prematurely.
8. Do not remove the needle cover until just before administering the injection.
9. The syringe cannot be reused. Once used, dispose of the syringe in a sharps container.

Storage of Cosentyx 150 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 (15-30 minutes).
3. Do not use the syringe after the expiry date that appears 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 150 mg in pre-filled syringe ready for use

Note: For a dose of 150 mg, prepare 1 pre-filled syringe and inject the contents. For a dose of 300 mg, prepare 2 pre-filled syringes and inject the contents of both.

1. Take the pack with the syringe out of the refrigerator and leave itunopenedfor 15-30 minutes 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 moist towelette soaked 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 some small air bubbles, 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 150 mg

Disposal instructions