Label: information for the user

Cosentyx 300 mg injectable solution in pre-filled pen

secukinumab

Read this label carefully before starting to use this medicine, as it contains important information for you.

• Keep this label, 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, and you should not give it to others even if they have the same symptoms as you, as it may harm them.

• If you experience any side effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this label. See section 4.

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 quantities in diseases such as psoriasis, hidradenitis supurativa, psoriatic arthritis, and axial spondyloarthritis.Psoriasis, hidradenitis supurativa, 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

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 (from 6 years of age) who suffer from plaque psoriasis of moderate to severe nature.

Using Cosentyx for plaque psoriasis will benefit you as it produces improvements in the appearance of the skin 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 known 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. It may also cause scarring in affected areas.

Cosentyx may reduce the number of nodules and abscesses you have and the pain that often accompanies the disease. If you have hidradenitis supurativa, 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 supurativa 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”. They 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.

Do not use Cosentyx:

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

• 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 an inflammatory bowel disease called Crohn's disease.
• if you have an inflammatory bowel disease called ulcerative colitis.

• if you have recently been vaccinated or are going 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 part of the stomach area.

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 sign 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 using Cosentyx.

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 section 4 “Possible side effects”.

Children and adolescents

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

Cosentyx is not recommended for use in children and adolescents (under 18 years) for other indications, as 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 take any other medicine.

• if you have been vaccinated recently or are going 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 20 weeks 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 20 weeks 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 you should administer Cosentyx yourself.

The important thing is 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.

The instructions for use are also available 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.

Pustular psoriasis

Adults

• The recommended dose is 300 mg per subcutaneous injection.

• A dose of 300 mgis administered through a 300 mg 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 recommend additional dose adjustments.At each visit, you will receive a 300 mg dose in a 300 mg injection.

Children aged 6 years and older

• The recommended dose is based on the following body weight:

• Pediatric patients weighing less than 25 kg: 75 mg via subcutaneous injection.

• Pediatric patients weighing between 25 kg and less than 50 kg: 75 mg via subcutaneous injection.

• Pediatric patients weighing 50 kg or more: 150 mgvia subcutaneous injection.

Your doctor may increase the dose to 300 mg.

• A dose of 300 mgis administered as a 300 mg injectionor as two 150mg injections.For the administration of 75mg and 150mg 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 300mg per subcutaneous injection.
• A dose of 300mgis administered as a 300mg injection.

After the first dose, you will receive weekly injections in weeks1, 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 also 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.

• A dose of 300 mgis administered through a 300 mg injection..

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 300 mg dose in a 300 mg injection.

For the rest of patients with psoriatic arthritis:

• The recommended dose is 150 mg per subcutaneous injection. Other dosing/concentration forms are available for the 150mg dose.

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. Other dosing/concentration forms are available for the 150mg dose.

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. A dose of 300 mg is administered through a 300 mg injection.

Non-radiographic axial spondyloarthritis

• The recommended dose is 150 mg per subcutaneous injection. Other dosing/concentration forms are available for the 150mg dose.

After the first dose, you 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 a dose of Cosentyx,inject the next dose as soon as you remember. Thentalk to your doctorto tell you when to inject the next dose.

If you interrupt Cosentyx treatment

It is not dangerous 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 can 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 10 people):

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

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

• 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 10,000 people):

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

Unknown frequency(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 throughthe national reporting system included in theAppendixV. 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 pen label after "CAD" or "EXP".

• if the liquid contains easily visible particles, is cloudy, or has a clearly brown color.

Store the pen sealed within 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 4 days at room temperature, not exceeding 30°C.

This medication is for single use only.

Medicines should not be disposed of through the 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 pen contains 300 mg of secukinumab.

• The other components are trehalose dihydrate, histidine, hydrochloride monohydrate, methionine, polisorbate 80, and water for injection.

Appearance of Cosentyx and contents of the pack

Cosentyx solution for injection is a clear liquid. Its color may vary from colorless to slightly yellow.

Cosentyx 300 mg solution for injection in pre-filled pen is presented in a pack containing 1 pre-filled pen and in multiple packs containing 3 (3 packs of 1) pre-filled pens. 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 authorization holder in your country:

Last update of this leaflet:11/2024

Other sources of information

Further 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 300 mg in pre-filled pen

secukinumab

Read all the instructions before administering the medicinal product.

These instructions will help you correctly administer Cosentyx in pre-filled pen.

It is essential that you do not attempt to administer the medicinal product until a doctor, nurse, or pharmacist has taught you how to do it.

Your Cosentyx 300 mg in pre-filled pen:

What you need for the injection:

Before the injection:

Take Cosentyx 300mg in pre-filled penout of therefrigerator30 to 45 minutes before the injectionto allow it to come to room temperature.

The injection:

After the injection: