COSENTYX 150 mg SOLUTION FOR INJECTION IN A PRE-FILLED PEN

2. What you need to know before you use Cosentyx

Do not use Cosentyx:

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

If you think you may be allergic, consult your doctor before using Cosentyx.

• if you have any active infectionthat your doctor thinks is important (for example, active tuberculosis).

Warnings and precautions

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

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

Tuberculosis

Tell your doctor if you have or have had tuberculosis or if you have recently been in close contact with someone who has tuberculosis. Your doctor will check you for tuberculosis and may do a test for tuberculosis before you start Cosentyx. If your doctor thinks you are at risk of getting tuberculosis, you may be given medicines to treat it. If you get symptoms of tuberculosis (such as a long-lasting cough, weight loss, tiredness or a low-grade fever) while you are being treated with Cosentyx, tell your doctor straight away.

Hepatitis B

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

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

Stop using Cosentyx and tell your doctor or seek medical help straight away if you notice stomach cramps and pain, diarrhea, weight loss, blood in your stools 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 are using Cosentyx.

Stop using Cosentyx and tell your doctor or seek medical help straight away if you notice any 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 as 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 as it has not been studied in this age group.

Other medicines and Cosentyx

Tell your doctor or pharmacist:

• if you are taking, have taken or might take any other medicines.
• if you have recently been vaccinated or are about to be vaccinated. You should not be given certain types of vaccines (live vaccines) while you are using Cosentyx.

Pregnancy, breastfeeding and fertility

• It is recommended that you avoid using Cosentyx during pregnancy. The effect of this medicine in pregnant women is not known. If you are a woman who can become pregnant, you are advised to avoid becoming pregnant and to use a suitable contraceptive while you are using Cosentyx and for at least 20 weeks after the last dose of Cosentyx. If you are pregnant or think you may be pregnant, consult your doctor.
• Ask your doctor if you are breastfeeding or plan to breastfeed. You and your doctor must decide whether you will breastfeed or use Cosentyx. You must not do both. After using Cosentyx, you must 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.

Cosentyx is given by injection under the skin (i.e. subcutaneously). You and your doctor will decide if you should inject Cosentyx yourself.

Do not try to inject Cosentyx until you have been trained by your doctor, nurse or pharmacist. The person who cares for you can also give you the injection of Cosentyx after they have received training.

Instructions on how to inject Cosentyx are given in the section “Instructions for use of Cosentyx 150 mg in pre-filled pen” 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 need and for how long.

Plaque Psoriasis

Adults

• The recommended dose is 300 mg given as a subcutaneous injection.
• A dose of 300 mg is given as two injections of 150mg.

After the first dose, you will receive injections every week in weeks 1, 2, 3 and 4 followed by monthly injections. Depending on your response, your doctor may recommend additional dose adjustments. At each visit, you will receive a dose of 300 mg given as two injections of 150 mg.

Children from 6 years of age

• The recommended dose is based on body weight as follows:
• • Weight below 25 kg: 75 mg given as a subcutaneous injection.
  • Weight from 25 kg to below 50 kg: 75 mg given as a subcutaneous injection.
  • Weight from 50 kg: 150 mg given as a subcutaneous injection.

Your doctor may increase the dose to 300 mg.

• Each dose of 150 mg is given as one injection of 150mg. Other formulations/concentrations may be available for administration of 75 mg and 300 mg doses.

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

Hidradenitis Suppurativa

• The recommended dose is 300 mg given as a subcutaneous injection.
• Each dose of 300 mg is given as two injections of 150mg.

After the first dose, you will receive injections every week in weeks 1, 2, 3 and 4 followed by monthly injections. Depending on your response, your doctor may recommend additional dose adjustments.

Psoriatic Arthritis

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

For patients who have not responded well to medicines known as tumor necrosis factor (TNF) blockers:

• The recommended dose is 300 mg given as a subcutaneous injection.
• Each dose of 300 mg is given as two injections of 150mg.

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

For other patients with psoriatic arthritis:

• The recommended dose is 150 mg given as a subcutaneous injection.

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

Your doctor may increase your dose to 300 mg.

Ankylosing Spondylitis (Radiographic Axial Spondyloarthritis)

• The recommended dose is 150 mg given as a subcutaneous injection.

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

Your doctor may increase your dose to 300 mg. Each dose of 300 mg is given as two injections of 150 mg.

Non-Radiographic Axial Spondyloarthritis

• The recommended dose is 150 mg given as a subcutaneous injection.

After the first dose, you will receive injections every week in 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 given as a subcutaneous injection.
  • Weight from 50 kg: 150 mg given as a subcutaneous injection.
• Each dose of 150 mg is given as one injection of 150mg. Other formulations/concentrations may be available for administration of the 75 mg dose.

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

Cosentyx is a long-term treatment. Your doctor will regularly check the state of your disease to see if the treatment is working.

If you use more Cosentyx than you should

If you 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 remember. Then talk to your doctor to find out when you should inject the next dose.

If you stop using Cosentyx

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 come back.

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

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them.

Severe Adverse Effects

Discontinue treatment with Cosentyx and inform your doctor or seek immediate medical attention if you notice any of the following adverse effects:

Possible Severe Infection– signs may include:

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

Severe Allergic Reaction– signs may include:

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

Your doctor will decide if you should and when to restart treatment.

Other Adverse Effects

Most of the following adverse effects are mild or moderate. If they become severe in any case, 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)

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

• oral thrush (oral candidiasis)
• signs of white blood cell deficiency, such as fever, sore throat, or mouth ulcers due to infections (neutropenia)
• outer ear infection (otitis externa)
• eye discharge with itching, redness, and swelling (conjunctivitis)
• itchy rash (urticaria)
• lower respiratory tract infections
• abdominal cramps, abdominal pain, diarrhea, weight loss, or blood in the stool (signs of intestinal 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 can 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 that can 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 swelling and ulceration of the skin (pyoderma gangrenosum)

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect that is not listed in this prospectus. You can also report them directly through the national reporting system included in Appendix V. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Cosentyx

Keep this medicine out of sight and reach of children.

Do not use this medicine:

• after the expiration date that appears on the box or on the label of the pen after "EXP".

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

This medicine is for single use only.

Medicines should not be thrown down the drain. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Package Contents and Additional Information

Cosentyx Composition

• The active ingredient is secukinumab. Each preloaded pen contains 150 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 Package Contents

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

Cosentyx 150 mg injectable solution in preloaded pen is presented in unit packs of 1 or 2 preloaded pens and in multiple packs containing 6 (3 packs of 2) preloaded 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

You can request more information about this medicine by contacting the local representative of the marketing authorization holder:

Date of Last Revision of this Prospectus:11/2024

Other Sources of Information

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

Instructions for Use of Cosentyx 150 mg in SensoReady Pen

Your Cosentyx 150 mg in SensoReady Pen:

What you need for the injection:

Before the injection:

The Injection:

After the injection: