COSENTYX 300 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 suspect that you are allergic, consult your doctor before using Cosentyx.

• if you have any active infectionthat your doctor considers important (e.g. active tuberculosis).

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 an inflammatory disease that affects your intestine called Crohn's disease.
• if you have an inflammation of the large intestine called ulcerative colitis.
• if you have been recently vaccinated or are going to be vaccinated during treatment with Cosentyx.
• if you are undergoing any other treatment for psoriasis, such as using other immunosuppressants or phototherapy with ultraviolet (UV) light.

Tuberculosis

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

Hepatitis B

Tell your doctor if you have or have had a hepatitis B infection in the past. This medicine may cause a reactivation of the infection. Before and during treatment with secukinumab, your doctor may examine you for signs of infection. Tell your doctor if you notice any of the following symptoms: worsening fatigue, 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 immediately if you notice abdominal cramps and pain, diarrhea, weight loss, blood in your stool, or any other sign of intestinal problems.

Monitor for infections and allergic reactions

Cosentyx may potentially cause serious side effects, including infections and allergic reactions. You should monitor for signs of these diseases while using Cosentyx.

Stop using Cosentyx and tell your doctor or seek medical help immediately if you notice any signs that may indicate a 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 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 been recently vaccinated or are going to be vaccinated soon. You 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 are a woman of childbearing age, you are advised to avoid becoming pregnant and should use adequate contraception 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 plan to become pregnant.

• Consult your doctor if you are breastfeeding or plan to breastfeed. You and your doctor will decide whether you should breastfeed or use Cosentyx. You cannot do both. After using Cosentyx, you 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 told by your doctor.

If you are unsure, consult your doctor, pharmacist, or nurse again.

Cosentyx is given by injection under the skin (i.e. subcutaneously).

You and your doctor will decide if you should inject Cosentyx yourself.

It is important that you do not try to inject the medicine until your doctor, nurse, or pharmacist has shown you how to do it. The person taking care of you can also give you the Cosentyx injection after receiving proper training.

In the section "Instructions for use of Cosentyx 300 mg in pre-filled pen UnoReady" at the end of this leaflet, you will find instructions on how to inject Cosentyx.

The 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 per subcutaneous injection.

• A dose of 300 mg is administered as a 300 mg injection.

After the first dose, you will receive weekly injections 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 in a 300 mg injection.

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 of 50 kg or more: 150 mg by subcutaneous injection.

Your doctor may increase the dose to 300 mg.

• Each dose of 300 mg is administered as a 300 mg injectionor as two 150 mg injections. Other formulations/concentrations may be available for the 75 mg and 150 mg doses.

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

Hidradenitis suppurativa

• The recommended dose is 300 mg per subcutaneous injection.
• Each dose of 300 mg is administered as a 300 mg injection.

After the first dose, you will receive weekly injections 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 did not respond well to medicines known as tumor necrosis factor (TNF) blockers:

• The recommended dose is 300 mg per subcutaneous injection.

• Each dose of 300 mg is administered as 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 dose of 300 mg in a 300 mg injection.

For other patients with psoriatic arthritis:

• The recommended dose is 150 mg per subcutaneous injection. Other formulations/concentrations are available for the 150 mg dose.

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

Depending on 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 formulations/concentrations are available for the 150 mg dose.

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

Depending on your response, your doctor may increase your dose to 300 mg. Each dose of 300 mg is administered as a 300 mg injection.

Non-radiographic axial spondyloarthritis

• The recommended dose is 150 mg per subcutaneous injection. Other formulations/concentrations are available for the 150 mg 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 regularly check the condition of your disease to see if the treatment is working as expected.

If you use more Cosentyx than you should

If you receive more Cosentyx than you should or the dose has been administered 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 return.

If you have any other questions about 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 whether you should and when to restart treatment.

Other Adverse Effects

Most of the following adverse 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)

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)

• infection of the outer ear (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 blisters with itching 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 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 not listed in this leaflet. You can also report them directly through the national reporting system included in Appendix V. By reporting adverse effects, you can help provide 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 "CAD"/"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.

Medicines should not be disposed of through wastewater. 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 300 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 varies from colorless to slightly yellow.

Cosentyx 300 mg injectable solution in a preloaded pen is presented in a package that contains 1 preloaded pen and in multiple packages that contain 3 (3 packages of 1) preloaded pens. Not all package 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 Leaflet: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 300 mg in UnoReady Pen

secukinumab

Your Cosentyx 300 mg in UnoReady Pen:

What you need for the injection:

Before the injection:

Remove Cosentyx 300 mg in UnoReady Pen from the refrigerator 30 to 45 minutesbefore the injection to allow it to reach room temperature.

The Injection:

After the injection: