Cosentyx 75 mg solution for injection in pre-filled syringe

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Cosentyx 75mg solution for injection in pre-filled syringe

secukinumab

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

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed only for you (or your child), and you should not give it to other people, even if they have the same symptoms as you (or your child), because it may harm them.
• If you (or your child) experience any side effects, consult your doctor, pharmacist or nurse, even if they are side effects not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Cosentyx is and what it is used for
2. What you need to know before you (or your child) start using Cosentyx
3. How to use Cosentyx
4. Possible side effects
5. How to store Cosentyx
6. Contents of the pack and other information

1. What Cosentyx is and what it is used for

Cosentyx contains the active substance secukinumab. Secukinumab is a monoclonal antibody belonging to a group of medicines known as "interleukin inhibitors". It works by neutralizing the activity of a protein called IL-17A, which is present at elevated levels in conditions such as psoriasis, psoriatic arthritis, and axial spondyloarthritis.

Cosentyx is used to treat the following inflammatory diseases:

• Pediatric plaque psoriasis
• Juvenile idiopathic arthritis, including enthesitis-related arthritis and juvenile psoriatic arthritis

Pediatric plaque psoriasis

Cosentyx is used to treat a skin disorder known as "plaque psoriasis", which causes inflammation of the skin. Cosentyx reduces inflammation and other symptoms of the disease. Cosentyx is used in children and adolescents (from 6 years of age) with moderate to severe plaque psoriasis.

Using Cosentyx for plaque psoriasis will benefit you (or your child) by improving the appearance of the skin and reducing 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 affecting the joints and the sites where tendons attach to bone.

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

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

Do not use Cosentyx:

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

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

• if you (or your child) have any active infection considered important by your doctor (for example, active tuberculosis).

Warnings and precautions

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

• if you (or your child) have had an infection.
• if you (or your child) suffer from repeated or long-lasting infections.
• if you (or your child) have ever had an allergic reaction to latex.
• if you (or your child) have an inflammatory bowel disease called Crohn's disease.
• if you (or your child) have an inflammation of the large intestine called ulcerative colitis.
• if you (or your child) have recently been vaccinated or are scheduled to be vaccinated during treatment with Cosentyx.
• if you (or your child) are receiving any other treatment for psoriasis, such as other immunosuppressants or ultraviolet (UV) light phototherapy.

Tuberculosis

Inform your doctor if you (or your child) currently have or have previously had tuberculosis, or if you (or your child) know you have recently been in close contact with someone who has tuberculosis. Your doctor will examine you (or your child) and may perform a tuberculosis test before you (or your child) receive Cosentyx. If your doctor believes you (or your child) are at risk of tuberculosis, you (or your child) may be given medication to treat it. If symptoms of tuberculosis appear during treatment with Cosentyx (such as persistent cough, weight loss, fatigue, or low-grade fever), inform your doctor immediately.

Hepatitis B

Inform your doctor if you (or your child) currently have or have previously 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 whites 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 inform your doctor or seek immediate medical help if you (or your child) experience abdominal cramps and pain, diarrhea, weight loss, blood in the stool, or any other signs of intestinal problems.

Monitor for infections and allergic reactions

Cosentyx may potentially cause serious adverse effects, including infections and allergic reactions. You should monitor for signs of these conditions while you (or your child) are using Cosentyx.

Discontinue treatment with Cosentyx and contact your doctor or seek immediate medical attention if you (or your child) experience any signs indicating a possible serious infection or allergic reaction. These signs are listed in section 4 “Possible side effects”.

Children and adolescents

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

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

The use of Cosentyx is not recommended in children and adolescents (under 18 years of age) for other indications, as the medicine has not been studied in individuals of this age.

Other medicines and Cosentyx

Inform your doctor or pharmacist:

• if you (or your child) are taking, have recently taken, or might need to take any other medicines.
• if you (or your child) have recently been vaccinated or are scheduled to be vaccinated. You (or your child) should 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 in pregnant women is unknown. If you (or your daughter) are of childbearing age, you are advised to avoid becoming pregnant and should use an effective contraceptive method while using Cosentyx and for at least 20 weeks after the last dose of Cosentyx. Consult your doctor if you (or your daughter) are pregnant, may be pregnant, or plan 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 20 weeks after the last dose.

Driving and using machines

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

3. How to use Cosentyx

Follow exactly the administration instructions for this medicine given by your doctor. If in doubt, consult your doctor, pharmacist, or nurse again.

Cosentyx is administered by injection under the skin (i.e., subcutaneously). You and your doctor should decide whether, after appropriate training, you will self-inject Cosentyx or whether a caregiver will administer the injection.

It is important that you do not attempt to inject Cosentyx before a doctor, nurse, or pharmacist has shown you how to do so.

Detailed instructions on how to administer Cosentyx are provided in the section “Instructions for use of Cosentyx 75 mg in pre-filled syringe” at the end of this leaflet.

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 should be administered and for how long

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

Pediatric plaque psoriasis (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 from 50 kg: 150 mg by subcutaneous injection.

Your doctor may increase the dose to 300 mg.

• Each 75 mg dose is administered as a single 75 mg injection. Other dosage forms/concentrations may be available for administration of 150 mg and 300 mg doses.

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

Juvenile idiopathic arthritis (juvenile enthesitis-related arthritis and juvenile psoriatic arthritis)

• The recommended dose is based on body weight as follows:
  • Weight below 50 kg: 75 mg by subcutaneous injection.
  • Weight from 50 kg: 150 mg by subcutaneous injection.
• Each 75 mg dose is administered as a single 75 mg injection. Other dosage forms/concentrations may be available for administration of the 150 mg dose.

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 periodically monitor your disease (or your child’s) to assess whether the treatment is having the desired effect.

If you use more Cosentyx than you should

If you (or your child) receive more Cosentyx than you should, or if the dose was administered earlier than indicated by your doctor, inform your doctor.

If you forget to use Cosentyx

If you have forgotten to inject a dose of Cosentyx, inject the missed dose as soon as you (or your child) remember. Then speak with your doctor to determine when the next dose should be administered.

If you (or your child) stop using Cosentyx

Stopping the use of Cosentyx is not dangerous. However, if you do stop, symptoms of your psoriasis (or your child’s) may return.

If you have any further 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 everyone will experience them.

Serious adverse effects

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

Possible serious infection – signs may include:

• fever, flu-like symptoms, night sweats
• feeling tired or short of breath, persistent cough
• skin that is warm, red and painful to touch, or painful rash with blisters
• burning sensation when urinating.

Severe allergic reaction – signs may include:

• difficulty breathing or swallowing
• low blood pressure, which may cause dizziness or mild lightheadedness
• swelling of the face, lips, tongue or throat
• intense skin itching (pruritus) accompanied by rash or blisters.

Your doctor will decide whether you (or your child) should resume treatment and when.

Other adverse effects

Most of the following adverse effects are mild or moderate. If any of them 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)
• diarrhoea
• runny nose (rhinorrhoea)
• headache
• nausea
• fatigue
• itching, redness and dryness of the skin (eczema)

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

• mouth sores (oral candidiasis)
• signs of low white blood cell counts, 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, stomach pain, diarrhoea, 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 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 large areas of the body, which may be itchy or painful (exfoliative dermatitis)
• inflammation of small blood vessels, which may result in a skin rash with small red or purple spots (vasculitis)
• swelling of the neck, face, mouth or throat that may cause difficulty swallowing or breathing (angioedema)

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

• fungal infections of the skin and mucous membranes (including oesophageal candidiasis)
• painful swelling and ulceration of the skin (pyoderma gangrenosum)

Reporting of adverse effects

If you (or your child) 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 may 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 the sight and reach of children.

Do not use this medicine:

• after the expiry date stated on the carton or on the label of the syringe following “CAD”/“EXP”.
• if the solution contains easily visible particles, is cloudy, or has clearly turned brown.

Store the sealed syringe in its carton to protect it from light. Store in a refrigerator between 2 °C and 8 °C. Do not freeze. Do not shake.

If necessary, Cosentyx may be kept outside 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 disposed of via wastewater. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

Composition of Cosentyx

• The active substance is secukinumab. Each pre-filled syringe contains 75 mg of secukinumab.
• The other components are trehalose dihydrate, histidine, histidine monohydrochloride monohydrate, methionine, polysorbate 80, and water for injections.

Appearance of Cosentyx and contents of the pack

Cosentyx solution for injection is a clear liquid. Its colour ranges from colourless to slightly yellow.

Cosentyx 75 mg solution for injection in a pre-filled syringe is available in single packs containing 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

Sandoz GmbH

Biochemiestrasse 10

6336 Langkampfen

Austria

Novartis Pharmaceutical Manufacturing GmbH

Biochemiestrasse 10

6336 Langkampfen

Austria

Novartis Pharma GmbH

Sophie-Germain-Strasse 10

90443 Nuremberg

Germany

For more information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:

Date of the most recent review of this leaflet:

Other sources of information

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

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

Read ALL instructions before injecting the medicine. It is important that you do not attempt to inject the medicine yourself or administer it to someone under your care until a doctor, nurse, or pharmacist has shown you how to do so. The pack contains one pre-filled syringe of Cosentyx 75 mg inside a plastic blister.

Your Cosentyx 75 mg pre-filled syringe

Once the medicine has been injected, the needle cover will automatically activate. This is designed to protect healthcare professionals, patients who self-inject the prescribed medicine, and individuals assisting patients with self-injection from accidental needle-stick injuries.

Important safety information

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

1. The needle cap of the syringe may contain dry rubber (latex), which should not be touched by individuals sensitive to it.
2. Do not open the box until you are ready to administer this medication.
3. Do not use this medication if the seal on the box or the blister pack is broken, as it may not be safe to use.
4. Do not use the syringe if it has been dropped on a hard surface or if it has been dropped after removing the needle cap.
5. Never leave the syringe where others could touch it.
6. Do not shake the syringe.
7. Be very careful not to press the activation clips before use. Doing so will prematurely activate the needle shield.
8. Do not remove the needle cap until immediately before administering the injection.
9. The syringe cannot be reused. After use, dispose of the syringe in a sharps disposal container.

Storage of Cosentyx 75mg in pre-filled syringe

1. Store this medication sealed in its original carton to protect it from light. Store in a refrigerator between 2°C and 8°C. DO NOT FREEZE.
2. Remember to remove the syringe from the refrigerator to allow it to reach room temperature before preparing the injection (15–30 minutes).
3. Do not use the syringe after the expiration date printed on the carton or syringe label following “CAD”/”EXP”. If expired, return the entire package to the pharmacy.

Injection sites

Preparation of Cosentyx 75mg in prefilled syringe ready for use

1. Remove the box containing the syringe from the refrigerator and leave it unopened for 15–30 minutes to allow it to reach room temperature.
2. When ready to use the syringe, wash your hands thoroughly with soap and water.
3. Clean the injection site thoroughly with an alcohol wipe.
4. Remove the syringe from the box and take it out of the blister pack by holding the syringe's protective body.
5. Inspect the syringe. The liquid should be clear and may vary in color from colorless to slightly yellowish. A small air bubble may be present, 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 broken. In all these cases, return the complete package to the pharmacy.

How to use the prefilled syringe of Cosentyx 75mg

Disposal instructions