Cosentyx 300 mg solution for injection in pre-filled pen

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Cosentyx 300 mg solution for injection in pre-filled pen

secukinumab

Read the entire leaflet carefully before you start using this medicine, because it contains important information for you.

• 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 for you only, and you should not give it to others, even if they have the same symptoms as you. It could harm them.

• If you experience any adverse reactions, consult your doctor, pharmacist or nurse, even if they are adverse reactions 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 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 that belongs to a group of medicines known as “interleukin inhibitors”. It works by neutralizing the activity of a protein called IL-17A, which is present in high levels in conditions such as psoriasis, hidradenitis suppurativa, psoriatic arthritis, and axial spondyloarthritis.

Cosentyx is used to treat the following inflammatory diseases:

• Plaque psoriasis
• Hidradenitis suppurativa
• 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”, which causes inflammation of 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 have moderate to severe plaque psoriasis.

Using Cosentyx for plaque psoriasis will benefit you by improving the appearance of your skin and reducing symptoms such as scaling, itching, and pain.

Hidradenitis suppurativa

Cosentyx is used to treat a condition known as hidradenitis suppurativa, sometimes also called inverse acne or Verneuil’s disease. This condition is a chronic, painful inflammatory skin disease. Symptoms may include painful nodules (lumps) and abscesses (boils) that may discharge pus. It commonly affects specific areas of the skin, such as under the breasts, armpits, inner thighs, groin, and buttocks. Scarring may also occur in the affected areas.

Cosentyx can 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 adequately to these medications, you will be given Cosentyx.

Cosentyx is used in adults with hidradenitis suppurativa and may be used alone or in combination with antibiotics.

Psoriatic arthritis

Cosentyx is used to treat a condition known as “psoriatic arthritis”. This is an inflammatory disease of the joints, often accompanied by psoriasis. If you have active psoriatic arthritis, you will first be given other medications. If you do not respond adequately 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 cartilage and bone in the affected joints.

Cosentyx is used in adults with active psoriatic arthritis and may be used alone or in combination with another medicine called methotrexate.

Using Cosentyx for psoriatic arthritis will benefit you by reducing the signs and symptoms of the disease, slowing down damage to cartilage and bone in the joints, and improving your ability to perform normal daily activities.

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

Cosentyx is used to treat conditions known as “ankylosing spondylitis” and “non-radiographic axial spondyloarthritis”. These are inflammatory diseases that primarily affect the spine, causing inflammation of the spinal joints. If you have ankylosing spondylitis or non-radiographic axial spondyloarthritis, you will first be given other medications. If you do not respond adequately to these medications, you will be given Cosentyx to reduce the signs and symptoms of the disease, reduce inflammation, and improve physical function.

Cosentyx is used in adults with active ankylosing spondylitis and active non-radiographic axial spondyloarthritis.

Using Cosentyx for ankylosing spondylitis and non-radiographic axial spondyloarthritis will benefit you by reducing the signs and symptoms of the disease and improving physical function.

2. What you need to know before using Cosentyx

Do not use Cosentyx:

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

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

• if you have an active infection that your doctor considers significant (e.g., active tuberculosis).

Warnings and precautions

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

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

Tuberculosis

Inform your doctor if you currently have or have previously had tuberculosis, or if you know 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 receive Cosentyx. If your doctor believes you are at risk of tuberculosis, you may be given medication to treat it. If symptoms of tuberculosis develop 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 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 monitor you for signs of infection. Inform your doctor if you experience 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 attention if you 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 using Cosentyx.

Discontinue treatment with Cosentyx and contact your doctor or seek immediate medical assistance if you notice any signs indicating a possible serious infection or severe 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 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 are taking, have recently taken, or might need to take any other medicines.
• if you have recently been vaccinated or are scheduled to be vaccinated. You 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 are a woman of childbearing potential, you are advised to avoid becoming pregnant and to 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 are pregnant, think you might be pregnant, or plan to become pregnant.

• Consult your doctor if you are breastfeeding or plan to breastfeed. You and your doctor must decide whether you will breastfeed or use Cosentyx. You cannot 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 operate machinery.

3. How to use Cosentyx

Follow exactly the administration instructions for this medicine as 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 you will self-inject Cosentyx.

It is important that you do not attempt to inject the medicine yourself until your doctor, nurse, or pharmacist has shown you how to do so. A caregiver may also administer the Cosentyx injection after receiving appropriate training.

Instructions on how to inject Cosentyx are provided in the section “Instructions for use of Cosentyx 300 mg in the UnoReady pen” 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 need and for how long.

Plaque psoriasis

Adults

• The recommended dose is 300 mg by subcutaneous injection.

• A dose of 300 mg is administered as a single 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 as a single 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 50 kg and above: 150 mg by subcutaneous injection.

Your doctor may increase the dose to 300 mg.

• Each 300 mg dose is administered as a single 300 mg injection or as two 150 mg injections. Other dosage forms/concentrations may be available for administering 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 by subcutaneous injection.
• Each 300 mg dose is administered as a single 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 moderate to severe plaque psoriasis, your doctor may adjust the recommended dose as needed.

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

• The recommended dose is 300 mg by subcutaneous injection.

• Each 300 mg dose is administered as a single 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 as a single 300 mg injection.

For all other patients with psoriatic arthritis:

• The recommended dose is 150 mg by subcutaneous injection. Other dosage forms/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 by subcutaneous injection. Other dosage forms/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 300 mg dose is administered as a single 300 mg injection.

Non-radiographic axial spondyloarthritis

• The recommended dose is 150 mg by subcutaneous injection. Other dosage forms/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 periodically monitor your disease status to assess whether the treatment is achieving the desired effect.

If you use more Cosentyx than you should

If you receive more Cosentyx than prescribed or the dose was administered earlier than scheduled, inform 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 speak with your doctor to determine when you should administer the next dose.

If you stop using Cosentyx

It is not dangerous to stop using Cosentyx. However, if you do so, symptoms of psoriasis, psoriatic arthritis, or axial spondyloarthritis may return.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.

Serious side effects

Stop treatment with Cosentyx and contact your doctor or seek immediate medical help if you notice any of the following side 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 a 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 slight lightheadedness

• swelling of the face, lips, tongue or throat

• intense skin itching (pruritus) accompanied by rash or blisters

Your doctor will decide whether and when treatment should be restarted.

Other side effects

Most of the following side 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 count, 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 a large area of the body, which may be itchy or painful (exfoliative dermatitis)

• inflammation of small blood vessels, which may cause a skin rash with small red or purple spots (vasculitis)

• swelling of the neck, face, mouth or throat which 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 side effects

If you experience any side effects, talk to your doctor, pharmacist or nurse, including any possible side effects not listed in this leaflet. You can also report them directly through the national reporting system included in Appendix V. By reporting side 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 pen label following "CAD"/"EXP".

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

Store the pen sealed in its carton to protect it from light. Store in the 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 you no longer need. This will help protect the environment.

6. Contents of the container and other information

Composition of Cosentyx

• The active substance is secukinumab. Each pre-filled pen contains 300 mg of secukinumab.

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

Appearance of Cosentyx and contents of the container

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

Cosentyx 300 mg solution for injection in a pre-filled pen is available 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 Authorisation 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 Authorisation Holder:

Belgium/Belgium/Belgium Novartis Pharma N.V. Tel/Tel: +32 2 246 16 11	Lithuania SIA Novartis Baltics Lithuania branch Tel: +370 5 269 16 50
	Luxembourg/Luxembourg Novartis Pharma N.V. Tel/Tel: +32 2 246 16 11
Czech Republic Novartis s.r.o. Tel: +420 225 775 111	Hungary Novartis Hungária Kft. Tel.: +36 1 457 65 00
Denmark Novartis Healthcare A/S Tlf.: +45 39 16 84 00	Malta Novartis Pharma Services Inc. Tel: +356 2122 2872
Germany Novartis Pharma GmbH Tel: +49 911 273 0	Netherlands Novartis Pharma B.V. Tel: +31 88 04 52 111
Estonia SIA Novartis Baltics Estonia branch Tel: +372 66 30 810	Norway Novartis Norge AS Tlf: +47 23 05 20 00
Greece Novartis (Hellas) S.A.E. Tel: +30 210 281 17 12	Austria Novartis Pharma GmbH Tel: +43 1 86 6570
Spain Novartis Farmacéutica, S.A. Tel: +34 93 306 42 00	Poland Novartis Poland Sp. z o.o. Tel.: +48 22 375 4888
France Novartis Pharma S.A.S. Tél: +33 1 55 47 66 00	Portugal Novartis Farma - Produtos Farmacêuticos, S.A. Tel: +351 21 000 8600
Croatia Novartis Hrvatska d.o.o. Tel. +385 1 6274 220	Romania Novartis Pharma Services Romania SRL Tel: +40 21 31299 01
Ireland Novartis Ireland Limited Tel: +353 1 260 12 55	Slovenia Novartis Pharma Services Inc. Tel: +386 1 300 75 50
Iceland Vistor hf. Tel: +354 535 7000	Slovakia Novartis Slovakia s.r.o. Tel: +421 2 5542 5439
Italy Novartis Farma S.p.A. Tel: +39 02 96 54 1	Finland Novartis Finland Oy Puh/Tel: +358 (0)10 6133 200
Cyprus Novartis Pharma Services Inc. Tel: +357 22 690 690	Sweden Novartis Sverige AB Tel: +46 8 732 32 00
Latvia SIA Novartis Baltics Tel: +371 67 887 070

Date of the most recent review of this leaflet:

Other sources of information

Detailed information on 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 UnoReady pen:

Do not use the Cosentyx UnoReady pen if the seal on the outer carton is broken. Keep the Cosentyx UnoReady pen in the sealed outer carton until ready to use to protect it from light. Store the Cosentyx UnoReady pen in the refrigerator at 2°C to 8°C and out of the reach of children. Do not freeze the pen. Do not shake the pen. Do not use the pen if it is dropped without the cap. The needle is covered by the needle shield and is not visible. Do not touch or push the needle shield as you may get injured from a needle stick.

Shown above is Cosentyx 300 mg in a UnoReady pen without the cap. Do not remove the cap until you are ready to administer the injection.

What you need for the injection:

Contents in the box: One Cosentyx UnoReady pen 300 mg new and unused.

Not included in the box: Alcohol-impregnated swab. Cotton and gauze. Sharps disposal container

Before injection:

Remove Cosentyx 300 mg in the UnoReady pen from the refrigerator 30 to 45 minutes before injection to allow it to reach room temperature.

Before injecting, check the important safety aspects: Through the “Viewing Window”: The liquid should be clear and transparent. Its color may vary from colorless to slightly yellowish. Do not use if the liquid contains particles, appears cloudy, or has a clearly brown color. Small air bubbles may be visible, which is normal. Regarding the “Expiration Date”: Check the expiration date (EXP) on your Cosentyx UnoReady pen. Do not use the pen if the expiration date has passed. Ensure your pen contains the correct medication and dosage. Contact your pharmacist if the pen does not meet any of these requirements.

2a. Choose an injection site: The top of the thighs is recommended. You may also use the lower abdomen, but not within a 5 cm area around the navel. Always select a new injection site each time. Do not inject into areas where the skin is tender, damaged, red, scaly, or hard. Avoid areas with scars or stretch marks. 2b. For caregivers or healthcare professionals only: If the injection is administered by the patient's caregiver or a healthcare professional, the upper arms may also be used.

Disinfect the injection site: Wash your hands with warm water and soap before starting. Disinfect the injection site using an alcohol wipe, using a circular motion. Allow it to dry before administering the injection. Do not touch the cleaned area again before the injection.

The injection:

	Remove the cap: Remove the cap only when you are ready to use the pen. Remove the cap straight off in the direction of the arrow as shown in the figure on the left. Once removed, discard it. Do not attempt to replace the cap. Use the pen within 5 minutes after removing the cap.
	Hold your pen: Hold the pen at a 90º angle from the disinfected injection site

Start of injection: Firmly press the pen against the skin to start the injection. The 1st click indicates the start of the injection. Keep the pen firmly pressed against the skin. The green indicator with the gray tip will show the progress of the injection.

End of injection: Listen for the second click. This indicates that the injection is about to finish. Check that the green indicator with the gray tip has filled the window and has stopped moving. You may now remove the pen.

After the injection:

Check that the green indicator fills the window: This means the medication has been administered. If the green indicator is not visible, contact your doctor. There may be a small amount of blood at the injection site. You may press with cotton or gauze on the injection area for 10 seconds. Do not rub the injection site. You may apply a bandage if needed. Disposal of Cosentyx 300 mg pre-filled pen UnoReady: Dispose of the used pen in a sharps disposal container (a closable, puncture-resistant container or similar). Never attempt to reuse the pen.