COSENTYX 150 mg SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE

Introduction

Package Leaflet: Information for the User

Cosentyx 150mg solution for injection in pre-filled syringe

secukinumab

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist or nurse.

− This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

• If you experience any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What is Cosentyx and what is it used for
2. What you need to know before you use Cosentyx
3. How to use Cosentyx
4. Possible side effects
5. Storing Cosentyx
6. Contents of the pack and other information

1. What is Cosentyx and what is it 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 amounts in diseases 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
• Juvenile idiopathic arthritis, including enthesitis-related arthritis and juvenile psoriatic arthritis

Plaque Psoriasis

Cosentyx is used to treat a skin condition called “plaque psoriasis” that 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 as it improves the appearance of your skin and reduces symptoms such as scaling, itching, and pain.

Hidradenitis Suppurativa

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

Cosentyx can reduce the number of nodules and abscesses you have and the pain that is often associated with the disease. If you have hidradenitis suppurativa, you will first be given other medicines. If you do not respond well enough to these medicines, you will be given Cosentyx.

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

Psoriatic Arthritis

Cosentyx is used to treat a condition called “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 medicines. If you do not respond well enough to these medicines, 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 medicine 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 normal daily activities.

Axial Spondyloarthritis, including Ankylosing Spondylitis (Radiographic Axial Spondyloarthritis) and Non-Radiographic Axial Spondyloarthritis

Cosentyx is used to treat conditions called “ankylosing spondylitis” and “non-radiographic axial spondyloarthritis”. These are inflammatory diseases that mainly affect the spine, causing inflammation of the joints of the spine. If you have ankylosing spondylitis or non-radiographic axial spondyloarthritis, you will first be given other medicines. If you do not respond well enough to these medicines, 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 as it reduces the signs and symptoms of the disease and improves physical function.

Juvenile Idiopathic Arthritis (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 called “enthesitis-related arthritis” and “juvenile psoriatic arthritis”. These are inflammatory diseases that affect the joints and the places where tendons join the bone.

Using Cosentyx in 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 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 cough that won't go away, weight loss, lack of energy or a low-grade fever), tell your doctor right away.

Hepatitis B

Tell your doctor if you have or have had a 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 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 right 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 infections and allergic reactions

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

Stop using Cosentyx and tell your doctor or seek medical help right 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 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 must use a suitable contraceptive while using Cosentyx and for at least 20 weeks after the last dose of Cosentyx. Talk to your doctor if you are pregnant, think you may be pregnant or plan to become pregnant.
• Talk to 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 exactly the instructions for administration of this medicine given by your doctor. If you are not sure, talk to your doctor, pharmacist or nurse.

Cosentyx is given by injection under the skin (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 who takes care of you can also give you the injection of Cosentyx after they have received proper training.

Detailed instructions on how to administer Cosentyx are given in the section “Instructions for use of Cosentyx 150 mg pre-filled syringe” 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 for the first 4 weeks, 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 between 25 kg and below 50 kg: 75 mg given as a subcutaneous injection.
  • Weight 50 kg and above: 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 for the first 4 weeks, 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 for the first 4 weeks, followed by monthly injections. Depending on your response, your doctor may recommend additional dose adjustments.

Psoriatic arthritis

If you have psoriatic arthritis and also plaque psoriasis of moderate to severe intensity, 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 for the first 4 weeks, 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 for the first 4 weeks, 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 for the first 4 weeks, 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 for the first 4 weeks, 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 50 kg and above: 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 for the first 4 weeks, 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 given before the time indicated by your doctor, tell your doctor.

If you forget to use Cosentyx

If you miss a dose of Cosentyx, inject the next dose as soon as you remember. Then talk to your doctor to find out when you should have your 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 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 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, 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 (pharyngitis, 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):

• mouth 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 syringe after "CAD"/"EXP".

Store the syringe 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 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 pre-filled syringe 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 varies from colorless to slightly yellow.

Cosentyx 150 mg injectable solution in pre-filled syringe is presented in unit packs of 1 or 2 pre-filled syringe(s) and in multiple packs containing 6 (3 packs of 2) 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

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:

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 Pre-filled Syringe

Read ALL the instructions before injecting the medicine. It is important that you do not attempt to inject the medicine or a person under your care until your doctor, nurse, or pharmacist has taught you how to do it. The box contains the pre-filled syringe(s) of Cosentyx 150 mg inside a plastic blister.

Your Cosentyx 150 mg in Pre-filled Syringe

Once the medicine has been injected, the needle protector will be activated. This is designed to protect against accidental needlestick injuries to healthcare professionals, patients who self-inject the prescribed medicine, and individuals who help patients self-inject the medicine.

Important Safety Information

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

1. The needle cap of the syringe may contain dry rubber (latex) that should not be touched by people sensitive to it.
2. Do not open the box until you are ready to administer this medicine.
3. Do not use this medicine if the box seal or blister is broken, as it may not be safe to use.
4. Do not use the syringe if it has been dropped onto a hard surface or if it has been dropped after removing the needle cap.
5. Never leave the syringe in places where other people can touch it.
6. Do not shake the syringe.
7. Be very careful not to touch the activation clips before use. If you do, the needle protector will trigger prematurely.
8. Do not remove the needle cap until just before administering the injection.
9. The syringe cannot be reused. Once used, dispose of the syringe in the sharps disposal container.

Storage of Cosentyx 150 mg in Pre-filled Syringe

1. Store this medicine sealed in its box to protect it from light. Store in the 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 that appears on the box or on the label of the syringe after "CAD"/"EXP". If it has expired, return the complete package to the pharmacy.

Injection Sites

Preparing Cosentyx 150 mg in Pre-filled Syringe for Use

Note: For a 150 mg dose, prepare 1 pre-filled syringe and inject the contents. For a 300 mg dose, prepare 2 pre-filled syringes and inject the contents of both.

1. Remove the box with the syringe from the refrigerator and let it unopenedfor 15-30 minutes to reach room temperature.
2. When you are ready to use the syringe, wash your hands well with soap and water.
3. Disinfect the injection site well with an alcohol swab.
4. Remove the syringe from the box and take it out of the blister by holding the syringe protector.
5. Inspect the syringe. The liquid should be clear. Its color may vary from colorless to slightly yellowish. There may be a small air bubble, 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.

Using the Cosentyx 150 mg Pre-filled Syringe

Disposal Instructions