Cosentyx ® 75 mg/0,5 ml Solution

What COSENTYX ® is

COSENTYX ® contains the active substance secukinumab. Secukinumab is a monoclonal antibody which belongs to a group of medicines called interleukin (IL) inhibitors. This medicine works by neutralising the activity of a protein called IL - 17A, which is present at increased levels in diseases such as psoriasis, psoriatic arthritis, ankylosing spondylitis and hidradenitis suppurativa.

What COSENTYX ® is used for

COSENTYX ® is used for the treatment of the following inflammatory diseases:

• Plaque psoriasis
• Psoriatic arthritis
• Axial spondyloarthritis (axSpA) - Ankylosing spondylitis - Non - radiographic axial spondyloarthritis
• Juvenile idiopathic arthritis, including Enthesitis Related Arthritis (ERA) and Juvenile Psoriatic Arthritis (JPsA)
• Hidradenitis Suppurativa

Plaque psoriasis

COSENTYX ® is used to treat a skin condition called “plaque psoriasis”, which causes inflammation affecting the skin. COSENTYX ® reduces the inflammation and other symptoms of the disease. COSENTYX ® is used in patients 6 years and older with moderate to severe plaque psoriasis. Using COSENTYX ® in plaque psoriasis will benefit you by leading to improvements of skin clearance and reducing your symptoms such as scaling, itching and pain.

Psoriatic arthritis

COSENTYX ® is used to treat a condition called “psoriatic arthritis”. The condition 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 the damage to the cartilage and bone 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 ® in psoriatic arthritis will benefit you by reducing the signs and symptoms of the disease, slowing down the damage to the cartilage and bone of the joints and improving your ability to do normal daily activities.

Axial spondyloarthritis (axSpA) with or without radiographic damage

Ankylosing spondylitis (AS) & Non - radiographic axial spondyloarthritis (nr - axSpA) COSENTYX ® is used to treat the conditions called “ankylosing spondylitis” and “non - radiographic axial spondyloarthritis”. These conditions are inflammatory diseases primarily affecting the spine which causes inflammation of the spinal joints. 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 your physical function. COSENTYX ® is used in adults with active ankylosing spondylitis or non - radiographic axial spondyloarthritis. Using COSENTYX ® in ankylosing spondylitis or non - radiographic axial spondyloarthritis will benefit you by reducing the signs and symptoms of your disease and improving your physical function.

Juvenile idiopathic arthritis, including Enthesitis Related (ERA) and Juvenile Psoriatic Arthritis (JPsA) COSENTYX ® is used to treat the Enthesitis Related (ERA) and Juvenile Psoriatic Arthritis (JPsA) categories of Juvenile Idiopathic Arthritis (JIA) in patients 2 years and older. Using COSENTYX ® in the JIA categories of ERA and JPsA will benefit you by reducing the symptoms of your disease and improving your physical function. These conditions are inflammatory diseases affecting the joints and the places where tendons join the bone.

Hidradenitis Suppurativa

COSENTYX ® is used to treat a condition called hidradenitis suppurativa, also sometimes called acne inversa or Verneuil’s disease. This condition is a chronic and painful inflammatory skin disease. Symptoms may include tender nodules (lumps) and abscesses (boils) that may leak pus. It commonly affects specific areas of the skin, such as under the breasts, the armpits, inner thighs, groin and buttocks. Scarring may also occur in affected areas. COSENTYX ® can reduce the number of nodules and abscesses you have and the pain that is often associated with the disease. COSENTYX ® is used in adults with hidradenitis suppurativa and can be used alone or with antibiotics. Using COSENTYX ® in hidradenitis suppurativa will benefit you by reducing the number of nodules and abscesses you have and the pain that is often associated with the disease. If you have any questions about COSENTYX ®, how it works or why this medicine has been prescribed for you, ask your doctor.

Do not use COSENTYX ®:

• if you are allergic to secukinumab or any of the other ingredients of this medicine (listed in section 6). If you think you may be allergic, ask your doctor for advice before using COSENTYX ®;
• if you have an active infection which your doctor thinks is important.

Warnings and precautions

Tell your doctor or pharmacist before using COSENTYX ®:

• if you currently have an infection;
• if you have long - term or repeated infections;
• if you have tuberculosis or have had a past history of tuberculosis;
• if you have ever been diagnosed with Crohn’s disease;
• if you have ulcerative colitis;
• if you have recently had a vaccination or if you are due to have a vaccination during treatment with COSENTYX ®;
• if you are receiving any other treatment for psoriasis, such as another immunosuppressant or phototherapy with ultraviolet (UV) light.

If any of these apply to you, your doctor will decide whether you should be given COSENTYX ®. Tell your doctor or pharmacist immediately if you get any of these symptoms during treatment with Cosentyx:

• If you develop itchy rash, dry skin, dry patches, inflamed skin, coin - shaped spots on the skin [dermatitis (including eczema)].
• If you develop severe inflammation of the entire skin surface (dermatitis exfoliative).

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, diarrhoea, weight loss, blood in the stool or any other signs of bowel problems.

Look out for infections and allergic reactions COSENTYX ® can potentially cause serious side effects, including infections and allergic reactions. You must look out for signs of these conditions while you are taking COSENTYX ®. Stop using COSENTYX ® and tell your doctor or seek medical help immediately if you notice any signs indicating a possible serious infection or an allergic reaction. Such signs are listed under “Serious side effects” in section 4.

Children and adolescents COSENTYX ® is not recommended for children under 2 years of age with the Enthesitis Related Arthritis (ERA) and Juvenile Psoriatic Arthritis (JPsA) categories of Juvenile Idiopathic Arthritis (JIA) because it has not been studied in this age group. COSENTYX ® is not recommended for children under 6 years of age with plaque psoriasis because it has not been studied in this age group. COSENTYX ® is not recommended for children and adolescents (under 18 years of age) in other indications because it has not been studied in this age group.

Older people (65 years or above) COSENTYX ® may be used by people aged 65 years and over with no dose adjustment required.

Other medicines and COSENTYX ® Always tell your healthcare professional if you are taking any other medicine, including complementary or traditional medicines. Tell your doctor or pharmacist:

• if you are taking, have recently taken or might take any other medicines;
• if you have recently had or are due to have a vaccination. You should not be given certain types of vaccines (live vaccines) while using COSENTYX ®.

Pregnancy and breastfeeding and fertility COSENTYX ® is not to be used during pregnancy. If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, please consult your doctor, pharmacist or other health care provider for advice before taking this medicine. If you are breastfeeding or plan to breastfeed your baby, you should not be administered COSENTYX ®.

Driving and using machines COSENTYX ® is unlikely to influence your ability to drive and use machines.

Important information about some of the ingredients of COSENTYX ®: If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking COSENTYX ®.

COSENTYX ® Solution for Injection: Always use this medicine exactly as your doctor has told you. Check with your doctor, nurse or pharmacist if you are not sure. COSENTYX ® is given via injection under your skin (known as a subcutaneous injection). You and your doctor should decide if you should inject COSENTYX ® yourself. It is important not to try to inject yourself until you have been trained by your doctor, nurse or pharmacist. A caregiver may also give you your COSENTYX ® injection after proper training.

For detailed instructions on how to inject COSENTYX ®, see “Instructions for use of COSENTYX ®” in this leaflet.

How much COSENTYX ® is given and for how long Your doctor will decide how much COSENTYX ® you need and for how long.

Plaque psoriasis In adults the recommended dose is 300 mg by subcutaneous injection. Each 300 mg dose is given as one subcutaneous injection of 300 mg or as two injections of 150 mg. In children 6 years and older, the recommended dose is based on body weight and is given by subcutaneous injection with initial dosing at Weeks 0, 1, 2, 3, and 4 followed by monthly maintenance dosing. For children receiving the 75 mg dose, the 75 mg/0.5 mL pre - filled syringe should be used. After the first dose you will receive further weekly injections at weeks 1, 2, 3 and 4 followed by monthly injections. Further adjustments to your dose may be recommended by your doctor. At each timepoint you will receive a 300 mg dose given as one subcutaneous injection of 300 mg or as two injections of 150 mg.

Psoriatic arthritis For psoriatic arthritis patients who also have moderate to severe plaque psoriasis, your doctor may adjust the dose recommendation as needed. For patients who did not respond well to medicines called tumour necrosis factor (TNF) blockers: The recommended dose is 300 mg by subcutaneous injection. Each 300 mg dose is given as one subcutaneous injection of 300 mg or as two injections of 150 mg. After the first dose you will receive further weekly injections at weeks 1, 2, 3 and 4 followed by monthly injections. At each timepoint you will receive a 300 mg dose given as one subcutaneous injection of 300 mg or as two injections of 150 mg. For other psoriatic arthritis patients: The recommended dose is 150 mg by subcutaneous injection. After the first dose you will receive further weekly injections at weeks 1, 2, 3 and 4 followed by monthly injections. Based on your response, your doctor may increase your dose to 300 mg.

Axial spondyloarthritis (axSpA) Ankylosing spondylitis The recommended dose is 150 mg by subcutaneous injection. After the first dose you will receive further weekly injections at weeks 1, 2, 3 and 4 followed by monthly injections. Based on your response, your doctor may increase your dose to 300 mg. Each 300 mg dose is given as one subcutaneous injection of 300 mg or as two injections of 150 mg. Non - radiographic axial spondyloarthritis The recommended dose is 150 mg by subcutaneous injection. After the first dose you will receive further weekly injections at weeks 1, 2, 3 and 4 followed by monthly injections.

Enthesitis Related (ERA) and Juvenile Psoriatic Arthritis (JPsA) forms of Juvenile Idiopathic Arthritis (JIA) In children 2 years and older, the recommended dose is based on body weight and is given by subcutaneous injection at Weeks 0, 1, 2, 3, and 4 followed by monthly maintenance dosing. For patients weighing < 50 kg the dose is 75 mg. For patients weighing ≥ 50 kg the dose is 150 mg.

Hidradenitis Suppurativa The recommended dose is 300 mg by subcutaneous injection with initial dosing at Weeks 0, 1, 2, 3, and 4 followed by an injection every two weeks. Each 300 mg dose is given as one subcutaneous injection of 300 mg or two subcutaneous injections of 150 mg. COSENTYX ® is for long term treatment. Your doctor will regularly monitor your condition to check that the treatment is having the desired effect.

If you use more COSENTYX ® than you should In the event of overdosage, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison centre.

If you forget to use COSENTYX ® If you have missed a COSENTYX ® injection, talk to your doctor.

If you stop using COSENTYX ® It is not dangerous to stop using COSENTYX ®. However, if you stop, your psoriasis, psoriatic arthritis or ankylosing spondylitis symptoms may come back. If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.

COSENTYX ® can have side effects. Not all side effects reported for COSENTYX ® are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking COSENTYX ®, please consult your health care provider for advice.

Serious side effects Stop using COSENTYX ® and tell your doctor or seek medical help immediately if you get any of the following side effects:

Possible serious infection - the signs may include:

• fever, flu - like symptoms, night sweats
• feeling tired or short of breath, cough which will not go away
• warm, red and painful skin, or a painful skin rash with blisters
• burning sensation when passing urine.

Serious allergic reaction - the signs may include:

• difficulty breathing or swallowing
• low blood pressure, which can cause dizziness or light - headedness
• swelling of the face, lips, tongue or throat
• severe itching of the skin, with a red rash or raised bumps.

Your doctor will decide if and when you may restart the treatment.

Other side effects Most of the following side effects are mild to moderate. If any of these side effects becomes severe, tell 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 stuffy nose (nasopharyngitis, rhinitis)

Common (may affect up to 1 in 10 people):

• cold sores (oral herpes)
• diarrhoea
• runny nose (rhinorrhoea)
• Itchy rash, dry skin, dry patches, inflamed skin, coin - shaped spots on the skin [dermatitis (including eczema)]

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

• oral thrush (oral candidiasis)
• signs of low levels of white blood cells, such as fever, sore throat or mouth ulcers due to infections (neutropenia)
• athlete’s foot (tinea pedis)
• infection of the external ear (otitis externa)
• discharge from the eye with itching, redness and swelling (conjunctivitis)
• itchy rash (urticaria)
• lower respiratory tract infections
• nausea, abdominal cramps and pain, diarrhoea, vomiting, weight loss or blood in the stool (signs of bowel problems) and fever (symptoms of inflammatory bowel disease)
• Small, itchy blisters on the palms of hands, soles of feet and edges of the fingers and toes (dyshidrotic eczema).

Rare (may affect up to 1 in 1,000 people):

• severe allergic reaction with shock (anaphylactic reaction)
• redness and shedding of skin over a larger area of the body, which may be itchy or painful (exfoliative dermatitis)

Not known (frequency cannot be estimated from the available data):

• fungal infections of the skin and mucous membranes (including oesophageal candidiasis)
• Painful swelling and skin ulceration (pyoderma gangrenosum)
• Severe inflammation of the entire skin surface (dermatitis exfoliative)
• Swelling of the face, lips, tongue or throat (angioedema)

Reporting of side effects If you get side effects, talk to your doctor. You can also report side effects to SAHPRA via the “6.04 Adverse Drug Reaction Reporting Form”, found online under SAHPRA’s publications: https://www.sahpra.org.za/Publications/Index/8. By reporting side effects, you can help provide more information on the safety of COSENTYX ®.

Store all medicines out of reach of children.

SOLUTION FOR INJECTION IN A PRE - FILLED SYRINGE OR PRE - FILLED PEN

• Store COSENTYX ® pre - filled syringe or SensoReady or UNOREADY pens sealed in its box to protect from light.
• Store in the refrigerator between 2 °C and 8 °C. DO NOT FREEZE.
• Do not shake.
• When necessary, COSENTYX ® can be left out of the refrigerator for up to 4 days at room temperature, not above 30 °C.

Do not use COSENTYX ® pre - filled syringe or SensoReady or UNOREADY pens:

• After the expiration date shown on the outer box or the label on the syringe or pen.
• If the liquid contains easily visible particles, is cloudy or is distinctly brown.

Do not throw away any medicines via wastewater. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.