COSENTYX^® for ankylosing spondylitis

How should I store COSENTYX^®?

You should store the COSENTYX^® SensoReady^® pen sealed in its outer box to protect it from light. It should be kept in the refrigerator between 2°C and 8°C. DO NOT FREEZE.

If necessary, the pre-filled syringe and the SensoReady pen may be stored unrefrigerated for a single period of up to 4 days at room temperature, not above 30°C. Discard the pre-filled syringe or SensoReady pen after 4 days if left unrefrigerated.

What happens if I use too much COSENTYX^®?

If you accidentally inject more COSENTYX^® or sooner than instructed, inform your doctor immediately. In the event of drug overdose, contact your doctor, a member of your health care team, your local hospital emergency department, or regional Poison Control Centre immediately, even if there are no symptoms.

What if I miss a dose?

If you have forgotten to inject a dose of COSENTYX^®, take the dose when you remember and return to your regular schedule. Then talk to your doctor to discuss when you should inject the next dose.

BEFORE you use COSENTYX^® talk to your doctor or pharmacist if:

• - You currently have an infection or if you have long-term or repeated infections
• - You have tuberculosis. Your doctor should check for tuberculosis before starting treatment
• - You ever had an allergic reaction to latex. The needle cap on the COSENTYX^® SensoReady^® pen and pre-filled syringe contains a derivative of latex
• - You have Crohn’s disease or ulcerative colitis
• - You had a recent vaccination or if you will receive a vaccination during treatment with COSENTYX^®

Who should not use COSENTYX^®?

Do not use COSENTYX^® if you had a severe allergic reaction to secukinumab or any of the other ingredients of COSENTYX^®. If you think you may be allergic, talk to your doctor, and ask for advice before using COSENTYX^®. Do not take COSENTYX^® if you have any signs of infection or an active tuberculosis infection unless you are instructed to by your health care provider. COSENTYX^® is not recommended for children and adolescents (under 18 years of age) because it has not been studied in this age group.

Can I take COSENTYX^® if I am pregnant, planning to become pregnant or breastfeeding?

Talk to your doctor before using COSENTYX^®:

• - If you are pregnant, think that you may be pregnant or are planning to have a baby
• - COSENTYX^® is not recommended during pregnancy unless the benefits clearly outweigh the potential risks
• - If you are breastfeeding or plan to breastfeed
• - It is not known if COSENTYX^® passes into your breast milk

What are the most common side effects associated with COSENTYX^®?

As with all medicines, patients treated with COSENTYX^® may experience side effects. Most of the side effects with COSENTYX^® are mild to moderate. The most common side effects include:

• - Upper respiratory tract infections with symptoms such as sore
• - Throat and stuffy nose (nasopharyngitis, rhinitis)
• - Cold sores (oral herpes)
• - Diarrhea
• - Itchy rash (urticaria)
• - Runny nose (rhinorrhea)

The above is not a complete list of side effects; for more complete information, refer to the Consumer Information leaflet available here.

What if I feel unwell during my treatment?

Talk to your doctor or pharmacist immediately if you get any of these symptoms during your COSENTYX^® treatment.

You have worsening symptoms or develop new symptoms of stomach pain or diarrhea.

Signs or symptoms of a potentially serious infection. These may include:

• - Fever, flu-like symptoms, muscle aches, 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 when passing water

Signs or symptoms of an allergic reaction. These may include:

• - Chest tightness, difficulty breathing or swallowing
• - Low blood pressure, which can cause dizziness or light-headedness
• - Swelling of the face, lips, mouth or throat

Do not use COSENTYX^® if you have any signs of infection or an allergic reaction unless you are instructed to by your health care provider.

STOP using COSENTYX^® and seek medical help immediately if you experience any of the following, which are signs of an allergic reaction:

• - Difficulty breathing or swallowing
• - Swelling of the face, lips, tongue or throat
• - Severe itching of the skin, with a red rash or raised bumps

You should always tell your doctor about any other medications you are taking before starting COSENTYX^®.

• - Talk to your doctor if you have recently had or are going to have a vaccination. You should not receive certain types of vaccines (live vaccines) while using COSENTYX^®