INDICATIONS
COSENTYX® (secukinumab) is a prescription medicine used to treat:
- people 6 years of age and older with moderate to severe plaque psoriasis that involves large areas or many areas of the body, and who may benefit from taking injections or pills (systemic therapy) or phototherapy (treatment using ultraviolet or UV light alone or with systemic therapy)
- people 2 years of age and older with active psoriatic arthritis
- adults with active ankylosing spondylitis
- adults with active non-radiographic axial spondyloarthritis and objective signs of inflammation
- people 4 years of age and older with active enthesitis-related arthritis
IMPORTANT SAFETY INFORMATION
Do not use COSENTYX if you have had a severe allergic reaction to secukinumab or any of the other ingredients in COSENTYX. See the Medication Guide for a complete list of ingredients.
COSENTYX is a medicine that affects your immune system. COSENTYX may increase your risk of having serious side effects such as:
Infections
COSENTYX may lower the ability of your immune system to fight infections and may increase your risk of infections, sometimes serious.
- Your doctor should check you for tuberculosis (TB) before starting treatment with COSENTYX.
- If your doctor feels that you are at risk for TB, you may be treated with medicine for TB before you begin treatment with COSENTYX and during treatment with COSENTYX.
- Your doctor should watch you closely for signs and symptoms of TB during treatment with COSENTYX. Do not take COSENTYX if you have an active TB infection.
Before starting COSENTYX, tell your doctor if you:
- are being treated for an infection
- have an infection that does not go away or that keeps coming back
- have TB or have been in close contact with someone with TB
- think you have an infection or have symptoms of an infection such as: fevers, sweats, or chills; muscle aches; cough; shortness of breath; blood in your phlegm; weight loss; warm, red, or painful skin or sores on your body; diarrhea or stomach pain; burning when you urinate or urinate more often than normal
After starting COSENTYX, call your doctor right away if you have any signs of infection listed above. Do not use COSENTYX if you have any signs of infection unless you are instructed to by your doctor.
Inflammatory bowel disease
New cases of inflammatory bowel disease or “flare‐ups” can happen with COSENTYX, and can sometimes be serious. If you have inflammatory bowel disease (ulcerative colitis or Crohn’s disease), tell your doctor if you have worsening disease symptoms during treatment with COSENTYX or develop new symptoms of stomach pain or diarrhea.
Serious allergic reactions
Serious allergic reactions can occur. Get emergency medical help right away if you get any of the following symptoms: feeling faint; swelling of your face, eyelids, lips, mouth, tongue, or throat; trouble breathing or throat tightness; chest tightness; skin rash or hives (red, itchy bumps). If you have a severe allergic reaction, do not give another injection of COSENTYX.
Before starting COSENTYX, tell your doctor if you:
- have any of the conditions or symptoms listed above for infections.
- have inflammatory bowel disease (Crohn’s disease or ulcerative colitis).
- are allergic to latex. The needle cap on the COSENTYX Sensoready® 150 mg/mL pen and the 150 mg/mL and 75 mg/0.5 mL prefilled syringes contains latex.
- have recently received or are scheduled to receive an immunization (vaccine). People who take COSENTYX should not receive live vaccines. Children should be brought up to date with all vaccines before starting COSENTYX.
- have any other medical conditions.
- are pregnant or plan to become pregnant. It is not known if COSENTYX can harm your unborn baby. You and your doctor should decide if you will use COSENTYX.
- are breastfeeding or plan to breastfeed. It is not known if COSENTYX passes into your breast milk.
Tell your doctor about all the medicines you take, including prescription and over‐the‐counter medicines, vitamins, and herbal supplements. Know the medicines you take. Keep a list of your medicines to show your doctor and pharmacist when you get a new medicine.
How should I use COSENTYX?
See the detailed Instructions for Use that comes with your COSENTYX for information on how to prepare and inject a dose of COSENTYX, and how to properly throw away (dispose of) used COSENTYX Sensoready pens and prefilled syringes.
- Use COSENTYX exactly as prescribed by your doctor.
- If your doctor decides that you or a caregiver may give your injections of COSENTYX at home, you should receive training on the right way to prepare and inject COSENTYX. Do not try to inject COSENTYX yourself, until you or your caregiver has been shown how to inject COSENTYX by your doctor or nurse.
The most common side effects of COSENTYX include: cold symptoms, diarrhea, and upper respiratory infections. These are not all of the possible side effects of COSENTYX. Call your doctor for medical advice about side effects.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.
For additional information, visit COSENTYX.com. Before starting any treatment, patients should talk to their doctor and review the Important Safety Information to understand the potential risks. To learn more, please see the full Prescribing Information and Medication Guide.
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