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0:00Cosentyx®
0:00(secukinumab)
0:00IMPORTANT SAFETY INFORMATION
0:00Do 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.
0:00What is the most important information I should know about COSENTYX?
0:00COSENTYX is a medicine that affects your immune system. COSENTYX may increase your risk of having serious side effects such as:
0:00Infections
0:00COSENTYX may lower the ability of your immune system to fight infections and may increase your risk of infections. Some people have had serious infections while taking COSENTYX, including tuberculosis (TB), and infections caused by bacteria, fungi, or viruses. Some people have died from these infections.
0:00Your doctor should check you for TB before starting treatment with COSENTYX.
0:00If 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.
0:00Your doctor should watch you closely for signs and symptoms of TB during treatment with COSENTYX. Do not use COSENTYX if you have an active TB infection.
0:00Before starting COSENTYX, tell your doctor if you:
0:00are being treated for an infection
0:00have an infection that does not go away or that keeps coming back
0:00have TB or have been in close contact with someone with TB
0:00think 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
0:00After 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.
0:00What are the possible side effects of COSENTYX?
0:00COSENTYX may cause serious side effects, including:
0:00Serious allergic reactions
0:00Serious 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).
0:00If you have a severe allergic reaction, do not give another injection of COSENTYX.
0:00Inflammatory bowel disease
0:00New 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.
0:00Severe skin reactions that look like eczema can happen during treatment with COSENTYX from days to months after your first dose and can sometimes lead to hospitalization. Your doctor may temporarily stop treatment with COSENTYX if you develop severe skin reactions. Tell your doctor if you have any of the following signs or symptoms: redness or rash; itching; small bumps or patches; your skin is dry or feels like leather; blisters on the hands or feet that ooze or become crusty or skin peeling.
0:00The most common side effects of COSENTYX include: cold symptoms, diarrhea, and upper respiratory tract infections.
0:00These are not all of the possible side effects of COSENTYX. Call your doctor for medical advice about side effects.
0:00Before using COSENTYX, tell your doctor if you:
0:00have any of the conditions or symptoms listed above for infections.
0:00have inflammatory bowel disease (Crohn's disease or ulcerative colitis).
0:00are allergic to latex. The needle cap on the COSENTYX Sensoready® pen, and 150 mg/mL and 75 mg/0.5 mL prefilled syringes contains latex.
0:00have 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.
0:00have any other medical conditions and all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Keep a list of your medicines to show your healthcare provider and pharmacist when you get a new medicine.
0:00are 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.
0:00are breastfeeding or plan to breastfeed. It is not known if COSENTYX passes into your breast milk.
0:00You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.
0:00INDICATIONS
0:00COSENTYX® (secukinumab) is a prescription medicine used to treat:
0:00people 6 years of age and older with moderate to severe plaque psoriasis (PSO) 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)
0:00people 2 years of age and older with active psoriatic arthritis (PsA)
0:00adults with active ankylosing spondylitis (AS)
0:00adults with active non-radiographic axial spondyloarthritis (nr-axSpA) and objective signs of inflammation
0:00people 4 years of age and older with active enthesitis-related arthritis (ERA)
0:00adults with moderate to severe hidradenitis suppurativa (HS)
0:00Please see full Prescribing Information, including Medication Guide.
