Does Cosentyx have a black box warning?

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Official answer

by Drugs.com

No, Cosentyx does not contain a Boxed Warning, also commonly called a “black box warning”. A Boxed Warning is the most serious safety drug warning issued by the U.S. Food and Drug Administration (FDA).

A Boxed Warning details important or life-threatening risks or side effects that may occur with treatment. Boxed warnings appear prominently at the top of the package insert as well as in the Patient Medication Guide.

This does not mean there are not important warnings and side effects with the use of Cosentyx (secukinumab). Important safety concerns and warnings, some of which may be serious, include:

  • Risk of serious infections due to a lowered ability of your immune system to fight infections. Before starting Cosentyx, tell your doctor if you have an infection, or think you might have an infection.
  • Tuberculosis (TB): your healthcare provider should check you for tuberculosis (a bacterial infection that mainly affects the lungs) before you start treatment. Tell your doctor if you have TB or have been in close contact with someone with TB.
  • Tell your healthcare provider if you have inflammatory bowel disease (Crohn’s disease or ulcerative colitis) before you start treatment. Cases of inflammatory bowel disease were observed in clinical studies.
  • Serious allergic (hypersensitivity) reactions: do not use this medicine if you have had a serious allergic reaction to it or any inactive ingredients. Anaphylaxis, a serious and life-threatening type of allergic reaction, has occurred with Cosentyx. Contact emergency medical services (call 911) or your doctor immediately if you experience a serious allergic reaction. Symptoms of a serious allergic reaction include: swelling of your face, lips, tongue or throat; problems breathing or swallowing; severe rash or itching; fainting or feeling dizzy; and very rapid heartbeat.
  • Live vaccines: you should not receive live vaccines if you take Cosentyx. Examples of live vaccines include the nasal influenza vaccine (FluMist), measles, mumps and rubella (MMR), chickenpox, and yellow fever. Discuss with your doctor if you need any vaccines before you start treatment with Cosentyx.

    • This is not a complete listing of warnings, precaution and side effects. Discuss important safety information with your doctor before you start treatment with Cosentyx.

    Cosentyx is an immunosuppressant prescription medicine approved to treat:

  • moderate-to-severe plaque psoriasis in people 6 years of age and older
  • psoriatic arthritis in adults and children 2 years and older
  • ankylosing spondylitis in adults
  • non-radiographic axial spondyloarthritis (with inflammation) in adults
  • active enthesitis-related arthritis (ERA) in patients 4 years of age and older.

    • Cosentyx may improve these conditions but may also lower your ability to fight infections.

    This is not all the information you need to know about Cosentyx (secukinumab) for safe and effective use and does not take the place of talking to your doctor about your treatment. Review the full Cosentyx information, and discuss this information and any questions you have with your doctor or other health care provider.

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