Secukinumab

COSENTYX is a human interleukin-17A antagonist indicated for the treatment of: moderate to severe plaque psoriasis (PsO) in adults and pediatric patients 6 years and older who are candidates for systemic therapy or phototherapy. active psoriatic arthritis (PsA) in adults and pediatric patients 2 years of age and older. active ankylosing spondylitis (AS) in adults and pediatric patients 12 years of age and older. active non-radiographic axial spondyloarthritis (nr-axSpA) in adults with objective signs of inflammation. active enthesitis-related arthritis (ERA) in pediatric patients 4 years of age and older. moderate to severe hidradenitis suppurativa (HS) in adults and pediatric patients 12 years of age and older.

Secukinumab is a human IgG1 monoclonal antibody that selectively binds to the interleukin-17A (IL-17A) cytokine and inhibits its interaction with the IL-17 receptor. IL-17A is a naturally occurring cytokine that is involved in normal inflammatory and immune responses. Secukinumab inhibits the release of proinflammatory cytokines and chemokines.

Prior to COSENTYX initiation, complete all age-appropriate vaccinations, evaluate patients for tuberculosis (TB). See Full Prescribing Information for instructions on preparation and administration of COSENTYX. Moderate to Severe Plaque Psoriasis: Subcutaneous Dosage in Adults: Recommended dosage is 300 mg by subcutaneous injection at Weeks 0, 1, 2, 3, and 4 and every 4 weeks thereafter. For some patients, a dose of 150 mg may be acceptable. Subcutaneous Dosage in Pediatric Patients 6 Years and Older: Recommended weight-based dosage is administered by subcutaneous injection at Weeks 0, 1, 2, 3, and 4 and every 4 weeks thereafter.

COSENTYX is contraindicated in patients with a previous serious hypersensitivity reaction to secukinumab or to any of the excipients in COSENTYX. Cases of anaphylaxis and angioedema have been reported during treatment with COSENTYX. Serious hypersensitivity to secukinumab or any excipients in COSENTYX.

Infections: Serious infections have occurred. Exercise caution when considering the use of COSENTYX in patients with a chronic infection or a history of recurrent infection. If a serious infection develops, discontinue COSENTYX until the infection resolves. Hypersensitivity Reactions: If an anaphylactic reaction or other serious allergic reaction occurs, discontinue COSENTYX immediately and initiate appropriate therapy. Tuberculosis (TB): Prior to initiating treatment with COSENTYX, evaluate for TB. Inflammatory Bowel Disease (IBD): Cases of IBD were observed in clinical trials. Exercise caution when prescribing COSENTYX to patients with IBD. Eczematous Eruptions: Cases of severe eczematous eruptions have occurred in patients receiving COSENTYX. Immunizations: Avoid use of live vaccines in patients treated with COSENTYX.

The following adverse reactions are discussed in greater detail elsewhere in the labeling: Infections Hypersensitivity Reactions Inflammatory Bowel Disease Eczematous Eruptions Most common adverse reactions (> 1%) are nasopharyngitis, diarrhea, and upper respiratory tract infection.

Certain CYP450 Substrates Increased concentrations of cytokines (e.g., IL-17) during chronic inflammation associated with certain diseases including PsO, PsA, AS, nr-axSpA, ERA, and HS may suppress the formation of CYP enzymes. Upon initiation or discontinuation of COSENTYX in patients who are receiving concomitant CYP450 substrates, particularly those where minimal decreases in the concentration may reduce CYP substrate effectiveness or minimal increases in the concentration may increase CYP substrate adverse reactions, consider monitoring for therapeutic effect or concentration of the CYP substrate and consider dosage adjustment of the CYP substrate as needed.

Refrigerate COSENTYX at 2ºC to 8ºC (36ºF to 46ºF). Do not freeze. If removed from refrigeration, COSENTYX Sensoready pen and prefilled syringes (150 mg/mL, 75 mg/0.5 mL): May be stored for up to 4 days at room temperature not to exceed 30°C (86°F). Write the date COSENTYX is removed from and returned to the refrigerator in the space provided on the carton. Discard if stored outside of the refrigerator over 4 days. May be returned to the refrigerator only one time and must be stored at 2ºC to 8ºC (36ºF to 46ºF) until used or expired. Keep COSENTYX in the original carton to protect from light until the time of use. To avoid foaming, do not shake.