Interleukin-17A Antagonist

Interleukin-17A Antagonists

Ankylosing Spondylitis

Psoriatic Arthritis

<section class="Section" data-sectioncode="34089-3"><a name="section-10"></a><h1>11     DESCRIPTION</h1>Secukinumab, a recombinant human monoclonal IgG1/κ antibody, is an interleukin-17A antagonist. It is expressed in a recombinant Chinese Hamster Ovary (CHO) cell line. Secukinumab has a molecular mass of approximately 151 kDa; both heavy chains of secukinumab contain oligosaccharide chains.COSENTYX InjectionCOSENTYX injection is a sterile, preservative-free, clear to slightly opalescent, colorless to slightly yellow solution for subcutaneous use. COSENTYX is supplied in a single-dose Sensoready pen with a 27-gauge fixed ½-inch needle, or a single-dose prefilled syringe with a 27-gauge fixed ½-inch needle. The removable cap of the COSENTYX Sensoready pen or prefilled syringe contains natural rubber latex.Each COSENTYX Sensoready pen or prefilled syringe contains 150 mg of secukinumab formulated in: L-histidine/histidine hydrochloride monohydrate (3.103 mg), L-methionine (0.746 mg), polysorbate 80 (0.2 mg), trehalose dihydrate (75.67 mg), and Sterile Water for Injection, USP, at pH of 5.8.Each COSENTYX 75 mg/0.5 mL prefilled syringe contains 75 mg of secukinumab formulated in: L-histidine/histidine hydrochloride monohydrate (1.552 mg), L-methionine (0.373 mg), polysorbate 80 (0.1 mg), trehalose dihydrate (37.83 mg), and Sterile Water for Injection, USP, at pH of 5.8. COSENTYX for InjectionCOSENTYX for injection is supplied as a sterile, preservative free, white to slightly yellow, lyophilized powder in single-dose vials for subcutaneous use after reconstitution. Each COSENTYX vial contains 150 mg of secukinumab formulated in L-histidine/histidine hydrochloride monohydrate (4.656 mg), polysorbate 80 (0.6 mg), and sucrose (92.43 mg). Following reconstitution with 1 mL Sterile Water for Injection, USP, the resulting pH is approximately 5.8.</section>

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