Generic Name and Formulations:
Ipilimumab 5mg/mL; soln for IV infusion; preservative-free.
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Indications for YERVOY:
Treatment of unresectable or metastatic melanoma in patients ≥12yrs. Adjuvant treatment of cutaneous melanoma in patients with pathologic involvement of regional lymph nodes >1mm who have undergone complete resection, including total lymphadenectomy.
Give by IV infusion over 90 mins. Unresectable, metastatic: 3mg/kg every 3 weeks for a maximum of 4 doses; may delay doses if toxicity occurs, but all treatment must be given within 16 weeks of the first dose. Adjuvant: 10mg/kg every 3 weeks for 4 doses, followed by 10mg/kg every 12 weeks for up to 3 years; may omit doses if toxicity occurs. Dose modifications: see full labeling.
Severe and fatal immune-mediated adverse reactions can develop. Permanently discontinue therapy and initiate systemic high-dose corticosteroids for severe, persistent, or recurring immune-mediated reactions. Withhold dose for moderate immune-mediated adverse reactions until return to baseline, improvement to mild severity, or complete resolution, and patient is receiving <7.5mg prednisone or equivalent per day. Monitor for enterocolitis, hepatitis, dermatitis, neuropathy, endocrinopathy, and others including ocular manifestations; perform clinical chemistries including LFTs, ACTH levels, and thyroid tests at baseline and before each dose. Give steroid eye drops if uveitis, iritis, or episcleritis develops (may need systemic treatment if a Vogt-Koyanagi-Harada-like syndrome develops); permanently discontinue if unresponsive to local therapy. Moderate or severe hepatic impairment. Embryo-fetal toxicity. Females of reproductive potential should use effective contraception during and for 3 months after final dose. Pregnancy. Nursing mothers: not recommended (during and for 3 months after final dose).
Cytotoxic T-lymphocyte antigen 4 (CTLA-4)-blocking antibody.
Fatigue, diarrhea, pruritus, rash, colitis, headache, weight loss, nausea, pyrexia, decreased appetite, vomiting, insomnia; immune-mediated reactions.
To enroll pregnant patients in the Pregnancy Safety Surveillance Study, call (844) 593-7869.
Single-use vial (50mg, 200mg)—1
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