Yervoy

/ BMS

The recommended dose of YERVOY as a single agent is 3 mg/kg administered intravenously over 90 minutes every 3 weeks for a maximum of 4 doses. In the event of toxicity, doses may be delayed, but all treatment must be administered within 16 weeks of the first dose.
YERVOY (ipilimumab), in combination with OPDIVO (nivolumab): Review the Full Prescribing Information for OPDIVO (nivolumab) prior to initiation.
Recommended Dose Modifications presented at table 1 at the attached doctor’s leaflet.
Pediatric Use: Safety and effectiveness of YERVOY have not been established in pediatric patients.
Geriatric Use: No overall differences in safety or efficacy were reported between the elderly patients (65 years and over) and younger patients (less than 65 years).
Renal Impairment: No dose adjustment is needed for patients with renal impairment.
Hepatic Impairment: No dose adjustment is needed for patients with mild hepatic impairment (total bilirubin [TB] >1.0 to 1.5 times the upper limit of normal [ULN] or AST >ULN). YERVOY has not been studied in patients with moderate (TB >1.5 × to 3.0 times ULN and any AST) or severe (TB >3 times ULN and any AST) hepatic impairment.
See prescribing information for full details.

Ipilimumab indicated for the treatment of advanced (unresectable or
metastatic) melanoma.
Ipilimumab, in combination with nivolumab, is indicated for the treatment of
patients with advanced (unresectable or metastatic) melanoma.

Hypersensitivity to ipilimumab or to any of the excipients.

WARNING: IMMUNE-MEDIATED ADVERSE REACTIONS
YERVOY can result in severe and fatal immune-mediated adverse reactions. These immune-mediated reactions may involve any organ system; however, the most common severe immune-mediated adverse reactions are enterocolitis, hepatitis, dermatitis (including toxic epidermal necrolysis), neuropathy, and endocrinopathy. The majority of these immune-mediated reactions initially manifested during treatment; however, a minority occurred weeks to months after discontinuation of YERVOY.
Permanently discontinue YERVOY and initiate systemic high-dose corticosteroid therapy for severe immune-mediated reactions.
Assess patients for signs and symptoms of enterocolitis, dermatitis, neuropathy, and endocrinopathy and evaluate clinical chemistries including liver function tests, adrenocorticotropic hormone (ACTH) level, and thyroid function tests at baseline and before each dose.
See prescribing information for full details.

Fatigue, Diarrhea, Colitis, Pruritus, Rush.
See prescribing information for full details.

No formal pharmacokinetic drug interaction studies have been conducted with this drug.

Pregnancy: There is insufficient human data for YERVOY exposure in
pregnant women. Advise pregnant women of the potential risk to a fetus.
Lactation: It is not known whether ipilimumab is secreted in human milk. Advise women to discontinue breastfeeding during treatment with YERVOY and for 3 months following the final dose.
See prescribing information for full details.

There is no information on overdose with this drug.

Storage: Store YERVOY under refrigeration at 2°C to 8°C . Protect YERVOY from light by storing in the original carton until time of use. Do not freeze or shake.