Malignant melanoma, Cutaneous with involvement of regional lymph nodes following complete resection; Adjuvant.
Malignant melanoma, Unresectable or metastatic.

The effect of ipilimumab (a recombinant, human monoclonal antibody that binds to cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4)) in the treatment of melanoma results in augmentation of T-cell activation and proliferation and an increase in T-cell responsiveness, including antitumor immune responses.

Distribution:
Vd: 7.21 L
Elimination Half Life:
15.4 days

Specific contraindications have not been determined.

Fetal risk cannot be ruled out. (TH)

Infant risk cannot be ruled out.(MDX)

Common:
Dermatologic: Pruritus (Unresectable or metastatic melanoma, 21% to 31% ; cutaneous melanoma with lymph node involvement, 45% ), Rash (Unresectable or metastatic melanoma, 25% to 29% ; cutaneous melanoma with lymph node involvement, 50% )
Gastrointestinal: Colitis (Unresectable or metastatic melanoma, 5% to 8% ; cutaneous melanoma with lymph node involvement, 16% ), Diarrhea (Unresectable or metastatic melanoma, 32% to 37% ; cutaneous melanoma with lymph node involvement, 49% )
Other: Fatigue (Unresectable or metastatic melanoma, 34% to 41% ; cutaneous melanoma with lymph node involvement, 46% )
Serious:
Cardiovascular: Myocarditis, Pericarditis
Dermatologic: Dermatitis
Endocrine metabolic: Adrenal insufficiency, Disorder of endocrine system, Hypogonadism, Hypopituitarism Gastrointestinal: Enterocolitis (Unresectable or metastatic melanoma, 5% to 7% ; cutaneous melanoma with lymph node involvement, 16% ), Pancreatitis (1.3% ), Perforation of intestine (1% )
Hematologic: Eosinophil count raised (2.1% ), Hemolytic anemia (Less than 1% )
Hepatic: Hepatitis, Hepatotoxicity
Musculoskeletal: Myositis (Less than 1% ), Polymyositis (Less than 1% )
Neurologic: Encephalitis (Less than 1% ), Guillain-Barr? syndrome, Meningitis, Neuropathy, Peripheral motor neuropathy
Ophthalmic: Iritis (Less than 1% ), Orbital myositis (Less than 1%), Uveitis (Less than 1% )
Renal: Nephritis, Renal failure (less than 1% )
Respiratory: Pneumonitis

Malignant melanoma, Cutaneous with involvement of regional lymph nodes following complete resection; Adjuvant:
10 mg/kg IV over 90 minutes every 3 weeks for 4 doses followed by 10 mg/kg every 12 weeks for up to 3 years. In the event of toxicity, omit doses, do not delay .
Malignant melanoma, Unresectable or metastatic:
3 mg/kg IV infusion over 90 minutes every 3 weeks for a maximum of 4 doses; treatment can be delayed for toxicities, but all doses must be administered within 16 weeks of the first dose (FDA dosage)
Increased infusion rate, 3 mg/kg IV infusion over 30 minutes followed by a 1-hour observation period after the first dose; if an infusion reaction occurs, give additional doses with standard premedication for biologic therapy (off-label dosage) .
10 mg/kg IV infusion over 90 minutes every 3 weeks for MAX 4 doses; may retreat patients who subsequently progress, if had stable disease for at least 3 months or a partial or complete response, and absence of unacceptable toxicity after the last dose (off-label dosage).

Malignant melanoma, Unresectable or metastatic:
(12 years or older) 3 mg/kg IV infusion over 90 minutes every 3 weeks for a maximum of 4 doses; treatment can be delayed for toxicities, but all doses must be administered within 16 weeks of the first dose.

Hepatic impairment (Mild, total bilirubin greater than 1 to 1.5 times ULN or AST greater than ULN): No adjustment required.