Adult Dosing

Unresectable or metastatic melanoma

• 3 mg/kg IV infusion over 90 mins q3 wks x 4 doses

• Withhold the dose for any moderate immune-mediated adverse reactions or for symptomatic endocrinopathy
• Do not shake the product
• Refer package insert for preparation of solution and toxicity-related dose adjustments prior to prescribing ipilimumab

Pediatric Dosing

• Safety and effectiveness have not been established in pediatric patients

[Outline]

• Adult Dosing
• Pediatric Dosing

• Treatment of unresectable or metastatic melanoma

• Hypersensitivity to any of the ingredients of the product

• Therapy may cause severe and fatal immune-mediated adverse reactions due to T-cell activation and proliferation which may involve any organ system. The most common severe reactions are enterocolitis, hepatitis, dermatitis including toxic epidermal necrolysis [TEN]), neuropathy, and endocrinopathy. The majority of the reactions occur during treatment, however reactions may develop weeks to months after discontinuation of therapy
• If severe immune-mediated reactions occur, discontinue treatment and start systemic high-dose corticosteroid therapy
• Evaluate patients for signs and symptoms of enterocolitis, dermatitis, neuropathy, and endocrinopathy; examine clinical chemistries including LFTs and TFTs at baseline and prior to each dose

Renal Dose Adjustment

• Renal impairment: Dose adjustments not defined

Hepatic Dose Adjustment

• Hepatic impairment: Dose adjustments not defined

• Severe, life-threatening, or fatal immune-mediated enterocolitis has occurred in patients treated with ipilimumab. Patients should be monitored for signs and symptoms of enterocolitis and bowel perforation. Consider endoscopic evaluation for persistent or severe symptoms
• Permanently discontinue therapy in patients with severe enterocolitis and start with systemic corticosteroids at a dose of 1-2 mg/kg/day of prednisone or equivalent. In patients with moderate enterocolitis, consider withholding therapy. Administer anti-diarrheal treatment, and if persistent for more than one week, start with systemic corticosteroids at a dose of 0.5 mg/kg/day prednisone or equivalent
• Life-threatening or fatal hepatotoxicity has been reported with ipilimumab. Monitor LFTs and assess patients for signs and symptoms of hepatotoxicity prior to each dose. In patients with hepatotoxicity, diagnose infectious or malignant causes and increase frequency of LFT monitoring until resolution
• Immune-mediated dermatitis has been reported with ipilimumab. Patients should be monitored for signs and symptoms of dermatitis such as rash and pruritus. Permanently discontinue therapy and administer systemic corticosteroids at a dose of 1-2 mg/kg/day of prednisone or equivalent in patients with Stevens-Johnson syndrome, toxic epidermal necrolysis, or rash complicated by full thickness dermal ulceration, or necrotic, bullous/hemorrhagic manifestations
• Immune-mediated endocrinopathies may occur in patients treated with ipilimumab. Closely monitor patients for clinical signs and symptoms of hypophysitis, adrenal insufficiency and hyper- or hypothyroidism. Monitor thyroid function tests and clinical chemistries prior to each dose
• Rare cases of nephritis, pneumonitis, meningitis, pericarditis, uveitis, iritis, hemolytic anemia, myocarditis, angiopathy, temporal arteritis, vasculitis, polymyalgia rheumatica, conjunctivitis, blepharitis, episcleritis, scleritis, leukocytoclastic vasculitis, erythema multiforme, psoriasis, pancreatitis, arthritis, autoimmune thyroiditis, sarcoidosis, neurosensory hypoacusis, autoimmune central neuropathy (encephalitis), myositis, polymyositis, and ocular myositis have been reported with ipilimumab

Pregnancy Category:C

Breastfeeding: It is unknown whether ipilimumab is secreted in human milk. As many drugs are secreted in human milk and because of the potential for serious adverse reactions in nursing infants, a decision should be made whether to discontinue nursing or therapy, taking into account the importance of drug to the mother.

• NEURO: Guillain-Barre syndrome
• GI: Diarrhea, colitis
• HEMA: Hemolytic anemia
• DERM: Pruritus, rash, Stevens-Johnson syndrome, toxic epidermal necrolysis
• EENT: Uveitis, iritis
• HEPA: Hepatotoxicity
• IMMU: Immune-mediated enterocolitis, hepatitis, dermatitis, neuropathies, and endocrinopathies
• MISC: Fatigue

• Antineoplastics: blocks the CTLA-4 activity with its ligands by binding to CTLA-4; augmenting T-cell activation and proliferation
• Metabolism: Unknown
• Excretion: Unknown
• Half-life: 14.7 days

US Trade Name(s)

• Yervoy

US Availability

Yervoy

• INJ: 5 mg/mL (10 mL vial)
• INJ: 5 mg/mL (40 mL vial)

Canadian Trade Name(s)

• N/A

Canadian Availability

• N/A

UK Trade Name(s)

• Yervoy

UK Availability

Yervoy

• INJ: 5 mg/mL (10 mL vial)
• INJ: 5 mg/mL (40 mL vial)

Australian Trade Name(s)

• N/A

Australian Availability

• N/A

[Outline]

Hematology/Oncology

Antineoplastics

Monoclonal Antibodies