Applies to the following strength(s): 5 mg/mL
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Usual Adult Dose for:
Additional dosage information:
Usual Adult Dose for Melanoma - Metastatic
Initial dose: 3 mg/kg IV over 90 minutes every 3 weeks for a total 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.
Use: For the treatment of unresectable or metastatic melanoma
Usual Adult Dose for Malignant Melanoma of Skin
10 mg/kg administered IV over 90 minutes every 3 weeks for 4 doses, followed by 10 mg/kg every 12 weeks for up to 3 years or until documented disease recurrence or unacceptable toxicity
-In the event of toxicity, doses should be omitted, not delayed.
-Permanently discontinue for severe adverse reactions.
-For manufacturer recommended treatment modifications for immune-mediated adverse reactions, consult the manufacturer product information or local protocol.
Use: Adjuvant treatment of patients with cutaneous melanoma with pathologic involvement of regional lymph nodes of more than 1 mm who have undergone complete resection, including total lymphadenectomy
Renal Dose Adjustments
No adjustment recommended.
Liver Dose Adjustments
-Mild hepatic impairment (total bilirubin [TB] greater than 1.0 to 1.5 times the upper limit of normal [ULN], or AST greater than ULN): No adjustment recommended.
-Moderate or severe hepatic impairment (TB greater than 1.5 times the ULN): Data not available.
For the development of immune related hepatotoxicity:
-This drug should be withheld in patients with Grade 2 hepatotoxicity.
-This drug should be permanently discontinued in patients with Grade 3 to 5 hepatotoxicity.
Treatment should be permanently discontinued for any of the following conditions:
-Moderate adverse reactions or inability to reduce corticosteroid dose to 7.5 mg prednisone or equivalent daily.
-Failure to complete the full course of treatment within 16 weeks from the first dose.
-Severe life-threatening adverse reactions, including any of the following:
-Dermatologic: Stevens-Johnson syndrome, toxic epidermal necrolysis, or rash complicated by full thickness dermal ulceration, or necrotic, bullous, or hemorrhagic manifestations.
-Gastrointestinal: Colitis with abdominal pain, fever, ileus, or peritoneal signs; increase in stool frequency (7 or more over baseline), stool incontinence, need for IV hydration for more than 24 hours, GI hemorrhage, and GI perforation.
-Hepatic: AST or ALT greater than 5 times the ULN or total bilirubin greater than 3 times the ULN.
-Immunologic: Severe immune-mediated reactions affecting any organ system (e.g., nephritis, pneumonitis, pancreatitis, noninfectious myocarditis) or ocular disease that is unresponsive to topical immunosuppressive therapy.
-Nervous system: Severe motor or sensory neuropathy, Guillain-Barré syndrome, or myasthenia gravis.
-Scheduled dose should be withheld for any moderate immune-mediated adverse reaction or symptomatic endocrinopathy.
-For patients with complete or partial resolution of adverse reactions (grade 0 to 1), and who are taking less than 7.5 mg prednisone or equivalent daily, the drug may be resumed at a dose of 3 mg/kg every 3 weeks until all 4 doses are administered or 16 weeks from the first dose, whichever occurs first.
Management when treatment is permanently discontinued in patients with immune-related reactions:
-Systemic corticosteroid therapy should be initiated if the elevations are demonstrated or suspected to be immune-related.
-Once symptoms have resolved, corticosteroid taper, and liver function tests (LFTs) show sustained improvement or return to baseline. Tapering should occur over at least one month.
-Alternative immunosuppressive therapy may be required.
US REMS: The US FDA requires a Risk Evaluation and Mitigation Strategy (REMS) for ipilimumab. It includes a communication plan. For additional information: www.fda.gov/REMS.
US BOXED WARNINGS:
-Ipilimumab can result in severe and fatal immune-mediated adverse reactions due to T-cell activation and proliferation. These immune-mediated reactions may affect any organ system. The most common severe immune-mediated adverse reactions are: enterocolitis, hepatitis, dermatitis (including toxic epidermal necrolysis), neuropathy, and endocrinopathy. Most of these immune-mediated reactions initially manifested during treatment; however, some occurred weeks to months after discontinuation of ipilimumab.
-Ipilimumab should be discontinued permanently and systemic high-dose corticosteroid therapy should be initiated for severe immune-mediated reactions.
-Patients should be evaluated for signs and symptoms of enterocolitis, dermatitis, neuropathy, and endocrinopathy and liver function tests and thyroid function tests should be evaluated at baseline and before each dose.
Safety and efficacy have not been established in patients younger than 18 years.
Consult WARNINGS section for additional precautions.
Data not available
-It should not be mixed or administered with any other drug. The diluted solution should be administered over 90 minutes through an IV line containing a sterile, nonpyogenic, low-protein binding in-line filter. Following each administration, the IV line should be flushed with 0.9% sodium chloride or 5% dextrose.
-This drug should be stored in a refrigerator at 36 to 46 degrees Fahrenheit (2 to 8 degrees Celsius) and protected from light.
-Vials should not be shaken or frozen.
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- Drug class: anti-CTLA-4 monoclonal antibodies
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