Applies to the following strengths: 5 mg/mL
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Usual Adult Dose for:
Additional dosage information:
Usual Adult Dose for Melanoma - Metastatic
3 mg/kg IV 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.
Use: For the treatment of unresectable or metastatic melanoma
Usual Adult Dose for Malignant Melanoma of Skin
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 or until disease recurrence or unacceptable toxicity
-In the event of toxicity, doses should be omitted, not delayed.
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.
-Treat symptomatically for mild to moderate dermatitis (e.g., localized rash, pruritus); administer topical or systemic corticosteroids if no improvement within 1 week; withhold therapy for moderate to severe dermatologic toxicity; permanently discontinue therapy for Stevens-Johnson syndrome, toxic epidermal necrolysis, or rash complicated by dermal ulceration (full thickness) or necrotic, bullous, or hemorrhagic manifestations and initiate prednisone 1 to 2 mg/kg/day (or equivalent); when dermatitis is controlled, taper corticosteroid over at least 1 month.
-Withhold therapy for symptomatic endocrinopathy and consider referral to an endocrinologist; initiate prednisone at 1 to 2 mg/kg/day (or equivalent); begin hormone replacement; resume therapy in patients with complete or partial resolution of reactions to Grade 0 or 1 and who are receiving prednisone 7.5 mg daily or less (or equivalent); permanently discontinue therapy for symptomatic endocrinopathy lasting 6 weeks or longer or if unable to reduce prednisone to 7.5 mg daily or less (or equivalent).
-Moderate Enterocolitis: Withhold therapy; administer an antidiarrheal; if moderate enterocolitis persists for more than 1 week, initiate prednisone at 0.5 mg/kg/day (or equivalent); resume therapy in patients with complete or partial resolution of toxicity (Grade 0 or 1) and who are receiving less than 7.5 mg/day prednisone (or equivalent).
-Severe Enterocolitis: Permanently discontinue therapy; initiate prednisone at 1 to 2 mg/kg/day (or equivalent); upon improvement to Grade 1 or less, taper corticosteroids slowly over at least 1 month (rapid tapering may cause recurrence or worsen symptoms); consider adding anti-TNF or other immunosuppressive therapy for management of immune-mediated enterocolitis unresponsive to 3 to 5 days of systemic corticosteroids or recurring after symptomatic improvement.
-Withhold therapy for moderate neuropathy (not interfering with daily activities). -Permanently discontinue therapy for severe neuropathy which interferes with daily activities (e.g., Guillain-Barre-like syndromes); consider initiating prednisone at 1 to 2 mg/kg/day (or equivalent) for severe neuropathies.
-Initiate prednisone at 1 to 2 mg/kg/day (or equivalent) for severe immune-mediated adverse reactions.
-Administer corticosteroid eye drops for uveitis, iritis, or episcleritis.
-Permanently discontinue therapy for Grade 2 through 4 reactions not improving to Grade 1 within 2 weeks while receiving topical therapy or requiring systemic therapy.
-Withhold therapy for Grade 2 adverse reactions; resume therapy in patients with complete or partial resolution of toxicity (Grade 0 to 1) and who are receiving less than 7.5 mg daily prednisone (or equivalent).
-Permanently discontinue therapy for Grade 2 reactions lasting 6 weeks or longer OR inability to reduce corticosteroid dose to prednisone 7.5 mg/day (or equivalent) OR Grade 3 or 4 toxicities.
-Permanently discontinue therapy for severe immune-mediated adverse reactions; initiate prednisone at 1 to 2 mg/day (or equivalent).
US BOXED WARNINGS:
-This drug can cause 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.
-Discontinue therapy permanently and institute systemic high-dose corticosteroid therapy for severe immune-mediated reactions.
-Evaluate patients for enterocolitis, dermatitis, neuropathy, and endocrinopathy and liver function tests and thyroid function tests 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
Other brands: Yervoy