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Ipilimumab Dosage

Medically reviewed on May 15, 2018.

Applies to the following strengths: 5 mg/mL

Usual Adult Dose for Melanoma - Metastatic

UNRESECTABLE OR METASTATIC MELANOMA:
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

ADJUVANT TREATMENT OF MELANOMA:
10 mg/kg IV over 90 minutes every 3 weeks for 4 doses followed by 10 mg/kg IV every 12 weeks for up to 3 years; in the event of toxicity, doses are omitted, not delayed

Uses:
-For unresectable or metastatic melanoma
-For the adjuvant treatment of cutaneous melanoma with pathologic involvement of regional lymph nodes of more than 1 mm who have undergone complete resection, including total lymphadenectomy

Usual Adult Dose for Renal Cell Carcinoma

Nivolumab 3 mg/kg IV over 30 minutes, followed by ipilimumab 1 mg/kg IV over 30 minutes on the same day, every 3 weeks for 4 doses; after completing 4 doses of the combination, administer nivolumab as a single agent, either 240 mg IV over 30 minutes every 2 weeks OR 480 mg IV over 30 minutes every 4 weeks until disease progression or unacceptable toxicity

Comments:
-Review the full prescribing information for nivolumab prior to initiation.

Use: For intermediate or poor risk, previously untreated advanced renal cell carcinoma (RCC) in combination with nivolumab

Usual Adult Dose for Colorectal Cancer

-IN COMBINATION WITH NIVOLUMAB: Nivolumab 3 mg/kg IV over 30 minutes, followed by ipilimumab 1 mg/kg IV over 30 minutes on the same day, every 3 weeks up to 4 doses or until intolerable toxicity or disease progression

Comments:
-Review the full prescribing information for nivolumab prior to initiation.

Use: In combination with nivolumab for the treatment of microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer (CRC) that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan

Usual Pediatric 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

Comment:
-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 in pediatric patients 12 years and older

Usual Pediatric Dose for Colorectal Cancer

12 years and older:
IN COMBINATION WITH NIVOLUMAB: Nivolumab 3 mg/kg IV over 30 minutes, followed by ipilimumab 1 mg/kg IV over 30 minutes on the same day, every 3 weeks up to 4 doses or until intolerable toxicity or disease progression

Comments:
-Review the full prescribing information for nivolumab prior to initiation.

Use: In combination with nivolumab for the treatment of pediatric patients 12 years of age and older for the treatment of microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer (CRC) that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan

Renal Dose Adjustments

No adjustment recommended.

Liver Dose Adjustments

Mild hepatic impairment (total bilirubin [TB] greater than 1 to 1.5 times the upper limit of normal [ULN], or AST greater than ULN): No adjustment recommended.
Moderate (TB greater than 1.5 to 3 x ULN and any AST) or severe (TB greater 3 x ULN and any AST) hepatic impairment: 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.

Dose Adjustments

-When ipilimumab is administered in combination with nivolumab, if ipilimumab is withheld, nivolumab should also be withheld.
-Interrupt or slow the rate of infusion in patients with mild or moderate infusion reactions.
-Discontinue in patients with severe or life-threatening infusion reactions.

IMMUNE-MEDIATED DERMATITIS:
-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.

ENDOCRINOPATHY:
-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).

GASTROINTESTINAL TOXICITY:
-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.

NEUROPATHY:
-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.

OPHTHALMOLOGIC TOXICITY:
-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.

OTHER TOXICITIES:
-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).

Precautions

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 12 years.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:
-This drug should be administered via an IV infusion over 90 minutes. It should not be administered as an IV push or bolus injection.
-An in-line, sterile, non-pyrogenic, low protein binding filter must be used for IV administration.
-A separate infusion line should be used for infusion; it should not be infused concomitantly in the same IV line with another drug.
-The line must be flushed with sterile 0.9% sodium chloride solution for injection at the end of infusion.

Storage requirements:
-Vials should be stored in their original packaging and kept under refrigeration between 2C and 8C. Vials should not be frozen.
-This drug should be used as soon as possible after opening. If needed, it may be stored for up to 24 hours in a refrigerator between 2C and 8C or at room temperature between 20C and 25C.

Patient advice:
-Any signs or symptoms which may indicate immune-related adverse events should be immediately reported; patients should not treat symptoms of these reactions with over-the-counter medications without consulting a health care provider.
-Patients should be advised to use caution when driving or operating machinery until they are certain that the drug does not adversely affect them.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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