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Ipilimumab Dosage

Medically reviewed by Drugs.com. Last updated on Oct 5, 2020.

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

ADJUVANT TREATMENT OF MELANOMA:
10 mg/kg IV over 90 minutes every 3 weeks for 4 doses followed by 10 mg/kg IV over 90 minutes every 12 weeks for up to 3 years

Uses:
-For the treatment of 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

Ipilimumab 1 mg/kg IV over 30 minutes every 3 weeks with nivolumab 3 mg/kg IV over 30 minutes on the same day for 4 doses; after completing 4 doses of the combination, administer nivolumab as a single agent 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

Ipilimumab 1 mg/kg IV over 30 minutes every 3 weeks with nivolumab 3 mg/kg IV over 30 minutes on the same day; after completing 4 doses of combination therapy, administer nivolumab as a single agent until disease progression or unacceptable toxicity

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 Adult Dose for Hepatocellular Carcinoma

Ipilimumab 3 mg/kg IV over 30 minutes every 3 weeks with nivolumab 1 mg/kg IV over 30 minutes on the same day for 4 doses; after completing 4 doses of combination therapy, administer nivolumab as a single agent until disease progression or unacceptable toxicity

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

Use: In combination with nivolumab for the treatment of patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib

Usual Adult Dose for Non-Small Cell Lung Cancer

METASTATIC NON-SMALL CELL LUNG CANCER EXPRESSING PD-L1:
Ipilimumab 1 mg/kg IV over 30 minutes every 6 weeks with nivolumab 3 mg/kg IV over 30 minutes every 2 weeks until disease progression, unacceptable toxicity, or up to 2 years in patients without disease progression

METASTATIC OR RECURRENT NON-SMALL CELL LUNG CANCER:
Ipilimumab 1 mg/kg IV over 30 minutes every 6 weeks with nivolumab 360 mg IV over 30 minutes every 3 weeks until disease progression, unacceptable toxicity, or up to 2 years in patients without disease progression; this is given with histology-based platinum-doublet chemotherapy every 3 weeks for 2 cycles

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

Uses:
-In combination with nivolumab for the first-line treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors express PD-L1 (1% or greater) as determined by an FDA-approved test. with no EGFR or ALK genomic tumor aberrations
-In combination with nivolumab and 2 cycles of platinum-doublet chemotherapy for the first-line treatment of adult patients with metastatic or recurrent NSCLC, with no EGFR or ALK genomic tumor aberrations

Usual Adult Dose for Malignant Pleural Mesothelioma

Ipilimumab 1 mg/kg IV over 30 minutes every 6 weeks with nivolumab 360 mg IV over 30 minutes every 3 weeks until disease progression, unacceptable toxicity, or up to 2 years in patients without disease progression

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

Use: For the first-line treatment of unresectable malignant pleural mesothelioma in combination with nivolumab

Usual Pediatric Dose for Melanoma - Metastatic

12 years and older:
UNRESECTABLE OR METASTATIC MELANOMA:
3 mg/kg IV over 90 minutes every 3 weeks for a maximum of 4 doses

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:
Ipilimumab 1 mg/kg IV over 30 minutes every 3 weeks with nivolumab 3 mg/kg IV over 30 minutes on the same day; after completing 4 doses of combination therapy, administer nivolumab as a single agent until disease progression or unacceptable toxicity

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 in pediatric patients 12 years and older

Renal Dose Adjustments

See dose adjustments.

Liver Dose Adjustments

See dose adjustments.

Dose Adjustments

When ipilimumab is administered in combination with nivolumab, if ipilimumab is withheld, nivolumab should also be withheld.

No dose reduction for ipilimumab is recommended:
-Withhold for severe (Grade 3) immune-mediated adverse reactions.
-Permanently discontinue for life-threatening (Grade 4) immune-mediated adverse reactions, recurrent severe (Grade 3) immune-mediated reactions that require systemic immunosuppressive treatment, persistent moderate (Grade 2) or severe (Grade 3) reactions lasting 12 weeks or longer after last dose (excluding endocrinopathy), or an inability to reduce corticosteroid dose to 10 mg or less of prednisone or equivalent per day within 12 weeks of initiating steroids.
-Dose modifications for ipilimumab or ipilimumab in combination with nivolumab for adverse reactions that require management different from these general guidelines are summarized below.

IMMUNE-MEDIATED COLITIS:
-Grade 2: Withhold therapy; resume in patients with complete or partial resolution (Grade 0 or 1) after corticosteroid taper; permanently discontinue if no complete or partial resolution within 12 weeks of last dose or inability to reduce prednisone to 10 mg per day (or equivalent) or less within 12 weeks of initiating steroids.
-Grade 3 or 4: Permanently discontinue therapy.

IMMUNE-RELATED HEPATITIS:
HEPATITIS WITH NO TUMOR INVOLVEMENT OF THE LIVER:
-AST or ALT increases to more than 3 times and up to 5 times the upper limit of normal (ULN) OR total bilirubin increases to more than 1.5 and up to 3 x ULN: Withhold therapy; resume in patients with complete or partial resolution (Grade 0 or 1) after corticosteroid taper; permanently discontinue if no complete or partial resolution within 12 weeks of last dose or inability to reduce prednisone to 10 mg per day (or equivalent) or less within 12 weeks of initiating steroids
OR
HEPATITIS WITH TUMOR INVOLVEMENT OF THE LIVER/NON-HCC:
-AST or ALT more than 1.5 and up to 3 x ULN OR total bilirubin more than 3 x ULN: Permanently discontinue therapy.
HEPATITIS WITH TUMOR INVOLVEMENT OF THE LIVER/HCCC:
-Baseline AST/ALT is more than 1 and up to 3 x ULN and increases to more than 5 and up to 10 x ULN OR baseline AST/ALT is more than 3 and up to 5 x ULN and increases to more than 8 and up to 10 x ULN: Withhold therapy; resume in patients with complete or partial resolution (Grade 0 or 1) after corticosteroid taper; permanently discontinue if no complete or partial resolution within 12 weeks of last dose or inability to reduce prednisone to 10 mg per day (or equivalent) or less within 12 weeks of initiating steroids.
-AST/ALT increases to more than 10 x ULN OR total bilirubin increases to more than 3 x ULN: Permanently discontinue therapy.

IMMUNE-MEDIATED EXFOLIATIVE DERMATOLOGIC CONDITIONS:
-Suspected Stevens Johnson Syndrome (SJS), toxic epidermal necrolysis (TEN), or drug rash with eosinophilia and systemic symptoms (DRESS): Withhold therapy.
-Confirmed SJS, TEN, or DRESS: Permanently discontinue therapy.

IMMUNE-RELATED ENDOCRINOPATHIES (Depending on severity, consider withholding for Grade 2 endocrinopathy until symptom improvement with hormone replacement; resume once acute symptoms have resolved):
-Grade 3 or 4: Withhold therapy until stable or permanently discontinue depending on severity.

IMMUNE-RELATED PNEUMONITIS:
-Grade 2: Withhold therapy; resume in patients with complete or partial resolution (Grade 0 or 1) after corticosteroid taper; permanently discontinue if no complete or partial resolution within 12 weeks of last dose or inability to reduce prednisone to 10 mg per day (or equivalent) or less within 12 weeks of initiating steroids.
-Grade 3 or 4: Permanently discontinue therapy.

IMMUNE-RELATED NEPHRITIS WITH RENAL DYSFUNCTION:
-Grade 2 or 3 increased blood creatinine: Withhold therapy; resume in patients with complete or partial resolution (Grade 0 or 1) after corticosteroid taper; permanently discontinue if no complete or partial resolution within 12 weeks of last dose or inability to reduce prednisone to 10 mg per day (or equivalent) or less within 12 weeks of initiating steroids.
-Grade 3 or 4 increased blood creatinine: Permanently discontinue therapy.

IMMUNE-RELATED NEUROLOGICAL TOXICITIES:
-Grade 2: Withhold therapy; resume in patients with complete or partial resolution (Grade 0 or 1) after corticosteroid taper; permanently discontinue if no complete or partial resolution within 12 weeks of last dose or inability to reduce prednisone to 10 mg per day (or equivalent) or less within 12 weeks of initiating steroids.
-Grade 2: Withhold therapy; resume in patients with complete or partial resolution (Grade 0 or 1) after corticosteroid taper; permanently discontinue if no complete or partial resolution within 12 weeks of last dose or inability to reduce prednisone to 10 mg per day (or equivalent) or less within 12 weeks of initiating steroids.
-Grade 3 or 4: Permanently discontinue therapy.

IMMUNE-RELATED MYOCARDITIS:
-Grade 2, 3, or 4: Permanently discontinue therapy.

IMMUNE-RELATED OPHTHALMOLOGIC:
-Grade 2, 3, or 4 that does not improve to Grade 1 within 2 weeks while receiving topical therapy or that requires systemic treatment: Permanently discontinue therapy.
IMMUNE-RELATED INFUSION REACTIONS:
-Grade 1 or 2: Interrupt or slow the rate of infusion.
-Grade 3 or 4: Permanently discontinue therapy.

Consult the manufacturer product information and/or local protocol for information on corticosteroid therapy.

Precautions

CONTRAINDICATIONS:
-None

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.