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Nivolumab Dosage

Medically reviewed on April 23, 2018.

Applies to the following strengths: 10 mg/mL

Usual Adult Dose for Melanoma - Metastatic

UNRESECTABLE OR METASTATIC MELANOMA:
-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
-IN COMBINATION WITH IPILIMUMAB: 1 mg/kg IV over 30 minutes, followed by ipilimumab 3 mg/kg IV over 90 minutes on the same day, every 3 weeks for 4 doses or until unacceptable toxicity, whichever occurs earlier. After completing 4 doses of the combination, administer this drug (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

ADJUVANT TREATMENT OF MELANOMA:
-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 for up to 1 year

Comments:
-Manufacturer prescribing information should be consulted for ipilimumab dosing.
-When this drug is administered in combination with ipilimumab, if this drug is withheld, ipilimumab should also be withheld.
-When this drug is administered in combination with ipilimumab, infuse this drug first followed by ipilimumab on the same day. Use separate infusion bags and filters for each infusion.

Uses:
1) For unresectable or metastatic melanoma:
-As a single agent in patients with BRAF V600 wild-type unresectable or metastatic melanoma
-As a single agent in patients with BRAF V600 mutation-positive unresectable or metastatic melanoma
-In combination with ipilimumab, in patients with unresectable or metastatic melanoma
2) Adjuvant treatment of melanoma:
-For adjuvant treatment of patients with melanoma with involvement of lymph nodes or metastatic disease who have undergone complete resection

Usual Adult Dose for Non-Small Cell Lung Cancer

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

Use: For metastatic non-small cell lung cancer (NSCLC) with progression on or after platinum-based chemotherapy (patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA approved therapy for these aberrations prior to receiving this drug)

Usual Adult Dose for Renal Cell Carcinoma

-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
-IN COMBINATION WITH IPILIMUMAB: 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 a maximum of 4 doses or until unacceptable toxicity, whichever occurs earlier. After completing 4 doses of the combination, administer this drug (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

Use: For advanced renal cell carcinoma (RCC) in patients who have received prior anti-angiogenic therapy

Usual Adult Dose for Hodgkin's Disease

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

Use: For classical Hodgkin lymphoma (cHL) that has relapsed or progressed after autologous hematopoietic stem cell transplantation (HSCT) and brentuximab vedotin, or 3 or more lines of systemic therapy that includes autologous HSCT

Usual Adult Dose for Head and Neck Cancer

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

Use: For recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) with disease progression on or after platinum-based therapy

Usual Adult Dose for Urothelial Carcinoma

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

Use: For locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-containing chemotherapy or have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy

Usual Adult Dose for Colorectal Cancer

-AS A SINGLE AGENT: 240 mg IV over 30 minutes every 2 weeks until disease progression or unacceptable toxicity
-IN COMBINATION WITH IPILIMUMAB: 3 mg/kg IV over 30 minutes, followed by ipilimumab 1 mg/kg IV over 30 minutes on the same day, every 3 weeks 4 doses. After completing 4 doses of the combination, administer this drug (as a single agent): 240 mg IV over 30 minutes every 2 weeks until disease progression or unacceptable toxicity

Use: For 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

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

Use: For hepatocellular carcinoma (HCC) who have been previously treated with sorafenib

Usual Pediatric Dose for Colorectal Cancer

12 years and older:
-AS A SINGLE AGENT: 240 mg IV over 30 minutes every 2 weeks until disease progression or unacceptable toxicity
-IN COMBINATION WITH IPILIMUMAB: 3 mg/kg IV over 30 minutes, followed by ipilimumab 1 mg/kg IV over 30 minutes on the same day, every 3 weeks 4 doses. After completing 4 doses of the combination, administer this drug (as a single agent): 240 mg IV over 30 minutes every 2 weeks until disease progression or unacceptable toxicity

Use: For 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

No adjustment recommended.

See NEPHRITIS AND RENAL DYSFUNCTION in DOSE ADJUSTMENTS for further information.

Liver Dose Adjustments

Mild hepatic impairment: No adjustment recommended.
Moderate to severe hepatic impairment: Data not available

See HEPATITIS in DOSE ADJUSTMENTS for further information.

Dose Adjustments

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

-There are no recommended dose modifications for hypothyroidism or hyperthyroidism.
-Interrupt or slow the rate of infusion in patients with mild or moderate infusion reactions.
-Discontinue therapy in patients with severe or life-threatening infusion reactions.

COLITIS:
-Moderate (Grade 2) colitis or diarrhea of more than 5 days duration: Administer corticosteroids at 0.5 to 1 mg/kg/day prednisone equivalents, followed by a corticosteroid taper; withhold therapy until the adverse reaction falls to Grade 1 or less; if no improvement or worsening occurs, increase the corticosteroid dose to 1 to 2 mg/kg/day prednisone equivalents
-Severe (Grade 3) colitis or diarrhea: Administer corticosteroids at 1 to 2 mg/kg/day prednisone equivalents, followed by a corticosteroid taper and withhold therapy until the adverse reaction falls to Grade 1 or less when administered as a single agent; permanently discontinue therapy when administered with ipilimumab
-Life-threatening (Grade 3 or 4) colitis or diarrhea: Administer corticosteroids at a dose of 1 to 2 mg/kg/day prednisone equivalents, followed by a corticosteroid taper; permanently discontinue therapy

PNEUMONITIS:
-Moderate (Grade 2) pneumonitis: Administer corticosteroids at a dose of 1 to 2 mg/kg/day prednisone equivalents, followed by a corticosteroid taper; withhold therapy; resume therapy when adverse reaction improves to Grade 0 or 1
-Severe (Grade 3) or life-threatening (Grade 4) pneumonitis: Administer corticosteroids at a dose of 1 to 2 mg/kg/day prednisone equivalents, followed by a corticosteroid taper; permanently discontinue therapy

HEPATITIS/NON-HEPATOCELLULAR CARCINOMA (NON-HCC):
-If aspartate aminotransferase (AST) or alanine aminotransferase (ALT) is more than 3 and up to 5 times upper limit of normal (ULN) or total bilirubin is more than 1.5 and up to 3 x ULN: Withhold dose; resume therapy when adverse reaction improves to Grade 0 or 1
-If AST or ALT is more than 5 x ULN or total bilirubin is more than 3 x ULN: Permanently discontinue therapy

HEPATITIS/HCC:
-If AST/ALT is within normal limits at baseline and increases to more than 3 and up to 5 x ULN: Withhold dose; resume therapy when adverse reaction improves to Grade 0 or 1
-AST/ALT is more than 1 and up to 3 x ULN at baseline and increases to more than 5 and up to 10 x ULN: Withhold dose; resume therapy when adverse reaction improves to Grade 0 or 1
-If AST/ALT is more than 3 and up to 5 x ULN at baseline and increases to more than 8 and up to 10 x ULN: Withhold dose; resume therapy when adverse reaction improves to Grade 0 or 1
-If AST or ALT increases to more than 10 x ULN or total bilirubin increases to more than 3 x ULN: Permanently discontinue therapy
-Administer corticosteroids at 1 to 2 mg/kg/day prednisone equivalents, followed by a corticosteroid taper when this drug is withheld or discontinued due to immune-mediated hepatitis

HYPOPHYSITIS:
-Moderate (Grade 2) or severe (Grade 3) hypophysitis: Administer hormone replacement as clinically indicated and corticosteroids at 1 mg/kg/day prednisone equivalents, followed by a corticosteroid taper; resume therapy when adverse reaction improves to Grade 0 or 1
-Life-threatening (Grade 4) hypophysitis: Administer hormone replacement as clinically indicated and corticosteroids at 1 mg/kg/day prednisone equivalents, followed by a corticosteroid taper; permanently discontinue therapy

ADRENAL INSUFFICIENCY:
-Moderate (Grade 2) adrenal insufficiency: Withhold therapy; resume therapy when adverse reaction improves to Grade 0 or 1
-Severe (Grade 3) or life-threatening (Grade 4) adrenal insufficiency: Permanently discontinue therapy; administer corticosteroids at 1 to 2 mg/kg/day prednisone equivalents, followed by a corticosteroid taper

TYPE 1 DIABETES MELLITUS:
-Severe (Grade 3) hyperglycemia: Withhold therapy; resume therapy when adverse reaction improves to Grade 0 or 1
-Life-threatening (Grade 4) hyperglycemia: Permanently discontinue therapy

NEPHRITIS AND RENAL DYSFUNCTION:
-Moderate (Grade 2) or severe (Grade 3) increased serum creatinine (serum creatinine more than 1.5 and up to 6 x ULN): Withhold therapy; resume therapy when adverse reaction improves to Grade 0 or 1; administer corticosteroids at 0.5 to 1 mg/kg/day prednisone equivalents; if worsening or no improvement occurs, increase dose of corticosteroids to 1 to 2 mg/kg/day prednisone equivalents
-Life-threatening (Grade 4) increased serum creatinine (serum creatinine more than 6 x ULN): Administer corticosteroids at 1 to 2 mg/kg/day prednisone equivalents followed by a corticosteroid taper; permanently discontinue therapy

RASH:
-Severe (Grade 3) rash or suspected Stevens-Johnson syndrome (SJS) or toxic epidermal necrolysis (TEN): Withhold therapy; resume therapy when adverse reaction improves to Grade 0 or 1; administer corticosteroids at 1 to 2 mg/kg/day prednisone equivalents followed by a corticosteroid taper and refer patient for specialized care
-Life-threatening (Grade 4) rash or confirmed SJS or TEN: permanently discontinue therapy; administer corticosteroids at 1 to 2 mg/kg/day prednisone equivalents followed by a corticosteroid taper and refer patient for specialized care

ENCEPHALITIS:
-New-onset moderate or severe neurologic signs or symptoms: Withhold therapy; resume therapy when adverse reaction improves to Grade 0 or 1; administer corticosteroids at 1 to 2 mg/kg/day prednisone equivalents, followed by a corticosteroid taper
-Immune-mediated encephalitis: Permanently discontinue therapy

OTHER:
-For any suspected immune-mediated adverse reactions, exclude other causes.
-Based on the severity of the adverse reaction, permanently discontinue or withhold therapy, administer high-dose corticosteroids, and if appropriate, initiate hormone-replacement therapy. Upon improvement to Grade 1 or less, initiate corticosteroid taper and continue to taper over at least 1 month.
-Consider restarting therapy after completion of corticosteroid taper based on the severity of the event.
-First occurrence: Withhold therapy and resume treatment when adverse reaction falls to Grade 1 or less
-Recurrence of same Grade 3 adverse reactions: Permanently discontinue therapy
-Life-threatening or Grade 4 adverse reaction: Permanently discontinue therapy
-Grade 3 myocarditis: Permanently discontinue therapy
-Requirement for 10 mg per day or greater prednisone or equivalent for more than 12 weeks: Permanently discontinue therapy
-Persistent Grade 2 or 3 adverse reactions lasting 12 weeks or longer: Permanently discontinue therapy

Precautions

-Safety and efficacy have not been established in patients younger than 12 years for colorectal cancer.
-Safety and efficacy have not been established in patients younger than 18 years for all indications except colorectal cancer.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration Advice:
-Administer IV over 60 minutes.
-Use sterile, non-pyrogenic, low protein binding in-line filter with a 0.2 to 1.2 micrometer pore.
-Flush IV line after infusion.
-When this drug is administered in combination with ipilimumab, infuse this drug first followed by ipilimumab on the same day. Use separate infusion bags and filters for each infusion.
-When this drug is administered in combination with ipilimumab, if this drug is withheld, ipilimumab should also be withheld.

Reconstitution/preparation techniques:
-Dilute the drug with either normal saline or 5% dextrose to a concentration of 1 to 10 mg/mL.
-Invert to mix; do not shake.

Storage requirements:
-Refrigerate; protect from light; store in original package until use.
-After preparation, keep at room temperature for no more than 4 hours or in the refrigerator for no more than 24 hours, include infusion time.
-Do not freeze.

IV compatibility:
-Do not coadminister other drugs through the same line.

Monitoring:
-Hepatic: Liver function tests prior to initiating therapy and periodically thereafter
-Renal: Serum creatinine prior to initiating therapy and periodically thereafter
-Endocrine: Thyroid function prior to initiating therapy and periodically thereafter

Patient Education:
-Inform patients about the risk of immune-mediated reactions that may occur and lead to disruption or discontinuation of therapy and corticosteroid treatment.
-Advise females of reproductive age to use effective contraception during treatment and for at least 5 months after the last dose.
-Advise women against breastfeeding while taking this drug.
-Inform patients about the importance of having regular blood work and lab tests done while taking this drug.

Further information

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

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