Skip to Content

Nivolumab Dosage

Applies to the following strength(s): 10 mg/mL

The information at Drugs.com is not a substitute for medical advice. Always consult your doctor or pharmacist.

Usual Adult Dose for:

Additional dosage information:

Usual Adult Dose for Melanoma - Metastatic

As a single agent:
240 mg IV over 60 minutes every 2 weeks
Duration of therapy: Continue therapy until disease progresses or unacceptable toxicity occurs.

In combination with ipilimumab:
1 mg/kg IV over 60 minutes, followed by ipilimumab on the same day, every 3 weeks for 4 doses. The recommended subsequent dose of this drug, as a single agent, is 240 mg IV over 60 minutes every 2 weeks until disease progression or unacceptable toxicity

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: 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

Usual Adult Dose for Lung Cancer

240 mg IV over 60 minutes every 2 weeks
Duration of therapy: Continue therapy until disease progresses or unacceptable toxicity occurs.

Use: 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

240 mg IV over 60 minutes every 2 weeks
Duration of therapy: Continue therapy until disease progression or unacceptable toxicity occurs.

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

Usual Adult Dose for Hodgkin's Disease

3 mg/kg IV over 60 minutes every 2 weeks
Duration of therapy: Continue therapy until disease progression or unacceptable toxicity occurs.

Use: For the treatment of patients with classical Hodgkin lymphoma (cHL) that has relapsed or progressed after autologous hematopoietic stem cell transplantation (HSCT) and post-transplantation brentuximab vedotin

Usual Adult Dose for Head and Neck Cancer

3 mg/kg IV over 60 minutes every 2 weeks
Duration of therapy: Continue therapy until disease progression or unacceptable toxicity occurs.

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

Renal Dose Adjustments

Initial therapy: No dosage adjustment recommended

Elevations in serum creatinine:
-For serum creatinine greater than 1.5 and up to 6 x ULN, or greater than 1.5 times baseline: Withhold therapy
-For serum creatinine greater than 6 times the upper limit of normal (6 x ULN): Permanently discontinue therapy

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

-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.

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

COLITIS:
-Moderate (Grade 2) colitis or diarrhea of more than 5 days: Administer corticosteroids at a dose of 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 a dose of 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; permanently discontinue therapy when administered with ipilimumab
-Life-threatening (Grade 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 until the adverse reaction falls to Grade 1 or less
-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:
-Moderate (Grade 2) transaminase elevations: Administer corticosteroids at a dose of 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
-Severe (Grade 3) or life-threatening (Grade 4) transaminase elevations:
Administer corticosteroids at a dose of 1 to 2 mg/kg/day prednisone equivalents, followed by a corticosteroid taper; permanently discontinue therapy

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

ADRENAL INSUFFICIENCY:
-Moderate (Grade 2) adrenal insufficiency: Withhold therapy until the adverse reaction falls to Grade 1 or less
-Severe (Grade 3) or life-threatening (Grade 4) adrenal insufficiency: Administer corticosteroids at a dose of 1 to 2 mg/kg/day prednisone equivalents, followed by a corticosteroid taper; permanently discontinue therapy

TYPE 1 DIABETES MELLITUS:
-Severe (Grade 3) hyperglycemia: Withhold therapy and resume treatment when adverse reaction falls to Grade 1 or less
-Life-threatening (Grade 4) hyperglycemia: Permanently discontinue therapy

NEPHRITIS AND RENAL DYSFUNCTION:
-Moderate (Grade 2) or severe (Grade 3) increased serum creatinine: Administer corticosteroids at a dose of 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; withhold therapy and resume treatment when adverse reaction falls to Grade 1 or less
-Life-threatening (Grade 4) increased serum creatinine: Administer corticosteroids at a dose of 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): Administer corticosteroids at a dose of 1 to 2 mg/kg/day prednisone equivalents followed by a corticosteroid taper and refer patient for specialized care; withhold therapy until the adverse reaction falls to a Grade 1 or less
-Life-threatening (Grade 4) rash or confirmed SJS or TEN: Administer corticosteroids at a dose of 1 to 2 mg/kg/day prednisone equivalents followed by
a corticosteroid taper and refer patient for specialized care; permanently discontinue therapy

ENCEPHALITIS:
-New-onset moderate or severe neurologic signs or symptoms: Withhold therapy and evaluate to rule out infections or other causes; if other etiologies are ruled out, administer corticosteroids at a dose of 1 to 2 mg/kg/day prednisone equivalents, followed by a corticosteroid taper; resume treatment when the adverse reaction falls to Grade 1 or less
-Immune-mediated encephalitis: Permanently discontinue therapy

OTHER:
-For severe (Grade 3) immune-mediated reactions: Administer high dose corticosteroids, and if appropriate, initiate hormone replacement therapy; upon improvement to Grade 1 or less, initiate a corticosteroid taper and continue to taper over at least 1 month; permanently discontinue the drug if the reaction recurs after restarting the drug
-Other life-threatening (Grade 4) immune-mediated reactions: Administer high-dose corticosteroids and taper over at least 1 month; permanently discontinue therapy; initiate hormone-replacement therapy as appropriate
-Requirement for 10 mg per day or greater prednisone or equivalent for more than 12 weeks: Permanently discontinue therapy
-Persistent moderate (Grade 2) or severe (Grade 3) adverse reactions lasting 12 weeks or longer: Permanently discontinue therapy

Precautions

Safety and efficacy have not been established in patients younger than 18 years.

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.

Hide