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Nivolumab Dosage

Applies to the following strengths: 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 Melanoma - Metastatic

As a single agent:
240 mg IV over 60 minutes every 2 weeks until disease progression or unacceptable toxicity

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 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: 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

Usual Adult Dose for Non-Small Cell Lung Cancer

240 mg IV over 60 minutes every 2 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

240 mg IV over 60 minutes every 2 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

240 mg IV over 60 minutes every 2 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

3 mg/kg IV over 60 minutes every 2 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

240 mg IV over 60 minutes every 2 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

240 mg IV over 60 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

240 mg IV over 60 minutes every 2 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:
240 mg IV over 60 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

-Serum creatinine more than 1.5 and up to 6 x ULN: Withhold therapy and resume treatment when adverse reaction falls to Grade 1 or less
-Serum creatinine more than 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

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

Dose escalation or reduction is not recommended. Dosing delay or discontinuation may be required based on individual safety and tolerability.

PNEUMONITIS:
-Moderate (Grade 2) pneumonitis: Administer corticosteroids at a dose of 1 mg/kg/day methylprednisolone equivalents, followed by a corticosteroid taper; withhold therapy until the adverse reaction falls to Grade 1 or less; if worsening or no improvement occurs, increase the corticosteroid dose to 2 to 4 mg/kg/day methylprednisolone equivalents and permanently discontinue therapy
-Severe (Grade 3) or life-threatening (Grade 4) pneumonitis: Administer corticosteroids at a dose of 2 to 4 mg/kg/day methylprednisolone equivalents and permanently discontinue therapy

COLITIS:
-Moderate (Grade 2) colitis or diarrhea: Administer corticosteroids at a dose of 0.5 to 1 mg/kg/day methylprednisolone 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 methylprednisolone equivalents and permanently discontinue therapy
-Severe (Grade 3) colitis or diarrhea: Administer corticosteroids at a dose of 1 to 2 mg/kg/day methylprednisolone equivalents, followed by a corticosteroid taper and withhold therapy until the adverse reaction falls to Grade 1 or less; permanently discontinue therapy if worsening or no improvement occurs despite initiation of corticosteroids OR when administered with ipilimumab.
-Life-threatening (Grade 4) colitis or diarrhea: Administer corticosteroids at a dose of 1 to 2 mg/kg/day methylprednisolone equivalents, followed by a corticosteroid taper; permanently discontinue therapy

HEPATITIS:
-Moderate (Grade 2) transaminase elevations or total bilirubin elevation: Administer corticosteroids at a dose of 0.5 to 1 mg/kg/day methylprednisolone equivalents, followed by a corticosteroid taper; withhold therapy until the adverse reaction falls to Grade 1 or less; if worsening or no improvement occurs, increase the corticosteroid dose to 1 to 2 mg/kg/day methylprednisolone equivalents and permanently discontinue therapy
-Severe (Grade 3) or life-threatening (Grade 4) transaminase elevations:
Administer corticosteroids at a dose of 1 to 2 mg/kg/day methylprednisolone equivalents, followed by a corticosteroid taper; 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 methylprednisolone equivalents; withhold therapy and resume treatment when adverse reaction falls to Grade 1 or less; if worsening or no improvement occurs despite initiation of corticosteroids, increase the corticosteroid dose to 1 to 2 mg/kg/day methylprednisolone equivalents and permanently discontinue therapy.
-Life-threatening (Grade 4) increased serum creatinine: Administer corticosteroids at a dose of 1 to 2 mg/kg/day methylprednisolone equivalents followed by a corticosteroid taper; permanently discontinue therapy

HYPOTHYROIDISM:
-Symptomatic hypothyroidism/hyperthyroidism: Withhold therapy and initiate thyroid hormone replacement or antithyroid therapy as needed; administer corticosteroids at a dose of 1 to 2 mg/kg/day methylprednisolone equivalents if acute inflammation of the thyroid is suspected; upon improvement, therapy may be resumed after corticosteroid taper, if needed; monitor thyroid function
-Life-threatening hypothyroidism/hyperthyroidism: Permanently discontinue therapy.

ADRENAL INSUFFICIENCY:
-Moderate (Grade 2) adrenal insufficiency: Withhold therapy until the adverse reaction falls to Grade 1 or less; initiate corticosteroid replacement if needed
-Severe (Grade 3) or life-threatening (Grade 4) adrenal insufficiency: Permanently discontinue therapy; initiate corticosteroid replacement if needed

HYPOPHYSITIS:
-Moderate (Grade 2) or severe (Grade 3) hypophysitis: Administer hormone replacement as clinically indicated and corticosteroids at a dose of 1 to 2 mg/kg/day methylprednisolone equivalents if acute inflammation of the pituitary gland is suspected, 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 methylprednisolone equivalents, followed by a corticosteroid taper; permanently discontinue therapy

DIABETES:
-For symptomatic diabetes, withhold therapy and initiate insulin replacement as needed; blood sugar should be monitored.
-Permanently discontinue therapy for life-threatening diabetes.

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 methylprednisolone 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 methylprednisolone equivalents followed by a corticosteroid taper and refer patient for specialized care; permanently discontinue therapy

Other Immune-Mediated Reactions:
-Other immune-related adverse reactions reported in less than 1% of patients have included pancreatitis, uveitis, demyelination, autoimmune neuropathy (including facial and abducens nerve paresis), Guillain-Barre syndrome, hypopituitarism, myasthenic syndrome, gastritis, sarcoidosis, and duodenitis.
-For suspected immune-related adverse reactions, other causes should be ruled out.
-Based on the severity of the adverse reaction, therapy should be withheld and corticosteroids administered. Upon improvement, therapy may be resumed after corticosteroid taper.
-Permanently discontinue therapy for any severe immune-related adverse reaction that recurs and for any life-threatening immune-related adverse reaction.

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.

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