Drug Index

Nivolumab

 
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Mechanism :

Nivolumab is a fully human immunoglobulin G4 (IgG4) monoclonal antibody that selectively inhibits programmed cell death-1 (PD-1) activity by binding to the PD-1 receptor to block the ligands PD-L1 and PD-L2 from binding.


Indication :

• Hodgkin lymphoma, classical

• Hepatocellular carcinoma

• Colorectal cancer, metastatic (microsatellite instability-high or mismatch repair deficient)

• Head and neck cancer, squamous cell (recurrent or metastatic)

• Melanoma

• Non-small cell lung cancer, metastatic, progressive

• Small cell lung cancer, metastatic

• Renal cell cancer, advanced


Contraindications :

Hypersensitivity to nivolumab or any component of the formulation.


Dosing :

Colorectal cancer, metastatic (Microsatellite instability-high or mismatch repair deficient; combination therapy):

≥12 years: IV: 3 mg/kg once every 3 weeks (in combination with ipilimumab) for 4 combination doses, followed by 240 mg (flat dose) once every 2 weeks (nivolumab monotherapy) until disease progression or unacceptable toxicity.

Colorectal cancer, metastatic (Microsatellite instability-high or mismatch repair deficient; single agent):

≥12 years: IV 240 mg (flat dose) once every 2 weeks until disease progression or unacceptable toxicity.


Adverse Effect :

Edema, fatigue, malaise, headache. Peripheral neuropathy, skin rash, pruritus, hyperglycemia, hyponatremia, hyperkalemia, hypocalcemia, hypertriglyceridemia, increased TSH level, diarrhea, nausea, abdominal pain, anorexia, increased serum lipases, AST, ALT, ALP & creatinine, UTI, anemia, granulocytopenia, thrombocytopenia, GVHD, antibody development, asthenia, musculoskeletal pain.


Interaction :

Belimumab: Monoclonal Antibodies may enhance the adverse/toxic effect of Belimumab.
Immunosuppressants: May diminish the therapeutic effect of Nivolumab.



Hepatic Dose :

Baseline hepatic impairment
Mild or moderate hepatic impairment (with either normal total bilirubin level and elevated AST level OR an elevated total bilirubin level but < 3 times upper limit of normal (ULN) with any AST level): No dosage adjustment required.
Severe hepatic impairment (total bilirubin > 3 times the ULN and any AST level): Dosage adjustment recommendations are not available. Use with caution.

Hepatotoxicity during treatment WITHOUT hepatocellular carcinoma (HCC):
AST or ALT level 3 to 5 times ULN or a total bilirubin level 1.5 to 3 times the ULN: Withhold Hold nivolumab and administer prednisone 0.5 to 1 mg/kg per day (or equivalent) followed by a corticosteroid taper. Consider resuming therapy when hepatotoxicity resolves.
AST or ALT level > 5 times the ULN or a total bilirubin level > 3 times the ULN: Permanently discontinue nivolumab and administer prednisone 1 to 2 mg/kg per day (or equivalent) followed by a corticosteroid taper.

Hepatotoxicity during treatment WITH HCC:
AST/ALT 3 to 5 times the ULN (with normal limits at baseline) or AST/ALT 5 to 10 times the ULN (with 1 to 3 times ULN at baseline) or AST/ALT 8 to 10 times the ULN (with 3 to 5 times ULN at baseline): Withhold nivolumab and administer prednisone 1 to 2 mg/kg per day (or equivalent) followed by a corticosteroid taper. Resume treatment when AST/ALT returns to baseline.
AST/ALT more than 10 times ULN, or total bilirubin more than 3 times ULN: Permanently discontinue nivolumab and administer prednisone 1 to 2 mg/kg per day (or equivalent) followed by a corticosteroid taper.
05/26/2020 04:43:49 Nivolumab
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