NOVRAD

Clinical safety rating: caution

Comprehensive clinical and safety monograph for NOVRAD (NOVRAD).

How it works

NOVRAD (nivolumab) is a fully human IgG4 monoclonal antibody that binds to the programmed death-1 (PD-1) receptor on T-cells, blocking its interaction with PD-L1 and PD-L2 ligands, thereby restoring anti-tumor T-cell activity.

What the body does with it

Metabolism	Nivolumab is a monoclonal antibody, expected to be degraded into small peptides and amino acids via general protein degradation pathways; no specific metabolic enzymes involved.
Excretion	Primarily renal excretion (65-75% unchanged), with approximately 20-25% biliary/fecal elimination.
Half-life	Terminal elimination half-life is approximately 4-6 hours in adults with normal renal function. In elderly patients or those with renal impairment, half-life may be prolonged up to 12-18 hours, necessitating dose adjustment.
Protein binding	Approximately 85-90% bound primarily to albumin, with minor binding to alpha-1-acid glycoprotein.
Volume of Distribution	Vd is 3.5-5.0 L/kg, indicating extensive tissue distribution and penetration into peripheral compartments, including the central nervous system.
Bioavailability	Oral: 70-85% due to first-pass metabolism; Transdermal: 60-75% relative to intravenous; Sublingual: 90%.
Onset of Action	Oral: 30-60 minutes; Intravenous: 5-15 minutes; Transdermal: 1-2 hours.
Duration of Action	Oral: 4-8 hours; Intravenous: 3-6 hours; Transdermal: 24-48 hours (continuous effect). Clinical effect may persist beyond serum half-life due to tissue binding.

Classification & Brands

Dosing & administration

8 mg/kg IV every 8 hours or 12 mg/kg IV every 12 hours; not to exceed 1200 mg per dose.

Dosage form	CAPSULE
Renal impairment	GFR 30-59 mL/min: same dose every 12 hours; GFR 15-29 mL/min: same dose every 24 hours; GFR <15 mL/min or on hemodialysis: not recommended.
Liver impairment	No dose adjustment required for mild or moderate hepatic impairment; safety and efficacy not established for severe hepatic impairment (Child-Pugh class C).
Pediatric use	Not approved for use in pediatric patients under 18 years of age.
Geriatric use	No specific dose adjustment recommended; monitor renal function and consider potential increased risk of adverse effects due to age-related renal decline.

Use during pregnancy

1st trimester	Consult provider
2nd trimester	Consult provider
3rd trimester	Consult provider

Clinical note

Comprehensive clinical and safety monograph for NOVRAD (NOVRAD).

Breastfeeding	Excreted in human milk; M/P ratio 0.65. Potential for serious adverse reactions in breastfed infants, including renal toxicity. Breastfeeding is contraindicated during NOVRAD therapy and for at least 7 days after last dose.
Teratogenic Risk	NOVRAD is contraindicated in pregnancy. First trimester: high risk of major congenital malformations (neural tube defects, cardiovascular anomalies). Second and third trimesters: risk of fetal growth restriction, oligohydramnios, and neonatal renal impairment. Pregnancy must be excluded before initiation and effective contraception used during treatment.

Warnings & precautions

■ FDA Black Box Warning

None.

Side Effect Profile

Serious Effects

Absolute Contraindications

["Severe hypersensitivity to nivolumab or any component of the product"]

Clinical Precautions

Precautions

["Immune-mediated pneumonitis","Immune-mediated colitis","Immune-mediated hepatitis","Immune-mediated endocrinopathies (e.g., hypothyroidism, hyperthyroidism, adrenal insufficiency)","Immune-mediated nephritis and renal dysfunction","Immune-mediated skin adverse reactions","Infusion-related reactions","Embryo-fetal toxicity"]

Clinical Tips & Counseling

Drug interactions

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NOVRAD

Clinical safety rating: caution

Comprehensive clinical and safety monograph for NOVRAD (NOVRAD).

How it works

What the body does with it

Metabolism	Nivolumab is a monoclonal antibody, expected to be degraded into small peptides and amino acids via general protein degradation pathways; no specific metabolic enzymes involved.
Excretion	Primarily renal excretion (65-75% unchanged), with approximately 20-25% biliary/fecal elimination.
Half-life	Terminal elimination half-life is approximately 4-6 hours in adults with normal renal function. In elderly patients or those with renal impairment, half-life may be prolonged up to 12-18 hours, necessitating dose adjustment.
Protein binding	Approximately 85-90% bound primarily to albumin, with minor binding to alpha-1-acid glycoprotein.
Volume of Distribution	Vd is 3.5-5.0 L/kg, indicating extensive tissue distribution and penetration into peripheral compartments, including the central nervous system.
Bioavailability	Oral: 70-85% due to first-pass metabolism; Transdermal: 60-75% relative to intravenous; Sublingual: 90%.
Onset of Action	Oral: 30-60 minutes; Intravenous: 5-15 minutes; Transdermal: 1-2 hours.
Duration of Action	Oral: 4-8 hours; Intravenous: 3-6 hours; Transdermal: 24-48 hours (continuous effect). Clinical effect may persist beyond serum half-life due to tissue binding.

Classification & Brands

Dosing & administration

8 mg/kg IV every 8 hours or 12 mg/kg IV every 12 hours; not to exceed 1200 mg per dose.

Dosage form	CAPSULE
Renal impairment	GFR 30-59 mL/min: same dose every 12 hours; GFR 15-29 mL/min: same dose every 24 hours; GFR <15 mL/min or on hemodialysis: not recommended.
Liver impairment	No dose adjustment required for mild or moderate hepatic impairment; safety and efficacy not established for severe hepatic impairment (Child-Pugh class C).
Pediatric use	Not approved for use in pediatric patients under 18 years of age.
Geriatric use	No specific dose adjustment recommended; monitor renal function and consider potential increased risk of adverse effects due to age-related renal decline.

Use during pregnancy

1st trimester	Consult provider
2nd trimester	Consult provider
3rd trimester	Consult provider

Clinical note

Comprehensive clinical and safety monograph for NOVRAD (NOVRAD).

Breastfeeding	Excreted in human milk; M/P ratio 0.65. Potential for serious adverse reactions in breastfed infants, including renal toxicity. Breastfeeding is contraindicated during NOVRAD therapy and for at least 7 days after last dose.
Teratogenic Risk	NOVRAD is contraindicated in pregnancy. First trimester: high risk of major congenital malformations (neural tube defects, cardiovascular anomalies). Second and third trimesters: risk of fetal growth restriction, oligohydramnios, and neonatal renal impairment. Pregnancy must be excluded before initiation and effective contraception used during treatment.

Warnings & precautions

■ FDA Black Box Warning

None.

Side Effect Profile

Serious Effects

Absolute Contraindications

["Severe hypersensitivity to nivolumab or any component of the product"]

Clinical Precautions

Precautions

Clinical Tips & Counseling

Drug interactions

Loading safety data…