Generic
Nivolumab
1 brands available in the market
At a glance
Nivolumab is a programmed death receptor-1 (PD-1) blocking antibody used for various cancers. It blocks the PD-1 protein on T-cells to activate T-cells to locate and kill cancer cells.
Description
Nivolumab is a human immunoglobulin G4 (IgG4) monoclonal antibody that binds to the PD-1 receptor and blocks its interaction with PD-L1 and PD-L2, releasing PD-1 pathway-mediated inhibition of the immune response, including the anti-tumor immune response.
Indications
- BRAF V600 wild-type or mutation-positive melanoma
- Metastatic non-small cell lung cancer (after platinum-based chemotherapy)
- Advanced renal cell carcinoma
- Classical Hodgkin lymphoma
- Recurrent or metastatic squamous cell carcinoma of head and neck
- Urothelial carcinoma
- Microsatellite instability-high (MSI-H) colorectal cancer
- Hepatocellular carcinoma (after sorafenib)
Therapeutic class
Immunological Chemotherapy, Immunosuppressant
Pharmacological class
PD-1 Inhibitor (Monoclonal Antibody)
Pharmacology
Nivolumab binds to PD-1 receptor and blocks its interaction with PD-L1 and PD-L2, releasing PD-1 pathway-mediated inhibition of immune response. It enhances T-cell activation and proliferation to activate anti-tumor immune response.
Mechanism of action
Activates T-cells to locate and destroy cancer cells.
Dosage
Adult Dose (IV):
- Single agent: 240 mg every 2 weeks OR 480 mg every 4 weeks; IV infusion over 30 minutes
- With ipilimumab: 1 mg/kg nivolumab + 3 mg/kg ipilimumab every 3 weeks (max 4 doses); then 240 mg every 2 weeks or 480 mg every 4 weeks
Administration
- Administered by doctor or nurse IV only
- Infuse over 30 minutes
- Use within 8 hours (room temperature) or 24 hours (2-8°C) after dilution
- Do not co-administer other drugs through same IV line
Missed dose
Not generally applicable (scheduled administration); consult doctor if needed.
Side effects
Common Side Effects (≥20%):
- Fatigue
- Rash
- Musculoskeletal pain
- Pruritus
- Diarrhea
- Nausea
- Asthenia
- Cough
- Dyspnea
- Constipation
- Decreased appetite
- Back pain
- Arthralgia
- Upper respiratory tract infection
- Pyrexia
- Headache
- Abdominal pain
Serious: Immune-mediated pneumonitis, colitis, hepatitis, endocrinopathies, nephritis, encephalitis, infusion reactions
Precautions & warnings
- Monitor for immune-mediated adverse reactions
- Withhold for moderate reactions; permanently discontinue for severe or life-threatening
- Can cause fetal harm; use effective contraception (5 months after last dose)
- Discontinue breastfeeding
Contraindications
- Hypersensitivity
Drug interactions
No known interactions.
Food interactions
Safety with alcohol not known; consult doctor.
Use in pregnancy
Use in Pregnancy: Nivolumab is highly unsafe during pregnancy; definite evidence of severe fetal harm. Do not use.
Pregnancy Category: D — always consult a doctor before taking during pregnancy.
Use in lactation
Use in Lactation: Nivolumab is probably unsafe during breastfeeding; discontinue breastfeeding.
Pediatric use
Safety not established in children <12 years for MSI-H mCRC; not established in children <18 years for other indications.
Geriatric use
No overall difference in safety reported between elderly and younger patients.
Renal / hepatic impairment
Renal Impairment: Safe in kidney disease; no dose adjustment needed.
Hepatic Impairment: Safe in liver disease; no dose adjustment needed.
Overdose effects
Limited information on overdose; symptomatic treatment.
Storage conditions
Store at 2-8°C (refrigerator); do not freeze; protect from light; keep out of reach of children.
Chemical structure
Nivolumab