Product Details

OPDIVO 10MG/ML 4ML SDV 1/EA

Manufacturer: Bristol Myers

MFG#: 3377211

NDC: 3377211

PID: 422394

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Additional Information

Product NameOpdivo 10 mg/mL 4 mL SDV 1/Ea
ApplicationImmunotherapy (PD-1 Inhibitor)
Generic Drug NameNivolumab
Mechanism of ActionBlocks PD-1 receptor, enhancing T-cell activity against tumor cells
Strength10 mg/mL
Volume4 mL
TypeIntravenous
Administration InstructionsInfuse over 30 to 60 minutes; must be diluted before administration; do not shake
Half-life~25 days
Common Adverse EffectsFatigue, rash, pruritus, diarrhea, nausea, musculoskeletal pain, decreased appetite
Serious RisksPneumonitis, colitis, hepatitis, nephritis, myocarditis, endocrinopathies
Storage ConditionsRefrigerate at 2°C to 8°C (36°F to 46°F); protect from light; do not freeze
IndicationsNon-small cell lung cancer (NSCLC), melanoma, renal cell carcinoma, Hodgkin lymphoma, MSI-H colorectal cancer, head and neck squamous cell carcinoma, urothelial carcinoma

Description

Opdivo (Nivolumab 10 mg/mL) Injection is a monoclonal antibody classified as a programmed death-1 (PD-1) inhibitor, indicated for the treatment of various cancers, including non-small cell lung cancer (NSCLC), melanoma, renal cell carcinoma, Hodgkin lymphoma, and microsatellite instability-high (MSI-H) colorectal cancer. It functions by blocking PD-1 receptor activity, enhancing the immune system’s ability to recognize and attack cancer cells.

Opdivo is supplied as a 10 mg/mL intravenous solution in a 4 mL single-dose vial. The dosing schedule depends on the specific cancer type and treatment regimen, typically administered every 2 to 4 weeks as an intravenous infusion over 30 to 60 minutes. It is often used as monotherapy or in combination with other immune checkpoint inhibitors, such as ipilimumab, to improve therapeutic outcomes.

Common adverse effects include fatigue, rash, pruritus, nausea, diarrhea, musculoskeletal pain, and decreased appetite. Serious immune-mediated toxicities involve pneumonitis, colitis, hepatitis, nephritis, endocrinopathies, and myocarditis, requiring careful monitoring and corticosteroid intervention if severe toxicity occurs.

Frequently Asked Questions (FAQs)

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OPDIVO 10MG/ML 4ML SDV 1/EA is manufactured by Bristol Myers.

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