opdivo nivolumab injection 10mg per ml per vial

Description

Indication & Scope

Nivolumab Injection (Opdivo®) is a fully human monoclonal antibody targeting PD-1. It inhibits the binding of PD-1 to its ligands PD-L1 and PD-L2, removes tumor-mediated immune escape suppression, restores the anti-tumor activity of tumor-specific T lymphocytes, and thereby kills tumor cells.

Mechanism
Block PD-1/PD-L1/PD-L2 binding to recover anti-tumor immune activity of T lymphocytes
Drug class
Intravenous anti-PD-1 immune checkpoint inhibitor concentrate
Clinical use
Melanoma, non-small cell lung cancer, renal cell carcinoma, classical Hodgkin lymphoma, head and neck squamous cell carcinoma, urothelial carcinoma, esophageal squamous cell carcinoma

Specification

Generic Name	Nivolumab Injection
Brand Name	Opdivo®
Ingredient	Nivolumab
Dosage Form	Injection
Package	10mg/ml/Vial
Conditions Treated	Unresectable or metastatic melanoma; Adjuvant therapy for completely resected melanoma with lymph node involvement; Metastatic non-small cell lung cancer after prior chemotherapy
Taboos	Severe hypersensitivity to nivolumab or any excipients; active autoimmune disease, pregnancy and lactation
Place of origin	Puerto Rico, USA
Priscription Type	Prescription Drug, Class B Medicare
Storage Conditions	Store at 2℃-8℃, protected from light, sealed
Manufacturer	Bristol-Myers Squibb Holdings Pharma, Ltd. Liability Company
Registration Authority	National Medical Products Administration (NMPA)
Approval number	SJ20180015
Approval Date	March 31, 2023
Shelf Life	24 months

How to use ?

Recommended Dose: Most adult solid tumors: 3mg/kg once every 2 weeks or 240mg once every 2 weeks via intravenous infusion

Time: Administer as an intravenous infusion over 30 minutes; do not administer as rapid bolus or intravenous push

Interaction: Avoid long-term high-dose systemic corticosteroids and immunosuppressants prior to treatment, except for intervention of immune-related adverse reactions

Side effects: Fatigue, rash, pruritus, diarrhea, nausea, decreased appetite; severe risks: Immune-related pneumonitis, colitis, hepatitis, nephritis, endocrinopathies and severe infusion-related reactions

Important Notice

This product shall only be used for post-exposure rabies prophylaxis by professional medical staff. It must be applied combined with rabies vaccine and injected via wound infiltration plus intramuscular routes as specified. Do not administer intravenously or alter the dosage at will. Hypersensitivity monitoring is required throughout the whole injection process.

Packaging & Shipping

Packaging

Original manufacturer’s packaging with secure export carton. Customized export packaging is available upon request.

Shipping Methods

Express Courier (EMS, DHL, FedEx, UPS), Air Freight, and Sea Freight. Cold-chain transportation is available for products requiring temperature-controlled logistics.

Export Support

Certificate of Analysis

GMP Certificate

Commercial Invoice

Packing List & CPP

Cold Chain Logistics

Customs Documentation

Scientific and regulatory sources

1.WHO References

2.NMPA

3.FDA

4.EMA

FAQ

Is it a chemotherapy?

Nivolumab is a type of immunotherapy called a checkpoint inhibitor.

How successful is nivolumab?

Patients received a median of 8 nivolumab cycles; 33.3% completed ≥15 cycles. Median OS reached 23 months, with 1-, 3-, and 5-year survival rates of 93.3%, 54.1% and 18.6%.

Do you lose your hair with Opdivo?

Opdivo may rarely cause hair loss. This side effect can also result from concurrent chemotherapy, a common combined treatment with Opdivo.

Can nivolumab cause hearing loss?

Schlacter et al. reported a melanoma patient treated with ipilimumab plus nivolumab who developed irreversible bilateral severe hearing loss unresponsive to systemic steroids and required cochlear implantation.