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Opdualag

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Opdualag

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Medicine Name: Opdualag
Generic Name (API): Nivolumab/Relatlimab
Dosage Form & Strength: 240 mg
Route: Intravenous Infusion
Drug Class:

Manufacturer / Innovator:

USA

Regulatory Approval:

N/A

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Understanding Opdualag and Its Medical Uses

Opdualag (nivolumab and relatlimab-rmbw) is a fixed-dose combination immunotherapy approved by the FDA for the treatment of adult and pediatric patients 12 years of age or older with unresectable or metastatic melanoma.

How Opdualag Works

Opdualag combines nivolumab, a PD-1 inhibitor, with relatlimab, the first FDA-approved LAG-3 inhibitor. Together, these two checkpoint inhibitors block two distinct immune checkpoint pathways that cancer cells use to evade the immune system, providing a dual mechanism of immune activation against melanoma.

Approved Patient Population

Opdualag is intended for patients with unresectable or metastatic melanoma who have not previously been treated, offering a combination immunotherapy approach for this advanced skin cancer.

Dosage and Administration

The recommended dose of Opdualag is 480 mg nivolumab and 160 mg relatlimab administered as an intravenous infusion over 30 minutes, every 4 weeks, until disease progression or unacceptable toxicity.

Warnings and Precautions for Opdualag

Opdualag does not carry a formal FDA boxed warning. However, patients and prescribers should be aware of the following important safety information.

Immune-Mediated Adverse Reactions

Opdualag can cause severe or fatal immune-mediated adverse reactions affecting any organ system, including pneumonitis, colitis, hepatitis, endocrinopathies, and skin reactions. Close monitoring and management with corticosteroids or treatment interruption may be required.

Complications of Stem Cell Transplantation

Fatal and other serious complications can occur in patients who undergo allogeneic hematopoietic stem cell transplantation before or after Opdualag treatment.

Infusion-Related Reactions

Infusion-related reactions have been reported. Treatment should be interrupted, slowed, or discontinued based on severity.

Embryo-Fetal Toxicity

Opdualag may cause fetal harm. Effective contraception should be used during treatment and for a period after the final dose, as advised by the treating physician.

How to Access Opdualag in India: A 6-Step Process

Step 1 – Search & request your medicine: The patient or treating doctor submits a request with basic details to initiate the access process.

Step 2 – Verification & eligibility review: The team verifies availability and reviews eligibility against regulatory and clinical requirements to ensure a compliant pathway.

Step 3 – Receive quote & delivery timeline: A transparent quotation is shared, covering medicine cost, logistics, and a clear delivery timeline.

Step 4 – Regulatory approval process: Assistance is provided to secure the approvals and documentation required for legal cross-border access.

Step 5 – Temperature-controlled import & handling: The medicine is sourced and transported under strict GDP-compliant conditions to maintain product integrity.

Step 6 – Secure delivery: The medicine is delivered to the patient or treating hospital, with updates provided at each stage.

Note: From request to delivery, every step is designed to ensure your treatment reaches you safely, compliantly, and without unnecessary delays.

Documentation and Availability of Opdualag

Opdualag is manufactured and marketed by Bristol-Myers Squibb. It is sourced through authorized distribution channels for patients seeking named-patient import into India. Opdualag's nivolumab component is also available separately as Opdivo.

Required Documentation

Patients typically need a valid prescription from a treating oncologist confirming a diagnosis of unresectable or metastatic melanoma. NPP's regulatory team assists in preparing and verifying the documentation needed for a compliant import.

Availability

As an FDA-approved dual-checkpoint immunotherapy for melanoma, Opdualag is sourced through authorized channels and imported under GDP-compliant, cold-chain logistics to preserve product quality throughout transit.

Sourcing and Delivery of Opdualag

NPP sources Opdualag directly from authorized pharmaceutical distributors to ensure product authenticity and full traceability. Every shipment is handled under Good Distribution Practice (GDP) conditions from origin to the patient's doorstep.

Cold Chain and Handling

Opdualag requires refrigerated storage at 2°C to 8°C, protected from light. NPP maintains a continuous, monitored cold chain throughout transit.

Delivery Timelines

Once documentation and regulatory approvals are in place, delivery timelines are communicated transparently at the time of quotation, accounting for import clearance and last-mile cold-chain logistics to the patient's city.

Availability of Opdualag Across Major Cities in India

Patients across India can access Opdualag through NPP's regulated import pathway, with oncology specialists in major cities supporting the treatment process.

Mumbai

Leading hospitals in Mumbai support oncology care coordination and documentation for Opdualag access.

Delhi

Delhi's major hospitals assist patients with prescription support and documentation for Opdualag.

Bangalore

Bangalore's specialist network offers access coordination for eligible melanoma patients seeking Opdualag.

Chennai

Chennai-based oncology specialists coordinate Opdualag access alongside comprehensive melanoma care.

Hyderabad

Hyderabad's care institutions support patients pursuing Opdualag therapy.

Kolkata

Kolkata's specialist centers help coordinate documentation and treatment access for Opdualag.

Pune

Pune-based specialists assist with prescription support and Opdualag treatment planning.

Ahmedabad

Ahmedabad's specialty hospitals support the import and treatment process for Opdualag.

Kochi

Kochi's specialist units assist patients with the documentation needed for Opdualag access.

Chandigarh

Chandigarh's care centers support Opdualag treatment coordination for patients from North India.

Jaipur

Jaipur's specialists help patients navigate the Opdualag access process.

Lucknow

Lucknow-based centers assist patients pursuing Opdualag therapy.

Bhubaneswar

Bhubaneswar's institutions support access to Opdualag for eligible patients.

Guwahati

Guwahati's specialists help coordinate Opdualag access for patients across the Northeast.

Patients in other cities across India can also access Opdualag through NPP's nationwide coordination network.

Written By:

Written By: Nitin Goswami, Senior Medical Content Writer
Last Updated: 15 September 2026
Sources: FDA

Medically Reviewed By:

Medically Reviewed By: Shilpi Banerjee, Registered Pharmacist (M.Pharm)
Last Updated: 15 September 2026

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