Nivolumab/relatlimab

What is Nivolumab/relatlimab?

• Nivolumab/relatlimab (Opdualag) is a combination of nivolumab, a programmed death receptor-1 (PD-1) blocking antibody, and relatlimab, a lymphocyte activation gene-3 (LAG-3) blocking antibody used to treat unresectable or metastatic melanoma.

What are the uses of this medicine?

Nivolumab/relatlimab (Opdualag) is a prescription medicine used to treat:

• adults and children 12 years of age or older with a type of skin cancer called melanoma that has spread or cannot be removed by surgery.

How does this medicine work?

Relatlimab:

• Relatlimab is a human IgG4 monoclonal antibody that binds to the LAG-3 receptor, blocks interaction with its ligands, including MHC II, and reduces LAG-3 pathway-mediated inhibition of the immune response.
• Antagonism of this pathway promotes T cell proliferation and cytokine secretion.
• Binding of the PD-1 ligands, PD-L1 and PD-L2, to the PD-1 receptor found on T cells, inhibits T-cell proliferation and cytokine production.

Nivolumab:

• Nivolumab is a human IgG4 monoclonal antibody that binds to the PD-1 receptor, blocks interaction with its ligands PD-L1 and PD-L2, and reduces PD-1 pathway-mediated inhibition of the immune response, including the anti-tumor immune response.
• The combination of nivolumab (anti-PD-1) and relatlimab (anti-LAG-3) results in increased T-cell activation compared to the activity of either antibody alone.

Who Should Not Use this medicine ?

• This medicine have no usage limitations.

What drug interactions can this medicine cause?

• No formal drug interaction studies have been conducted.

Is this medicine FDA approved?

• It was approved for medical use in the United States in March 2022.

How should this medicine be used?

Recommended dosage:

• The recommended dosage of OPDUALAG for adult patients and pediatric patients 12 years of age or older who weigh at least 40 kg is 480 mg nivolumab and 160 mg relatlimab administered intravenously every 4 weeks until disease progression or unacceptable toxicity occurs.

Administration:

• Your healthcare provider will give you OPDUALAG into your vein through an intravenous (IV) line over 30 minutes.
• OPDUALAG is usually given every 4 weeks.
• Your healthcare provider will decide how many treatments you need.
• Your healthcare provider will do blood tests to check you for side effects.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Injection: 240 mg of nivolumab and 80 mg of relatlimab per 20 mL (12 mg and 4 mg per mL) in a single-dose vial.

This medicine is available in fallowing brand namesː

• OPDUALAG

What side effects can this medication cause?

The most common side effects of this medicine include:

• muscle and bone pain
• tiredness
• decreased red blood cell and white blood cell counts
• increased liver function test results
• rash
• itching
• diarrhea
• decreased salt (sodium) in your blood

OPDUALAG can cause serious side effects, including:

• Lung problems
• Intestinal problems

What special precautions should I follow?

• Immune-mediated adverse reactions, which may be severe or fatal, can occur in any organ system or tissue, including the following immune-mediated pneumonitis, immune-mediated colitis, immune-mediated hepatitis, immune-mediated endocrinopathies, immune-mediated dermatologic adverse reactions, immune-mediated nephritis with renal dysfunction, and immune-mediated myocarditis. Monitor for early identification and management. Evaluate liver enzymes, creatinine, and thyroid function at baseline and periodically during treatment. Withhold or permanently discontinue based on severity and type of reaction.
• OPDUALAG can cause severe infusion-related reactions. Interrupt, slow the rate of infusion, or permanently discontinue OPDUALAG based on severity of reaction.
• Fatal and other serious complications can occur in patients who receive allogeneic hematopoietic stem cell transplantation (HSCT) before or after being treated with a PD-1/PD-L1 receptor blocking antibody.
• Based on its mechanism of action and data from animal studies, OPDUALAG can cause fetal harm when administered to a pregnant woman. Advise females of reproductive potential of potential risk to a fetus and to use effective contraception.

What to do in case of emergency/overdose?

• In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.

Can this medicine be used in pregnancy?

• Based on its mechanism of action and data from animal studies, OPDUALAG can cause fetal harm when administered to a pregnant woman.

Can this medicine be used in children?

It is not known if OPDUALAG is safe and effective when used:

• in children 12 years of age or older who weigh less than 88 pounds (40 kg), or
• in children younger than 12 years of age.

What are the active and inactive ingredients in this medicine?

• Active ingredients: nivolumab and relatlimab
• Inactive ingredients: histidine, L-histidine hydrochloride monohydrate, pentetic acid, polysorbate 80, sucrose, and Water for Injection.

Who manufactures and distributes this medicine?

• Manufactured by: Bristol-Myers Squibb Company Princeton, NJ USA

What should I know about storage and disposal of this medication?

• Store OPDUALAG refrigerated at 2°C to 8°C (36°F to 46°F) in the original carton to protect from light until time of use.
• Do not freeze or shake.

• Dailymed label info on Nivolumab/relatlimab
• FDA Nivolumab/relatlimab

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