Opdualag is a fixed-dose combination preparation composed of nivolumab and relatlimab-rmbw. It is indicated for the treatment of patients aged 12 years and older with unresectable or metastatic melanoma. As a combination therapy of immune checkpoint inhibitors, its use must strictly comply with specifications.

How to Use Opdualag

Standard Dosage Regimen

Adults and pediatric patients aged 12 years and older with a body weight of ≥ 40 kg: 480 mg nivolumab combined with 160 mg relatlimab, administered as an intravenous infusion once every 4 weeks.

Administration method: Intravenous infusion over 30 minutes, continuing until disease progression or the occurrence of unacceptable toxicity.

Dosage form and specification: Each 20 mL single-dose vial contains 240 mg nivolumab and 80 mg relatlimab (concentrations: 12 mg/mL and 4 mg/mL respectively).

Specific Administration Requirements

Pretreatment requirement: Before use, the LAG-3 expression status must be confirmed through FDA-approved testing.

Infusion preparation: Inspect the solution; it should be clear to opalescent, colorless to slightly yellow.

It can be diluted with 0.9% sodium chloride injection or 5% dextrose injection.

After dilution, the solution can be stored at room temperature for no more than 8 hours, or refrigerated at 2–8°C for no more than 24 hours.

Infusion operation: Use a 0.2–1.2 micron filter, and flush the intravenous line after the infusion is completed.

Dosage Adjustment of Opdualag

Management of Immune-Mediated Adverse Reactions (IMARs)

General principle: For Grade 3 IMARs: withhold administration; for Grade 4 IMARs: permanently discontinue the medication.

For recurrent Grade 3 IMARs requiring systemic immunosuppressive therapy: permanently discontinue the medication.

Management of Specific Adverse Reactions

Pneumonitis: Withhold administration for Grade 2; permanently discontinue for Grade 3–4.

Colitis: Withhold administration for Grade 2–3; permanently discontinue for Grade 4.

Management of Infusion Reactions

Grade 1–2: Slow down the infusion rate or interrupt the infusion.

Grade 3–4: Permanently discontinue the medication.

Opdualag Administration in Special Populations

Pregnancy and Lactation

Pregnancy risk: Based on animal data, it may cause fetal harm; use is prohibited during pregnancy.

Contraception requirement:

Female patients: Effective contraception is required during treatment and for at least 5 months after the last dose.

Male patients: Male patients with female partners of childbearing potential should ensure their partners take contraceptive measures.

Lactation: Breastfeeding is prohibited during treatment and for 5 months after the last dose.

Pediatric Use

Population for which it is indicated: Patients aged 12 years and older with a body weight of ≥ 40 kg.

Pediatric patients with a body weight of < 40 kg: The recommended dosage has not been determined yet.

Children aged < 12 years: The efficacy has not been established.

Effects on Fertility

It may affect female fertility.

Animal studies have shown no significant impact on male fertility.