Opdualag is a fixed-dose combination preparation of nivolumab and relatlimab-rmbw, indicated for the treatment of patients aged 12 years and older with unresectable or metastatic melanoma.

Precautions for Opdualag Administration

Patients with Renal Impairment

Patients with an estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73m² should not initiate treatment.

When eGFR persists at < 30 mL/min/1.73m², the necessity of continuing medication should be evaluated.

For patients with eGFR ranging from 30 to 45 mL/min/1.73m², the therapeutic effect needs to be assessed cautiously.

Patients with Hepatic Impairment

Safety data are lacking for patients with Child-Pugh Class C hepatic impairment (score > 9).

Patients with mild to moderate hepatic impairment require close monitoring.

Elderly Patients

Age-related decline in physiological function increases the risk of adverse reactions.

No dose adjustment is required, but enhanced monitoring is necessary.

Immune-Mediated Adverse Reactions (IMARs)

IMARs can occur in any organ system, including pneumonitis, colitis, hepatitis, endocrinopathies, nephritis, skin reactions, myocarditis, etc.

Early identification and management are crucial; regular monitoring of liver enzymes, creatinine, and thyroid function is required.

Depending on the severity, treatment should be temporarily withheld or permanently discontinued, and systemic corticosteroid therapy is usually required.

Infusion-Related Reactions

The incidence rate is 7%, presenting with symptoms such as chills, dizziness, pruritus, rash, flushing, fever, etc.

For mild to moderate reactions, the infusion should be interrupted or the infusion rate slowed down.

For severe or life-threatening reactions, permanent discontinuation of the medication is required.

Treatment Monitoring for Opdualag

Baseline Assessment

Comprehensive medical history and physical examination.

Liver function tests (alanine aminotransferase [ALT], aspartate aminotransferase [AST], total bilirubin).

Thyroid function tests.

Renal function tests (creatinine, eGFR).

Complete blood count.

Monitoring During Treatment

Evaluate clinical symptoms and signs every 3–4 weeks.

Recheck liver function, renal function, and thyroid function regularly.

Monitor blood glucose levels (as diabetes may be induced).

Monitoring for Immune-Mediated Adverse Reactions

Pneumonitis: New or worsening cough, chest pain, shortness of breath.

Colitis: Diarrhea, abdominal pain, bloody stools.

Hepatitis: Jaundice, nausea and vomiting, right upper abdominal pain.

Endocrinopathies: Fatigue, headache, vision changes, palpitations, weight changes.

Nephritis: Decreased urine output, hematuria, edema.

Myocarditis: Chest pain, palpitations, shortness of breath, fatigue.