Opdualag

— THERAPEUTIC CATEGORIES —
  • Melanoma and other skin cancers

Opdualag Generic Name & Formulations

General Description

Nivolumab 12mg/mL, relatlimab-rmbw 4mg/mL; per vial; soln for IV infusion; preservative-free.

Pharmacological Class

Programmed death receptor-1 (PD-1) blocking antibody + lymphocyte activation gene-3 (LAG-3) blocking antibody.

How Supplied

Single-dose vial (20mL)—1

Manufacturer

Generic Availability

NO

Opdualag Indications

Indications

Unresectable or metastatic melanoma.

Opdualag Dosage and Administration

Adult

Give as IV infusion over 30mins. Can be administered diluted or undiluted. ≥12yrs (≥40kg): 480mg/160mg every 4 weeks until disease progression or unacceptable toxicity. Dose modifications: see full labeling.

Children

<12yrs (<40kg): not established.

Opdualag Contraindications

Not Applicable

Opdualag Boxed Warnings

Not Applicable

Opdualag Warnings/Precautions

Warnings/Precautions

Severe and fatal immune-mediated adverse reactions can develop. Monitor closely for immune-related pneumonitis, hepatitis, colitis, endocrinopathies (thyroid disorders, adrenal insufficiency, diabetes, hypophysitis/hypopituitarism), nephritis/renal dysfunction, dermatologic reactions, myocarditis, neurological toxicities, others. Withhold or permanently discontinue based on severity and type of adverse reaction; see full labeling for management guidelines. Obtain liver enzymes, creatinine and thyroid function at baseline and periodically during therapy. Monitor for infection. Evaluate for Vogt-Koyanagi-Harada-like syndrome if uveitis in combination with other immune-mediated reactions occur. Interrupt, slow the infusion rate, or permanently discontinue based on severity of infusion-related reactions. Monitor closely for allogeneic HSCT-related complications (eg, graft-versus-host-disease, hepatic veno-occlusive disease, steroid-requiring febrile syndrome) and manage promptly. Embryo-fetal toxicity. Advise females of reproductive potential to use effective contraception during and for ≥5 months after the last dose. Pregnancy (esp. during 2nd & 3rd trimesters): avoid; exclude status prior to initiation. Nursing mothers: not recommended (during and for 5 months after the last dose).

Opdualag Pharmacokinetics

See Literature

Opdualag Interactions

Interactions

Increased risk of pneumonitis in patients treated with other PD-1/PD-L1 blocking antibodies who have received prior thoracic radiation.

Opdualag Adverse Reactions

Adverse Reactions

Musculoskeletal pain, fatigue, rash, pruritus, diarrhea, lab abnormalities (decreased hemoglobin, decreased lymphocytes, increased AST/ALT, decreased sodium); infusion-related reactions.

Opdualag Clinical Trials

See Literature

Opdualag Note

Not Applicable

Opdualag Patient Counseling

See Literature

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