Melanoma and other skin cancers:

Indications for: OPDUALAG

Unresectable or metastatic melanoma.

Adult Dosage:

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 Dosage:

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

OPDUALAG 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 Classification:

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

OPDUALAG Interactions:

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

Adverse Reactions:

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

Generic Drug Availability:


How Supplied:

Single-dose vial (20mL)—1