Opdualag Generic Name & Formulations
Legal Class
Rx
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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