Names and pronunciation
(nye-vol′-ue-mab/rel-at-li-mab) Opdualag
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Drug reference
(nye-vol′-ue-mab/rel-at-li-mab) Opdualag
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Func. class.: Antineoplastic
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Chem. class.: Human IgG4 mono- clonal antibody ACTIONS: A combination product with a programmed death receptor-1 (PD-1) blocking antibody and a lympho- cyte activation gene-3 (LAG-3) blocking antibody. When combined leads to addi- tive inhibitory effects on T-cell function and results in improved tumor response in melanoma
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USES: Unresectable or metastatic melanoma in adults and those over 12 yr
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CONTRAINDICATIONS Hypersensitivity Precautions: Pregnancy, breastfeeding, Crohn disease, hepatitis, immunosup- pression, inflammatory bowel disease, iritis, ocular disease, organ transplant, pancreatitis, renal disease, rheumatoid arthritis, sarcoidosis, systemic lupus erythematosus, thyroid disease, ulcer- ative colitis, uveitis, adrenal insuffi- ciency, diarrhea, Guillain-Barré syn- drome, hepatic disease, myasthenia gravis, hypo/hyperthyroidism, hypopitu- APPENDIX A itarism, peripheral neuropathy, serious rash, hypophysitis
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SIDE EFFECTS CNS: Severe and fatal immune-mediated neuropathies, fatigue, headache, fever EENT: Uveitis, iritis, episcleritis ENDO: Severe and fatal immune- mediated endocrinopathies GI: Severe and fatal immune-mediated enterocolitis, hepatitis, pancreatitis, abdominal pain, nausea, diarrhea, appe- tite decreased, vomiting, constipation, colitis INTEG: Severe and fatal immune- mediated dermatitis, pruritus, rash, urticaria MISC: Cough, dyspnea, anemia, eosino- philia, nephritis SYST: Antibody formation, Stevens- Johnson syndrome, toxic epidermal necrolysis
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DOSAGE AND ROUTES • Adult/child >12 yr and >40 kg: IV 480 mg nivolumab and 160 mg relatlimab q4wk; max volume 160 mL (nivolumab: 3 mg/mL to 12 mg/mL; relatlimab: 1 mg/ mL to 4 mg/mL)
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Available forms: Injection: 240 mg nivolumab and 80 mg relatlimab per 20 mL (12 mg and 4 mg per mL) in a single- dose vial
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Administer: Intermittent IV INFUSION route • May be administered diluted or undi- luted and administered at a final concen- tration as ordered • Withdraw the required volume of and transfer into an IV container made of PVC, EVA, PO • If diluting, dilute solution with 0.9% NaCl injection, USP or 5% dextrose injec- tion, USP to final concentration and maximum infusion volume, mix by inver- sion, do not shake • Discard any unused solution • Run over 30 min, do not give with other products; after each infusion, flush the line with 0.9% sodium chloride injec- tion • Store once diluted for no more than 24 hr refrigerated, 8 hr at room tempera- ture
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Assess: • Serious skin disorders: Stevens- Johnson syndrome, toxic epidermal necrolysis: permanently discontinue in these or rash complicated by full- thickness dermal ulceration; give sys- temic corticosteroids at a dose of 1-2 mg/ kg/day of predniSONE or equivalent; when dermatitis is controlled, taper corti- costeroids over at least 1 mo, withhold in patients with moderate to severe reac- tions; for mild to moderate dermatitis (localized rash and pruritus), give topical or systemic corticosteroids • Immune-mediated reactions: prior to starting treatment, assess for enterocolitis, hepatitis, dermatitis, neuropathy, endocri- nopathy; take LFTs, ACTH, and thyroid function tests; permanently discontinue if these conditions occur • Hepatotoxicity: LFTs baseline and prior to each dose; increase the fre- quency of liver function test monitor- ing until resolution; permanently dis- continue in grade 3-5 toxicity; give systemic corticosteroids at a dose of 1-2 mg/kg/day of predniSONE or equivalent • Neuropathy: monitor for motor or sensory neuropathy (unilateral or bilat- eral weakness, sensory alterations, or paresthesias) prior to each dose; per- manently discontinue if severe neurop- athy (interfering with daily activities), such as Guillain-Barré–like syndromes, occurs • Endocrinopathy: monitor thyroid func- tion tests at baseline and prior to each dose; monitor hypophysitis, adrenal insuf- ficiency, adrenal crisis, hypo/hyperthy- roidism (fatigue, headache, mental status changes, abdominal pain, unusual bowel habits, hypotension, or nonspecific symp- toms that may resemble other causes) • Vision changes: uveitis, iritis; cortico- steroids may be used • Pregnancy/breastfeeding: do not use in pregnancy, breastfeeding, pregnancy testing prior to first dose
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Evaluate: • Decreasing spread or recurrence of malignant melanoma
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CLINICAL CONSIDERATIONS
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Patient and caregiver information: • To immediately report allergic reac- tions, skin rash, severe abdominal pain, yellowing of skin or eyes, tingling of extremities, change in bowel habits, di- arrhea, cough, chest pain, decreased urine • About the reason for treatment and expected results; to read medication guide provided • Pregnancy/breastfeeding: to notify pre- scriber if pregnancy is planned or sus- pected or if breastfeeding; to use contra- ception during and for 5 mo after final dose, not to breastfeed
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PHARMACOKINETICS: Terminal half-life 26.5 days
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• Adult/child >12 yr and >40 kg: IV 480 mg nivolumab and 160 mg relatlimab q4wk; max volume 160 mL (nivolumab: 3 mg/mL to 12 mg/mL; relatlimab: 1 mg/ mL to 4 mg/mL)
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