HIGH ALERT
nivolumab/relatlimab (Rx)
Pronunciation: (nye-vol′-ue-mab/rel-at-li-mab)
Trade Name(s): Opdualag
Func. class.: Antineoplastic
Chem. class.: Human IgG4 monoclonal antibody
HIGH ALERT
nivolumab/relatlimab (Rx)
Pronunciation: (nye-vol′-ue-mab/rel-at-li-mab)
Trade Name(s): Opdualag
Func. class.: Antineoplastic
Chem. class.: Human IgG4 monoclonal antibody
Hypersensitivity
Precautions: Pregnancy, breastfeeding, Crohn disease, hepatitis, immunosuppression, inflammatory bowel disease, iritis, ocular disease, organ transplant, pancreatitis, renal disease, rheumatoid arthritis, sarcoidosis, systemic lupus erythematosus, thyroid disease, ulcerative colitis, uveitis, adrenal insufficiency, diarrhea, Guillain-Barré syndrome, hepatic disease, myasthenia gravis, hypo/hyperthyroidism, hypopituitarism, peripheral neuropathy, serious rash, hypophysitis
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)
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
Administer:
Intermittent IV INFUSION routeMay be administered diluted or undiluted and administered at a final concentration 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 injection, USP to final concentration and maximum infusion volume, mix by inversion, 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 injection
Store once diluted for no more than 24 hr refrigerated, 8 hr at room temperature
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, appetite decreased, vomiting, constipation, colitis
INTEG: Severe and fatal immune-mediated dermatitis,pruritus, rash, urticaria
MISC: Cough, dyspnea, anemia, eosinophilia, nephritis
SYST: Antibody formation, Stevens-Johnson syndrome, toxic epidermal necrolysis
Side effects: italics = common;red = life-threatening
Serious skin disorders: Stevens-Johnson syndrome, toxic epidermal necrolysis: permanently discontinue in these or rash complicated by full-thickness dermal ulceration; give systemic corticosteroids at a dose of 1-2 mg/kg/day of predniSONE or equivalent; when dermatitis is controlled, taper corticosteroids over at least 1 mo, withhold in patients with moderate to severe reactions; 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, endocrinopathy; take LFTs, ACTH, and thyroid function tests; permanently discontinue if these conditions occur
Hepatotoxicity: LFTs baseline and prior to each dose; increase the frequency of liver function test monitoring until resolution; permanently discontinue 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 bilateral weakness, sensory alterations, or paresthesias) prior to each dose; permanently discontinue if severe neuropathy (interfering with daily activities), such as Guillain-Barré–like syndromes, occurs
Endocrinopathy: monitor thyroid function tests at baseline and prior to each dose; monitor hypophysitis, adrenal insufficiency, adrenal crisis, hypo/hyperthyroidism (fatigue, headache, mental status changes, abdominal pain, unusual bowel habits, hypotension, or nonspecific symptoms that may resemble other causes)
Vision changes: uveitis, iritis; corticosteroids may be used
Pregnancy/breastfeeding: do not use in pregnancy, breastfeeding, pregnancy testing prior to first dose
Decreasing spread or recurrence of malignant melanoma
To immediately report allergic reactions, skin rash, severe abdominal pain, yellowing of skin or eyes, tingling of extremities, change in bowel habits, diarrhea, cough, chest pain, decreased urine
About the reason for treatment and expected results; to read medication guide provided
Pregnancy/breastfeeding: to notify prescriber if pregnancy is planned or suspected or if breastfeeding; to use contraception during and for 5 mo after final dose, not to breastfeed