Bristol-Myers Squibb




Bristol-Myers Squibb
Concise Prescribing Info
As monotherapy or in combination w/ ipilimumab for advanced (unresectable or metastatic) melanoma in adults. As monotherapy for locally advanced or metastatic non-small cell lung cancer (NSCLC) after prior chemotherapy in adults. As monotherapy for advanced renal cell carcinoma after prior therapy in adults. As monotherapy for relapsed or refractory classical Hodgkin's lymphoma after autologous stem cell transplant (ASCT) & treatment w/ brentuximab vedotin in adults. As monotherapy for squamous cell cancer of the head & neck in adults progressing on or after platinum-based therapy. As monotherapy for locally advanced unresectable or metastatic urothelial carcinoma in adults after failure of prior platinum-containing therapy.
Dosage/Direction for Use
Monotherapy 3 mg/kg over 60 min IV every 2 wk. In combination w/ ipilimumab 1 mg/kg administered as an IV infusion over 60 min every 3 wk for the first 4 doses in combination w/ 3 mg/kg ipilimumab administered IV over 90 min. Then, followed by 3 mg/kg nivolumab administered as an IV infusion over 60 min every 2 wk. 1st dose of nivolumab monotherapy should be administered 3 wk following the last dose of nivolumab & ipilimumab combination.
Special Precautions
Do not administer as IV push or bolus inj. Moderate or severe hepatic impairment. Monitor continuously patients during or after discontinuation therapy (at least up to 5 mth after last dose) for immune-related adverse reactions (may occur at any time during or after discontinuation of the therapy); cardiac & pulmonary adverse reactions, & electrolyte disturbances & dehydration prior to & periodically during treatment. Discontinue therapy in combination w/ ipilimumab for life-threatening or recurrent severe cardiac & pulmonary adverse reactions. Withhold therapy based on adverse reaction severity, in Grade 2 pneumonitis, transaminase or total bilirubin elevation, diarrhea or colitis, adrenal insufficiency, & Grade 2 or 3 serum creatinine elevation then, administer corticosteroids. Do not resume Opdivo while patients are receiving immunosuppressive corticosteroid dose or other immunosuppressive therapy. Permanently discontinue in Grade 3 or 4 pneumonitis & transaminase or total bilirubin elevation, adrenal insufficiency, Grade 3 diarrhea or colitis, & Grade 4 serum creatinine elevation & hyperthyroidism or hypothyroidism, hypophysitis occurs then, administer corticosteroids. Melanoma patients w/ rapidly progressing disease. Patients w/ poorer prognostic features &/or aggressive disease, history of or concurrent brain metastases, active autoimmune disease, & symptomatic interstitial lung disease. Monitor patients for signs & symptoms of pneumonitis, nephritis & renal dysfunction, endocrinopathies & thyroid function changes, diarrhea & additional symptoms of colitis eg, abdominal pain & mucus or blood in stool, hepatitis; adrenal function & hormone levels, pituitary function, & blood sugar. Withhold therapy if symptomatic hypothyroidism, hyperthyroidism, Grade 2 adrenal insufficiency, Grade 2 or 3 hypophysitis, & diabetes occurs then, administer thyroid hormone replacement, methimazole, physiologic corticosteroid replacement, hormone replacement, & insulin replacement, respectively. Withhold for Grade 3 & discontinue for Grade 4 rash. Patients previously experienced severe or life-threatening skin adverse reaction prior to treatment w/ other stimulatory anticancer agents. Permanently discontinue for any severe immune-related adverse reaction that recurs & is life-threatening. Controlled Na diet patients. Caution when driving or operating machinery. Pregnancy & lactation. Women of childbearing potential not using effective contraception. Childn <18 yr.
Adverse Reactions
Fatigue, rash, pruritus, diarrhoea, nausea, increased AST & ALT, alkaline phosphatase, lipase, & amylase, hypocalcaemia, increased creatinine, lymphopaenia, leucopoenia, thrombocytopaenia, anaemia, hypercalcaemia, hyperkalaemia, hypokalaemia, hypomagnesaemia, hyponatraemia, neutropaenia. Upper resp tract infection, infusion-related reaction, hypersensitivity, hyperthyroidism, hyperglycaemia, peripheral neuropathy, dizziness, HTN, pneumonitis, dyspnoea, cough, stomatitis, constipation, dry mouth, vitiligo, dry skin, erythema, alopecia, musculoskeletal pain, oedema (including peripheral oedema), hypermagnesaemia, hypernatraemia, decreased wt. Monotherapy: Hypercalcaemia. Hypothyroidism, decreased appetite, headache, vomiting, abdominal pain, arthralgia, pyrexia, increased total bilirubin. In combination w/ ipilimumab: Pyrexia, decreased appetite, hypothyroidism, vomiting, colitis, abdominal pain, arthralgia, & headache, increased total bilirubin, hypocalcaemia. Pneumonia, eosinophilia, adrenal insufficiency, hypopituitarism, hypophysitis, thyroiditis, dehydration, hepatitis, uveitis, blurred vision, tachycardia, pulmonary embolism, gastritis, urticaria, renal failure, pain, hypercalcaemia.
Drug Interactions
Potential interference w/ pharmacodynamic activity may occur w/ systemic corticosteroids & other immunosuppressants at baseline before starting therapy.
ATC Classification
L01XC17 - nivolumab ; Belongs to the class of monoclonal antibodies, other antineoplastic agents. Used in the treatment of cancer.
Opdivo soln for infusion 40 mg/4 mL
Opdivo soln for infusion 100 mg/10 mL
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