Opdivo

Nivolumab

Monotherapy or in combination w/ ipilimumab for advanced unresectable or metastatic melanoma in adults. Monotherapy for adjuvant melanoma w/ involvement of lymph nodes or metastatic disease that has undergone complete resection. 1st-line treatment of metastatic or recurrent NSCLC in combination w/ ipilimumab in adults w/ no EGFR or ALK genomic tumor mutations, whose tumor PD-L1 expression ≥1% w/ ECOG performance status 0-1; in combination w/ ipilimumab & 2 cycles of platinum-doublet chemotherapy in adults w/ no EGFR or ALK genomic tumor mutations & ECOG performance status 0-1. Advanced renal cell carcinoma (RCC) as monotherapy in adults after prior therapy; in combination w/ ipilimumab for previously untreated intermediate or poor risk patients. Monotherapy or in combination w/ ipilimumab for microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic CRC following treatment w/ fluoropyrimidine, oxaliplatin & irinotecan in adult & ped ≥12 yr. Monotherapy for locally advanced or metastatic NSCLC in adults after prior chemotherapy; relapsed or refractory classical Hodgkin's lymphoma (cHL) in adults after autologous stem cell transplant & treatment w/ brentuximab vedotin; squamous cell cancer of head & neck (SCCHN) in adults progressing on or after platinum-based therapy; locally advanced unresectable or metastatic urothelial carcinoma (UC) in adults after failure of prior platinum-containing therapy; hepatocellular carcinoma (HCC) previously treated w/ sorafenib; advanced or recurrent gastric or gastroesophageal junction adenocarcinoma (GC/GEJC) after ≥2 prior systemic therapies; unresectable advanced, recurrent or metastatic esophageal squamous cell carcinoma (ESCC) after prior fluoropyrimidine- & platinum-based chemotherapy.

IV Unresectable or metastatic melanoma In combination w/ ipilimumab: 1 mg/kg IV infusion over 30 min every 3 wk for 1st 4 doses + ipilimumab 3 mg/kg IV over 90 min. Then, followed by 3 mg/kg nivolumab IV infusion over 30 min every 2 wk. Monotherapy: Administer 1st dose 3 wk following last dose of combination therapy. NSCLC In combination w/ ipilimumab: 3 mg/kg IV over 30 min every 2 wk + ipilimumab 1 mg/kg IV over 30 min every 6 wk until disease progression, unacceptable toxicity, or up to 24 mth in patients w/o disease progression. In combination w/ ipilimumab & platinum-doublet chemotherapy: 360 mg IV infusion over 30 min every 3 wk + ipilimumab 1 mg/kg IV infusion over 30 min every 6 wk & platinum chemotherapy every 3 wk. After completion of 2 cycles chemotherapy, continue w/ nivolumab 360 mg IV infusion every 3 wk + ipilimumab 1 mg/kg every 6 wk until disease progression, unacceptable toxicity, or up to 24 mth in patients w/o disease progression. RCC, MSI-H/dMMR CRC In combination w/ ipilimumab: 3 mg/kg IV infusion over 30 min every 3 wk for 1st 4 doses + ipilimumab 1 mg/kg IV over 30 min. After completing 4 doses, administer nivolumab as single agent 3 mg/kg IV over 30 min every 2 wk, or 480 mg IV over 30 min every 4 wk (for RCC). Monotherapy: Melanoma, NSCLC, RCC, cHL, SCCHN, UC, HCC, CRC, GC/GEJC 3 mg/kg over 30 min IV every 2 wk. ESCC 3 mg every 2 wk or 480 mg every 4 wk IV infusion over 30 min until disease progression or unacceptable toxicity.

Hypersensitivity.

Not to administer as IV push or bolus inj. Permanently discontinue for any severe immune-related adverse reaction that recurs & is life-threatening; in grade 3 or 4 pneumonitis & transaminase or total bilirubin elevation, adrenal insufficiency, grade 3 diarrhea or colitis, & grade 4 serum creatinine elevation & hyper-/hypothyroidism, hypophysitis. Discontinue therapy in combination w/ ipilimumab for life-threatening or recurrent severe cardiac & pulmonary adverse reactions; in grade 4 rash. Withhold therapy in grade 3 rash; grade 2 pneumonitis, transaminase or total bilirubin elevation, diarrhea or colitis, adrenal insufficiency, & grade 2 or 3 serum creatinine elevation; if symptomatic hypo-/hyperthyroidism, grade 2 adrenal insufficiency, grade 2 or 3 hypophysitis, & diabetes occurs. Not to resume nivolumab while receiving immunosuppressive corticosteroid or other immunosuppressive therapy. Melanoma patients w/ rapidly progressing disease. Patients w/ poorer prognostic features &/or aggressive disease, history of or concurrent brain metastases, active autoimmune disease, & symptomatic ILD; who previously experienced severe or life-threatening skin adverse reaction prior to treatment w/ other stimulatory anticancer agents; on controlled Na diet. Monitor patients continuously during or after discontinuation of therapy (at least up to 5 mth after last dose) for immune-related adverse reactions that may occur at any time during or after discontinuation of therapy; cardiac & pulmonary adverse reactions, & electrolyte disturbances & dehydration prior to & periodically during treatment; 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. May affect ability to drive or operate machinery. Women of childbearing potential not using effective contraception. Pregnancy & lactation. Childn <18 yr.

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. URTI, 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 & appetite, headache, vomiting, abdominal pain, arthralgia, pyrexia, increased total bilirubin. In combination w/ ipilimumab: Colitis. Pneumonia, eosinophilia, adrenal insufficiency, hypopituitarism, hypophysitis, thyroiditis, dehydration, hepatitis, uveitis, blurred vision, tachycardia, pulmonary embolism, gastritis, urticaria, renal failure, pain.

Potential interference w/ pharmacodynamic activity w/ systemic corticosteroids & other immunosuppressants.

Targeted Cancer Therapy / Cancer Immunotherapy

L01FF01 - nivolumab ; Belongs to the class of PD-1/PDL-1 (Programmed cell death protein 1/death ligand 1) inhibitors. Used in the treatment of cancer.

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