Monotherapy for locally advanced or metastatic urothelial cancer (mUC) in adults who have previously received programmed death receptor-1 or death-ligand 1 inhibitor & platinum-containing chemotherapy. In combination w/ pembrolizumab in adults w/ locally advanced or mUC who are not eligible for cisplatin-containing therapy.
IV infusion Infuse over 30 min. Monotherapy Recommended dose: 1.25 mg/kg on days 1, 8 & 15 of 28-day cycle until disease progression or unacceptable toxicity. In combination w/ pembrolizumab Recommended dose: 1.25 mg/kg on days 1 & 8 of 21-day cycle until disease progression or unacceptable toxicity. Patient weighing ≥100 kg Max: 125 mg. 1st dose reduction: 1 mg/kg up to 100 mg. 2nd dose reduction: 0.75 mg/kg up to 75 mg. 3rd reduction: 0.5 mg/kg up to 50 mg.
Not to be administered as IV push or bolus inj. Permanently discontinue treatment in confirmed SJS or TEN, grade 4 or recurrent severe skin reactions; grade ≥3 pneumonitis/ILD & peripheral neuropathy occur. Withhold treatment in suspected SJS, TEN or bullous lesions onset; grade 2 worsening, grade 2 w/ fever or grade 3 skin reactions; Grade 2 pneumonitis/ILD; if blood glucose is elevated (>13.9 mmol/L, >250 mg/dL). Stop infusion & monitor for adverse reactions if extravasation occurs. Mild to moderate skin reactions predominantly maculopapular rash. Severe cutaneous adverse reactions including SJS & TEN. Hyperglycemia & diabetic ketoacidosis in patients w/ & w/o pre-existing DM. Severe, life-threatening or fatal pneumonitis/ILD. Peripheral neuropathy, predominantly peripheral sensory neuropathy. Skin & soft tissue injury. Patients w/ pre-existing hyperglycemia or high BMI (≥30 kg/m2). Monitor patients starting w/ 1st cycle & throughout treatment for skin reactions; for signs & symptoms indicative of pneumonitis/ILD eg, hypoxia, cough, dyspnea or interstitial infiltrates on radiologic exams; symptoms of new or worsening peripheral neuropathy; ocular disorders eg, dry eye; possible infusion site extravasation during administration. Monitor blood glucose levels prior to dosing & periodically throughout treatment in patients w/ or at risk for DM or hyperglycemia. Consider artificial tears for prophylaxis of dry eye & referral for ophth evaluation if ocular symptoms do not resolve or worsen. Higher incidence of skin reactions in combination w/ pembrolizumab. ESRD. Moderate & severe hepatic impairment. Females of reproductive potential should have pregnancy test w/in 7 days prior to starting treatment & use effective contraception during, & for at least 12 mth after stopping treatment. Men should not father a child during treatment & up to 9 mth following last dose & have sperm samples frozen & stored before treatment. Not recommended during pregnancy. Discontinue lactation during treatment & for at least 6 mth after last dose. Ped patients.
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