Monotherapy for locally advanced or metastatic urothelial cancer in adults who have previously received a platinum-containing chemotherapy & a programmed death receptor-1 or programmed death-ligand 1 inhibitor.
IV 1.25 mg/kg (up to max 125 mg for patients ≥100 kg) infused over 30 min on days 1, 8, & 15 of a 28-day cycle until disease progression or unacceptable toxicity.
Do not administer as IV push or bolus inj. Monitor patients for skin reactions; signs & symptoms indicative of pneumonitis/ILD; symptoms of new or worsening peripheral neuropathy; ocular disorders. Permanently discontinue treatment for confirmed SJS or TEN, grade 4 or recurrent severe skin reactions; grade ≥3 pneumonitis/ILD; grade ≥3 peripheral neuropathy. Monitor blood glucose levels prior to dosing & periodically throughout treatment as clinically indicated in patients w/ or at risk for DM or hyperglycaemia. Ensure good venous access prior to treatment initiation & monitor for possible infusion site extravasation during administration. Patients w/ ESRD (CrCl <15 mL/min); moderate or severe hepatic impairment. Can cause foetal harm. Not recommended during pregnancy & in women of childbearing potential not using effective contraception. Females of reproductive potential should have a pregnancy test w/in 7 days prior to treatment initiation, & use effective contraception during treatment & for at least 12 mth after stopping treatment. Men should not father a child during treatment & for up to 9 mth following the last dose. Discontinue breast-feeding during treatment & for at least 6 mth after the last dose. No relevant use in paed population.
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