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Trodelvy (sacituzumab govitecan-hziy)
sacituzumab govitecan
Black Box Warnings .
Neutropenia
severe or life-threatening cases may occur; hold tx if ANC <1500/mm^3 or febrile neutropenia; monitor CBC w/ diff during tx; initiate antimicrobial tx immed. if febrile neutropenia; consider G-CSF for secondary prophylaxis
Diarrhea
severe cases may occur; hold tx for severe cases until resolved to Grade 1 or less, and reduce subsequent doses; monitor pts w/ diarrhea, give fluid and electrolytes as needed; at the onset of diarrhea, evaluate for infectious cases and if negative, promptly initiate loperamide
Adult Dosing .
Dosage forms: INJ
Special Note
- [formulation clarification]
- Info: nonproprietary name = sacituzumab govitecan-hziy; not interchangeable w/ other irinotecan- or SN-38-containing products
- [uses, dosing may vary]
- Info: refer to institution protocols and pkg insert prior to prescribing for uses, premeds, and dosing incl. toxicity-related dose adjustments
breast CA, unresectable locally advanced or metastatic
- [ER/PR-negative HER2-negative dz]
- Dose: 10 mg/kg/dose IV x1 on days 1, 8 of 21-day cycle; Max: 10 mg/kg/dose; Info: for pts who have received at least 2 systemic tx
- [hormone receptor-positive HER2-negative dz]
- Dose: 10 mg/kg/dose IV x1 on days 1, 8 of 21-day cycle; Max: 10 mg/kg/dose; Info: for pts who have received endocrine-based tx and at least 2 additional systemic tx
urothelial carcinoma, locally advanced or metastatic
- [indication withdrawn in US]
- Info: drug not shown to improve survival in pts w/ locally advanced or metastatic urothelial carcinoma who have received platinum-containing chemo and PD-1/PD-L1 inhibitor
renal dosing
- [see below]
- CrCl >30: no adjustment; CrCl <30: not defined
- HD/PD: not defined
hepatic dosing
- [see below]
- bilirubin <1.5x ULN: no adjustment; bilirubin >1.5x ULN: not defined
Peds Dosing .
Peds dosing is currently unavailable or not applicable for this drug.