Sacituzumab Govitecan-hziy
Class: Antineoplastic Agents
Chemical Name: (2R)-2-amino-3-[1-[[4-[[1-[2-[2-[2-[2-[2-[2-[2-[2-[2-[[2-[2-[[(2S)- 6-amino-1-[4-[[(19S)-10,19-diethyl-7-hydroxy-14,18-dioxo-17-oxa-3,13- diazapentacyclo[11.8.0.02,11.04,9.015,20]henicosa-1(21),2,4(9),5,7,10,15(20)-heptaen-19-yl]oxycarbonyloxymethyl]anilino]-1-oxohexan-2-yl]amino]-2-oxoethoxy]acetyl]amino]ethoxy]ethoxy]ethoxy]ethoxy]ethoxy]ethoxy]ethoxy]ethox y]ethyl]triazol-4-yl]methylcarbamoyl]cyclohexyl]methyl]-2,5-dioxopyrrolidin-3-yl]sulfanylpropanoic acid
Molecular Formula: C76H104N12O24S
CAS Number: 1491917-83-9
Brands: Trodelvy
Warning
- Severe Neutropenia
Severe neutropenia reported.
Monitor CBCs periodically during treatment.
Temporary interruption of therapy and dosage reduction may be necessary. (See Dosage Modification for Toxicity under Dosage and Administration.)
Consider granulocyte colony-stimulating factor (G-CSF) for secondary prophylaxis. Promptly initiate anti-infective treatment in patients who develop febrile neutropenia. (See Neutropenia under Cautions.)
- Severe Diarrhea
Severe diarrhea reported.
Monitor patients with diarrhea and provide appropriate therapy (e.g., antidiarrheal agents, fluid replacement, electrolytes) as needed. (See Diarrhea under Cautions.)
Temporary interruption of therapy and dosage reduction may be necessary. (See Dosage Modification for Toxicity under Dosing and Administration.)
Introduction
Antineoplastic agent; an anti-trophoblast antigen-2 (anti-Trop-2) antibody conjugated with a topoisomerase I inhibitor (SN-38).
Uses for Sacituzumab Govitecan-hziy
Breast Cancer
Treatment of metastatic triple-negative (i.e., estrogen receptor-, progesterone receptor-, and human epidermal growth factor receptor type 2 [HER2]-negative) breast cancer (mTNBC) previously treated with at least 2 prior therapies for metastatic disease.
Accelerated approval based on tumor response rate and duration of response; continued approval may be contingent on verification and description of clinical benefit in a confirmatory study.
Sacituzumab Govitecan-hziy Dosage and Administration
General
Do not substitute for or use with other drugs containing irinotecan or its active metabolite SN-38.
Monitor patients during and for at least 30 minutes following each infusion. Administer in settings where emergency equipment and appropriate medical support are available for the management of potential infusion-related or hypersensitivity reactions. (See Hypersensitivity Reactions under Cautions.)
Administer an antipyretic, a histamine H1-receptor antagonist, and a histamine H2-receptor antagonist prior to each infusion. If an infusion-related reaction occurs, may use corticosteroids for subsequent infusions.
Administer a 2- or 3-drug antiemetic regimen (e.g., dexamethasone with either a type 3 serotonin [5-HT3] r.