8USE IN SPECIFIC POPULATIONS
Based on its mechanism of action, TRODELVY can cause teratogenicity and/or embryo-fetal lethality when administered to a pregnant woman. There are no available data in pregnant women to inform the drug-associated risk. TRODELVY contains a genotoxic component, SN-38, and is toxic to rapidly dividing cells [see Clinical Pharmacology (12.1) and Nonclinical Toxicology (13.1)]. Advise pregnant women and females of reproductive potential of the potential risk to a fetus.
The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 – 4% and 15 – 20%, respectively.
There were no reproductive and developmental toxicology studies conducted with sacituzumab govitecan-hziy.
There is no information regarding the presence of sacituzumab govitecan-hziy or SN-38 in human milk, the effects on the breastfed child, or the effects on milk production. Because of the potential for serious adverse reactions in a breastfed child, advise women not to breastfeed during treatment and for 1 month after the last dose of TRODELVY.
8.3 Females and Males of Reproductive Potential
Verify the pregnancy status of females of reproductive potential prior to the initiation of TRODELVY.
TRODELVY can cause fetal harm when administered to a pregnant woman [see Use in Specific Populations (8.1)]. Advise females of reproductive potential to use effective contraception during treatment with TRODELVY and for 6 months after the last dose.
Because of the potential for genotoxicity, advise male patients with female partners of reproductive potential to use effective contraception during treatment with TRODELVY and for 3 months after the last dose.
Based on findings in animals, TRODELVY may impair fertility in females of reproductive potential [see Nonclinical Toxicology (13.1)].
8.4 Pediatric Use
Safety and effectiveness of TRODELVY have not been established in pediatric patients.
8.5 Geriatric Use
Of the patients who received TRODELVY, 19/108 (18%) patients with mTNBC and 144/408 (35%) of all patients were ≥ 65 years old. No overall differences in safety and effectiveness were observed between these patients and younger patients.
8.6 Hepatic Impairment
No adjustment to the starting dose is required when administering TRODELVY to patients with mild hepatic impairment (bilirubin less than or equal to 1.5 ULN and AST/ALT < 3 ULN).
The exposure of TRODELVY in patients with mild hepatic impairment (bilirubin less than or equal to ULN and AST greater than ULN, or bilirubin greater than 1.0 to 1.5 ULN and AST of any level; n=12) was similar to patients with normal hepatic function (bilirubin or AST less than ULN; n=45).
The safety of TRODELVY in patients with moderate or severe hepatic impairment has not been established. TRODELVY has not been tested in patients with serum bilirubin > 1.5 ULN, or AST and ALT > 3 ULN, or AST and ALT > 5 ULN and associated with liver metastases.
No dedicated trial was performed to investigate the tolerability of TRODELVY in patients with moderate or severe hepatic impairment. No recommendations can be made for the starting dose in these patients.
In a clinical trial, planned doses of up to 18 mg/kg (approximately 1.8 times the maximum recommended dose of 10 mg/kg) of TRODELVY were administered. In these patients, a higher incidence of severe neutropenia was observed.