General Information
Version
1.6
Revision date
2024-08-30
Product name
XTANDI (enzalutamide) Capsules
Chemical name
4-{3-[4-Cyano-3-(trifluoromethyl)phenyl]-5,5-dimethyl-4-oxo-2-sulfanylideneimidazolidin-1-yl}-2-fluoro-N-methylbenzamide
CAS No.
915087-33-1
1.2.1 Relevant identified uses
Androgen receptor inhibitor indicated for the treatment of patients with cancer. For
1.2.2. Uses advised against
professional use only
Icons in SDS
Company Information
company name
Astellas US LLC
Section 2
SECTION 2: Hazards identification
This product is a drug, as defined by the US Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.) It is in solid, final form for direct administration to the patient. Therefore, it is exempt from labeling, as defined in the 29 CFR 1910.1200(b)(5)(iii). Potential to cause seizures, especially in those predisposed to seizure activity. The toxicological, physical and other potential hazards associated with this compound have not been fully characterized. Should avoid ingestion, inhalation, skin and eye contact. Given anti-androgen effects of the compound, histopathological changes have been observed in endocrine and reproductive organs in rats and dogs. As teratogenicity was induced at a low dose level (10 mg/kg) in the embryo-fetal development study in mice, pregnant women and women suspected to be pregnant should avoid contact with this material. ADI=300 μg/day
