Enzalutamide Pregnancy Warnings
Animal studies have shown evidence of maternal toxicity and impaired male fertility including hypospermatogenesis and atrophy of the prostate, seminal vesicles, and epididymides. Studies in animals have also revealed embryofetal developmental toxicity and lethality, increased post-implantation loss and resorptions, decreased anogenital distance, cleft palate, and absent palatine bone. The drug may cause fetal harm when administered to a pregnant woman as use of an androgen receptor inhibitor could affect fetus development. There are no controlled data in human pregnancy.
AU TGA pregnancy category X: Drugs which have such a high risk of causing permanent damage to the fetus that they should not be used in pregnancy or when there is a possibility of pregnancy.
US FDA pregnancy category Not Assigned: The US FDA has amended the pregnancy labeling rule for prescription drug products to require labeling that includes a summary of risk, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy. Pregnancy categories A, B, C, D and X are being phased out
Use is contraindicated.
AU TGA pregnancy category: X
US FDA pregnancy category: Not assigned.
Risk Summary: There are no data in pregnant women; however, in animal studies giving this drug during organogenesis caused adverse developmental effects at doses lower than the equivalent maximum recommended human dose (MRHD).
Comments:
-This drug is not indicated for use in females.
-This drug should not be handled by women who are or may become pregnant.
-Male patients with female partners of reproductive potential should use effective contraception during therapy and for 3 months after the last dose.
-This drug may impair fertility in males of reproductive potential.
See references
