This drug caused embryo-fetal lethality in animal studies at maternal exposures that were 0.3 times the human exposure at the recommended dose of 120 mg daily based on AUC. There are no controlled data on human 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.

Safety and efficacy have not been established during pregnancy.

US FDA pregnancy category: Not assigned.

Comments:
-Based on animal studies and the drug mechanism of action, this drug can cause fetal harm and loss of pregnancy.
-Patients should be advised of the potential risk to the fetus.
-This drug may impair fertility.
-Advise males with female partners of reproductive potential to use effective contraception during therapy and for at least 2 weeks after the last dose.

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The manufacturer makes no recommendation regarding use during lactation.

Excreted into human milk: Unknown
Excreted into animal milk: Yes

Comments:
-The effects in the nursing infant are unknown.
-This drug and its metabolites were present in the milk of lactating animals.

Lactating animals administered a single oral dose of 30 mg/kg radiolabeled drug on post-partum day 14 showed the presence of this drug and its metabolites at a concentration up to 10-fold higher than in plasma at 2 hours post dose. No information is available on the use of this drug during breastfeeding. Because it is 68 to 71% bound to plasma proteins, the amount in milk is likely to be low; however, its half-life is about 25 hours, which might accumulate in the infant.

See references