Animal studies of this drug showed reductions in the number of live fetuses and fetal body weight, increased resorptions and post-implantation losses, and skeletal variations (e.g. asymmetric sternal centra, angulated hyoid) at approximately 13 and 18 times the maximum recommended human dose (MRHD). Animals administered this drug from organogenesis through weaning showed lower pup weights and adverse kidney findings (e.g. membranoproliferative glomerulonephritis, tubular atrophy/hypoplasia, vessel ectasia occasionally associated with hemorrhage) at exposures 1.6 times the MRHD. There are no controlled data in human pregnancy. This drug may impair female fertility; fertility effects were reversible after a 14 week recovery period. The background birth defect and miscarriage risk for the indicated population is not known. In the US general population, the estimated major birth defect risk is 2 to 4% and the miscarriage risk is 15 to 20%.

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.

The manufacturer makes no recommendation regarding use during pregnancy.

US FDA pregnancy category: Not assigned

Comments:
-There is no data on use in pregnant women to know this drugs risks, including the risk of fetal harm or reproductive effects.
-Animal studies indicate that fetal harm may occur from use of this drug; administration during organogenesis caused adverse developmental outcomes and embryo-fetal mortality, growth alterations, and structural abnormalities at exposures above the maximum recommended human dose.
-Advise pregnant patients of the potential risk to the fetus.
-Females of reproductive potential should use effective contraception during treatment and for 3 months after the final dose.
-Pregnancy testing is recommended for females of reproductive potential prior to treatment with this drug.

See references

Breastfeeding is not recommended during use of this drug.

Excreted into human milk: Data not available
Excreted into animal milk: Yes

Comments:
-Drugs that are present in animal milk are likely to be present in human milk.
-There is no information regarding this drug on the presence in human milk, the effects on a breastfed infant, or effects on milk production.
-Breastfeeding is not recommended during use of this drug or for 3 months after the last dose.

See references