Animal studies have revealed evidence of fetal malformations; after administration via oral gavage to pregnant rabbits during organogenesis (at dose exposures greater or equal to about 5 times the human exposure at the recommended human dose [RHD] based on AUC comparison), rare malformations (including absent forelimb[s], absent hindpaw, absent ear pinna, and thoracogastroschisis) were observed. In rabbits, fetal malformations (including absent ear pinna, craniorachischisis, thoracogastroschisis, trunk kyphosis, absent forelimbs, absent forepaws, and absent hindpaw) occurred at about 5 times the RHD (based on AUC comparison) in a single fetus, while malformations (including absent hindpaw and anencephaly) occurred with an increased litter incidence at about 13 times the RHD (based on AUC comparison) and other malformations occurred in single fetuses and litters (absent ear pinna, thoracogastroschisis, absent forelimb, absent thyroid gland); no changes in embryofetal survival or fetal body weights were seen at any dose and no fetal malformations were observed at about 2 times the RHD (based on AUC comparison). After administration via oral gavage to pregnant rats during organogenesis (at dose exposures up to about 5 times the human exposure at the RHD based on AUC comparison), no fetal malformations, changes in embryofetal survival, or changes in fetal body weights occurred. There are no controlled data in human pregnancy.

To monitor the outcomes of pregnant women exposed to this drug, a pregnancy safety study has been established. If this drug is inadvertently administered during pregnancy or if pregnancy is detected within 4 days after administration, pregnant women exposed to this drug and health care providers are encouraged to report pregnancies by calling 1-888-982-7299.

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.

US FDA pregnancy category: Not assigned.

Risk summary: Based on animal data, this drug may cause fetal harm when administered to a pregnant patient.

Comments:
-A pregnancy exposure registry is available.
-The pregnancy status in patients of childbearing potential should be verified before starting treatment with this drug.
-Patients of childbearing potential should be advised to use effective contraception during treatment with this drug and for 4 days after the last dose.

See references

The manufacturer makes no recommendation regarding use during lactation.

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

Comments:
-Developmental and health benefits of breastfeeding should be considered as well as the mother's clinical need for this drug.
-The effects in the nursing infant are unknown; potential side effects in the breastfed child due to this drug or the mother's underlying condition should be considered.

See references