Use is contraindicated.

AU TGA pregnancy category: X
US FDA pregnancy category: Not assigned.

Risk Summary: Based on its mechanism of action and animal studies, this drug can cause fetal harm when administered to a pregnant woman.

Comments:
-Adequate methods of contraception should be encouraged.
-Verify negative pregnancy status in females of reproductive potential prior to initiating therapy.
-If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential harm to the fetus.
-Report pregnancies to Sun Pharmaceutical Industries, Inc. at 1-800-406-7984.
-Advise females of reproductive potential to use effective contraception during therapy and for at least 20 months after.
-It is not known if this drug is present in semen. Advise male patients to use condoms, even after a vasectomy, to avoid potential drug exposure to pregnant partners and female partners of reproductive potential during therapy and for at least 8 months after.
-Advise males not to donate semen during therapy and for at least 8 months after.
-Based on findings from animal studies, female fertility may be compromised by this drug.

Animal studies during organogenesis at doses far below the equivalent recommended human dose revealed embryotoxicity, fetotoxicity, and teratogenicity. Teratogenic effects included severe midline defects, missing digits, and other irreversible malformations. Abortion and complete resorption of fetuses was reported. Skeletal variations were observed when maternal exposure to this drug was below the limit of detection. 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.

See references

No information is available on the use of this drug during breastfeeding. Because it is 97% bound to plasma proteins, the amount in milk is likely to be low; however, its half-life is about 28 days and it might accumulate in the infant.

Use is contraindicated.

Excreted into human milk: Unknown/Data not available
Excreted into animal milk: Data not available

Comments:
-Because of the potential for serious adverse reactions in breastfed infants, advise women not to breastfeed during therapy and for 20 months after.

See references