Use should be avoided.

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

Risk Summary: Based on animal reproduction studies and its mechanism of action this drug can cause fetal harm when administered to a pregnant woman. In animal studies, oral administration to pregnant animals throughout organogenesis caused teratogenicity and abortion at systemic exposures lower than the equivalent therapeutic human dose.

Comments:
-This drug can harm a developing fetus.
-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.
-Advise females of reproductive potential to use effective contraception during therapy and for at least 2 weeks after.
-Advise males (including those who have had vasectomies) with female partners of reproductive potential to use condoms during therapy and for at least 2 weeks after.
-Based on findings from animal studies, this drug may impair fertility in females and males of reproductive potential.

Animal studies revealed evidence of teratogenicity, embryotoxicity, embryolethality, fetotoxicity, maternal toxicity, reduced maternal and fetal weight, cardiovascular malformations, incomplete or absent ossification, increased pre- and post-implantation loss, early resorptions, and abortifacient properties. There are no controlled data in human pregnancy.

AU TGA pregnancy category D: Drugs which have caused, are suspected to have caused or may be expected to cause, an increased incidence of human fetal malformations or irreversible damage. These drugs may also have adverse pharmacological effects. Accompanying texts should be consulted for further details.

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

Use should be avoided.

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

Comments:
-The effects in the nursing infant are unknown.
-No information is available on the use of this drug during breastfeeding. Because it is more than 99% bound to plasma proteins, the amount in milk is likely to be low; however, its half-life is about 31 hours and it might accumulate in the infant.
-The manufacturer recommends that breastfeeding be discontinued during therapy and for 2 weeks after.

See references