Use should be avoided.

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

Risk Summary: Based on animal studies and its mechanism of action this drug can cause fetal harm when administered to a pregnant woman. The limited available data on the use of it in pregnant women are insufficient to inform a risk.

Comments:
-This drug can harm a developing fetus.
-Advise females of reproductive potential to use effective contraception during therapy and for 6 months after.
-Based on the potential for genotoxicity, advise males with female partners of reproductive potential to use condoms during therapy and for 3 months after.
-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.

Animal studies during organogenesis at levels less than the recommended human dose showed increased skeletal anomalies including incomplete ossification and skeletal variations; low incidence of visceral anomalies, including absent or malpositioned gallbladder and retroesophageal subclavian cardiac artery. Maternal toxicity and abortion occurred in rabbits at doses of 35 mg/kg or higher; embryolethality was observed at a dose of 50 mg/kg. There is 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

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.

A decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother.

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

Comments:
-The effects in the nursing infant are unknown.
-The manufacturer recommends that breastfeeding be discontinued during therapy and for 2 weeks after.

See references