Use should be avoided.

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

Risk Summary: There are no available data on use in pregnant women to inform a drug-associated risk. Animal studies have shown embryofetal toxicity and based on its mechanism of action, this drug can cause fetal harm when administered to a pregnant woman.

Comments:
-A pregnancy test is recommended prior to initiating treatment.
-Females of reproductive potential should use effective contraception during therapy and for at least 7 months following the last dose; male patients with female partners of reproductive potential or who are pregnant should use effective contraception during treatment and for at least 4 months following the last dose.
-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 in pregnant rats have shown fetal malformations and structural skeletal variations and embryofetal death with administration during the period of organogenesis at doses estimated to be 0.24 times the equivalent recommended human dose of 1 mg/day. There are no controlled data in human pregnancy.

Animal studies have shown this drug may impair fertility in males of reproductive potential.

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 clinical use of this drug during breastfeeding. Because it is 74% bound to plasma proteins, the amount in milk is likely to be low.

Breastfeeding is not recommended during use of this drug

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

Comments:
-Because of the potential for serious adverse reactions in breastfed infants, advise lactating women not to breastfeed during therapy and for at least 1 month after the final dose.

See references