Use is not recommended.

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

Risk Summary: Based on findings in animals and its mechanism of action, this drug can cause fetal harm when administered to a pregnant woman. In animal reproduction studies, administration during organogenesis was teratogenic and caused decreased fetal weight at maternal exposures that were similar to human clinical exposure based on the maximum recommended human dose.

Comments:
-Women of childbearing potential should use highly effective contraception methods (e.g. double-barrier contraception) during therapy and for at least 3 weeks after.
-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.
-Based on findings in animals, this drug may impair fertility in males of reproductive potential.

Animal studies have revealed evidence of reproductive toxicity embryotoxicity (e.g., reduced fetal weights, increased incidence of cardiovascular and skeletal malformations and variations [absent innominate artery and aortic arch, malpositioned subclavian artery, unossified sternebra, bipartite ossification of thoracic centrum, and rudimentary or nodulated ribs]). There are no controlled data in human pregnancy. It is not known whether this drug can cause fetal harm or adversely affect reproductive capacity in humans.

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 over 90% 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 3 weeks after.

See references