Animal models have revealed evidence of dose-related increased fetal mortality and decreased fetal weight when given this drug intramuscularly. An animal model species revealed evidence of major fetal malformations when this drug was administered during organogenesis. 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 X: Studies in animals or humans have demonstrated fetal abnormalities and/or there is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience, and the risks involved in use of the drug in pregnant women clearly outweigh potential benefits.

Use in women who are or may become pregnant is contraindicated.

AU TGA pregnancy category: D
US FDA pregnancy category: X

Comments:
-Pregnancy should be excluded prior to starting treatment, and barrier methods of contraception should be used for the duration of treatment.
-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. Some experts recommend discontinuation of treatment if a patient becomes pregnant. The manufacturer product information should be consulted regarding recommendations.

See references

Use is contraindicated.

Excreted into human milk: Unknown
Excreted into animal milk: Unknown

Comments: The effects in the nursing infant are unknown.

See references