Use is not recommended.

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

Risk Summary: Based on its mechanism of action and findings in animals, this drug can cause fetal harm when administered to a pregnant woman. Administration to pregnant rats during the period of organogenesis resulted in dose-related skeletal anomalies at doses as low as 12.5 mg/kg/day (approximately 0.7 times the human exposure at 180 mg once daily) as well as increased post-implantation loss, malformations, and decreased fetal body weight at doses of 25 mg/kg/day (approximately 1.26 times the human exposure at 180 mg once daily) or greater.

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.
-This drug induces CYP450 3A in vitro, potentially resulting in decreased concentrations and loss of efficacy of hormonal contraceptives and other CYP450 3A substrates.
-Advise females of reproductive potential to use effective nonhormonal contraception during treatment with this drug and for at least 4 months following the final dose.
-Due to the genotoxicity potential, advise male patients with female partners to use effective contraception during treatment and for at least 3 months after the last dose.

Animal studies have revealed evidence of dose-related skeletal and visceral anomalies, increased post-implantation loss, malformations, and decreased fetal body weight at doses as low as 0.7 and 1.26 times the human exposure by AUC at 180 mg once daily. Additionally, findings in the reproductive organs of male animals (e.g., testicular toxicity) indicate this drug may cause reduced fertility in males. 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

No information is available on the clinical use of this drug during breastfeeding.

Use is not recommended.

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

Comments:
-The effects in the nursing infant and on milk production are unknown.
-The manufacturer recommends that breastfeeding be discontinued during therapy and for 1 week after.

See references