Use should be avoided.

AU pregnancy category: C
US FDA pregnancy category: Not assigned.

Risk Summary: This drug can cause fetal harm based on findings from animal studies and its mechanism of action.

Comments:
-Based on animal studies and its mechanism of action this drug can harm a developing fetus.
-Advise females of reproductive potential to use effective contraception and avoid becoming pregnant during therapy and for at least 6 months after.
-Advise males with female partners of reproductive potential to use effective contraception during therapy and for at least 3 months after.
-Apprise the patient of the potential hazard to the fetus if this drug is used during pregnancy or if the patient becomes pregnant while taking this drug.
-Based on its mechanism of action, this drug may have an adverse effect on either male or female fertility.

Animal studies have revealed evidence of embryofetal toxicity at doses that were lower than in patients receiving the recommended dose, but have failed to show teratogenicity. No effects on reproductive tissues were noted during animal toxicity studies. There are no controlled data in human pregnancy.

AU TGA pregnancy category C: Drugs which, owing to their pharmacological effects, have caused or may be suspected of causing, harmful effects on the human fetus or neonate without causing malformations. These effects may be reversible. 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

Use is contraindicated.

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

Comments:
-Because of the potential for serious adverse reactions in the breastfed child, advise women not to breastfeed during therapy and for 2 weeks after.

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.

See references