Use is contraindicated.

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

Risk Summary: Based on findings from animal studies and its mechanism of action, this drug can cause fetal harm when administered to a pregnant woman. Avoid use during the first trimester. Available human data do not establish the presence or absence of major birth defects and miscarriage related to use during the second and third trimesters. Fetal and/or neonatal cardiotoxicity following in utero exposure has been reported.

Comments:
-This drug can cause fetal harm when administered to a pregnant woman.
-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.
-Advise females of reproductive potential to use effective contraception during therapy and for 6 months after.
-Advise male patients with female partners of reproductive potential to use effective contraception during therapy and for 3 months after.
-Advise male patients with pregnant partners use condoms during therapy and for at least 7 days after.
-This drug may cause oligospermia, azoospermia, and permanent loss of fertility. Sperm counts have been reported to return to normal levels in some men. This may occur several years after the end of therapy.
-Men undergoing therapy should seek advice on sperm preservation due to the possibility of irreversible infertility.
-This drug may impair female fertility and result in amenorrhea. Premature menopause can occur. Recovery of menses and ovulation is related to age at treatment.

Animal studies have revealed evidence of embryofetal toxicity and lethality and structural abnormalities when administered during organogenesis at doses less than the maximum recommended human dose on a body surface area basis. 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

Animal data have reported that the drug is excreted into animal milk.

Use is contraindicated.

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

Comments:
-Because of the potential for serious adverse reactions in the breastfed child, advise lactating women not to breastfeed during therapy and for at least 7 days after.

See references