Use should be avoided.

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

Risk Summary: This drug, when given to pregnant women, has caused oligohydramnios and oligohydramnios sequence, manifesting as pulmonary hypoplasia, skeletal abnormalities, and neonatal death.

Comments:
-This drug can harm a developing fetus.
-Verify the pregnancy status of females of reproductive potential prior to initiation of therapy.
-Adequate methods of contraception should be encouraged.
-Advise women against becoming pregnant during therapy and for at least 7 months following the last dose.
-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.

Use of this drug during pregnancy resulted in cases of oligohydramnios and of oligohydramnios sequence, manifesting in the fetus as pulmonary hypoplasia, skeletal abnormalities, and neonatal death. These reports described oligohydramnios in pregnant women who received this drug either alone or in combination with chemotherapy. In some cases, amniotic fluid index increased after therapy was stopped. In one case, therapy resumed after amniotic index improved, and oligohydramnios recurred.

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

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: Yes

Comments:
-Human IgG is present in human milk but does not enter the neonatal and infant circulation in substantial amounts.
-Breastfeeding should be avoided during therapy and for 7 months after the last dose.

See references