This drug should be used during pregnancy only if the benefit outweighs the risk to the fetus.

US FDA pregnancy category: Not assigned

Comments:
-There is no data on use in pregnant women to know this drugs risks, including the risk of major birth defects or miscarriage.
-Animal studies showed adverse developmental outcomes at maternotoxic doses higher than the maximum theoretical human exposure.
-Advise patients who could become pregnant to use effective contraception during treatment and for at least 2 weeks after completion of therapy.

Animal studies of fertility and early embryonic development administering 40 mg/kg intravenously three times per week showed no fetotoxicity but was maternally toxic. A study of a 1-hour administration of 20 to 30 mg/kg/day during organogenesis showed not maternal or fetal toxicity; maternotoxic doses of 40 or 90 mg/kg/day affected embryo-fetal development (post-implantation loss/early resorptions, abnormal placentae, decreased fetal weight, and fetal head and vertebral malformations). Pre- and post-natal studies of 90 mg/kg/day intravenously was maternotoxic with fewer live offspring and lower offspring weights; no adverse survival effects were seen at 30 mg/kg/day; no effects were seen on behavior, sexual maturation, or reproductive parameters in offspring at any dose level. There are no controlled data in human pregnancy. The background birth defect and miscarriage risk for the indicated population is not known. In the US general population, the estimated major birth defect risk is 2 to 4% and the miscarriage risk is 15 to 20%.

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

The manufacturer makes no recommendation regarding use during lactation.

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

Comments:
-There is no information regarding this drug on the presence in human milk, the effects on a breastfed infant, or effects on milk production.
-Consider the developmental and health benefits of breastfeeding along with the mother's clinical need for this medication as well as any potential adverse effects from this drug or the underlying maternal condition.

See references