When given orally to pregnant rats and rabbits during organogenesis, this drug resulted in fetal adverse outcomes, such as embryonic and fetal loss, as well as reduced fetal weight. These outcomes were observed at doses that caused maternal toxicity and polycythemia. There are no controlled data in human pregnancy.

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.

Use is not recommended.

US FDA pregnancy category: Not assigned

Risk summary:
Insufficient data available on use of this drug in pregnant women to inform a drug-related risk.

Comment:
-Pregnant women should be informed about the potential risk associated with this drug.
-Chronic kidney disease (CKD) poses risks for maternal hypertension, preeclampsia, miscarriage, stillbirth, preterm delivery, low birth weight infants, and polyhydramnios to both the mother and the fetus.

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Breastfeeding is not recommended during use of this drug and for one week after the final dose.

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

Comments:
-The effects in the nursing infant or on milk production are unknown.
-Presence of this drug was reported in milk of lactating rats.
-When a drug is present in animal milk, it is likely to be present in human milk.

When given orally to maternal rats during lactation, this drug was detected in the plasma of suckling pups on postnatal day 10 in a pre- and postnatal development study. The concentration of this drug in the pups' plasma was between 2.3% to 3.7% of what was detected in the dams' plasma when administered at a dose of 40 mg/kg/day.

See references