Atrasentan Pregnancy and Breastfeeding Warnings

Brand names: Vanrafia

Medically reviewed by Drugs.com. Last updated on May 12, 2025.

Atrasentan Pregnancy Warnings

Use is contraindicated.

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, including birth defects and fetal death, when administered to a pregnant woman. No data available on use of this drug in pregnant women to inform a drug-related risk.

Comments:
-Exclude pregnancy before initiating therapy in women of childbearing potential.
-Females of reproductive potential should use effective contraception to prevent pregnancy prior to therapy, during treatment, and for 2 weeks after the last dose.
-Inform patients to contact their health care provider in the event of delayed menses or suspected pregnancy; stop treatment as soon as possible if pregnancy is confirmed.
-Apprise patients of the potential risk to a fetus if this drug is used during pregnancy.
-Male fertility may be compromised by this drug.

Animal studies have revealed evidence of teratogenicity and embryofetal toxicity. Oral administration of this drug during the period of organogenesis at doses below the maximum recommended human dose based on AUC caused teratogenic effects (visceral and skeletal malformations) in rats and rabbits. There are no controlled data in human pregnancy.

Available human data from postmarketing reports and published literature with use of other endothelin receptor antagonists have not identified a major risk of adverse effects; however, methodological limitations and small data sets preclude the ability to determine a reliable estimate of risk with use of this drug during pregnancy.

Decreased sperm counts were observed in some men with diabetic kidney disease treated with this drug; sperm counts returned to normal levels within about 3 months of treatment discontinuation. This effect has not been studied in patients with primary immunoglobulin A nephropathy.

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

Atrasentan Breastfeeding Warnings

Use should be avoided.

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

Comments:
-The effects in the nursing infant are unknown; there is a potential for serious adverse reactions, including fluid retention in the breastfed infant.
-There are no data on the effect of this drug on milk production.

See references

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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