Crinecerfont Pregnancy and Breastfeeding Warnings

Brand names: Crenessity

Medically reviewed by Drugs.com. Last updated on Feb 11, 2025.

Crinecerfont Pregnancy Warnings

The manufacturer makes no recommendation regarding use during pregnancy.

US FDA pregnancy category: Not Assigned

No data are available on the use of this drug in pregnant women to inform a drug-related risk.

Comments
-A pregnancy exposure registry is available.
-If a patient is pregnant or becomes pregnant while taking this drug, the healthcare provider should report exposure by calling 1-855-CRNSITY (1-855-276-7489).

Level 2:
Animal studies have revealed evidence of fetal harm. A low frequency of craniofacial defects was reported in animals at an exposure two times the maximum recommended human dose. 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.

See references

Crinecerfont Breastfeeding Warnings

Benefit should outweigh risk.

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

Comment:
-This drug is present in animal milk. When a drug is present in animal milk, it is likely that the drug will be present in human milk.
-The breastfed infant should be monitored for signs of adrenal insufficiency such as weakness, decreased feeding, and weight loss.

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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