Palovarotene Pregnancy and Breastfeeding Warnings

Brand names: Sohonos

Medically reviewed by Drugs.com. Last updated on Oct 10, 2023.

Palovarotene Pregnancy Warnings

Use is contraindicated.

US FDA pregnancy category: Not assigned.

Risk summary: Based on animal data and class effects of retinoids, this drug can cause fetal harm when administered to a pregnant woman.

Comments:
-Retinoids, including this drug, carry a high risk of teratogenicity.
-Negative serum pregnancy test should be obtained within 1 week before starting this treatment.
-Pregnancy status should be verified in patients of childbearing potential periodically during therapy, as needed, and for 1 month after the last dose.
-If a patient becomes pregnant while taking this drug, treatment should be discontinued at once, and the patient should be referred to a specialist for evaluation and advice.
-In patients of childbearing potential, effective contraception is required at least 1 month before starting the treatment, during treatment, and for 1 month after the end of treatment, unless continuous abstinence is chosen.

Animal studies have revealed evidence of teratogenicity. Administration of this drug to pregnant rats during organogenesis at doses 0.25 mg/kg/day or greater (less than the clinical exposure) resulted in fetal external, visceral, and skeletal malformations typical of retinoids, including defects in the mouth (cleft palate, protruding tongue), eye (anophthalmia, microphthalmia), skull (dilated cerebral ventricle, misshapen brain), skeleton (shortening of the long bones), blood vessels, kidney, and ureters. 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

Palovarotene Breastfeeding Warnings

Breastfeeding is not recommended during use of this drug and for at least 1 month after the final dose.

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

Comments:
-The effects in the nursing infant are unknown; there is a potential for serious adverse reactions.

See references

Further information

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

Medical Disclaimer