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.

AU TGA pregnancy category: X
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. No data are available on the use of this drug in pregnant women to inform a drug-related risk.

Comments:
-According to some authorities: Pregnancy is an absolute contraindication to use of this drug due to the potential of severe and life-threatening birth defects; patients of childbearing potential must follow the conditions for pregnancy prevention.
-Retinoids (including this drug) carry a high risk of teratogenicity.
-Negative serum pregnancy test should be obtained within 1 week before starting this drug.
-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 further evaluation and advice.
---If pregnancy occurs within 1 month of stopping this drug, there is still a risk of severe and serious fetal malformation; the patient should be referred to her physician.
-In patients of childbearing potential:
----Pregnancy status should be verified periodically during therapy, as needed, and for 1 month after the last dose, unless the patient is not at risk of pregnancy.
---Effective contraception is required at least 1 month before treatment, during treatment, and for 1 month after the last dose, 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.

This drug is present in semen (0.7 ng/mL) in amounts 100-fold lower than the maternal plasma exposure at the no observed adverse effect level for fetal toxicity seen in animal studies. Use of this drug in a male patient is considered unlikely to affect development of an embryo or fetus carried by a pregnant sexual partner exposed to this drug via the patient's semen.

AU TGA pregnancy category X: Drugs which have such a high risk of causing permanent damage to the fetus that they should not be used in pregnancy or when there is a possibility of 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 last dose.

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

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

See references

Further information

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