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Glycerol phenylbutyrate Pregnancy and Breastfeeding Warnings

Glycerol phenylbutyrate is also known as: Ravicti

Medically reviewed by Drugs.com. Last updated on Mar 12, 2021.

Glycerol phenylbutyrate Pregnancy Warnings

Studies in rabbits have shown maternal toxicity at doses approximately 2.7 times the adult dose, but no effects on embryofetal development. In rats, doses of 1.9 times the estimated adult dose during the period of organogenesis, had no effect on embryo fetal development. Doses greater than or equal to 5.7 times the estimated dose in adult patients produced maternal toxicity and adverse effects on embryo-fetal development including reduced fetal weights and cervical ribs at the 7th cervical vertebra. 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 unless clearly needed

US FDA pregnancy category: Not assigned

Risk Summary: There is limited data in pregnant women to inform a drug associated risk of major birth defects and miscarriage; animal studies with doses up to 2.7 times the adult doses have shown no effects on embryo fetal development, but did produce maternal toxicity.

Comments:
-Use of adequate methods of contraception should be encouraged.
-In the US, report pregnancies to Horizon at 1-866-479-6742.

See references

Glycerol phenylbutyrate Breastfeeding Warnings

A decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother.

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

Comments:
-The effects in the nursing infant are unknown; however due to the potential for serious adverse reactions, including neurotoxicity and tumorigenicity in the breastfed infant, breastfeeding is not recommended during therapy.

See references

References for pregnancy information

  1. "Product Information. Ravicti (glycerol phenylbutyrate)." Hyperion Therapeutics Inc, South San Francisco, CA.
  2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

References for breastfeeding information

  1. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  2. "Product Information. Ravicti (glycerol phenylbutyrate)." Hyperion Therapeutics Inc, South San Francisco, CA.

Further information

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