Glycerol phenylbutyrate Pregnancy and Breastfeeding Warnings

Glycerol phenylbutyrate is also known as: Ravicti

Glycerol phenylbutyrate Pregnancy Warnings

Animal studies showed maternal toxicity, reduced fetal weights, and variations in skeletal development at doses greater than or equal to 5.7 times the dose of 6.87 mL/m2/day in adult patients. There are no controlled data in human pregnancy. For information on a voluntary patient registry to evaluate pregnancy outcomes in patients with Urea Cycle Disorders (UCDs), visit www.udcregistry.com or call 1-855-823-2595 FDA pregnancy category C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

FDA pregnancy category: C Potential benefit should outweigh the potential risk.

Glycerol phenylbutyrate Breastfeeding Warnings

A decision should be made to discontinue breast-feeding 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 The effects in the nursing infant are unknown.

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