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Glycerol phenylbutyrate Pregnancy and Breastfeeding Warnings

Glycerol phenylbutyrate is also known as: Ravicti

Glycerol phenylbutyrate Pregnancy Warnings

Based on animal data, this drug may cause fetal harm. 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. 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.

This drug should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. FDA pregnancy category: C Comments: A voluntary patient registry to evaluate pregnancy outcomes in patients with Urea Cycle Disorders (UCDs) is available; for information visit www.ucdregistry.com or call 1-855-823-2595

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.

In animal studies, a potential for tumorigenicity was observed. This drug is contraindicated for use in infants less than 2 months of age due to immature pancreatic exocrine function which could impair hydrolysis of the drug. Pancreatic lipases may be necessary for intestinal hydrolysis allowing release of phenylbutyrate and subsequent formation of PAA, the active moiety. If there is inadequate intestinal hydrolysis of this drug, impaired absorption of phenylbutyrate and hyper ammonemia could occur. The safety of this drug in patients 2 months through 2 years of age has not been established.

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