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Carglumic acid Pregnancy and Breastfeeding Warnings

Carglumic acid is also known as: Carbaglu

Carglumic acid Pregnancy Warnings

In embryofetal developmental toxicity studies, pregnant rats and rabbits received oral carglumic acid during organogenesis at doses up to 1.3 times the maximum recommended human starting dose based on body surface area (mg/m2). Actual doses were 500 and 2000 mg/kg/day (rats) and 250 and 1000 mg/kg/day (rabbits). The high doses resulted in maternal toxicity in both rats and rabbits. No effects on embryofetal development were observed in either species. In a perinatal and postnatal developmental study, female rats received oral carglumic acid from organogenesis through day 21 postpartum at doses up to 1.3 times the maximum recommended starting human dose based on body surface area (mg/m2). Actual doses were 500 and 2000 mg/kg/day. A reduction in offspring survival was seen at the high dose and a reduction in offspring growth was seen at both doses.

Carglumic acid has been assigned to pregnancy category C by the FDA. Decreased survival and growth occurred in offspring born to animals that received carglumic acid at doses similar to the maximum recommended starting human dose during pregnancy and lactation. Because untreated N-acetylglutamate synthase (NAGS) deficiency results in irreversible neurologic damage and death, women with NAGS must remain on carglumic acid therapy throughout pregnancy.

Carglumic acid Breastfeeding Warnings

There are no data on the excretion of carglumic acid into human milk. Carglumic acid is excreted into the milk of lactating rats, and an increase in mortality and impairment of body weight gain occurred in neonatal rats nursed by mothers receiving carglumic acid. The manufacturer recommends that mothers discontinue nursing prior to initiation of carglumic acid.

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