Lomitapide Pregnancy and Breastfeeding Warnings

Lomitapide is also known as: Juxtapid

Lomitapide Pregnancy Warnings

Lomitapide may cause fetal harm when administered to a pregnant woman. Animal studies at 2- to 5-times the human dose resulted in umbilical hernia, gastroschisis, imperforate anus, alterations in heart shape and size, kinking and skeletal malformations of the tail, delayed ossification of cranial, vertebral and pelvic bones, medially rotated or short limbs, absent or fused digits on paws, cleft palate, open eye lids, and lowset ears. Females of reproductive potential should have a negative pregnancy test before starting lomitapide. If oral contraceptives are used, the maximum recommended dosage is 30 mg daily.

FDA pregnancy category: X Use of lomitapide is contraindicated. Comments: Encourage use of adequate methods of contraception. If lomitapide is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to a fetus.

Lomitapide Breastfeeding Warnings

Lomitapide has been shown to have tumorigenicity potential in mouse studies.

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: Yes The effects in the nursing infant are unknown.

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