Juxtapid 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. There are no controlled data in human pregnancy.
Females of reproductive potential should have a negative pregnancy test before starting lomitapide.
To monitor the outcomes of pregnant women exposed to lomitapide, a pregnancy registry has been established. Physicians are encouraged to register patients and pregnant women are encouraged to register themselves at www.JUXTAPID.com or call the Global Lomitapide Pregnancy Exposure Registry (PER) at 1-877-902-4099.
US FDA pregnancy category X: Studies in animals or humans have demonstrated fetal abnormalities and/or there is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience, and the risks involved in use of the drug in pregnant women clearly outweigh potential benefits.
Use of lomitapide is contraindicated.
US FDA pregnancy category: X
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.
See references
Juxtapid Breastfeeding Warnings
No information exists on the use of lomitapide during breastfeeding. Lomitapide should not be used during breastfeeding due to possible disruption of infant lipid metabolism.
UK: A decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother.
US: Use of lomitapide is contraindicated.
Excreted into human milk: Unknown (a small amount of another drug in this class is excreted in human milk)
The effects in the nursing infant are unknown.
.
See references
