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Cyclosporine Pregnancy and Breastfeeding Warnings

Cyclosporine is also known as: Gengraf, Neoral, Sandimmune

Cyclosporine Pregnancy Warnings

One meta-analysis of fifteen studies (n=410) found that the overall prevalence of major malformations in the study population did not vary substantially from that reported in the general population. The meta-analysis concluded that cyclosporine does not appear to be a major human teratogen. However, it may be associated with increased rates of prematurity. The manufacturer has reported an analysis of 116 pregnancy outcomes (90% of which were in posttransplant patients) revealed a pattern of premature birth and low birth weight for gestational age. In addition, seven malformations in five live births and in 2 cases of fetal loss occurred. The majority of these cases were complicated by preeclampsia, eclampsia, oligohydramnios, and other disorders. A limited number of observations in children exposed to cyclosporine in utero is available up to approximately seven years of age. Renal function and blood pressure in these children were normal.

Cyclosporine has been assigned to pregnancy category C by the FDA. Human data have revealed evidence of premature birth and low birth weight for gestational age. There are no controlled data in human pregnancy. The alcohol content of the particular cyclosporine formulation should be taken into account in pregnant women. Cyclosporine should be given during pregnancy only when benefit outweighs risk.

Cyclosporine Breastfeeding Warnings

A decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother. Excreted into human milk: Yes Excreted into animal milk: Unknown The effects in the nursing infant are unknown.

Due to potential effects in the nursing infant, such as immunosuppression, neutropenia, growth retardation, and possible carcinogenesis, cyclosporine is not recommended during lactation. Cyclosporine use during lactation is considered contraindicated by the American Academy of Pediatrics. Some formulations of cyclosporine contain ethanol. Ethanol will be present in human milk at levels similar to that found in maternal serum and if present in breast milk will be orally absorbed by a nursing infant. However, some investigators have suggested that women on cyclosporine may breast-feed, challenging the conventional view that cyclosporine is contraindicated during breast-feeding. One study of five mother-infant pairs reported a wide range of infant exposures to the drug in milk, noting that one of the infants had therapeutic blood concentrations of cyclosporine despite relatively low concentrations of the drug in the milk. It was not known if this was a transient phenomenon caused by immaturity of the enzyme system in the neonate. No clinically evident adverse events were noted in any of the infants. Another case has been reported of a woman who exclusively breast-fed her infant during the first 10.5 months of life while she was being treated with cyclosporine. Cyclosporine measurements in infant and maternal blood and breast milk have been reported to have revealed a mean breast milk/maternal blood level ratio of 84%, but undetectable levels in the infant. The infant was reported to have grown and developed normally. Another case examined blood cyclosporine levels in an infant who was breastfed exclusively for six months by the 19 year old mother taking cyclosporine 4.8 mg/kg/day for plaque psoriasis. The authors concluded that cyclosporine was not found in detectable amounts in the infant's blood. No clinically evident adverse effects were observed in the infant after 12 months and the infant's growth and development were normal.

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