Generic Gengraf

CYCLOSPORINE
(Sandimmune)
Cyclosporine is a cyclic polypeptide of fungal origin. It is used as an immunosuppressant in the prevention and treatment of allograft rejection and also in the treatment of some autoimmune disorders. The usual oral dose is 5-10 mg/kg of body weight per day, although up to 25 mg/kg/d may be used immediately preceding or following transplantation and somewhat smaller doses may be given intravenously.

Teratogenic Risk
Magnitude of teratogenic risk to child born after exposure during gestation:
Malformations: Minimal
Fetal growth retardation: Small to moderate
Quality and quantity of data on which risk estimate is based:
Malformations: Fair
Fetal growth retardation: Fair
Women who are treated with cyclosporine during pregnancy have serious medical problems and often are treated with other medications concomitantly. It is impossible to separate the effects of cyclosporine from the effects of other medication and maternal illness in available human studies of cyclosporine teratogenicity.
It is unclear whether the growth retardation and malformations that have been reported in infants born to women treated with cyclosporine during pregnancy are manifestations of the same or different pathogenic processes.

More than 200 pregnancies have been reported among women who were treated with cyclosporine, often in combination with other drugs, throughout pregnancy. It is impossible to determine what the total number of reported cases is because the series overlap. Most of the reports are of single cases or small groups of cases, and many are not described in sufficient detail to interpret fully.
Congenital anomalies have been described in at least 13 children of women who were treated with cyclosporine during pregnancy, but no recurrent pattern of anomalies has been noted. It is impossible to determine which, if any, of the reported malformations are related to the maternal cyclosporine therapy.
Most children born to women treated with cyclosporine during pregnancy do not have malformations, but few cases have been followed beyond infancy. Malformations were observed in only two of 107 newborns of renal transplant recipients treated with cyclosporine during pregnancy and reported to the National Transplantation Pregnancy Register. In another group of 21 children born to women who had been treated with cyclosporine and other immunosuppressants during pregnancy because of a previous organ transplant, there were two infants with major congenital anomalies and unexpectedly high rates of fetal growth retardation and prematurity. No malformations were observed among the infants of 23 female heart transplant recipients who were treated with cyclosporine during pregnancy in another series.
Fetal growth retardation and prematurity are unusually frequent among the children of women treated with cyclosporine during pregnancy, but these appear to be related, at least in part, to the mothers' underlying illnesses or other aspects of their treatment. Of 137 live-born infants of renal transplant recipients reported to the National Transplantation Pregnancy Register who were treated with cyclosporine during pregnancy, 54% were premature ( There was no evidence of nephrotoxicity in 26 children followed in one study to an average age of 39 months after their birth to women who were treated with cyclosporine during pregnancy.
Transient neonatal thrombocytopenia, neutropenia, and lymphopenia have occasionally been reported in the infants of women treated with cyclosporine during pregnancy. Lower than expected numbers of B-lymphocytes were found in the cord blood of six infants whose mothers had been treated with cyclosporine and other immunosuppressive agents during pregnancy. This deficiency of B-cells persisted for at least the first six months of life in most cases. No abnormality of immunological function was found among five one- to six-year-old children whose mothers had been treated with cyclosporine during pregnancy in another series, but these children did exhibit a slight delay in T-cell development.
Alterations of immunological function have been observed among the offspring of pregnant mice treated with cyclosporine in doses similar to those used therapeutically in humans. Studies in rats, mice, and rabbits suggest that treatment of pregnant women with cyclosporine in usual therapeutic doses is unlikely to increase the children's risk of malformations greatly. Fetal growth retardation and death were increased in all of these species at doses at or just above the maximum used therapeutically in humans; such doses were often toxic to the mothers as well.

Risk Related to Breast-feeding
Cyclosporine is excreted into breast milk in low concentrations. The amount of cyclosporine that the nursing infant would be expected to ingest is GENERAL HEALTH

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