Cipol-N Use In Pregnancy & Lactation

Although there are no adequate and well-controlled studies using cyclosporine in pregnant women, the drug has been shown to be embryotoxic and fetotoxic in rats and rabbits when administered orally at maternally toxic doses.
In women who received cyclosporine therapy throughout pregnancy, premature birth (gestational age of 28-36 weeks) and reduced neonatal weight occurred consistently. Most of the pregnancies also were complicated by growth retardation (which may be severe), fetal loss, preeclampsia, eclampsia, premature labor, abruptio placentae, oligohydramnios, Rh incompatibility, and fetoplacental dysfunction.
Cyclosporine should be used during pregnancy only when the potential benefits justify the possible risks to the fetus. In patients with psoriasis, the risks and benefits of therapy with cyclosporine during pregnancy should be evaluated carefully, with discontinuance of therapy considered seriously because of possible disruption of the interaction between the mother and fetus.
Since cyclosporine is distributed into milk, nursing should be avoided in women receiving the drug.