Sandimmun/Sandimmun Neoral Use In Pregnancy & Lactation

Animal studies have shown reproductive toxicity in rats and rabbits (see Pharmacology: Toxicology: Preclinical data under Actions).
There are limited data on the use of Sandimmun/Sandimmun Neoral in pregnant women. Pregnant women receiving immunosuppressive therapies after transplantation, including ciclosporin and ciclosporin-containing regimens, are at increased risk of premature delivery (< 37 weeks).
A limited number of observations in children exposed to ciclosporin in utero is available, up to an age of 7 years (data collected in 12 children). Renal function and blood pressure in these children were normal.
Based on the data available, Sandimmun should not be used during pregnancy unless the expected benefit outweighs the potential risk.
Ciclosporin passes into the breast milk. As Sandimmun/Sandimmun Neoral can lead to severe adverse effects in breastfed infants, women being treated with Sandimmun/Sandimmun Neoral should not breastfeed.
Sandimmun Neoral: The ethanol content of Sandimmun Neoral oral solution should also be taken into account in pregnant women (see Precautions).