Ikervis Use In Pregnancy & Lactation

Women of childbearing potential/contraception in females: IKERVIS is not recommended in women of childbearing potential not using effective contraception.
Pregnancy: There is no data from the use of IKERVIS in pregnant women.
Studies in animals have shown reproductive toxicity following systemic administration of ciclosporin at exposure considered sufficiently in excess of the maximum human exposure indicating little relevance to the clinical use of IKERVIS.
IKERVIS is not recommended during pregnancy unless the potential benefit to the mother outweighs the potential risk to the foetus.
Breast-feeding: Following oral administration, ciclosporin is excreted in breast milk.
There is insufficient information on the effects of ciclosporin in newborns/infants.
However, at therapeutic doses of ciclosporin in eye drops, it is unlikely that sufficient amounts would be present in breast milk. A decision must be made whether to discontinue breastfeeding or to discontinue/abstain from IKERVIS therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
Fertility: There is no data on the effects of IKERVIS on human fertility.
No impairment of fertility has been reported in animals receiving intravenous ciclosporin (see Pharmacology: Toxicology: Preclinical safety data under Actions).