Rydapt Use In Pregnancy & Lactation

Women of childbearing potential: Women of childbearing potential should be informed that animal studies show midostaurin to be harmful to the developing foetus. Sexually active women of childbearing potential are advised to have a pregnancy test prior to starting treatment with Rydapt and that they should use effective contraception (methods that result in less than 1% pregnancy rates) when using Rydapt and for at least 4 months after stopping treatment with Rydapt. It is currently unknown whether midostaurin may reduce the effectiveness of hormonal contraceptives, and therefore women using hormonal contraceptives should add a barrier method of contraception.
Pregnancy: Midostaurin can cause foetal harm when administered to a pregnant woman. There are no adequate and well-controlled studies in pregnant women. Reproductive studies in rats and rabbits demonstrated that midostaurin induced foetotoxicity (see Pharmacology: Toxicology: Preclinical safety data under Actions). Rydapt is not recommended during pregnancy or in women of childbearing potential not using contraception. Pregnant women should be advised of the potential risk to the foetus.
Breast-feeding: It is unknown whether midostaurin or its active metabolites are excreted in human milk. Available animal data have shown that midostaurin and its active metabolites pass into the milk of lactating rats. Breast-feeding should be discontinued during treatment with Rydapt and for at least 4 months after stopping treatment.
Fertility: There are no data on the effect of Rydapt on human fertility. Animal studies with midostaurin have shown impaired fertility (see Pharmacology: Toxicology: Preclinical safety data under Actions).