Linadex Use In Pregnancy & Lactation

Due to the teratogenic potential, Lenalidomide must be prescribed under a Pregnancy Prevention Program, unless there is reliable evidence that the patient does not have childbearing potential.
a. Women of childbearing potential/Contraception in males and females: Women of childbearing potential should use effective method of contraception. If pregnancy occurs in a woman treated with Lenalidomide, treatment must be stopped and the patient should be referred to a physician specialised or experienced in teratology for evaluation and advice. If pregnancy occurs in a partner of a male patient taking Lenalidomide, it is recommended to refer the female partner to a physician specialised or experienced in teratology for evaluation and advice.
Lenalidomide is present in human semen at extremely low levels during treatment and is undetectable in human semen 3 days after stopping the substance in the healthy subject. As a precaution, and taking into account special populations with prolonged elimination time such as renal impairment, all male patients taking lenalidomide should use condoms throughout treatment duration, during dose interruption and for 1 week after cessation of treatment if their partner is pregnant or of childbearing potential and has no contraception.
b. Pregnancy: Lenalidomide is structurally related to thalidomide. Thalidomide is a known human teratogenic active substance that causes severe life-threatening birth defects.
c. Breast-feeding: It is not known whether lenalidomide is excreted in human milk. Therefore breast-feeding should be discontinued during therapy with lenalidomide.
d. Fertility: A fertility study in rats with lenalidomide produced no adverse effects on fertility and no parental toxicity.