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Pregnancy: HPCT is contraindicated in pregnant women; therefore, Busulfex is contraindicated during pregnancy. Busulfan may cause fetal harm when administered to a pregnant woman. Busulfex should not be administered to pregnant women or women who may possibly be pregnant.
Studies in animals have shown reproductive toxicity (embryo-fetal lethality and malformations). (See Pharmacology: Toxicology: Preclinical safety data under Actions.)
There are no or limited amount of data from the use of busulfan or DMA in pregnant women. A few cases of congenital abnormalities have been reported with low-dose oral busulfan, not necessarily attributable to the active substance, and third trimester exposure may be associated with impaired intrauterine growth.
Women of childbearing potential: Women of childbearing potential have to use effective contraception during and up to 6 months after treatment.
Breast-feeding: It is unknown whether busulfan and DMA are excreted in human milk. Because of the potential for tumorigenicity shown for busulfan in human and animal studies, breast-feeding should be discontinued during treatment with busulfan.
Fertility: Busulfan and DMA can impair fertility in man or woman. Therefore it is advised not to father child during the treatment and up to 6 months after treatment and to seek advice on cryo-conservation of sperm prior to treatment because of the possibility of irreversible infertility (see Precautions). Busulfan may cause temporary or permanent infertility in females.
