Paclitero Use In Pregnancy & Lactation



Hetero Labs


Full Prescribing Info
Use In Pregnancy & Lactation
Use in Pregnancy: There are very limited data on the use of paclitaxel in human pregnancy. Paclitaxel is suspected to cause serious birth defects when administered during pregnancy. Paclitaxel has been shown to be both embryotoxic and foetotoxic in rabbits, and to reduce fertility in rats. As with other cytotoxic medicinal products, paclitaxel may cause fetal harm when administered to pregnant women. Therefore, paclitaxel should not be used during pregnancy unless clearly necessary. Also Paclitaxel should not be used in women of childbearing potential not using effective contraception, unless the clinical condition of the mother requires treatment with paclitaxel.
Women of childbearing potential should use effective contraception during and up to 6 months after receiving treatment with Paclitaxel.
Male patients treated with paclitaxel are advised not to father a child during and up to six months after treatment.
Use in Lactation: Paclitaxel is contraindicated during lactation (refer to Contraindications). It is not known whether paclitaxel excreted in human breast milk. Studies in animals have shown transfer of paclitaxel into milk. Breastfeeding should be discontinued for the duration of therapy.
Fertility: Paclitaxel induced infertility in male rats (refer to Pharmacology: Toxicology: Preclinical safety data under Actions). The relevance for humans is unknown. Male patients should seek advice regarding cryoconservation of sperm prior to treatment with paclitaxel because of the possibility of irreversible infertility.
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