Abraxane Use In Pregnancy & Lactation

Contraception in males and females: Women of childbearing potential should use effective contraception during treatment and up to 1 month after receiving treatment with Abraxane. Male patients treated with Abraxane are advised to use effective contraception and to avoid fathering a child during and up to six months after treatment.
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. Studies in animals have shown reproductive toxicity (see Pharmacology: Toxicology under Actions). Women of childbearing potential should have a pregnancy test prior to starting treatment with Abraxane. Abraxane should not be used in pregnancy, and in women of childbpotential not using effective contraception, unless the clinical condition of the mother requires treatment with paclitaxel.
Breast-feeding: Paclitaxel and/or its metabolites w ere excreted into the milk of lactating rats (see Pharmacology: Toxicology: Preclinical safety data under Actions). It is not known if paclitaxel is excreted in human milk. Because of potential serious adverse reactions in breast-feeding infants, Abraxane is contraindicated during lactation. Breast-feeding must be discontinued for the duration of therapy.
Fertility: Abraxane induced infertility in male rats (see Pharmacology: Toxicology: Preclinical safety data under Actions). Based on findings in animals, male and female fertility may be compromised. Male patients should seek advice on conservation of sperm prior to treatment because of the possibility of irreversible infertility due to therapy with Abraxane.