Antiemetic
PREGNANCY RECOMMENDATION: No Human Data—Animal Data Suggest Low Risk
BREASTFEEDING RECOMMENDATION: No Human Data—Probably Compatible
PREGNANCY SUMMARY
Summary: No reports describing the use of dolasetron during human pregnancy have been located. Among other agents with similar mechanisms of actions and indications (see Granisetron and Ondansetron), only ondansetron has published human pregnancy experience. Based on this experience and the lack of embryo–fetal toxicity in two animal species, dolasetron appears to represent minimal, if any, risk to a human fetus.
FETAL RISK SUMMARY
Dolasetron is a specific and selective serotonin subtype 3 (5-HT3) receptor antagonist that is used for the treatment and prevention of nausea and vomiting in the postoperative period and after chemotherapy. The drug has no effect on plasma prolactin levels (1).
Dolasetron had no effect on fertility and reproductive performance in female rats at doses up to 8 times the recommended human dose based on BSA (RHD) or in male rats at doses up to 32 times the RHD. No evidence of impaired fertility or fetal harm was observed in pregnant rats and rabbits at oral doses up to 8 and 16 times, respectively, the RHD (1). In 24-month carcinogenicity studies, there was a dose-related significant increase in combined hepatocellular adenomas and carcinomas in male mice, but not in female mice or in male and female rats. No mutagenicity was observed in various tests (1).
It is not known if dolasetron crosses the human placenta. The molecular weight of the free base (about 325 for the free base) is low enough that transfer to the fetus should be expected.
BREASTFEEDING SUMMARY
No reports describing the use of dolasetron in human lactation have been located. The molecular weight (about 325 for the free base) is low enough that excretion into breast milk should be expected. The effect of this exposure on a nursing infant is unknown.
Reference
1.Product information. Anzemet. Aventis Pharmaceuticals, 2001.