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Netupitant / palonosetron Pregnancy and Breastfeeding Warnings

Netupitant / palonosetron is also known as: Akynzeo

Netupitant / palonosetron Pregnancy Warnings

There are no controlled data in human pregnancy. -Netupitant: Animal studies have shown varying results. In studies with pregnant rats, there were no effects on embryo-fetal development, no adverse effects in the offspring, and no effects on fertility or reproductive performance following daily administration of doses up to 3.7 times the human AUC at the recommended human dose. However, studies with pregnant rabbits revealed an increased incidence of external and skeletal fetal abnormalities, reduced fetal weight, and maternal toxicity following daily administration of doses at least 0.2 times the human AUC. -Palonosetron: Animal studies in rats revealed no effects on embryo-fetal development, fertility, or reproductive performance in rats at oral doses up to 921 times the recommended human oral dose. Embryo-fetal development was also not affected in rabbits administered oral doses up to 1841 times the recommended human oral dose. US FDA pregnancy category C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

Benefit should outweigh risk US FDA pregnancy category: C

See references

Netupitant / palonosetron Breastfeeding Warnings

A decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother. Excreted into human milk: Unknown Excreted into animal milk: Data not available Comments: The effects in the nursing infant are unknown.

See references

References for pregnancy information

  1. "Product Information. Akynzeo (netupitant-palonosetron)." Eisai Inc, Woodcliff Lake, NJ.

References for breastfeeding information

  1. "Product Information. Akynzeo (netupitant-palonosetron)." Eisai Inc, Woodcliff Lake, NJ.

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