Miltefosine Pregnancy and Breastfeeding Warnings
Miltefosine is also known as: Impavido
Medically reviewed by Drugs.com. Last updated on Jun 15, 2020.
Miltefosine Pregnancy Warnings
Animal studies have revealed embryo-fetal toxicity including death and teratogenicity. Animal studies, have also shown evidence of impaired fertility and reduced viable sperm counts. There are no controlled data in human pregnancy.
This drug is contraindicated in pregnant women.
US FDA pregnancy category: D
Comments: Use of adequate methods of contraception should be advised during therapy and for 5 months after therapy.
US FDA pregnancy category D: There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.
Miltefosine Breastfeeding Warnings
A decision should be made whether to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother.
Breastfeeding should be avoided for 5 months after therapy.
Excreted into human milk: Unknown
Excreted into animal milk: Data not available
References for pregnancy information
- "Product Information. Impavido (miltefosine)." Paladin Therapeutics Inc, Wilmington, DE.
References for breastfeeding information
- "Product Information. Impavido (miltefosine)." Paladin Therapeutics Inc, Wilmington, DE.
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Further information
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