Treprostinil Pregnancy and Breastfeeding Warnings
Treprostinil Pregnancy Warnings
Oral formulation: FDA pregnancy category C Infusion or inhalation: FDA pregnancy category B Potential benefit should outweigh the potential risk.
Oral formulation: Animal reproductive studies have shown an adverse effect on the fetus. Infusion or inhalation: Studies in rats have failed to reveal evidence of fetotoxicity or teratogenicity. An increased incidence of fetal skeletal variations associated with maternal toxicity were reported in rabbit studies (at 41 times the human starting dose). There are no controlled data in human pregnancy. FDA pregnancy category B: Animal reproduction studies have failed to demonstrate a risk to the fetus and there are no adequate and well-controlled studies in pregnant women. 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.
Treprostinil Breastfeeding Warnings
Oral formulation: A decision should be made to discontinue breast-feeding or discontinue the drug, taking into account the importance of the drug to the mother. Infusion or inhalation: Caution is recommended. Excreted into human milk: Unknown The effects in the nursing infant are unknown.
References for breastfeeding information
- "Product Information. Remodulin (treprostinil)." United Therapeutics Corp, Silver Spring, MD.
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