The Basics
What is Treprostinil?
Used for the treatment of pulmonary arterial hypertension.
Brand names for Treprostinil
Remodulin
How Treprostinil is classified
Antihypertensive Agents, Prostaglandins
Treprostinil During Pregnancy
Treprostinil pregnancy category
Category BNote that the FDA has deprecated the use of pregnancy categories, so for some medications, this information isn’t available. We still think it’s useful to list historical info, however, given what a common proxy this has been in the past.
What we know about taking Treprostinil while pregnant
Limited case reports of treprostinil use in pregnant women are insufficient to inform a drug-associated risk of adverse developmental outcomes. However, there are risks to the mother and the fetus associated with pulmonary arterial hypertension (see Clinical Considerations). In animal studies, no adverse reproductive and developmental effects were seen in rats at about 123 and 48 times the human exposure based on Cmax and AUC, respectively. In rabbits, external fetal and soft tissue malformations and skeletal malformations were observed at about 7 and 5 times the human exposure based on Cmax and AUC, respectively (see Data). The estimated background risk of major birth defects and miscarriage for the indicated populations is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.
Taking Treprostinil While Breastfeeding
What are recommendations for lactation if you're taking Treprostinil?
One patient taking treprostinil breastfed her infant for one year without any complications. However, until more data are available, treprostinil should only be used with careful monitoring during breastfeeding.
Maternal / infant drug levels
One patient taking treprostinil breastfed her infant for one year without any complications. However, until more data are available, treprostinil should only be used with careful monitoring during breastfeeding.
Possible effects of Treprostinil on milk supply
Relevant published information was not found as of the revision date.
Possible alternatives to Treprostinil
None listed
List of References
Lactation sources: Drugs and Lactation Database (LactMed) [Internet]. Bethesda (MD): National Library of Medicine (US); 2006-. Available from: https://www.ncbi.nlm.nih.gov/books/NBK501922/1. Franco V, Mueller J, Daniels CJ. Is the use of remodulin safe for pregnant and breastfeeding patients with pulmonary arterial hypertension (PAH)? A case report. J Heart Lung Transplant. 2012;31 (4 Suppl):S71. Abstract 188. DOI: doi:10.1016/j.healun.2012.01.862
Disclaimer: This material is provided for educational purposes only and is not intended for medical advice, diagnosis, or treatment. Consult your healthcare provider with any questions.
