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Treprostinil Pregnancy and Breastfeeding Warnings

Treprostinil is also known as: Orenitram, Remodulin, Tyvaso

Medically reviewed on Sep 19, 2018

Treprostinil Pregnancy Warnings

This drug should be used during pregnancy only if clearly needed.

AU TGA pregnancy category: B3
US FDA pregnancy category: C (tablets); B (oral inhalation); Not assigned (parenteral)

Risk Summary: Insufficient data exists to inform a drug-associated risk of adverse developmental outcomes.

Animal studies in pregnant rats have failed to reveal evidence of teratogenicity at higher doses when administered by continuous subcutaneous infusion during organogenesis and late gestational development. Animal studies in pregnant rabbits have revealed evidence of increased fetal skeletal variations (bilateral full rib or rudimentary right rib on lumbar 1) at doses that produced maternal toxicity. Animal studies with the extended-release tablets revealed dose-dependent decreases in body weight gain and food consumption as well as increased post-implantation loss, decreased pregnancy rates, and fetal skeletal malformations at higher doses. Animal reproduction studies with the inhalation formulation have not been conducted. There are no controlled data in human pregnancy.

AU TGA pregnancy category B3: Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed. Studies in animals have shown evidence of an increased occurrence of fetal damage, the significance of which is considered uncertain in humans.

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.

US 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.

US FDA pregnancy category Not Assigned: The US FDA has amended the pregnancy labeling rule for prescription drug products to require labeling that includes a summary of risk, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy. Pregnancy categories A, B, C, D, and X are being phased out.

See references

Treprostinil Breastfeeding Warnings

Use with caution; according to some authorities, use is not recommended.

Excreted into human milk: Unknown
Excreted into animal milk: Unknown

Comments: The effects in the nursing infant are unknown.

See references

References for pregnancy information

  1. "Product Information. Tyvaso (treprostinil)." United Therapeutics Corporation, Silver Spring, MD.
  2. "Product Information. Orenitram (treprostinil)." United Therapeutics Corporation, Silver Spring, MD.
  3. "Product Information. Remodulin (treprostinil)." United Therapeutics Corp, Silver Spring, MD.
  4. Cerner Multum, Inc. "Australian Product Information." O 0

References for breastfeeding information

  1. "Product Information. Remodulin (treprostinil)." United Therapeutics Corp, Silver Spring, MD.
  2. "Product Information. Tyvaso (treprostinil)." United Therapeutics Corporation, Silver Spring, MD.
  3. "Product Information. Orenitram (treprostinil)." United Therapeutics Corporation, Silver Spring, MD.
  4. Cerner Multum, Inc. "Australian Product Information." O 0
  5. United States National Library of Medicine "Toxnet. Toxicology Data Network. Available from: URL: http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT." ([cited 2013 -]):

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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