Treprostinil use while Breastfeeding

Summary of Use during Lactation

The amount of treprostinil in milk appears to be low and it is not well absorbed orally. Two infants have been breastfed during maternal treprostinil therapy, one infant for one year, without any complications. However, until more data are available, treprostinil should be used with careful infant monitoring during breastfeeding.

Drug Levels

Maternal Levels. A woman with pulmonary arterial hypertension received treprostinil by continuous infusion in a dose of 30 ng/kg per minute (2,352 ng/min), for 10 days postpartum. A milk sample taken at that time contained no detectable treprostinil (<0.05 mcg/L). The milk sample was frozen at -80 degrees C, which was subsequently found to reduce the concentration of treprostinil in milk by 16 to 18%. The average maternal serum concentration at that time was 2.2 mcg/L and unaffected by freezing. Treprostinil was changed to the subcutaneous route at the same dose and at 7 weeks postpartum, the average treprostinil concentration in milk that was immediately assayed and not frozen was 1.02 mcg/L and serum the average serum level was 5.65 mcg/L.[1] Using the standard milk ingestion of 150 mL/kg daily, the relative infant dose would be 0.35%. Additionally, the oral bioavailability of treprostinil is only about 17%, for an effective RID of 0.06%.

Infant Levels. Relevant published information was not found as of the revision date.

Effects in Breastfed Infants

A woman developed pulmonary artery hypertension and was treated with intravenous treprostinil beginning at 32 weeks of gestation and titrated up to 26 ng/kg/min. The dose was nearly doubled postpartum because of worsening symptoms. She breastfed (extent not stated) her infant for one year with no apparent drug-related problems, although there was concern for obesity at 6 months of age. The infant was healthy and developing normally at 2 years of age.[2]

A woman with pulmonary arterial hypertension initially received treprostinil by continuous infusion and then by subcutaneous injection in a dose of 30 ng/kg per minute (2,352 ng/min). She partially (extent not stated) breastfed her infant and at 7 weeks postpartum, no adverse effects were reported in her infant.[1]

Effects on Lactation and Breastmilk

Relevant published information was not found as of the revision date.

Alternate Drugs to Consider

(Pulmonary Artery Hypertension) Bosentan, Epoprostenol, Nitric Oxide, Sildenafil

References

1.

Leary PJ, Koehn J, Barros LM, et al. Breastfeeding on treprostinil: New data, lingering questions. Eur Respir J 2025. [PubMed: 40268507]

2.

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. doi:10.1016/j.healun.2012.01.862 [CrossRef]

Substance Name

Treprostinil

CAS Registry Number

81846-19-7

Drug Class

Breast Feeding

Lactation

Milk, Human

Antihypertensive Agents

Cardiovascular Agents

Prostaglandins

Vasodilator Agents