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The Stability of Remodulin® (treprostinil) Injection Combined with Intravenous Medications in Normal Saline

Erick Borg

Susan Steinbis

Michael Scannell

Chad Messick

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Conference: 2017 PH Professional Network Symposium

Release Date: 10.06.2017

Presentation Type: Abstracts

File Download: 2017 PHPN Abstract 1033

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Abstract presented at the 2017 PH Professional Network Symposium held in Bethesda, MD on October 5-7, 2017

Purpose

To evaluate the chemical stability of treprostinil individually mixed with twelve intravenous (IV) medications in normal saline.

Background

Treprostinil is a prostacyclin analogue approved in the United States for the treatment of World Health Organization Group 1 pulmonary arterial hypertension (PAH). Patients with PAH and patients in clinical trials (e.g., neonates with persistent pulmonary hypertension of the newborn) treated with IV treprostinil in the hospital setting may be acutely ill or experience additional comorbidities requiring concomitant utilization of other IV medications. Lack of data demonstrating the chemical stability of treprostinil with other IV medications complicates the ability of healthcare teams to make decisions regarding co-administration.

Methods

Treprostinil and twelve IV medications (i.e., dexmedetomidine, dobutamine, dopamine, epinephrine, fentanyl, furosemide, heparin, midazolam, milrinone, morphine, norepinephrine, and vasopressin) were diluted with normal saline to low and high concentrations (unless otherwise noted) and combined. Combined medication solutions were stored at ambient conditions (20 to 23◦C) and concentrations were analyzed at t=0, t=18, and t=24 hours (and t=52 hours with heparin). Stability was defined as not less than 90% and not more than 110% of initial medication concentrations and no visible precipitation or color change.

Results

Chemical stability results of tested solutions are outlined in Table 1.

Conclusion

This study demonstrated the chemical stability of treprostinil individually mixed at low and high concentrations (unless otherwise noted) with: dopamine (low concentrations) at 18 hours; dexmedetomidine, dobutamine, fentanyl, furosemide, midazolam, milrinone, morphine, norepinephrine, and vasopressin (one concentration tested) at 24 hours; and heparin (one concentration tested) at 52 hours. A variety of diluents may be utilized when preparing treprostinil for IV infusion (e.g., Sterile Diluent for Remodulin, Sterile Diluent for Flolan, sterile water for injection, and 0.9% Sodium Chloride for injection). This study utilized normal saline as a diluent and samples were stored at ambient conditions. Additional studies should be considered to determine the chemical stability of treprostinil and these medications when mixed with other diluents and stored at higher temperatures.