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VELETRI® (epoprostenol)

Medical Information

VELETRI - Preparation and Stability of ≥3000 to <15,000 ng/mL Epoprostenol Solutions Derived From Vials Containing 1.5 mg Epoprostenol for Infusion

Last Updated: 09/04/2026

SUMMARY

Epoprostenol solutions diluted to final concentrations of ≥3000 to <15,000 ng/mL must be prepared using VELETRI for infusion vials containing 0.5 mg epoprostenol.¹
In the event that epoprostenol solutions diluted to final concentrations of >3000 to <15,000 ng/mL need to be prepared using VELETRI for infusion vials containing 1.5 mg epoprostenol (Table: Preparation of ≥3000 to <15,000 ng/mL Epoprostenol Solutions From Vials Containing 1.5 mg Epoprostenol for Infusion), these solutions will have a shorter duration of use compared with corresponding solutions made using 0.5 mg vials. This is because the increased dilution factor with the 1.5 mg vial results in a lower pH, which in turn reduces the stability of VELETRI.²^,³
Epoprostenol solutions diluted to final concentrations of ≥3000 to <15,000 ng/mL that have been prepared using 1.5 mg epoprostenol for infusion vials can be stored at 2°-8°C for 24 hours, following which they can be stored at 25°C for 24 hours.³

CLINICAL DATA

An in-house study has been performed to test the stability of ≥3000 ng/mL to <15,000 ng/mL epoprostenol solutions when prepared from vials containing 1.5 mg epoprostenol for infusion. Relevant information from this study and the conclusions that can be drawn from it are summarized below.³

Preparation of Epoprostenol Solutions Diluted to Final Concentrations of ≥3000 and <15,000 ng/mL Using Vials Containing 1.5 mg Epoprostenol for Infusion

Examples of reconstitution and dilution procedures for preparing epoprostenol solutions diluted to final concentrations of ≥3000 to <15,000 ng/mL prepared using vials containing 1.5 mg epoprostenol for infusion are outlined in Table: Preparation of ≥3000 to <15,000 ng/mL Epoprostenol Solutions From Vials Containing 1.5 mg Epoprostenol for Infusion.²^,³

Preparation of ≥3000 to <15,000 ng/mL Epoprostenol Solutions From Vials Containing 1.5 mg Epoprostenol for Infusion²^,³

Final Epoprostenol Concentration	Directions
3000 ng/mL	Reconstitute 1 vial containing 1.5 mg of epoprostenol for infusion with 5 mL of WFI or 0.9% NaCl. Withdraw 1 mL of the obtained solution. Fill the withdrawn solution in 100 mL infusion cassette and bring to final volume with WFI or 0.9% NaCl.
5000 ng/mL	Reconstitute 1 vial containing 1.5 mg of epoprostenol for infusion with 5 mL of WFI or 0.9% NaCl. Withdraw 1.7 mL of the obtained solution. Fill the withdrawn solution in 100 mL infusion cassette and bring to final volume with WFI or 0.9% NaCl.
10,000 ng/mL	Reconstitute 1 vial containing 1.5 mg of epoprostenol for infusion with 5 mL of WFI or 0.9% NaCl. Withdraw 3.4 mL of the obtained solution. Fill the withdrawn solution in 100 mL infusion cassette and bring to final volume with WFI or 0.9% NaCl.
Abbreviations: NaCl, sodium chloride; WFI, water for injection.

In the event that epoprostenol solutions diluted to final concentrations of ≥3000 to <15,000 ng/mL are prepared using vials containing 1.5 mg epoprostenol for infusion, these solutions will have a shorter maximum duration of use than corresponding solutions made using 0.5 mg vials. This is because the increased dilution factor with the 1.5 mg vial results in a lower pH, which in turn reduces the stability of VELETRI.²

The results of the in-house stability study indicate the following:

Epoprostenol solutions diluted to final concentrations of ≥3000 to <15,000 ng/mL that have been prepared using 1.5 mg epoprostenol for infusion vials can be stored at 2°-8°C for 24 hours, following which they can be stored at 25°C for 24 hours.³

Literature Search

A literature search of MEDLINE^®, Embase^®, BIOSIS Previews^®, and Derwent Drug File (and/or other resources, including internal/external databases) pertaining to this topic was conducted on 30 May 2025.

References

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1	Data on File. Epoprostenol for infusion 2 CCDS, version 6. Actelion Pharmaceuticals Ltd. EDMS-ERI-205912254; 2020.
2	Data on File. Techincal memo: VELETRI - preparation of solution for infusion with concentration between 3,000 ng/mL and 15,000 ng/mL. Actelion Pharmaceuticals Ltd; 2020.
3	Data on File. Stability report. In-use stability testing including mixed storage conditions of 3 µg/mL solutions prepared from 1.5 mg/vial epoprostenol for injection EFI2. Actelion Pharmaceuticals Ltd. SR23-02A; 2012.

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