AHFS Class:

48:48.28 Prostacyclin and Prostacyclin Derivatives

Treprostinil sodium injection is available in concentrations equivalent to treprostinil 1, 2.5, 5, 10, and 20 mg/mL in 20-mL multiple- use vials.³⁸⁴³ Each mL also contains sodium chloride 5.3 mg (except the 10- and 20-mg/mL concentrations which contain 4 mg), metacresol 3 mg, and sodium citrate 6.3 mg in water for injection.³⁸⁴³ Sodium hydroxide and/or hydrochloric acid may have been added to adjust the pH.³⁸⁴³

A 50-mL vial containing diluent for treprostinil (a high-pH glycine diluent) is available separately.³⁸⁴³ Each 50-mL vial of diluent for treprostinil contains glycine 94 mg, sodium chloride 73.3 mg, and sodium hydroxide for pH adjustment in water for injection.³⁸⁴³

pH

From 6.0 to 7.2.³⁸⁴³

The diluent for treprostinil has a pH of approximately 10.4.³⁸⁴³

Trade Name(s)

Remodulin

Treprostinil sodium injection is preferably administered by continuous subcutaneous infusion using an infusion pump designed for subcutaneous administration.³⁸⁴³

Alternatively, if subcutaneous infusion is not tolerated, the drug may be administered by intravenous infusion via a central venous catheter using an external or implantable intravenous infusion pump.³⁸⁴³ Intravenous infusion sets with an inline 0.22-µm filter should be used for administration.³⁸⁴³ If a central venous catheter is not available, treprostinil sodium injection may be temporarily administered by intravenous infusion through a peripheral, preferably large, vein; however infusion through a peripheral vein for more than a few hours increases the risk of thrombophlebitis.³⁸⁴³

For subcutaneous or intravenous infusion, treprostinil sodium may be diluted in sterile water for injection, sodium chloride 0.9%, or a high-pH glycine diluent (e.g., diluent for treprostinil, diluent for epoprostenol).³⁸⁴³

Subcutaneous or intravenous infusion pumps used to administer treprostinil sodium must have a reservoir made of polypropylene, polyvinyl chloride, or glass.³⁸⁴³

Intact vials of treprostinil sodium should be stored at 25°C with excursions permitted from 2 to 30°C.³⁸⁴³ After initial entry, vials should be used for no more than 30 days.³⁸⁴³ During administration, undiluted treprostinil sodium is stable for up to 16 weeks at 40°C.³⁸⁴³

Treprostinil sodium diluted with sterile water for injection or sodium chloride 0.9% may be stored for up to 4 hours at room temperature or for 24 hours refrigerated.³⁸⁴³ During administration, diluted solutions are stable for up to 48 hours at 40°C.³⁸⁴³

Treprostinil sodium diluted with a high-pH glycine diluent (e.g., diluent for treprostinil) to concentrations as low as 0.004 mg/mL (4000 ng/mL) is stable at room temperature for up to 14 days.³⁸⁴³ During administration, diluted solutions are stable for up to 48 hours at 40°C.³⁸⁴³

Intact vials of diluent for treprostinil should be stored at controlled room temperature.³⁸⁴³

Using proper technique to penetrate the vial stopper with a needle, limiting the number of punctures of a vial stopper to 10, and using a Clave Connector Multidose Vial Adapter were shown to reduce the amount of particulate matter from the stopper that was found upon multiple-day use of treprostinil sodium 1- and 10-mg/mL vials and to be within the USP limit for such particulate matter over the 30-day test period. No loss of treprostinil sodium occurred during this period as well. Improper needle technique and numerous stopper penetrations were found to result in unacceptable particulate matter from the vial stopper.²⁶¹¹

Filtration

Treprostinil sodium injection should be administered through infusion sets with an inline 0.22-µm filter.³⁸⁴³

Syringes

The chemical and physical stability of undiluted treprostinil sodium (United Therapeutics) 1, 2.5, 5, and 10 mg/mL was evaluated packaged in 3-mL MiniMed plastic syringe pump reservoirs sealed with plastic tip caps. The samples were stored at 37, 23, 4, and -20°C for 60 days. The samples were clear and colorless, and treprostinil was stable at all four storage temperatures, exhibiting concentrations of 95% or more over 60 days.²⁵²⁸

Solution Compatibility

Y-Site Injection Compatibility (1:1 Mixture)

For a list of references cited in the text of this monograph, search the monograph titled References.

ASHP^® Injectable Drug Information^TM. Selected Revisions January 10, 2024. © Copyright, 2024. American Society of Health-System Pharmacists^®, 4500 East-West Highway, Suite 900, Bethesda, Maryland 20814.