SPL Set ID: e8f6d534-115c-440e-bdbb-b443a29bb468
1 drug(s) with this SPL Set ID
YUTREPIA contains treprostinil sodium, a prostacyclin mimetic. The chemical name for tresprostinil sodium is 2-{[(1R,2R,3aS,9aS)-2-hydroxy-1-[(3S)-3-hydroxyoctyl]-1H,2H,3H,3aH,4H,9H,9aH-cyclopenta[b]naphthalen-5-yl]oxy}acetic acid, sodium salt with the structural formula: Treprostinil sodium has a molecular formula of C 23 H 33 O 5 Na and a molecular weight of 412.49 daltons equivalent to 390.5 daltons of Treprostinil. YUTREPIA inhalation powder contained in a capsule is intended for oral inhalation. The capsule contains white to off-white powder of treprostinil sodium and the inactive ingredients L-leucine, polysorbate 80, sodium chloride, sodium citrate, and trehalose. Each 5 mg of YUTREPIA inhalation powder contains 26.5 mcg of treprostinil, where 26.5 mcg of treprostinil is equivalent to 28 mcg of treprostinil sodium. The accompanying inhalation device for delivery of YUTREPIA inhalation powder is a disposable plastic device used to inhale the dry powder contained in the HPMC capsule. The amount of drug delivered to the lungs will vary depending on patient factors such as inspiratory flow and peak inspiratory flow through the inhalation device, which may vary from patient to patient. Under standardized in vitro testing, the inhalation device delivers the following amounts of treprostinil for each of the YUTREPIA inhalation powder capsule strengths: YUTREPIA Inhalation Powder Delivered Dose a Amount of treprostinil delivered from the device mouthpiece under an in vitro flow rate of 99 L/min with a collection time of 1.2 seconds (2 L total volume). Capsule Strength (treprostinil) Dose Delivered a 26.5 mcg 15.1 mcg 53 mcg 36.0 mcg 79.5 mcg 56.6 mcg 106 mcg 75.7 mcg Structural Formula