Yutrepia 53 ug/1
treprostinil · CAPSULE · Liquidia Technologies, Inc.
Yutrepia is a capsule containing treprostinil at 53 ug/1, taken respiratory (inhalation). Manufactured by Liquidia Technologies, Inc..
Key Facts
- Brand Name
- Yutrepia
- Generic Name
- treprostinil
- NDC Code (Product)
72964-012- Manufacturer
- Liquidia Technologies, Inc.
- Strength
- 53 ug/1
- Dosage Form
- CAPSULE
- Route
- RESPIRATORY (INHALATION)
- Marketing Status
- Application #
- NDA213005
- Marketing Start
- 05/23/2025
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE • Pulmonary arterial hypertension (PAH; WHO Group 1) to improve exercise ability. Studies establishing effectiveness predominately included patients with NYHA Functional Class III symptoms and etiologies of idiopathic or heritable PAH (56%) or PAH associated with connective tissue diseases (33%). ( 1.1 ) • Pulmonary hypertension associated with interstitial lung disease (PH-ILD; WHO Group 3) to improve exercise ability. The study establishing effectiveness predominately included patients with etiologies of idiopathic interstitial pneumonia (IIP) (45%) inclusive of idiopathic pulmonary fibrosis (IPF), combined pulmonary fibrosis and emphysema (CPFE) (25%), and WHO Group 3 connective tissue disease (22%). ( 1.2 ) 1.1 Pulmonary Arterial Hypertension YUTREPIA is indicated for the treatment of pulmonary arterial hypertension (PAH; WHO Group 1) to improve exercise ability. Studies establishing effectiveness predominately included patients with NYHA Functional Class III symptoms and etiologies of idiopathic or heritable PAH (56%) or PAH associated with connective tissue diseases (33%). The effects diminish over the minimum recommended dosing interval of 4 hours; tr…
Dosage & Administration
2 DOSAGE AND ADMINISTRATION • For oral inhalation only. Do not swallow YUTREPIA capsules. Use only with the provided inhaler ( 2 ) • YUTREPIA should be administered 3 to 5 times per day. The contents of each capsule can be inhaled in 2 breaths. ( 2.1 ) • See Dosage and Administration for full instructions on dosing of patients who are treprostinil-naïve or transitioning from treprostinil inhalation solution to YUTREPIA ( 2.1 ) 2.1 Usual Dosage In Adults YUTREPIA capsules are for oral inhalation only and should be used only with the supplied inhaler. Do not swallow YUTREPIA capsules. YUTREPIA Dosing in treprostinil-naïve patients : In patients naïve to treprostinil, therapy should begin with 26.5 mcg 3 to 5 times per day, in 2 breaths based on patient response. Dosing in patients transitioning from treprostinil inhalation solution (Tyvaso) : Patients transitioning from treprostinil inhalation solution (Tyvaso), can begin YUTREPIA therapy 3 to 5 times per day, in 2 breaths, using the doses specified below ( Table 1 ): Table 1: YUTREPIA Dosing in Patients Transitioning from Treprostinil Inhalation Solution *Each breath of Tyvaso delivers approximately 6 mcg of treprostinil. Current Ty…
Contraindications
4 CONTRAINDICATIONS None None ( 4 )
Drug Interactions
7 DRUG INTERACTIONS 7.1 Effect of Cytochrome P450 Inhibitors and Inducers In vitro studies of human hepatic microsomes showed that treprostinil does not inhibit cytochrome P450 (CYP) isoenzymes CYP1A2, CYP2A6, CYP2C8, CYP2C9, CYP2C19, CYP2D6, CYP2E1 and CYP3A. Additionally, treprostinil does not induce cytochrome P450 isoenzymes CYP1A2, CYP2B6, CYP2C9, CYP2C19, and CYP3A. Human pharmacokinetic studies with an oral formulation of treprostinil (treprostinil diolamine) indicated that co-administration of the cytochrome P450 (CYP) 2C8 enzyme inhibitor gemfibrozil increases exposure (both C max and AUC) to treprostinil. Co-administration of the CYP2C8 enzyme inducer rifampin decreases exposure to treprostinil. It is unclear if the safety and efficacy of treprostinil by the inhalation route are altered by inhibitors or inducers of CYP2C8 [see Warnings and Precautions ( 5.3 )] . 7.2 Effect of Other Drugs on Treprostinil Drug interaction studies have been carried out with treprostinil (oral or subcutaneous) co-administered with acetaminophen (4 g/day), warfarin (25 mg/day), and fluconazole (200 mg/day), respectively, in healthy volunteers. These studies did not show a clinically significan…
Adverse Reactions
6 ADVERSE REACTIONS The following potential adverse reactions are described in Warnings and Precautions ( 5 ): - Decrease in systemic blood pressure [see Warnings and Precautions ( 5.1 )] . - Bleeding [see Warnings and Precautions ( 5.2 )] . Most common adverse reactions with YUTREPIA (³10%) are cough, headache, throat irritation, and dizziness. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Liquidia Technologies, Inc. at 1-888-393-LQDA (5732) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The safety and tolerability of YUTREPIA was evaluated in an open label study (INSPIRE) of 121 patients with PAH (WHO Group 1 and NYHA Functional Class II [80 patients] and Class III [41 patients]) followed for up to 2 months. The most commonly reported adverse reactions included cough, headache, throat irritation, dizziness, which are known side effects of treprostinil inhalation solution. Table 2 …
Frequently Asked Questions
What is Yutrepia used for?
Yutrepia contains treprostinil. It is a capsule taken respiratory (inhalation). Consult your doctor for specific uses.
Is Yutrepia a controlled substance?
Yutrepia is not classified as a controlled substance by the DEA.
What is the generic name for Yutrepia?
The generic name for Yutrepia is treprostinil. There are 10 other brand versions of treprostinil.
What is the NDC code for Yutrepia 53 ug/1?
The NDC (National Drug Code) for Yutrepia 53 ug/1 is 72964-012, listed by Liquidia Technologies, Inc..