Treprostinil Dry Powder Inhaler (treprostinil)-Yutrepia Instructions Chinese Introduction

1. Name:treprostinil, treprostinil dry powder inhaler

Product name:Yutrepia

2. Who can use treprostinil dry powder inhaler? Indications

Treprostinil dry powder inhaler(treprostinil)-Yutrepia is indicated for the treatment of:

1. Pulmonary arterial hypertension: Suitable for the treatment of pulmonary arterial hypertension (PAH WHO group 1) to improve exercise capacity. Studies establishing effectiveness primarily included patients with NYHA functional class III symptoms and causes, including idiopathic or hereditary pulmonary hypertension (56%) or pulmonary hypertension associated with connective tissue disease (33%). Effects diminish after the minimum recommended dosing interval of 4 hours; treatment duration can be adjusted based on planned activities.

Although there are long-term data using treprostinil via other routes of administration, nearly all controlled clinical experience with inhaled treprostinil has been in the context of bosentan (an endothelin receptor antagonist) or sildenafil (a phosphodiesterase type 5 inhibitor). The duration of controlled clinical trials is limited to 12 weeks.

2. Pulmonary hypertension associated with ILD: Indicated for the treatment of pulmonary hypertension associated with interstitial lung disease (PH-ILD; WHO group 3) to improve exercise capacity. Studies to determine effectiveness primarily included patients with etiology idiopathic interstitial pneumonia (IIP) (45%), including idiopathic pulmonary fibrosis (IPF), pulmonary fibrosis with emphysema (CPFE) (25%), and WHO group 3 connective tissue disease (22%).

3. What are the side effects of treprostinil dry powder inhaler?

In clinical studies of treprostinil dry powder inhalation, common adverse reactions (≥10%) include cough, headache, throat irritation, and dizziness; warnings and precautions associated with them include symptomatic hypotension, increased risk of bleeding through inhibition of platelet aggregation, and bronchospasm.

4. How to use treprostinil dry powder inhaler?

1. Usual dosage for adults: Treprostinil dry powder inhalation is for oral inhalation only and should be used only with the inhaler provided. Do not swallow treprostinil dry powder inhaler.

Dosage for treatment-naïve patients:

1)For patients who are unfamiliar with treprostinil, treatment should start with 26.5mcg, 3 to 5 times a day, with 2 breaths based on the patient's response.

2) Dosage for patients transitioning from treprostinil inhalation solution (Tyvaso) (Tyvaso delivers approximately 6mcg of treprostinil per breath): 3 to 5 times per day, 2 breaths per day, at the following dosage:

Table1: YUTREPIA Dosage in Patients Transitioning from Treprostinil Inhalation Solution

CurrentTyvaso dose* YUTREPIA dose

(number of breaths) xa0 xa0 xa0 xa0 xa0 xa0 xa0 xa0 xa0 xa0 xa0 xa0 xa0 xa0 xa0 xa0 xa0 xa0 xa0 xa0 xa0 xa0 xa0 xa0 xa0 xa0 xa0 xa0

5 breaths or less 26.5 micrograms

6 to 8 breaths 53 micrograms

Breaths 9 to 11 79.5 micrograms

12 to 14 breaths 106 micrograms

15 to 17 breaths 32.5 micrograms

18 breaths or more 159 micrograms

For patients new to treprostinil and patients transitioning from treprostinil inhalation solution, the dose may be increased by 26.5 mcg per dose per week as tolerated. The target maintenance dose is 79.5 mcg to 106 mcg 4 times daily.

Doses above 848mcg per day have not been studied in patients with PAH

If a scheduled dose is missed, resume treatment at the regular dose as soon as possible.

5. How to store treprostinil dry powder inhaler?

Treprostinil dry powder inhaler should only be delivered with a capsule-based inhaler. The storage temperature is20°C to 25°C (68°F to 77°F); allows adjustment from 15°C to 30°C (59°F to 86°F).

6. How does Quprolinil work?

The main pharmacological effect of treprostinil is to directly relax the pulmonary and systemic arterial vascular beds and inhibit platelet aggregation. Treprostinil binds to and activates prostacyclin receptors, prostaglandin D2 receptor 1, and prostaglandin E2 receptors. Activation of these receptors leads to an increase in intracellular cyclic adenosine monophosphate (cAMP) levels, which promotes the opening of calcium-activated potassium channels, leading to cellular hyperpolarization. This mechanism promotes direct vasodilation and inhibition of platelet aggregation in the pulmonary and systemic arterial vascular beds. In addition to its direct vasodilatory effects, treprostinil also inhibits inflammatory pathways.

7. What will happen if you overdose on treprostinil dry powder inhaler?

In general, symptoms of overdose with treprostinil dry powder inhaler include flushing, headache, hypotension, nausea, vomiting, and diarrhea. Provide general supportive care until overdose symptoms resolve.

Reference materials:https://www.drugs.com/pro/yutrepia.html