What does Ensifentrine package insert contain?

Ohtuvayre (Ensifentrine)-ensefentine inhalation suspension is a new inhaled bronchodilator that combines the dual inhibitory effects of phosphodiesterase type 3 (PDE3) and phosphodiesterase type 4 (PDE4). It is an innovative maintenance treatment drug developed for chronic obstructive pulmonary disease (COPD). Starting in 2023, Ensifentrine will be approved by the US FDA for marketing under the trade name "Ohtuvayre".

1. Basic information about drugs

Common name:Ensifentrine

Product name:Ohtuvayre

Dosage form: solution inhalation preparation

Specification:3mg/2.5mL (per unit ampoule)

Route of administration: for inhalation, oral inhalation through a jet nebulizer

2. Indications and clinical uses

Indications: Exefentine is suitable for the treatment of chronic obstructive pulmonary disease (COPD) in adults. It is used as a maintenance treatment drug to relieve airflow limitation, reduce the frequency of acute exacerbations and improve lung function.

Main population: moderate to severePatients with COPD, especially those who have insufficient response or intolerance to traditional LAMA/LABA treatment.

Advantages: Different from traditional single-machine bronchiectasis drugs, exefentine’s dual PDE3/4 inhibitory mechanism has both bronchodilator and anti-inflammatory effects and is suitable for long-term inhalation control.

3. Instructions for usage and dosage

Recommended dosage: Inhalation twice daily One 3mg ampoule each time (once in the morning and once in the evening).

Usage: Standard jet nebulizer with interface should be used for oral inhalation. Ultrasonic nebulizers cannot be used. The inhalation device needs to be cleaned thoroughly before each use to ensure drug delivery efficiency.

Note: The medicinal solution cannot be taken orally or injected. Each ampoule is a single-use dose and must be used immediately after opening. Discard the remaining liquid after use. Lung function and control need to be evaluated regularly under the guidance of a doctor.

4. Pharmacological mechanism and treatment characteristics

Dual enzyme inhibition: Simultaneous inhibition by exefantinePDE3 and PDE4:

PDE3 inhibition: directly promotes bronchial smooth muscle relaxation and quickly improves airway resistance.

PDE4 inhibition: Reduces the release of inflammatory mediators in the airways and inhibits chronic inflammatory processes.

Comprehensive benefits: While relieving symptoms, it also reduces the frequency of acute exacerbations of COPD and improves the ability to tolerate daily activities.

Nonsteroidal drugs: do not contain glucocorticoids and are suitable for patients who are sensitive to hormones or have concerns about long-term use of hormones.

5. Adverse reactions and contraindications

Common adverse reactions: throat irritation, dry mouth, mild headache, nausea. Insomnia or mild palpitations are occasionally seen, usually transient.

Contraindications: People who are allergic toEnsifentrine or any of its ingredients. Patients with a history of severe cardiac arrhythmias should be carefully evaluated before use.

Use in Special Populations: Safety in children and pregnant women has not been determined. Patients with moderate liver and kidney function impairment need to weigh the pros and cons before use.

6. Storage methods and drug stability

Storage conditions: Store at room temperature (15–25°C), avoid direct sunlight and freezing.

Stability Tips: The ampoule must be used immediately after opening, and the residual liquid cannot be stored. Do not mix with other inhaled liquid medicines.

Ensefentine is an innovative achievement in the respiratory field in recent years, which fills in the shortcomings of long-term inhaled treatment of COPD with a single mechanism. Its dual-enzyme inhibition mechanism not only relaxes the airways, but also controls airway inflammation, making it superior in improving COPD symptoms and reducing the frequency of acute attacks. For patients whose symptoms are poorly controlled or repeatedly exacerbated, Ensifentrine provides a new and safe maintenance treatment. With the accumulation of subsequent real-world data, its status in the COPD management pathway is expected to continue to improve.

Reference materials:https://www.drugs.com/monograph/ensifentrine.html