Ohtuvayre (Ensifentrine) – Chronic Obstructive Pulmonary Disease

Ohtuvayre Application Scope

Ohtuvayre is an inhaled prescription medication for adults with chronic obstructive pulmonary disease (COPD) that helps improve breathing by relaxing airway muscles and reducing inflammation.

Characteristics

• Ingredients: Ensifentrine

• Properties:

  • Ensifentrine is a dual inhibitor of phosphodiesterase 3 (PDE3) and phosphodiesterase 4 (PDE4)

  • Providing both bronchodilator and anti-inflammatory effects.

• Packaging Specification: Supplied as 2.5 mL of sterile ensifentrine (1.2 mg/mL) suspension

• Storage:

  • Store at controlled room temperature (68°F to 77°F [20°C to 25°C])

  • With excursions permitted between 59°F and 86°F (15°C to 30°C)

  • Keep in the protective foil pouch until use. Do not freeze.

• Expiry Date: ​Refer to the expiration date printed on the packaging

• Executive Standard: Refer to the official prescribing information for detailed standards.

• Approval Number: FDA approval granted on June 26, 2024.

• Date of Revision: June 2024.

• Manufacturer: Verona Pharma, Inc.

Guidelines for the Use of Ohtuvayre

• Dosage and Administration:

  • Frequency: Twice daily (morning and evening).
  • Dose: 3 mg (one ampule) per administration.
  • Method: Oral inhalation using a standard jet nebulizer with a mouthpiece.
  • Preparation: Shake the ampule vigorously before use.
  • Post-Administration: Discard any residual content.

• Adverse Reactions:

  • Common Reactions (≥1% incidence and more frequent than placebo):
    • Back pain
    • Hypertension
    • Urinary tract infection
    • Diarrhea
  • Psychiatric Reactions:
    • Psychiatric adverse reactions have been reported, including suicidality.

• Contraindications: Contraindicated in patients with hypersensitivity to ensifentrine or any component of the product.

• Precautions:

  • Not for treating acute symptoms of bronchospasm.

  • Discontinue use if paradoxical bronchospasm occurs.

  • Use with caution in patients with hepatic impairment or a history of depression and/or suicidal thoughts or behavior.

Interactions

• Drug Interactions: Concomitant administration with CYP2C9 inhibitors (e.g., fluconazole) may increase ensifentrine exposure.

Note:

• If there is a new packaging for the drug, the new packaging shall prevail. The above information is sourced from DengYue Medicine.
• It is only for internal discussion among medical staff and does not serve as a basis for medication. For specific medication guidelines, please consult the attending physician.