Ohtuvayre (Ensifentrine) - Instructions for Ensifentrine

1. Common name:Ensifentrine

Product name:Ohtuvayre

Other names: Encefentine (transliteration)

2. Indications:

Ohtuvayre (Ensifentrine) - Ensifentrine is indicated for the maintenance treatment of chronic obstructive pulmonary disease (COPD) in adults.

3. Usage and dosage:

1. Recommended dose: The recommended dose of Ohtuvayre is 3 mg (one unit dose ampoule) twice daily, once in the morning and evening, and administered orally using a standard jet nebulizer with an interface.

2. Administration Instructions: Remove Ohtuvayre unit dose ampoules from the foil pouch immediately before use and shake vigorously. Squeeze and completely empty the contents of the ampoule into a nebulizer cup for administration by oral inhalation. Discard ampoules with any remaining contents. Administer Ohtuvayre by oral inhalation using a standard jet nebulizer equipped with a mouthpiece, connected to an air compressor.

3. Drug compatibility: The compatibility of Ohtuvayre when mixed with other drugs has not been determined. Ohtuvayre should not be physically mixed with other medications or added to solutions containing other medications.

4. Adverse reactions:

InOhtuvayre’s clinical studies, the most common adverse reactions included back pain, high blood pressure, urinary tract infection and diarrhea.

5. Supply and storage:

Ohtuvayre is a sterile aqueous suspension packed in unit-dose low-density polyethylene ampoules, with a specification of 60 bottles per box (3mg/2.5mL). Each ampoule is wrapped in a sealed foil bag. Before use, the ampoule containing Ohtuvayre should be shaken vigorously to ensure that the active ingredient is completely resuspended. Used ampoules and any remaining contents should be discarded after use.

willOhtuvayre is stored in a protective foil bag (remove from foil bag only before use) at controlled room temperature (68°F to 77°F [20°C to 25°C], tolerances 59°F to 86°F [15°C to 30°C] allowed), maintaining the orientation indicated on the carton. Avoid direct sunlight and excessive heat. Do not freeze.

6. Taboo:

Ohtuvayre is contraindicated in patients who are allergic to Ensifentrine or any component of this product.

7. Mechanism of action:

Ensifentrine, the active ingredient in Ohtuvayre, is a small molecule that is an inhibitor of the PDE3 and PDE4 enzymes. PDE3 mainly hydrolyzes the second messenger molecule cyclic adenosine monophosphate (cAMP), but can also hydrolyze cyclic guanosine monophosphate (cGMP). PDE4 only hydrolyzes cAMP. Inhibition of PDE3 and PDE4 results in accumulation of intracellular cAMP and/or cGMP levels, resulting in various downstream signaling effects.

8. Overdose:

OverdoseOhtuvayre may cause symptoms and signs such as headache, tachycardia, and palpitations. Treatment of overdose includes temporary interruption of Ohtuvayre and appropriate symptomatic and/or supportive therapy.

Reference materials:https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=e6433c98-41a0-4f99-8f7f-d0e9db6e3f40