Ensifentrine (1 brand name, 1 dosage form, 1 route)
Available dosage forms: SUSPENSION.
Routes of administration: INHALATION.
Brand Names
- OHTUVAYRE
Indications and Usage
OHTUVAYRE is indicated for the maintenance treatment of chronic obstructive pulmonary disease (COPD) in adult patients.
Dosage and Administration
The recommended dosage of OHTUVAYRE is 3 mg (one unit-dose ampule) twice daily, once in the morning and once in the evening, administered by oral inhalation using a standard jet nebulizer with a mouthpiece.
Contraindications
OHTUVAYRE is contraindicated in patients with hypersensitivity to ensifentrine or any component of this product.
Adverse Reactions
The following clinically significant adverse reactions are described elsewhere in the labeling: Paradoxical Bronchospasm [see Warnings and Precautions (5.2)] Psychiatric Events Including Suicidality [see Warnings and Precautions (5.3)]
Mechanism of Action
Ensifentrine is a small molecule that is an inhibitor of the PDE3 and PDE4 enzymes. PDE3 primarily hydrolyzes the second-messenger molecule cyclic adenosine monophosphate (cAMP) but is also capable of hydrolyzing cyclic guanosine monophosphate (cGMP). PDE4 hydrolyzes cAMP only. Inhibition of PDE3 and PDE4 results in accumulation of intracellular levels of cAMP and/or cGMP, resulting in various downstream signaling effects.
Overdosage
An overdosage of OHTUVAYRE may lead to signs and symptoms such as headache, tachycardia, and palpitations. Treatment of overdosage consists of temporary interruption of OHTUVAYRE along with appropriate symptomatic and/or supportive therapy.