Phosphodiesterase 3 InhibitorPrescription OnlyPregnancy Cat. Not classifiedFDA Yes

Ohtuvayre

ENSIFENTRINE

1 INDICATIONS AND USAGE OHTUVAYRE is indicated for the maintenance treatment of chronic obstructive pulmonary disease (COPD) in adult patients. OHTUVAYRE is a phosphodiesterase 3 (PDE3) inhibitor and phosphodiesterase 4 (PDE4) inhibitor indicated for the maintenance treatment of chronic obstructive pulmonary disease (COPD) in adult patients. ( 1 )

Medically reviewed by MedCentralHub Medical Review Board, Licensed Pharmacists & Physicians · May 2026

Brand names:Ohtuvayre

Rx Only

OhtuvayreMedication

Quick Reference

Medicine ClassPhosphodiesterase 3 Inhibitor

FDA ApprovedYes

PregnancyCategory Not classified

Check Interactions Dosage Details

Quick Facts

Active ingredient: ENSIFENTRINE
Medicine class: Phosphodiesterase 3 Inhibitor
Brand names: Ohtuvayre
Availability: Prescription only (Rx)
Pregnancy category: Not classified
Half-life: half-life ranged from 10
FDA approved: Yes

Ohtuvayre (ENSIFENTRINE) medication overview

What Is Ohtuvayre?

Ohtuvayre (ENSIFENTRINE) belongs to the Phosphodiesterase 3 Inhibitor class of medications. It was first approved by the FDA in Yes. This medication requires a prescription from a licensed healthcare provider.

Key Safety Information

•Always follow the dose recommended by your healthcare professional. Taking more than prescribed increases the risk of side effects including serious complications.
•Seek emergency care if you experience signs of an allergic reaction — hives, swelling, difficulty breathing, or rash. Stop the medication and call your doctor immediately.
•Some medications can increase the risk of cardiovascular events. Tell your doctor if you have high blood pressure, a history of heart attack or stroke, or any pre-existing health condition.
•Avoid or limit alcohol while taking Ohtuvayre. Do not drink alcohol without first discussing it with your healthcare provider as it may increase adverse effects.
•Take Ohtuvayre with food or a full glass of water if stomach upset occurs. Stop use and talk to your doctor if you experience persistent stomach pain or GI symptoms.
•Tell your doctor about all medications, supplements, and vitamins you take. Some combinations significantly increase the risk of harm.

This is a summary only. Always read the full prescribing information and consult your healthcare provider for personalized medical advice.

Uses & Indications

Ohtuvayre is prescribed for the following conditions. Some uses are FDA-approved indications; others may be evidence-based off-label uses. Consult your healthcare provider for personalized guidance.

1 INDICATIONS AND USAGE OHTUVAYRE is indicated for the maintenance treatment of chronic obstructive pulmonary disease (COPD) in adult patients.

OHTUVAYRE is a phosphodiesterase 3 (PDE3) inhibitor and phosphodiesterase 4 (PDE4) inhibitor indicated for the maintenance treatment of chronic obstructive pulmonary disease (COPD) in adult patients.

Dosage Guide

The following are general dosing guidelines only. Your actual dose should be determined by your healthcare provider based on your condition, renal/hepatic function, and other medications.

Adult Dosage

2 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. Recommended Dosage : 3 mg (one ampule) twice daily administered by oral inhalation using a standard jet nebulizer with a mouthpiece. ( 2 ) See full prescribing information for administration instructions. ( 2 ) Administration Instructions Remove OHTUVAYRE unit-dose ampule from foil pouch only immediately before use. For pouches of 5 ampules, remove one ampule and place the remaining ampules back into the pouch until next use. Once the foil pouch is opened, discard ampules if not used within 14 days. Shake OHTUVAYRE ampule vigorously. Squeeze and completely empty contents of the ampule into the nebulizer cup for administration of OHTUVAYRE by oral inhalation. Discard ampule with any residual content. Administer OHTUVAYRE by oral inhalation using a standard

Available Forms

Available Strengths

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Side Effects

Common

6 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) ] Most common adverse reactions (incidence greater and equal to 1% and more common than placebo) include back pain, hypertension, urinary tract infection, and diarrhea.
( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Merck Sharp & Dohme LLC at 1-800-672-6372 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The safety of OHTUVAYRE was based on the pooled safety population from two randomized, double-blind, placebo-controlled trials (ENHANCE-1 and ENHANCE-2) for 24 weeks, and a 48-week cohort that assessed safety in ENHANCE-
In these trials, a total of 975 patients received 3 mg of OHTUVAYRE twice daily administered by oral inhalation using a standard jet nebulizer [see Clinical Studies (14) ] .
The safety population included all patients who were randomized and received at least one dose of OHTUVAYRE or placebo.
Adverse reactions that occurred at an incidence greater than or equal to 1% in OHTUVAYRE and were more common than placebo in the pooled population are provided in Table

Serious

5 WARNINGS AND PRECAUTIONS Should not use OHTUVAYRE to treat acute symptoms of bronchospasm.
( 5.1 ) If paradoxical bronchospasm occurs, discontinue OHTUVAYRE and institute alternative therapy.
( 5.2 ) An increase in psychiatric adverse reactions, including suicidality, were reported with use of OHTUVAYRE.
Carefully weigh the risks and benefits of treatment with OHTUVAYRE in patients with a history of depression and/or suicidal thoughts or behavior.
( 5.3 ) 5.1 Acute Episodes of Bronchospasm OHTUVAYRE should not be used for the relief of acute symptoms, i.e., as rescue therapy for the treatment of acute episodes of bronchospasm.

Rare

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Medicine Interactions

Always inform your healthcare provider and pharmacist about ALL medications you take, including prescriptions, OTC medicines, vitamins, and supplements.

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Warnings & Contraindications

5 WARNINGS AND PRECAUTIONS Should not use OHTUVAYRE to treat acute symptoms of bronchospasm. ( 5.1 ) If paradoxical bronchospasm occurs, discontinue OHTUVAYRE and institute alternative therapy. ( 5.2 ) An increase in psychiatric adverse reactions, including suicidality, were reported with use of OHTUVAYRE. Carefully weigh the risks and benefits of treatment with OHTUVAYRE in patients with a histor

How Ohtuvayre Works

12.1 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.

Pharmacokinetics

Absorption

Absorption Following inhaled administration of OHTUVAYRE in healthy subjects and subjects with COPD, ensifentrine C max was attained around 0

Half-Life

half-life ranged from 10

Metabolism

Metabolism Following administration of a single nebulized dose, 8 times the recommended dose of ensifentrine, unchanged ensifentrine was identified as the major drug-related component in human plasma,

Excretion

Excretion The majority of ensifentrine is excreted in feces

Pregnancy & Breastfeeding Safety

Not classified

FDA Pregnancy Category Not classified

Consult your healthcare provider.

Full Pregnancy Information

Breastfeeding

Many medications pass into breast milk in varying amounts. Before using Ohtuvayrewhile breastfeeding, discuss the benefits and risks with your healthcare provider or pharmacist — they can weigh your dose, your infant's age, and available lactation safety data to find the safest option for you and your baby.

Storage & Handling

Store OHTUVAYRE in the protective foil pouch. Only remove an ampule from foil pouch immediately before use. For pouches of 5 ampules, remove one ampule and place the remaining ampules back into the foil pouch until next use. Once the foil pouch is opened, discard ampules if not used within 14 days.

Frequently Asked Questions

Sources & References

• FDA Prescribing Information — Official labeling and package insert for Ohtuvayre
• U.S. National Library of Medicine — MedlinePlus drug information
• American Hospital Formulary Service (AHFS) — Clinical pharmacology monograph
• PubMed / MEDLINE — View clinical studies

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Medical Disclaimer

The information on this page is for educational purposes only and is not intended as medical advice, diagnosis, or treatment. Always consult your doctor, pharmacist, or qualified healthcare provider before starting, stopping, or changing any medication.