Pronunciation: OH-too-vare
Generic name: ensifentrine
Dosage form: solution for inhalation
Drug class: Miscellaneous respiratory agents

Medically reviewed by Carmen Pope, BPharm. Last updated on Dec 10, 2024.

What is Ohtuvayre?

Ohtuvayre is an inhaled, steroid-free suspension that may be used as maintenance treatment for chronic obstructive pulmonary disease (COPD) in adults, to improve symptoms and reduce the number of flare-ups. 

• Ohtuvayre must be used with a nebulizer.
• Ohtuvayre is not a rescue treatment and will not relieve sudden breathing problems.
• Ohtuvayre opens up the airways and relieves inflammation. 

Ohtuvayre belongs to the drug class called inhaled dual phosphodiesterase inhibitors. Specifically, it is a dual PDE3/4 inhibitor. Ohtuvayre was the first inhaled medication with a unique mechanism of action to be introduced for COPD management in 20 years. 

Ohtuvayre (ensifentrine) gained FDA approval on June 26, 2024. There is no Ohtuvayre generic.

How does Ohtuvayre work?

Ohtuvayre's mechanism of action involves inhibiting two enzymes, phosphodiesterase 3 (PDE3) and phosphodiesterase 4 (PDE4). These enzymes are abundant in the lung's smooth muscle tissue and play a crucial role in breaking down cyclic AMP, an important cellular messenger. Cyclic AMP is involved in various physiological processes, including bronchial smooth muscle relaxation and inhibiting inflammatory substances.

By inhibiting PDE3, Ohtuvayre helps relax airway muscles, alleviating symptoms such as wheezing, coughing, chest tightness, and shortness of breath. Blocking PDE4 also reduces lung inflammation, another factor in respiratory conditions. Through this dual action, Ohtuvayre relieves both muscle constriction and inflammation associated with COPD.

What does Ohtuvayre cost?

The cost of Ohtuvayre depends on your insurance coverage. People with commercial insurance eligible for the Ohtuvayre Copay program may pay as little as $0 per month for Ohtuvayre. 

If you do not have insurance, are underinsured, or there is a coverage delay with your insurance, Verona Pathway Plus may be able to help in situations where Ohtuvayre is not covered. This pathway can also provide support and information about how to obtain Ohtuvayre which is only available from a specialty pharmacy. 

Ohtuvayre side effects

The most common Ohtyvayre side effects are:

• back pain
• high blood pressure
• bladder infection
• diarrhea.

Serious side effects and warnings

Ohtuvayre can cause the following serious side effects.

Sudden breathing problems immediately after inhaling your medicine. If you have sudden breathing problems immediately after inhaling your medicine, stop using Ohtuvayre and call your healthcare provider right away or go to the nearest hospital emergency room right away.

Mental health problems, including suicidal thoughts and behavior. You may experience mood or behavior changes when taking Ohtuvayre. Call your healthcare provider right away if you have any of these symptoms, especially if they are new, worse, or worry you:

• thoughts of suicide or dying or attempting to commit suicide
• new or worse anxiety or depression
• trouble sleeping (insomnia)
• acting on dangerous impulses
• other unusual changes in your behavior or mood.

These are not all the possible side effects of Ohtuvayre. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA1088.

Related/similar drugs

Before taking

Do not use Ohtuvayre if you have had an allergic reaction to ensifentrine, Ohtuvayre, or any inactive ingredients in the inhalation.

Before using an Ohtuvayre inhalation, tell your healthcare provider about all your medical conditions, including if you:

• have or have had a history of mental health problems including depression and suicidal behavior
• have liver problems.
• are pregnant or plan to become pregnant
• are breastfeeding.

Ohtuvayre should not be used in children.

Pregnancy

It is not known if Ohtuvayre may harm your unborn baby.

Breastfeeding

It is not known if the medicine in Ohtuvayre passes into your breast milk and if it can harm your baby.

How do I take Ohtuvayre?

Ohtuvayre should only be used with a standard jet nebulizer with a mouthpiece connected to an air compressor.

• Shake the Ohtuvayre ampule vigorously immediately before using it. When shaken, it will appear cloudy and yellow to pale yellow.
• Use 1 ampule of Ohtuvayre 2 times a day, 1 time in the morning and 1 time in the evening.
• Do not use more than 1 ampule in a single inhalation. Do not use more than 2 ampules a day.
• Squeeze the contents of the ampule into the nebulizer cup and discard the ampule.
• Do not mix other medicines with Ohtuvayre in your nebulizer.
• Ohtuvayre is pronounced OH-too-vare.

Do not use it unless your healthcare provider has taught you how to use it with your nebulizer and you understand how to use it correctly.

• Use it exactly as your healthcare provider tells you to use it.
• Do not use Ohtuvayre more often than prescribed.

Call your healthcare provider or get emergency medical care right away if:

• your breathing problems get worse
• you need to use your inhaled rescue medicine more often than usual
• your inhaled rescue medicine does not relieve your symptoms.

Do not stop using Ohtuvayre even if you are feeling better unless your healthcare provider tells you to because your symptoms might get worse.

Throw away the Ohtuvayre ampules immediately after use. Due to their small size, the ampules pose a danger of choking to young children.

What happens if I miss a dose?

If you miss a dose of Ohtuvayre, take it as soon as you remember, but if it is almost time for your next dose, skip that dose and go back to your usual dosing schedule. Do not double up on Ohtuvayre doses.

What happens if I overdose?

If you use too much Ohtuvayre call your healthcare provider or go to the nearest hospital emergency room right away if you have any unusual symptoms, such as increased heart rate or headaches.

• Ohtuvayre does not relieve sudden symptoms of COPD and you should not use extra doses to relieve these sudden symptoms.

Always have an inhaled rescue medicine with you to treat sudden symptoms. If you do not have an inhaled rescue medicine, call your healthcare provider to have one prescribed for you.

What other drugs will affect Ohtuvayre?

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Drug interaction studies for Ohtuvayre show that it slightly increases concentrations of the cytochrome p450 2C9 inhibitor fluconazole, although the clinical relevance of this is unknown.

Talk to your healthcare provider about interactions with Ohtuvayre.

Storage

Store Ohtuvayre at room temperature between 68°F to 77°F (20°C to 25°C). Keep away from direct sunlight and excessive heat. Do not freeze.

Store in the unopened protective foil pouch and only open the foil pouch immediately before using Ohtuvayre.

Throw away the used ampule and any leftover medicine after use.

Do not use Ohtuvayre after the expiration date provided on the foil pouch and ampule.

Keep out of the reach of children.

Ohtuvayre ingredients

Ohtuvayre active ingredient: ensifentrine

Inactive ingredients: dibasic sodium phosphate, monobasic sodium phosphate, polysorbate 20, sodium chloride, sorbitan monolaurate and water for injection.

Ohtuvayre inhalation suspension contains 3 mg/2.5 mL aqueous suspension in one unit-dose ampule.

Who makes Ohtuvayre?

Verona Pharma, Inc. makes Ohtuvayre.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Medical Disclaimer