Ohtuvayre
Ohtuvayre (ensifentrine) is an inhaled prescription medication for adults with chronic obstructive pulmonary disease (COPD). As a phosphodiesterase 3 (PDE3) and phosphodiesterase 4 (PDE4) inhibitor, it’s used to help people breathe better in the long run. This medication is inhaled by mouth through a nebulizer with a fitted mouthpiece. It's taken two times each day, once in the morning and once in the evening. As a maintenance treatment, Ohtuvayre (ensifentrine) shouldn’t be used as a replacement for your inhaled rescue medication in case of sudden breathing problems. Side effects of Ohtuvayre (ensifentrine) include back pain, high blood pressure, and diarrhea.
What is Ohtuvayre (ensifentrine)?
What is Ohtuvayre (ensifentrine) used for?
How Ohtuvayre (ensifentrine) works
Ohtuvayre (ensifentrine) is a phosphodiesterase 3 (PDE3) / phosphodiesterase 4 (PDE4) inhibitor. PDE3 and PDE4 are enzymes (proteins) in the body that control inflammation in the airways – they break down a chemical responsible for airway relaxation. So by blocking both PDE3 and PDE4, Ohtuvayre (ensifentrine) reduces inflammation and helps the muscles around the lungs stay relaxed. This helps lessen coughing, chest tightness, and trouble breathing.
Drug facts
Side effects of Ohtuvayre (ensifentrine)
The following side effects may get better over time as your body gets used to the medication. Let your healthcare provider know immediately if you continue to experience these symptoms or if they worsen over time.
Common Side Effects
- Back pain (2%)
- High blood pressure (2%)
- Urinary Tract Infection (1%)
- Diarrhea (1%)
Less Common Side Effects
- Toothache
- Pneumonia
- Common cold symptoms
- Inflammation of the sinuses
Ohtuvayre (ensifentrine) serious side effects
Contact your healthcare provider immediately if you experience any of the following.
- Sudden breathing problems: chest tightness, trouble breathing or swallowing
- Change in mood or behavior: new or worsening anxiety or depression, suicidal thoughts and behavior, trouble sleeping
The following Ohtuvayre (ensifentrine) side effects have also been reported
Side effects that you should report to your care team as soon as possible:
- Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
- Mood and behavior changes—anxiety, nervousness, confusion, hallucinations, irritability, hostility, thoughts of suicide or self-harm, worsening mood, feelings of depression
- Wheezing or trouble breathing that is worse after use
Side effects that usually do not require medical attention (report these to your care team if they continue or are bothersome):
Pros and cons of Ohtuvayre (ensifentrine)
Pros
- Can start working as early as the first day of treatment
- Can be used alongside other COPD treatments
- Doesn’t commonly cause side effects
Cons
- Must be taken twice daily
- Risk of mental health problems
- Must be inhaled using a nebulizer, which can be confusing to use for some people
Pharmacist tips for Ohtuvayre (ensifentrine)
- Ohtuvayre (ensifentrine) is an inhaled medication to be used with a nebulizer only. Don’t swallow or inject this medication since it won’t work as it’s supposed to.
- Even if your COPD symptoms get better, continue taking Ohtuvayre (ensifentrine) as prescribed. Your symptoms may come back after stopping the medication.
- Contact your prescriber or get emergency medical attention right away if your breathing problems worsen. Also, be sure to reach out if you need to use your rescue inhaler more often than usual or if it no longer provides relief for your symptoms. These could be signs that Ohtuvayre (ensifentrine) isn’t working for you, and you might need a different medication.
- Some people experience changes in their mood or behavior after starting Ohtuvayre (ensifentrine). If you notice symptoms like anxiety, depression, or suicidal thoughts and behaviors, seek medical help right away, as it could be life-threatening.
- Store Ohtuvayre (ensifentrine) at room temperature in the unopened protective foil pouch. This will help protect the medication from sunlight or heat.
- Don’t mix Ohtuvayre (ensifentrine) with other medications in the nebulizer. Doing so can change how the medication works and could potentially cause unwanted side effects.
How to use Ohtuvayre (ensifentrine):
- Carefully read and follow the instructions for use before you first use Ohtuvayre (ensifentrine). Speak to your prescriber or pharmacist if you have any questions on how to take this medication correctly.
- Ohtuvayre (ensifentrine) should only be used with a jet nebulizer with a mouthpiece.
- Open the pouch and take out the ampule. Forcefully shake the ampule until the contents are mixed – the liquid should look cloudy and yellow in color.
- Squeeze the medication out of the ampule into the nebulizer cup. Then throw away the empty ampule since it can be a choking hazard for children and pets.
- Connect the mouthpiece to the nebulizer. Attach one end of the tubing to the compressor and the other end to the bottom of the nebulizer cup.
- Sit upright and place the mouthpiece in your mouth. Close your lips around the mouthpiece.
- Turn on the compressor to begin treatment. Breathe slowly and deeply until you don’t see anymore mist coming out of the nebulizer. This will take about 5 to 7 minutes.
Common questions about Ohtuvayre (ensifentrine)
No, Ohtuvayre (ensifentrine) is a maintenance therapy that’s used on a daily basis. You take this medication twice a day every day to help with COPD in the long run, even if your symptoms start to improve during treatment. This is different from a rescue inhaler, like albuterol, which is used as needed. Don’t replace your inhaled rescue medication with Ohtuvayre (ensifentrine) to relieve sudden symptom flare ups, such as trouble breathing or chest tightness.. Tell your prescriber if you experience any sudden breathing problems after taking this medication.
No, COPD is a long-term lung condition, and there is no cure. Medications for this condition help manage and lessen symptoms rather than get rid of them completely. Ohtuvayre (ensifentrine) is a maintenance medication used to improve COPD symptoms and help you breathe better. Talk to your prescriber if you continue to experience these symptoms even after taking Ohtuvayre (ensifentrine).
Each person responds differently to medications, so Ohtuvayre (ensifentrine) may work better for some people than for others. At the end of a 12-week study, individuals who took Ohtuvayre (ensifentrine) were able to exhale an overall greater amount of air in one second. This is compared to individuals who didn’t take medication. This measurement of lung function is called forced expiratory volume (FEV1). Having a greater increase in overall FEV1 means that breathing improved with treatment. Follow up with your prescriber if you don’t notice improvements in your breathing or if your breathing gets worse while taking this medication.
Yes, Ohtuvayre (ensifentrine) became FDA approved in June 2024. It’s the first medication to target both PDE3 and PDE4 enzymes, working to open up the airways and reduce inflammation in the lungs.
No, it’s not recommended to mix other medications with Ohtuvayre (ensifentrine) in the nebulizer. Doing so can cause Ohtuvayre (ensifentrine) to not work as it’s intended to and might potentially lead to more side effects.
Studies suggest that people might begin breathing better the first day of taking Ohtuvayre (ensifentrine). But it can take a few weeks or longer for others to see the full effects. Because people react to medications in different ways, talk with your prescriber if you aren’t noticing any improvements to your symptoms after a few weeks.
Yes. Studies show that Ohtuvayre (ensifentrine) improves COPD symptoms and quality of life when given with or without other COPD medications. Talk with your prescriber about if you need to use other COPD medications while you’re taking Ohtuvayre (ensifentrine).
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Risks and warnings for Ohtuvayre (ensifentrine)
Ohtuvayre (ensifentrine) can cause some serious health issues. This risk may be even higher for certain groups. If this worries you, talk to your doctor or pharmacist about other options.
Not for use as a rescue inhaler
Ohtuvayre (ensifentrine) isn’t meant to stop sudden symptoms of COPD.Don’t take extra doses of the medication to relieve these symptoms. Instead, people should use a rescue inhaler such as albuterol to treat flare ups. Contact your prescriber if you find yourself using your rescue inhaler more, your rescue inhaler no longer relieves your symptoms, or your symptoms worsen after starting Ohtuvayre (ensifentrine). You may need to switch to a different medication.
Unexpected bronchospasm
Like other breathing treatments, Ohtuvayre (ensifentrine) can cause paradoxical bronchospasm, or unexpected tightening of the airways. This can be life threatening. If you start to feel sudden chest tightness or have trouble breathing, use your rescue inhaler right away to treat your symptoms. Stop using Ohtuvayre (ensifentrine) and let your prescriber know.
Changes in mood or behavior
- Risk factors: History of suicidal thoughts and behavior | History of anxiety or depression | History of insomnia
Ohtuvayre (ensifentrine) may be associated with mental health problems. Sometimes, these problems are serious, such as with suicidal thoughts and behavior. Other problems can include worsening insomnia, anxiety, or depression, and agitation. The risk for worsening mental health might be higher in those with a history of anxiety or depression, as well as prior thoughts of self-harm. If you or your loved ones notice a change in your mood or behavior, let your prescriber know immediately.
Ohtuvayre (ensifentrine) dosage
Typical dosage for Ohtuvayre (ensifentrine)
The typical dose is 3 mg (one ampule) inhaled by mouth twice daily, once in the morning and once in the evening. Use a nebulizer to inhale the medication.
