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Overview: Ohtuvayre is used to improve breathing and help prevent flare-ups in people with chronic obstructive pulmonary disease (COPD). It works by relaxing the muscles around the airways and reducing inflammation in the lungs. Common side effects include back pain, bladder infection, diarrhea, and increased blood pressure. Call your health care provider right away if you have trouble breathing, new or worsening thoughts of suicide, or mood changes. 

Uses

What is Ohtuvayre used for?

Ohtuvayre (ensifentrine) is commonly used for chronic obstructive pulmonary disease (COPD). 

COPD is a group of long-term lung conditions, including emphysema and chronic bronchitis. People with COPD have ongoing air flow problems and inflammation in the lungs. Common symptoms of COPD are coughing, wheezing, and shortness of breath. 

People with COPD may have flare-ups when their symptoms get worse than usual for several days. Ohtuvayre is used to improve breathing and helps to prevent COPD flare-ups.

Learn How Ohtuvayre Works for COPD.

Ohtuvayre may also be used for other conditions as determined by your health care provider.

How does Ohtuvayre work (mechanism of action)?

Ohtuvayre blocks two proteins in the body called PDE3 and PDE4. By blocking these proteins, the medicine helps relax the muscles around the airways in the lungs. This helps to reduce COPD symptoms such as coughing, wheezing, and shortness of breath. Ohtuvayre also helps to decrease inflammation in the lungs, which makes it easier to breathe.

How is Ohtuvayre supplied (dosage forms)?

Brands and other names

  • Ohtuvayre

Dosage forms and strengths

  • 3 mg/2.5 mL inhalation suspension

How should I store Ohtuvayre?

Ohtuvayre should be stored at room temperature, between 68 F and 77 F (20 C and 25 C). It can be exposed to temperatures between 59 F and 86 F (15 C and 30 C) for shorter periods of time, such as when transporting it. Store in a cool, dry place that is not in direct sunlight. Do not freeze this medicine.

Only open the foil pouch when you are ready to use the medicine.

Side Effects

What are the most common side effects of Ohtuvayre?

The most common side effects of Ohtuvayre are listed below. Tell your health care provider if you have any of these side effects that bother you.

  • Back pain
  • Bladder infection 
  • Diarrhea
  • Increased blood pressure (see below)

There may be other side effects of Ohtuvayre that are not listed here. Contact your health care provider if you think you are having a side effect of a medicine. In the U.S., you can report side effects to the FDA at www.fda.gov/medwatch or by calling 800-FDA-1088 (800-332-1088). In Canada, you can report side effects to Health Canada at www.health.gc.ca/medeffect or by calling 866-234-2345.

What are the serious side effects of Ohtuvayre?

While less common, the most serious side effects of Ohtuvayre are described below, along with what to do if they happen.

Severe Allergic Reactions. Ohtuvayre may cause allergic reactions, which can be serious. Stop using Ohtuvayre and get help right away if you have any of the following symptoms of a serious allergic reaction.

  • Breathing problems or wheezing
  • Racing heart
  • Fever or general ill feeling
  • Swollen lymph nodes
  • Swelling of the face, lips, mouth, tongue, or throat
  • Trouble swallowing or throat tightness
  • Itching or skin rash
  • Bumps on the skin called hives that can be red, pink, white, or brown depending on your skin tone
  • Nausea or vomiting
  • Dizziness, feeling lightheaded, or fainting
  • Stomach cramps
  • Joint pain

Sudden Breathing Problems. Ohtuvayre may cause the muscles around your airways to tighten (bronchospasm) right after you use it, instead of relaxing these muscles. In some cases, this can be serious. Stop using Ohtuvayre and contact your health care provider right away if your breathing gets worse instead of better after using Ohtuvayre.

Mood Changes, Including Suicidal Thoughts. Ohtuvayre may cause mood or mental health changes, including suicidal thoughts or actions in a small number of people. It may also cause trouble sleeping, anxiety, or depression.  If you are about to harm yourself, call 911 or call or text 988, the Suicide & Crisis Lifeline. Call your health care provider right away if you have any of the following symptoms.

  • New or increased thoughts of suicide or death
  • Suicide attempt
  • New or increased feelings of anxiety, depression, or other unusual changes in mood or behavior

Increased Blood Pressure. Ohtuvayre may increase your blood pressure or make it worse if you have a history of high blood pressure (hypertension). Call your health care provider if your blood pressure increases while using this medicine.

Warnings & Precautions

Who should not use Ohtuvayre?

Allergies to Ingredients. People who are allergic to any of the following should not use Ohtuvayre.

  • Ohtuvayre
  • Ensifentrine 
  • Any of the ingredients in the specific product dispensed

Your pharmacist can tell you all of the ingredients in Ohtuvayre.

What should I know about Ohtuvayre before using it?

Do not use Ohtuvayre unless it has been prescribed to you by a health care provider. Use it as prescribed.

Do not share Ohtuvayre with other people, even if they have the same condition as you. It may harm them.

Keep Ohtuvayre out of the reach of children.

Ohtuvayre is a medicine used on a regular basis to help prevent flare-ups of COPD. It is not a rescue treatment and should not be used when a quick response to breathing problems is needed. If you are using your rescue treatment (such as albuterol) more often than usual or your breathing is getting worse, contact your health care provider or get emergency care right away.

Ohtuvayre is inhaled using a nebulizer. A nebulizer is a small machine that turns a liquid medicine into a mist that you inhale through a mouthpiece. Make sure that you or a caregiver understands how to properly prepare and use Ohtuvayre. Refer to the instructions that come with this medicine and talk to your health care provider if you have any questions about how to use Ohtuvayre.

Shake the Ohtuvayre ampule well to make sure the medicine is mixed before putting it into the nebulizer. After shaking, it should look cloudy and pale yellow to yellow. If you use other nebulizer medicines, you should not mix them with Ohtuvayre in the nebulizer. Do not swallow or inject Ohtuvayre.

What should I tell my health care provider before using Ohtuvayre?

Tell your health care provider about all of your health conditions and any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. This will help them know if Ohtuvayre is right for you.

In particular, make sure that you discuss any of the following.

Mental Health Conditions. Ohtuvayre may cause serious mental health problems, including suicidal thoughts or actions. You may be at increased risk if you already have depression or other mental health conditions. Tell your health care provider about any past and current mental health conditions, especially if you have had thoughts of suicide or self-harm. 

Liver Problems. Ohtuvayre may not be safe to use if you have liver problems. If there is a concern about the health of your liver, your health care provider may do tests to know if it is working well enough to use this medicine.

Kidney Problems. It is not known if Ohtuvayre is safe to use if you have severe kidney problems. If there is a concern about the health of your kidneys, your health care provider may do tests to know if it is working well enough to use this medicine.

Pregnancy. It is not known if or how Ohtuvayre could affect pregnancy or harm a fetus. Tell your health care provider if you are or plan to become pregnant.

Breastfeeding. It is not known if Ohtuvayre passes into breast milk. Tell your health care provider if you are breastfeeding or plan to breastfeed. Your health care provider will let you know if you should use Ohtuvayre while breastfeeding.

How can I get more information about Ohtuvayre?

For more information about Ohtuvayre, you can visit the drugmaker's website at ohtuvayre.com or call them at 888-672-0371.

Interactions

Does Ohtuvayre interact with foods or drinks?

There are no known interactions between Ohtuvayre and foods or drinks.

It is unknown if drinking alcohol will affect Ohtuvayre.

Does Ohtuvayre interact with other medicines (drug interactions)?

There are no known interactions between Ohtuvayre and other medicines. Always tell your health care provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using.

Does interact with other drugs you are taking?

Enter your medication into the WebMD interaction checker

Overdose/Missed Dose

What should I do if I accidentally use too much Ohtuvayre?

If you or someone else has used too much Ohtuvayre, get medical help right away, call 911, or contact a Poison Control center at 800-222-1222.

What should I do if I miss a dose of Ohtuvayre?

If you miss a dose, use it as soon as you remember. If it is almost time for your next dose, skip the missed dose and only use the next dose. Do not use double or extra doses.