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.
Ohtuvayre may also be used for other conditions as determined by your healthcare 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)?
Ohtuvayre is available as a 3 mg/2.5 mL inhalation suspension.
How should I store Ohtuvayre?
Ohtuvayre should be stored at room temperature, between 68 F to 77 F (20 C to 25 C). It can be exposed to temperatures between 59 F to 86 F (15 C to 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 healthcare 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 healthcare 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. 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 that feel different or more severe than usual
- 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, skin rash, or pale red bumps on the skin called hives
- 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 healthcare 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 healthcare 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 healthcare provider if your blood pressure increases while taking this medicine.
Warnings & Precautions
Who should not use Ohtuvayre?
Allergies to Ingredients. People who are allergic to any of the following should not take 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 healthcare 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 healthcare 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 healthcare 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 healthcare provider before using Ohtuvayre?
Tell your healthcare 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 determine 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 healthcare 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 healthcare provider may do tests to determine if it is working well enough to take 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 healthcare provider may do tests to determine if it is working well enough to take this medicine.
Pregnancy. It is not known if or how Ohtuvayre could affect pregnancy or harm an unborn baby. Tell your healthcare provider if you are or plan to become pregnant.
Breastfeeding. It is not known if Ohtuvayre passes into breast milk. Tell your healthcare provider if you are breastfeeding or plan to breastfeed. Your healthcare provider will advise you if you should use Ohtuvayre while breastfeeding.
How can I get more information about Ohtuvayre?
For more information about Ohtuvayre, you can visit the manufacturer’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 healthcare provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using.
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, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and only take the next dose. Do not take double or extra doses.