TAKING OHTUVAYRE

OHTUVAYRE is taken through a standard jet nebulizer twice a day

Never used a nebulizer before? Here’s what to know.

Treatments that use a nebulizer are common in COPD, and your healthcare provider will be able to answer any questions you have about how to use one.

Here are some of the important details you should know before using OHTUVAYRE:

This treatment is taken as a breathing treatment by inhalation and should be used with a standard jet nebulizer with a mouthpiece

Do not mix other medicines with OHTUVAYRE in your nebulizer and always store your medicine in an upright position

Preparing to use OHTUVAYRE

  • Make sure you know how to use your nebulizer machine before using your first dose of OHTUVAYRE.
  • Each dose comes in an ampule (a small sealed vial) that is sealed in a foil pouch. Store upright, and don’t open it until you are ready to use a dose.
  • Download and read the following instructions before using OHTUVAYRE. If you have any questions, ask your healthcare provider.
Instructions for using OHTUVAYRE

How often should OHTUVAYRE be taken?

Two times each day—once in the morning and once in the evening

  • Do not use more than 1 ampule of OHTUVAYRE in a single treatment.
  • Do not use more than 2 ampules of OHTUVAYRE a day.

5—7 minute sessionsa

aTreatment time is dependent on your individual nebulizer.

Use OHTUVAYRE as prescribed.

OHTUVAYRE may improve the symptoms of COPD for better breathing.

How OHTUVAYRE works

View our clinical trials data

Results with OHTUVAYRE

Frequently asked questions

How long does it take for OHTUVAYRE to work?

In two studies, patients taking OHTUVAYRE had improved lung function at 12 weeks compared to patients taking placebo. This means OHTUVAYRE helped the lungs to work better. Lung function was measured by a test called FEV1, which is the amount of air a person can blow out of their lungs in the first second of a hard breath out.

How often do I need to use OHTUVAYRE?

OHTUVAYRE is taken two times each day—once in the morning and once in the evening. Each dose should take about 5 to 7 minutes.

Can I take OHTUVAYRE without a nebulizer?

No. OHTUVAYRE is only to be administered through a standard jet nebulizer with a mouthpiece connected to an air compressor. For correct use, please refer to OHTUVAYRE Instructions for Use.

Can I mix OHTUVAYRE with other medications in the nebulizer?

No, do not mix other medicines with OHTUVAYRE in your nebulizer and take it exactly as prescribed.

Indication

OHTUVAYRE® (ensifentrine) is a prescription medicine used to treat chronic obstructive pulmonary disease (COPD) in adults. COPD is a chronic (long-term) lung disease that includes chronic bronchitis, emphysema, or both.

Select Safety Information

What is the most important information I should know about OHTUVAYRE?

OHTUVAYRE can cause serious side effects, including:

  • 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, attempt to commit suicide, trouble sleeping (insomnia), new or worse anxiety, new or worse depression, acting on dangerous impulses, and/or other unusual changes in your behavior or mood.

Do not use OHTUVAYRE to treat sudden breathing problems. Always have a rescue inhaler with you.

 

Who should not use OHTUVAYRE?

 

Do not use OHTUVAYRE if you have had an allergic reaction to ensifentrine or any of the ingredients in OHTUVAYRE.

 

What should I tell my healthcare provider before using OHTUVAYRE?

 

Before you use OHTUVAYRE, tell your healthcare provider 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; or are breastfeeding. It is not known if OHTUVAYRE may harm your unborn baby. It is not known if the medicine in OHTUVAYRE passes into your breast milk and if it can harm your baby.

 

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

 

What are the most common side effects of OHTUVAYRE?

 

The most common side effects of OHTUVAYRE include back pain, high blood pressure, bladder infection, and diarrhea.

 

These are not all the possible side effects of OHTUVAYRE. Call your doctor for medical advice about side effects.

 

How should I use OHTUVAYRE?

  • OHTUVAYRE is only for use with a nebulizer.
  • Do not use OHTUVAYRE unless your healthcare provider has taught you how to use it with your nebulizer and you understand how to use it correctly.
  • Use OHTUVAYRE exactly as your healthcare provider tells you to use it. Do not use OHTUVAYRE more often than prescribed.
  • OHTUVAYRE is taken as a breathing treatment by oral (mouth) inhalation and should be used with a standard jet nebulizer with a mouthpiece connected to an air compressor.
  • Do not mix other medicines with OHTUVAYRE in your nebulizer.

 

This summary does not include all the information about OHTUVAYRE and is not meant to take the place of a discussion with your healthcare provider about your treatment. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

 

Please read the accompanying Patient Information and Instructions for Use for OHTUVAYRE, and discuss them with your doctor. The physician Prescribing Information also is available.

 

INDICATION
SELECT SAFETY INFORMATION

OHTUVAYRE® (ensifentrine) is a prescription medicine used to treat chronic obstructive pulmonary disease (COPD) in adults. COPD is a chronic (long-term) lung disease that includes chronic bronchitis, emphysema, or both.

SELECT SAFETY INFORMATION

What is the most important information I should know about OHTUVAYRE?

OHTUVAYRE can cause serious side effects, including:

  • 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, attempt to commit suicide, trouble sleeping (insomnia), new or worse anxiety, new or worse depression, acting on dangerous impulses, and/or other unusual changes in your behavior or mood.

Do not use OHTUVAYRE to treat sudden breathing problems. Always have a rescue inhaler with you.

 

Who should not use OHTUVAYRE?

 

Do not use OHTUVAYRE if you have had an allergic reaction to ensifentrine or any of the ingredients in OHTUVAYRE.

 

What should I tell my healthcare provider before using OHTUVAYRE?

 

Before you use OHTUVAYRE, tell your healthcare provider 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; or are breastfeeding. It is not known if OHTUVAYRE may harm your unborn baby. It is not known if the medicine in OHTUVAYRE passes into your breast milk and if it can harm your baby.

 

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

 

What are the most common side effects of OHTUVAYRE?

 

The most common side effects of OHTUVAYRE include back pain, high blood pressure, bladder infection, and diarrhea.

 

These are not all the possible side effects of OHTUVAYRE. Call your doctor for medical advice about side effects.

 

How should I use OHTUVAYRE?

  • OHTUVAYRE is only for use with a nebulizer.
  • Do not use OHTUVAYRE unless your healthcare provider has taught you how to use it with your nebulizer and you understand how to use it correctly.
  • Use OHTUVAYRE exactly as your healthcare provider tells you to use it. Do not use OHTUVAYRE more often than prescribed.
  • OHTUVAYRE is taken as a breathing treatment by oral (mouth) inhalation and should be used with a standard jet nebulizer with a mouthpiece connected to an air compressor.
  • Do not mix other medicines with OHTUVAYRE in your nebulizer.

 

This summary does not include all the information about OHTUVAYRE and is not meant to take the place of a discussion with your healthcare provider about your treatment. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

 

Please read the accompanying Patient Information and Instructions for Use for OHTUVAYRE, and discuss them with your doctor. The physician Prescribing Information also is available.