RESULTS WITH OHTUVAYRE

OHTUVAYRE may help improve symptoms of COPD for better breathing

OHTUVAYRE was studied in 2 clinical trials with adults who had moderate to severe COPD.

In the trials, people used a nebulizer 2 times a day to take either OHTUVAYRE or a placeboa:

  • Trial 1 had a total of 759 people take OHTUVAYRE (477) or placebo (282). 68% of these people were also taking other COPD maintenance medicinesb during the trial.
  • Trial 2 had a total of 789 people take OHTUVAYRE (498) or placebo (291). 55% of these people were also taking other COPD maintenance medicinesb during the trial.

aPlacebo = A substance that is not medicine.

bMaintenance medicines are medicines that people take regularly to treat long-term conditions, such as COPD. Maintenance medicines that participants took in these trials mostly included a long-acting muscarinic antagonist (LAMA), a long-acting beta2-agonist (LABA), and a LABA and an inhaled corticosteroid (ICS).

People taking OHTUVAYRE had improved lung function compared to people taking placebo after 12 weeks.

A lung function test called forced expiratory volume in one second (FEV1) was used to measure how people’s lungs worked. This test measures the amount of air a person can blow out of their lungs in the first second of a hard breath out.

COPD Symptom Improvement

In Trial 1:

At Week 24, about 58% of people who took OHTUVAYRE and about 46% who took placebo reported improved symptoms.

In Trial 2:

At Week 24, about 45% of people who took OHTUVAYRE and about 50% who took placebo reported improved symptoms.

Improvement in symptoms was measured with a survey called the St. George’s Respiratory Questionnaire (SGRQ). These symptoms included shortness of breath, coughing, wheezing, and mucus coming up from the lungs when coughing. In this survey, people answered questions about how COPD affected their daily life, how well they functioned, and their perceived well-being.

OHTUVAYRE can be used on its own or added to other treatments for COPD.

Talk to your healthcare provider to find out if OHTUVAYRE is right for you.

How OHTUVAYRE works

Get to know the possible side effects of OHTUVAYRE

Possible side effects

Using a nebulizer to take OHTUVAYRE

OHTUVAYRE is taken through a nebulizer—a common delivery method in COPD.

Taking OHTUVAYRE

Frequently asked questions

Can I take OHTUVAYRE if I’m on another COPD treatment?

Yes, OHTUVAYRE may be taken if you are currently on other COPD treatments. Please consult with your healthcare provider.

If my COPD symptoms improve, do I have to continue taking OHTUVAYRE?

Yes, do not stop taking OHTUVAYRE even if you are feeling better, unless your healthcare provider tells you to, because your symptoms might get worse.

What is COPD maintenance therapy?

Unlike rescue inhaler medications, which are taken to relieve sudden breathing problems, OHTUVAYRE is a maintenance therapy (long-term) designed to be taken two times each day—once in the morning and once in the evening. For the best results, take OHTUVAYRE exactly as prescribed by your healthcare provider.

Does OHTUVAYRE cure COPD completely?

No, currently there is no known cure for COPD. OHTUVAYRE is a maintenance therapy used to help improve symptoms of COPD for better breathing.

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.