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IS OHTUVAYRE SAFE?

Ohtuvayre was well tolerated among patients
and demonstrated a low rate of side effects.

The main side effects that occurred in clinical studies in at least 1% of patients taking Ohtuvayre and were more common than placebo were:
  • Back pain (1.8%)
  • High blood pressure (1.7%)
  • Bladder infection (1.3%)
  • Diarrhea (1.0%)

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.

Start and stay on Ohtuvayre.

In Ohtuvayre clinical studies, the proportion of patients taking Ohtuvayre who discontinued treatment due to side effects (7.6%) was similar to the proportion of patients who discontinued in the placebo group (8.2%). Talk to your healthcare provider if you experience side effects.

Frequently
Asked
Questions
Ohtuvayre is a COPD maintenance therapy, and is not used to relieve sudden breathing problems and will not replace an inhaled rescue medicine. Only use Ohtuvayre as prescribed by your healthcare provider and detailed in the Ohtuvayre Instructions for Use.
You should never stop treatment without direction from your healthcare provider. If you have questions about your treatment, please ask your healthcare provider directly.
Ohtuvayre was proven safe and well-tolerated in clinical trials. See Patient Information Leaflet for more detailed information.

Using a Nebulizer to Take Ohtuvayre

Using a Nebulizer to Take Ohtuvayre

Ohtuvayre works differently than other treatments, and it’s taken through a nebulizer—a common delivery method in COPD.

Reclaim your breath

You've seen the safety—now see what Ohtuvayre can do.

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 professional 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; 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. You may report side effects to FDA at
1-800-FDA-1088.

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.

For further information, please see the Full Prescribing Information, including the Patient Information Leaflet.

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.