
OHTUVAYRE
Generic Name/API: ensifentrine
Manufacturer: Verona Pharma
Dosage Forms & Strength & Pack Size:
Inhalation suspension: 3 mg/2.5 mL aqueous suspension in unit-dose ampules.
Storage:
Store OHTUVAYRE in the protective foil pouch (only remove from foil pouch immediately before use) at controlled room temperature (68°F to 77°F [20°C to 25°C], excursions permitted from 59ºF to 86ºF [15ºC to 30ºC]) [See USP Controlled Room Temperature], maintaining the orientation indicated on the carton. Protect from direct sunlight and excessive heat. Do not freeze.
- INDICATION
- IMPORTANT SAFETY INFORMATION
Ohtuvayre 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.
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 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.
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.
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