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The following safety information outlines crucial warnings associated with the use of Ohtuvayre (ensifentrine). It is important to understand these risks and precautions. Please consult your healthcare provider if you have any questions or concerns.

• Not a Rescue Inhaler: Ohtuvayre (ensifentrine) is not intended for the immediate relief of sudden COPD symptoms. Do not take extra doses to alleviate flare-ups. Use a rescue inhaler, such as albuterol, for sudden symptom relief. If you notice an increased need for your rescue inhaler, reduced effectiveness, or worsening symptoms after beginning Ohtuvayre, contact your healthcare provider as you may need an alternative treatment.

• Unexpected Bronchospasm: This medication may cause paradoxical bronchospasm, resulting in unexpected airway tightening, which can be life-threatening. If you experience sudden chest tightness or difficulty breathing, use your rescue inhaler immediately and stop using Ohtuvayre. Inform your healthcare provider promptly.

• Mood or Behavioral Changes: Ohtuvayre can be linked to mental health issues, including serious problems like suicidal thoughts and behaviors. Other potential issues are increased insomnia, anxiety, depression, or agitation. Individuals with a history of mental health conditions such as anxiety, depression, or suicidal thoughts may be at a higher risk. If you or those around you notice any changes in mood or behavior, notify your healthcare provider immediately.

There are no specific contraindications listed for Ohtuvayre (ensifentrine).

When taking this medication, some individuals might experience common side effects such as back pain, high blood pressure, urinary tract infections, and diarrhea. These effects are generally mild, but if they continue or worsen, it's important to consult a healthcare provider. Other side effects reported include toothache, pneumonia, common cold symptoms, and inflammation of the sinuses. While these are typically not severe, any persistent discomfort should be discussed with a medical professional.

There are also rare but serious side effects associated with this medication. These include sudden and severe breathing issues, such as chest tightness, difficulty breathing, or trouble swallowing. Immediate medical attention is crucial if such symptoms occur. Additionally, some patients may experience changes in mood or behavior, including anxiety, depression, suicidal thoughts, or trouble sleeping. These symptoms require urgent medical evaluation.

Although a very serious allergic reaction to this drug is uncommon, you should seek immediate medical help if you notice symptoms like a rash, itching or swelling, severe dizziness, or difficulty breathing. Always monitor your health while on this medication and promptly address any concerning changes with your healthcare provider.