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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 considering the use of Ohtuvayre (ensifentrine) for chronic obstructive pulmonary disease (COPD), it's important to be aware of potential interactions with other medications. Ohtuvayre has been identified to have interactions with 41 different drugs, categorized as one moderate and 40 minor interactions.

The moderate interaction involves Pretomanid, an antibiotic used to treat tuberculosis. When taken together, pretomanid may increase the levels of certain drugs in the body, potentially leading to enhanced effects or side effects. Therefore, if you're prescribed both Ohtuvayre and pretomanid, your healthcare provider may need to monitor you more closely and adjust dosages as necessary.

The minor interactions include medications such as ivacaftor (used for cystic fibrosis), Abiraterone (used for prostate cancer), and combination inhalers like Symbicort and Breyna, which contain Budesonide and Formoterol. While these interactions are considered minimal, it's still essential to inform your healthcare provider about all the medications you're taking to ensure safe and effective treatment.

Additionally, Ohtuvayre should not be mixed with other drugs in a nebulizer, as compatibility has not been established. Always use Ohtuvayre as directed and consult your healthcare provider before making any changes to your medication regimen.