Ohtuvayre (Ensifentrine) - What are the precautions for Ensifentrine?

In clinical studies ofOhtuvayre (Ensifentrine)-Ensefentine in the treatment of chronic obstructive pulmonary disease (COPD), warnings and precautions such as acute exacerbations of bronchospasm, paradoxical bronchospasm, and psychiatric events, including suicide, have emerged. Discontinue and resume at reduced dose upon recovery, or permanently discontinue based on severity.

1. Acute attack of bronchospasm

Ohtuvayre should not be used for the relief of acute symptoms, i.e. as rescue treatment for acute episodes of bronchospasm. Ohtuvayre has not been studied for relief of acute symptoms, so additional doses of Ohtuvayre should not be used for this purpose. The safety and effectiveness of Ohtuvayre in relieving acute symptoms have not been established. Acute symptoms should be treated with inhaled short-acting bronchodilators.

2. Paradoxical bronchospasm

Like other inhaled medications,Ohtuvayre may produce paradoxical bronchospasm, which may be life-threatening. If paradoxical bronchospasm occurs after taking Ohtuvayre, it should be treated immediately with an inhaled short-acting bronchodilator. Ohtuvayre should be discontinued immediately and alternative therapy instituted.

3. Psychiatric events, including suicide

Treatment withOhtuvayre is associated with an increase in psychiatric adverse effects. In clinical studies of patients treated with Ohtuvayre, psychiatric events, including suicidality-related adverse reactions, have been reported, as well as depression-related reactions, including adjustment disorders of depression, major depression, and depressed mood. Before initiating treatment with Ohtuvayre, healthcare providers should carefully weigh the risks and benefits of treatment with Ohtuvayre in patients with a history of depression and/or suicidal thoughts or behaviors. If such an event occurs, healthcare providers should carefully evaluate the risks and benefits of continued treatment with Ohtuvayre.

Reference materials:https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=e6433c98-41a0-4f99-8f7f-d0e9db6e3f40