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OHTUVAYRE® (ensifentrine) is indicated for the maintenance treatment of chronic obstructive pulmonary disease (COPD) in adult patients.
OHTUVAYRE is contraindicated in patients with hypersensitivity to ensifentrine or any component of this product.
Acute Episodes of Bronchospasm
OHTUVAYRE should not be used for the relief of acute symptoms, i.e., as rescue therapy for the treatment of acute episodes of bronchospasm. OHTUVAYRE has not been studied in the relief of acute symptoms and extra doses of OHTUVAYRE should not be used for that purpose. Acute symptoms should be treated with an inhaled, short-acting bronchodilator.
Paradoxical Bronchospasm
As with other inhaled medicines, OHTUVAYRE may produce paradoxical bronchospasm, which may be life threatening. If paradoxical bronchospasm occurs following dosing with OHTUVAYRE, it should be treated immediately with an inhaled, short-acting bronchodilator. OHTUVAYRE should be discontinued immediately and alternative therapy should be instituted.
Psychiatric Events Including Suicidality
Treatment with OHTUVAYRE is associated with an increase in psychiatric adverse reactions. Psychiatric events including suicide-related adverse reactions were reported in clinical studies in patients who received OHTUVAYRE (1 suicide attempt and 1 suicide). Additionally, the most commonly reported psychiatric adverse reactions in the pooled 24-week safety population were insomnia (6 patients [0.6%] OHTUVAYRE 3 mg; 2 patients [0.3%] placebo), and anxiety (2 patients [0.2%] OHTUVAYRE 3 mg; 1 patient [0.2%] placebo). Depression-related reactions including depression, major depression, and adjustment disorder with depressed mood occurred in 4 patients (0.4%) receiving OHTUVAYRE and no patients receiving placebo.
Before initiating treatment with OHTUVAYRE, healthcare providers should carefully weigh the risk and benefits of treatment with OHTUVAYRE in patients with a history of depression and/or suicidal thoughts or behavior. Patients, their caregivers, and families should be advised of the need to be alert for the emergence or worsening of insomnia, anxiety, depression, suicidal thoughts, or other mood changes, and if such changes occur to contact their healthcare provider. Healthcare providers should carefully evaluate the risks and benefits of continuing treatment with OHTUVAYRE if such events occur.
The most common adverse reactions ≥1% in OHTUVAYRE and greater than placebo in the pooled population in the ENHANCE-1 and ENHANCE-2 clinical trials were back pain (1.8% vs 1.0%), hypertension (1.7% vs 0.9%), urinary tract infection (1.3% vs 1.0%), and diarrhea (1.0% vs 0.7%).
These are not all of the possible risks associated with OHTUVAYRE.
The recommended dosage of OHTUVAYRE is 3 mg (one unit-dose ampule) twice daily, once in the morning and once in the evening, administered by oral inhalation using a standard jet nebulizer with a mouthpiece.
Pediatric Use
The safety and effectiveness of OHTUVAYRE have not been established in pediatric patients.
Lactation
There are no data on the presence of ensifentrine in human milk, the effects on the breastfed child, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for OHTUVAYRE and any potential adverse effects on the breastfed child from OHTUVAYRE or from the underlying maternal condition.
Geriatric Use
In clinical trials, patients aged 65 and older showed no overall differences in the safety or effectiveness of OHTUVAYRE compared with younger adults, but greater sensitivity in some older individuals cannot be ruled out.
Hepatic Impairment
Ensifentrine systemic exposure increased by 2.3-fold in subjects with moderate or severe hepatic impairment compared with healthy subjects. Use OHTUVAYRE with caution in patients with hepatic impairment.
Before prescribing OHTUVAYRE® (ensifentrine), please read the accompanying Prescribing Information. The Patient Information and Instructions for Use also are available.