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Ohtuvayre Safety
Profile

Ohtuvayre was well tolerated, with similar rates of adverse reactions
between the Ohtuvayre group and the placebo group throughout the
pivotal trials at 24 and 48 weeks.1,2

Discontinuation due to adverse reactions was low and similar to placebo:
  • 7.6% in the Ohtuvayre group vs 8.2% on placebo1

Adverse reactions reported in the
48-week cohort were consistent with those observed in the pooled 24-week safety population.1

Pooled Ohtuvayre Safety Profile Over 24 Weeks
(Adverse reactions ≥1% and greater than placebo)1

Adverse Reactions

Ohtuvayre
N=975 Placebo
N=574

Back Pain

1.8% 1.0%

Hyper-tension

1.7% 0.9%

Urinary Tract Infection

1.3% 1.0%

Diarrhea

1.0% 0.7%
Please see additional Warnings and Precautions within the Important Safety Information, including acute episodes of bronchospasm, paradoxical bronchospasm, and psychiatric events.

Learn about the delivery system of Ohtuvayre.

Warnings and Precautions:

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. 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 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.

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.

Adverse Reactions: The most common adverse reactions ≥1% in Ohtuvayre and greater than placebo in the pooled population were back pain 1.8%, hypertension 1.7%, urinary tract infection 1.3%, and diarrhea 1.0%.

These are not all of the possible risks associated with Ohtuvayre. Please see Full Prescribing Information for Ohtuvayre.

To report suspected adverse reactions, contact Verona Pharma, Inc. at
1-888-672-0371 or FDA at
1-800-FDA-1088 or
www.fda.gov/medwatch.

References:
1. Ohtuvayre™ (ensifentrine). Prescribing Information. Raleigh, NC: Verona Pharma plc; 2024. 2. Anzueto A, Barjaktarevic IZ, Siler TM, et al. Ensifentrine, a novel phosphodiesterase 3 and 4 inhibitor for the treatment of chronic obstructive pulmonary disease: randomized, double-blind, placebo-controlled, multicenter phase III trials (the ENHANCE Trials). Am J Respir Crit Care Med. 2023;208(4):406-416.