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OHTUVAYRE TRIALS EVALUATED

Lung function, safety, and 
health-related quality of life

Study design

The ENHANCE studies were pivotal phase 3 trials that enrolled a broad population of symptomatic adult patients with moderate to severe COPD1

The graphic shows a bar graph of parallel-group clinical trials: ENHANCE-1 and ENHANCE-2 spanning 24 weeks. A subset of ENHANCE-1 patients was evaluated for 48 weeks. The graphic depicts a horizontal x-axis with text markers and dotted lines of 0 weeks, 12 weeks, 24 weeks, and 48 weeks. In between the 24 weeks and 48 weeks text markers is the title, “ENHANCE-1 Safety Cohort.” The vertical y-axis labels the ENHANCE-1 N=763, R 5:3, in navy blue, and ENHANCE-2 N=790, R 5:3, in purple. The top bar on the x-axis is in the ENHANCE-1 navy blue category and is navy blue in color. It is labeled “OHTUVAYRE 3 mg BID n=477b” and begins at zero weeks and ends at 48 weeks. The bar originates at 0 weeks, reaches as a solid bar to 24 weeks, then extends further as a thinner bar from 24 to 48 weeks. The second to top bar on the x-axis is in the ENHANCE-1 navy blue category and is gray in color. It is labeled “Placebo BID n=282b” and begins at zero weeks and ends at 48 weeks. The bar originates at 0 weeks, reaches as a solid bar to 24 weeks, then extends further as a thinner bar from 24 to 48 weeks. The third bar from the top on the x-axis is in the ENHANCE-2 purple category and is purple in color. It is labeled “OHTUVAYRE 3 mg BID n=498b” and begins at zero weeks and ends at 24 weeks. The fourth bar from the top on the x-axis is in the ENHANCE-2 purple category and is gray in color. It is labeled “Placebo BID n=291b” and begins at zero weeks and ends at 24 weeks.
The graphic shows a bar graph of parallel-group clinical trials: ENHANCE-1 and ENHANCE-2 spanning 24 weeks. A subset of ENHANCE-1 patients was evaluated for 48 weeks. The graphic depicts a horizontal x-axis with text markers and dotted lines of 0 weeks, 12 weeks, 24 weeks, and 48 weeks. In between the 24 weeks and 48 weeks text markers is the title, “ENHANCE-1 Safety Cohort.” The vertical y-axis labels the ENHANCE-1 N=763, R 5:3, in navy blue, and ENHANCE-2 N=790, R 5:3, in purple. The top bar on the x-axis is in the ENHANCE-1 navy blue category and is navy blue in color. It is labeled “OHTUVAYRE 3 mg BID n=477b” and begins at zero weeks and ends at 48 weeks. The bar originates at 0 weeks, reaches as a solid bar to 24 weeks, then extends further as a thinner bar from 24 to 48 weeks. The second to top bar on the x-axis is in the ENHANCE-1 navy blue category and is gray in color. It is labeled “Placebo BID n=282b” and begins at zero weeks and ends at 48 weeks. The bar originates at 0 weeks, reaches as a solid bar to 24 weeks, then extends further as a thinner bar from 24 to 48 weeks. The third bar from the top on the x-axis is in the ENHANCE-2 purple category and is purple in color. It is labeled “OHTUVAYRE 3 mg BID n=498b” and begins at zero weeks and ends at 24 weeks. The fourth bar from the top on the x-axis is in the ENHANCE-2 purple category and is gray in color. It is labeled “Placebo BID n=291b” and begins at zero weeks and ends at 24 weeks.
The graphic shows a bar graph of parallel-group clinical trials: ENHANCE-1 and ENHANCE-2 spanning 24 weeks. A subset of ENHANCE-1 patients was evaluated for 48 weeks. The graphic depicts a horizontal x-axis with text markers and dotted lines of 0 weeks, 12 weeks, 24 weeks, and 48 weeks. In between the 24 weeks and 48 weeks text markers is the title, “ENHANCE-1 Safety Cohort.” The vertical y-axis labels the ENHANCE-1 N=763, R 5:3, in navy blue, and ENHANCE-2 N=790, R 5:3, in purple. The top bar on the x-axis is in the ENHANCE-1 navy blue category and is navy blue in color. It is labeled “OHTUVAYRE 3 mg BID n=477b” and begins at zero weeks and ends at 48 weeks. The bar originates at 0 weeks, reaches as a solid bar to 24 weeks, then extends further as a thinner bar from 24 to 48 weeks. The second to top bar on the x-axis is in the ENHANCE-1 navy blue category and is gray in color. It is labeled “Placebo BID n=282b” and begins at zero weeks and ends at 48 weeks. The bar originates at 0 weeks, reaches as a solid bar to 24 weeks, then extends further as a thinner bar from 24 to 48 weeks. The third bar from the top on the x-axis is in the ENHANCE-2 purple category and is purple in color. It is labeled “OHTUVAYRE 3 mg BID n=498b” and begins at zero weeks and ends at 24 weeks. The fourth bar from the top on the x-axis is in the ENHANCE-2 purple category and is gray in color. It is labeled “Placebo BID n=291b” and begins at zero weeks and ends at 24 weeks.

aN, number of all enrolled patients.

bn, number of patients who received at least one dose of study drug and had non-missing FEV1 value.

Safety of OHTUVAYRE was based on the pooled safety population for 24 weeks in ENHANCE-1 and ENHANCE-2 and on a 48-week cohort (OHTUVAYRE, n=280; placebo, n=89) in ENHANCE-1.

Overview

The ENHANCE Trials were designed to evaluate the efficacy and safety of OHTUVAYRE in patients with moderate to severe COPD in two 24-week randomized, double-blind, placebo-controlled, parallel-group clinical studies. After a 28-day run-in to ensure stable background medication use, a total of 1553 adults (763 in ENHANCE-1, 790 in ENHANCE-2) were randomized 5:3 to receive 3 mg of OHTUVAYRE or placebo twice daily administered by oral inhalation via standard jet nebulizer.1

ENHANCE-1

The ENHANCE-1 trial enrolled a total of 763 patients randomized to receive 3 mg of OHTUVAYRE or placebo twice daily administered by oral inhalation via standard jet nebulizer. A total of 68% of patients were taking concurrent therapy: 30% taking concurrent LAMA, 18% taking concurrent LABA, and 20% taking concurrent LABA/ICS therapy throughout the trial. A subset of patients was evaluated for 48 weeks.

ENHANCE-2

The ENHANCE-2 trial enrolled a total of 790 patients randomized to receive 3 mg of OHTUVAYRE or placebo twice daily administered by oral inhalation via standard jet nebulizer. A total of 55% of patients were taking concurrent therapy: 33% taking concurrent LAMA, 7% taking concurrent LABA, and 15% taking concurrent LABA/ICS therapy throughout the trial.

Patients were allowed to remain in the trials after treatment discontinuation.1

cSelected inclusion/exclusion criteria.
BID, twice daily; COPD, chronic obstructive pulmonary disease; ENHANCE, Ensifentrine as a Novel inHAled Nebulized COPD thErapy; FEV1, forced expiratory volume in one second; FVC, forced vital capacity; ICS, inhaled corticosteroids; LABA, long-acting beta2-agonist; LAMA, long-acting muscarinic antagonist; mMRC, modified Medical Research Council dyspnea scale; R, randomization.

Patients1

Selected eligibility criteriac:

  • COPD diagnosis: FEV1/FVC<0.71
  • Post-bronchodilator FEV1 30-70% predicted normal1
  • mMRC dyspnea scale score ≥21
  • Current smoker or smoking history (≥10 pack-years)1
  • No asthma diagnosis1
  • No exacerbation requiring oral or parenteral steroids in the 3 months prior to screening1,2

Selected baseline characteristics:

  • Approximately 62% of patients were on maintenance background therapy, which primarily included LAMA, LABA, or LABA + ICS1
  • ~38% weren’t currently on concomitant maintenance COPD therapy1
  • In the ENHANCE-1 and ENHANCE-2 trials, 25% and 21% of patients, respectively, reported exacerbations of COPD within the 15 months prior to the studies

Primary endpoint

Change from baseline in FEV1 AUC0-12h at Week 12a

Significantly improved lung function as demonstrated by average FEV1 AUC0-12h

The vertical y-axis of this graph is labeled, “LS Mean Change from Baseline FEV1 AUCo-12h(mL).” The y-axis numbers begin at -60 from the bottom of the graph and end at 80 at the top of the graph, counting up from -60 to 80 in increments of ten. The horizontal x-axis label of the graph gives two different title labels to four bar graphs, two of which are grouped under the title “ENHANCE-1” on a navy blue background with white text, and two of which are grouped under the title “ENHANCE-2” on a purple background with white text. Underneath the graph is a color label. Solid gray color indicates Placebo bars, and a light blue to dark blue gradient color indicates OHTUVAYRE bars. The first bar under the ENHANCE-1 grouping is labeled, “Placebo (n=282)b”. This placebo bar is colored in solid gray. Within the solid gray placebo bar illustration is the number “-26” in white text on the gray color of the bar. The ENHANCE-1 gray placebo bar begins at zero (of the y-axis) and extends downward to slightly more than halfway between -20 and -30 positions on the y-axis, illustrating its -26 position. The second bar, to its right, within the ENHANCE-1 grouping, is a light blue to dark blue gradient colored bar labeled, “OHTUVAYRE (n=477)b”. Within the blue gradient OHTUVAYRE bar illustration is the number “61” in white text on the gradient blue color of the bar. The ENHANCE-1 blue OHTUVAYRE bar begins at zero and extends upwards to just above the 60 position on the y-axis, illustrating its 61 position. In between the placebo bar and the OHTUVAYRE bar is a dotted line, extending from the -26 position upwards to the 61 position. Toward the top portion of this dotted line is a callout bubble, with a light purple background and dark purple text. The text reads, “+87 mL LS Mean Difference from Placebo p<0.0001.” The third bar on this graph, which is underneath the ENHANCE-2 grouping is labeled, “Placebo (n=291)b.” This placebo bar is colored in solid gray. Within the solid gray placebo bar illustration is the number “-46” in white text on the gray color of the bar. The ENHANCE-2 placebo bar begins at zero (of the y-axis) and extends downward to slightly more than halfway between -40 and -50 positions on the y-axis, illustrating its -46 position. The fourth bar on this graph, to its right, within the ENHANCE-2 grouping, is a light blue to dark blue gradient colored bar labeled, “OHTUVAYRE (n=498)b”. Within the blue gradient OHTUVAYRE bar illustration is the number “48” in white text on the gradient blue color of the bar. The ENHANCE-2 OHTUVAYRE bar begins at zero and extends upwards to just below the 50 position on the y-axis, illustrating its 48 position. In between the placebo bar and the OHTUVAYRE bar is a dotted line, extended from the -46 position upwards to the 48 position. Toward the top portion of this dotted line is a callout bubble, with a light purple background and dark purple text. The text reads, “+94 mL LS Mean Difference from Placebo p<0.0001.”
The vertical y-axis of this graph is labeled, “LS Mean Change from Baseline FEV1 AUCo-12h(mL).” The y-axis numbers begin at -60 from the bottom of the graph and end at 80 at the top of the graph, counting up from -60 to 80 in increments of ten. The horizontal x-axis label of the graph gives two different title labels to four bar graphs, two of which are grouped under the title “ENHANCE-1” on a navy blue background with white text, and two of which are grouped under the title “ENHANCE-2” on a purple background with white text. Underneath the graph is a color label. Solid gray color indicates Placebo bars, and a light blue to dark blue gradient color indicates OHTUVAYRE bars. The first bar under the ENHANCE-1 grouping is labeled, “Placebo (n=282)b”. This placebo bar is colored in solid gray. Within the solid gray placebo bar illustration is the number “-26” in white text on the gray color of the bar. The ENHANCE-1 gray placebo bar begins at zero (of the y-axis) and extends downward to slightly more than halfway between -20 and -30 positions on the y-axis, illustrating its -26 position. The second bar, to its right, within the ENHANCE-1 grouping, is a light blue to dark blue gradient colored bar labeled, “OHTUVAYRE (n=477)b”. Within the blue gradient OHTUVAYRE bar illustration is the number “61” in white text on the gradient blue color of the bar. The ENHANCE-1 blue OHTUVAYRE bar begins at zero and extends upwards to just above the 60 position on the y-axis, illustrating its 61 position. In between the placebo bar and the OHTUVAYRE bar is a dotted line, extending from the -26 position upwards to the 61 position. Toward the top portion of this dotted line is a callout bubble, with a light purple background and dark purple text. The text reads, “+87 mL LS Mean Difference from Placebo p<0.0001.” The third bar on this graph, which is underneath the ENHANCE-2 grouping is labeled, “Placebo (n=291)b.” This placebo bar is colored in solid gray. Within the solid gray placebo bar illustration is the number “-46” in white text on the gray color of the bar. The ENHANCE-2 placebo bar begins at zero (of the y-axis) and extends downward to slightly more than halfway between -40 and -50 positions on the y-axis, illustrating its -46 position. The fourth bar on this graph, to its right, within the ENHANCE-2 grouping, is a light blue to dark blue gradient colored bar labeled, “OHTUVAYRE (n=498)b”. Within the blue gradient OHTUVAYRE bar illustration is the number “48” in white text on the gradient blue color of the bar. The ENHANCE-2 OHTUVAYRE bar begins at zero and extends upwards to just below the 50 position on the y-axis, illustrating its 48 position. In between the placebo bar and the OHTUVAYRE bar is a dotted line, extended from the -46 position upwards to the 48 position. Toward the top portion of this dotted line is a callout bubble, with a light purple background and dark purple text. The text reads, “+94 mL LS Mean Difference from Placebo p<0.0001.”
The vertical y-axis of this graph is labeled, “LS Mean Change from Baseline FEV1 AUCo-12h(mL).” The y-axis numbers begin at -60 from the bottom of the graph and end at 80 at the top of the graph, counting up from -60 to 80 in increments of ten. The horizontal x-axis label of the graph gives two different title labels to four bar graphs, two of which are grouped under the title “ENHANCE-1” on a navy blue background with white text, and two of which are grouped under the title “ENHANCE-2” on a purple background with white text. Underneath the graph is a color label. Solid gray color indicates Placebo bars, and a light blue to dark blue gradient color indicates OHTUVAYRE bars. The first bar under the ENHANCE-1 grouping is labeled, “Placebo (n=282)b”. This placebo bar is colored in solid gray. Within the solid gray placebo bar illustration is the number “-26” in white text on the gray color of the bar. The ENHANCE-1 gray placebo bar begins at zero (of the y-axis) and extends downward to slightly more than halfway between -20 and -30 positions on the y-axis, illustrating its -26 position. The second bar, to its right, within the ENHANCE-1 grouping, is a light blue to dark blue gradient colored bar labeled, “OHTUVAYRE (n=477)b”. Within the blue gradient OHTUVAYRE bar illustration is the number “61” in white text on the gradient blue color of the bar. The ENHANCE-1 blue OHTUVAYRE bar begins at zero and extends upwards to just above the 60 position on the y-axis, illustrating its 61 position. In between the placebo bar and the OHTUVAYRE bar is a dotted line, extending from the -26 position upwards to the 61 position. Toward the top portion of this dotted line is a callout bubble, with a light purple background and dark purple text. The text reads, “+87 mL LS Mean Difference from Placebo p<0.0001.” The third bar on this graph, which is underneath the ENHANCE-2 grouping is labeled, “Placebo (n=291)b.” This placebo bar is colored in solid gray. Within the solid gray placebo bar illustration is the number “-46” in white text on the gray color of the bar. The ENHANCE-2 placebo bar begins at zero (of the y-axis) and extends downward to slightly more than halfway between -40 and -50 positions on the y-axis, illustrating its -46 position. The fourth bar on this graph, to its right, within the ENHANCE-2 grouping, is a light blue to dark blue gradient colored bar labeled, “OHTUVAYRE (n=498)b”. Within the blue gradient OHTUVAYRE bar illustration is the number “48” in white text on the gradient blue color of the bar. The ENHANCE-2 OHTUVAYRE bar begins at zero and extends upwards to just below the 50 position on the y-axis, illustrating its 48 position. In between the placebo bar and the OHTUVAYRE bar is a dotted line, extended from the -46 position upwards to the 48 position. Toward the top portion of this dotted line is a callout bubble, with a light purple background and dark purple text. The text reads, “+94 mL LS Mean Difference from Placebo p<0.0001.”

aAverage FEV1 AUC0-12h is defined as the AUC over 12 hours of the FEV1, divided by 12 hours.1
bn, number of patients who received at least one dose of study drug and had non-missing baseline FEV1 value.

AUC, area under the curve; ENHANCE, Ensifentrlne as a Novel inHAled Nebulized COPD thErapy; FEV1, forced expiratory volume in one second; mL, milliliter.

Learn about the delivery system of OHTUVAYRE.

Go to dosage and administration

Take a look at the safety profile of OHTUVAYRE.

Go to safety

References

  1. 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. doi:10.1164/rccm.202306-0944OC
  2. Identifier: NCT04542057. A phase 3 trial to evaluate the safety and efficacy of ensifentrine in patients with COPD. ClinicalTrials.gov. Last update posted October 16, 2023. Accessed April 27, 2026. https://clinicaltrials.gov/study/NCT004542057

INDICATION

OHTUVAYRE® (ensifentrine) is indicated for the maintenance treatment of chronic obstructive pulmonary disease (COPD) in adult patients.

SELECT SAFETY INFORMATION

CONTRAINDICATIONS

OHTUVAYRE is contraindicated in patients with hypersensitivity to ensifentrine or any component of this product.

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. 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.

ADVERSE REACTIONS

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.

DOSAGE AND ADMINISTRATION

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.

SPECIAL POPULATIONS

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.

 

INDICATION
SELECT SAFETY INFORMATION

OHTUVAYRE® (ensifentrine) is indicated for the maintenance treatment of chronic obstructive pulmonary disease (COPD) in adult patients.

SELECT SAFETY INFORMATION

CONTRAINDICATIONS

OHTUVAYRE is contraindicated in patients with hypersensitivity to ensifentrine or any component of this product.

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. 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.

ADVERSE REACTIONS

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.

DOSAGE AND ADMINISTRATION

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.

SPECIAL POPULATIONS

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.