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YUPELRI® (revefenacin) inhalation solution delivers a full 24 hours of efficacy in a single daily dose

  • YUPELRI was studied in two 12-week, randomized, double-blind, placebo-controlled, parallel-group confirmatory studies (studies 1 and 2) to evaluate the efficacy of once-daily YUPELRI vs placebo in patients with moderate to very severe COPD1

Consistent improvement in trough FEV1 vs placebo over 24 hours on days 84/851,11

  • In studies 1 and 2, a prespecified exploratory analysis was performed. In study 1, LS mean changes from baseline in FEV1 ranged from 55.8 mL to 240.4 mL in the YUPELRI group, and from -113.6 mL to 59.6 mL in the placebo group. In study 2, LS mean changes from baseline in FEV1 ranged from 19.8 mL to 148.5 mL in the YUPELRI group, and from -176.4 mL to -13.0 mL in the placebo group11
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Once-daily dosing

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Patients responded in as early as 30 minutes11

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24-hour duration

YUPELRI delivers consistent control over 12 weeks

Consistent improvements§ in trough FEV1 over the 12-week study period1,11

‡ In study 1, LS mean change from baseline in trough FEV1 on day 85 was 127 mL (YUPELRI, n=189) and -19 mL (placebo, n=191), with a statistically significant difference vs placebo of 146 mL (P<.0001). In study 2, LS mean change from baseline in trough FEV1 on day 85 was 102 mL (YUPELRI, n=181) and -45 mL (placebo, n=187), with a statistically significant difference of 147 mL (P<.0001).11

§ The first measurement was taken at 2 weeks.
‖ LS mean difference from placebo (SE) is 148.13 (16.782), pooled estimate adjusts the LS mean for placebo as well.11

Studies 1 and 2 patient characteristics1

  • Mean age 64 years (range, 41-88 years)
  • Mean smoking history of 53 pack-years; 48% current smokers
  • Moderate to very severe COPD (mean post-bronchodilator % predicted FEV1 of 55%)
  • 37% were on concomitant LABA or ICS/LABA therapy
     - The clinical relevance of combining YUPELRI with a LABA or ICS/LABA is unknown
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COPD symptom improvement

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Activities of daily living

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Social interaction

  • In study 1, the SGRQ responder rate for the YUPELRI treatment arm on day 85 was 49% compared to 34% for placebo (odds ratio=2.11; 95% CI, 1.14-3.92)1
  • In study 2, the SGRQ responder rate for the YUPELRI treatment arm was 45% compared to 39% for placebo (odds ratio=1.31; 95% CI, 0.72-2.38)1
  • The clinical relevance of the above data is unknown.

¶ SGRQ is a 100-point scale where a 4-point improvement is the minimum clinical improvement; up to 12 or more points is maximum improvement.18

Indication

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YUPELRI® inhalation solution is indicated for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD).

Important Safety Information

YUPELRI is contraindicated in patients with hypersensitivity to revefenacin or any component of this product.

YUPELRI should not be initiated in patients during acutely deteriorating or potentially life-threatening episodes of COPD, or 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 beta2-agonist.

YUPELRI® inhalation solution is indicated for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD).

Important Safety Information

YUPELRI is contraindicated in patients with hypersensitivity to revefenacin or any component of this product.

YUPELRI should not be initiated in patients during acutely deteriorating or potentially life-threatening episodes of COPD, or 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 beta2-agonist.

As with other inhaled medicines, YUPELRI can produce paradoxical bronchospasm that may be life-threatening. If paradoxical bronchospasm occurs following dosing with YUPELRI, it should be treated immediately with an inhaled, short-acting bronchodilator. YUPELRI should be discontinued immediately and alternative therapy should be instituted.

YUPELRI should be used with caution in patients with narrow-angle glaucoma. Patients should be instructed to immediately consult their healthcare provider if they develop any signs and symptoms of acute narrow-angle glaucoma, including eye pain or discomfort, blurred vision, visual halos or colored images in association with red eyes from conjunctival congestion and corneal edema.

Worsening of urinary retention may occur. Use with caution in patients with prostatic hyperplasia or bladder-neck obstruction and instruct patients to contact a healthcare provider immediately if symptoms occur.

Immediate hypersensitivity reactions may occur after administration of YUPELRI. If a reaction occurs, YUPELRI should be stopped at once and alternative treatments considered.

The most common adverse reactions occurring in clinical trials at an incidence greater than or equal to 2% in the YUPELRI group, and higher than placebo, included cough, nasopharyngitis, upper respiratory infection, headache and back pain.

Coadministration of anticholinergic medicines or OATP1B1 and OATP1B3 inhibitors with YUPELRI is not recommended.

YUPELRI is not recommended in patients with any degree of hepatic impairment.

For additional information please contact us at 800-395-3376.

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