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References

  1. YUPELRI [package insert]. Morgantown, WV: Mylan Specialty LP; Nov 2018.
  2. Gardenhire DS, Burnett D, Strickland S, Myers TR. A Guide to Aerosol Delivery Devices for Respiratory Therapists. 4th ed. Irving, TX: American Association for Respiratory Care; 2017.
  3. Hanania NA, Braman S, Adams SG, et al. The role of inhalation delivery devices in COPD: perspectives of patients and health care providers. Chronic Obstr Pulm Dis. 2018;5(2):111-123.
  4. Dhand R, Dolovich M, Chipps B, et al. The role of nebulized therapy in the management of COPD: evidence and recommendations. COPD. 2012;9(1):58-72.
  5. Dolovich MB, Dhand R. Aerosol drug delivery: developments in device design and clinical use. Lancet. 2011;377(9770):1032-1045.
  6. Ibrahim M, Verma R, Garcia-Contreras L. Inhalation drug delivery devices: technology update. Med Devices (Auckl). 2015;8:131-139.
  7. Martin AR, Finlay WH. Nebulizers for drug delivery to the lungs. Expert Opin Drug Deliv. 2014;12(6):889-900.
  8. Wise RA, Acevedo RA, Anzueto AR, et al. Guiding principles for the use of nebulized long-acting beta2-agonists in patients with COPD: an expert panel consensus. Chronic Obstr Pulm Dis. 2016;4(1):7-20.
  9. Dhand R, Cavanaugh T, Skolnik N. Considerations for optimal inhaler device selection in chronic obstructive pulmonary disease. Cleve Clin J Med. 2018;85(2 suppl 1):S19-S27.
  10. Taffet GE, Donohue JF, Altman PR. Considerations for managing chronic obstructive pulmonary disease in the elderly. Clin Interv Aging. 2014;9:23-30.
  11. Data on file, Theravance Biopharma.
  12. Schnell K, Weiss CO, Lee T, et al. The prevalence of clinically-relevant comorbid conditions in patients with physiciandiagnosed COPD: a cross-sectional study using data from NHANES 1999-2008. BMC Pulm Med. 2012;12:26.
  13. Sulaiman I, Cushen B, Greene G, et al. Objective assessment of adherence to inhalers by patients with chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 2017;195(10):1333-1343.
  14. Schure MB, Borson S, Nguyen HQ, et al. Associations of cognition with physical functioning and health-related quality of life among COPD patients. Respir Med. 2016;114:46-52.
  15. Baird C, Lovell J, Johnson M, et al. The impact of cognitive impairment on self-management in chronic obstructive pulmonary disease: a systematic review. Respir Med. 2017;129:130-139.
  16. Global Initiative for Chronic Obstructive Lung Disease. Global Strategy for the Diagnosis, Management, and Prevention of Chronic Obstructive Pulmonary Disease (2019 Report). https://goldcopd.org/wpcontent/uploads/2018/11/GOLD-2019-v1.7-FINAL-14Nov2018-WMS.pdf. Accessed December 10, 2018.
  17. Mahler DA, Waterman LA, Gifford AH. Prevalence and COPD phenotype for a suboptimal peak inspiratory flow rate against the simulated resistance of the Diskus® dry powder inhaler. J Aerosol Med Pulm Drug Deliv. 2013;26(3):174-179.
  18. Sharma G, Mahler DA, Mayorga VM, et al. Prevalence of low peak inspiratory fl ow rate at discharge in patients hospitalized for COPD exacerbation. Chronic Obstr Pulm Dis. 2017;4(3):217-224.
  19. American Thoracic Society website. St. George’s Respiratory Questionnaire. https://www.thoracic.org/members/assemblies/assemblies/srn/questionaires/sgrq.php. Accessed January 4, 2019.
  20. Centers for Medicare & Medicaid Services. MLN Matters. Number MM8304. https://www.cms.gov/Research-StatisticsData-and-Systems/Monitoring-Programs/Medicare-FFS-Compliance-Programs/MedicalReview/Downloads/DetailedWrittenOrdersandFacetoFaceEncounters.pdf. Published July 1, 2013. Accessed November 19, 2018.

Indication

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YUPELRITM 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.

YUPELRITM 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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