102
Views
5
CrossRef citations to date
0
Altmetric
Original Research

Pharmacokinetics and safety of revefenacin in subjects with impaired renal or hepatic function

ORCID Icon, ORCID Icon, , &
Pages 2305-2318 | Published online: 08 Oct 2019

References

  • Global Initiative for Chronic Obstructive Lung Disease (GOLD). Global Strategy for the Diagnosis, Management, and Prevention of Chronic Obstructive Pulmonary Disease; (2018 report) Available from: http://goldcopd.org/wp-content/uploads/2017/11/GOLD-2018-v6.0-FINAL-revised-20-Nov_WMS.pdf. Accessed 517, 2018.
  • Mejza F, Gnatiuc L, Buist AS, et al. Prevalence and burden of chronic bronchitis symptoms: results from the BOLD study. Eur Respir J. 2017;50(5):1700621. doi:10.1183/13993003.00711-201729167298
  • Naud J, Nolin TD, Leblond FA, Pichette V. Current understanding of drug disposition in kidney disease. J Clin Pharmacol. 2012;52(1 Suppl):10s–22s. doi:10.1177/009127001141358822232747
  • Bonini M, Usmani OS. The importance of inhaler devices in the treatment of COPD. COPD Res Pract. 2015;1(1):9. doi:10.1186/s40749-015-0011-0
  • Dhand R, Dolovich M, Chipps B, Myers TR, Restrepo R, Farrar JR. The role of nebulized therapy in the management of COPD: evidence and recommendations. COPD. 2012;9(1):58–72. doi:10.3109/15412555.2011.63004722292598
  • Tashkin DP. A review of nebulized drug delivery in COPD. Int J Chron Obstruct Pulmon Dis. 2016;11:2585–2596. doi:10.2147/COPD.S11403427799757
  • Pudi KK, Barnes CN, Moran EJ, Haumann B, Kerwin E. A 28-day, randomized, double-blind, placebo-controlled, parallel group study of nebulized revefenacin in patients with chronic obstructive pulmonary disease. Respir Res. 2017;18(1):182. doi:10.1186/s12931-017-0647-129096627
  • Quinn D, Barnes CN, Yates W, et al. Pharmacodynamics, pharmacokinetics and safety of revefenacin (TD-4208), a long-acting muscarinic antagonist, in patients with chronic obstructive pulmonary disease (COPD): results of two randomized, double-blind, phase 2 studies. Pulm Pharmacol Ther. 2018;48:71–79. doi:10.1016/j.pupt.2017.10.00328987804
  • Ferguson GT, Feldman G, Pudi KK, et al. Improvements in lung function with nebulized revefenacin in the treatment of patients with moderate to very severe COPD: results from two replicate phase III clinical trials. Chronic Obstr Pulm Dis. 2019;6:154–165. doi:10.15326/jcopdf.6.2.2018.015230974049
  • Donohue JF, Kerwin E, Sethi S, et al. Revefenacin, a once-daily, lung-selective, long-acting muscarinic antagonist for nebulized therapy: safety and tolerability results of a 52-week phase 3 trial in moderate to very severe chronic obstructive pulmonary disease. Respir Med. 2019;153:38–43.31150963
  • YUPELRI (revefenacin) Inhalation Solution, for Oral Inhalation [prescribing Information]. Morgantown, WV: Mylan Speciality L.P.; 2018 Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210598s000lbl.pdf. Accessed November 16, 2018.
  • Bourdet D, Yeola S, Colson P-J, Pendyala S, Barnes C, Borin M. Absorption, distribution, metabolism, and excretion of revefenacin, a long-acting muscarinic antagonist, in healthy male subjects. Presented at: Annual American Thoracic Society International Conference; May 18–23; 2018; San Diego, CA.
  • Dreisbach AW. The influence of chronic renal failure on drug metabolism and transport. Clin Pharmacol Ther. 2009;86(5):553–556. doi:10.1038/clpt.2009.16319776735
  • Zhang Y, Zhang L, Abraham S, et al. Assessment of the impact of renal impairment on systemic exposure of new molecular entities: evaluation of recent new drug applications. Clin Pharmacol Ther. 2009;85(3):305–311. doi:10.1038/clpt.2008.20819020495
  • Lin S, Smith BS. Drug dosing considerations for the critically ill patient with liver disease. Crit Care Nurs Clin North Am. 2010;22(3):335–340. doi:10.1016/j.ccell.2010.04.00620691384
  • Palatini P, De Martin S. Pharmacokinetic drug interactions in liver disease: an update. World J Gastroenterol. 2016;22(3):1260–1278. doi:10.3748/wjg.v22.i37.831426811663
  • Verbeeck RK, Horsmans Y. Effect of hepatic insufficiency on pharmacokinetics and drug dosing. Pharm World Sci. 1998;20(5):183–192. doi:10.1023/A:10086569300829820880
  • International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). Integrated addendum to ICH E6(R1): Guideline for Good Clinical Practice. E6 (R2); 6 11, 2015 Available from: https://goo.gl/CFOmR3. Accessed 720, 2017.
  • World Medical Association. World medical association declaration of helsinki: ethical principles for medical research involving human subjects. JAMA. 2013;310(20):2191–2194. doi:10.1001/jama.2013.28105324141714
  • Lo A, Borin MT, Bourdet DL. Sequential modeling of the population pharmacokinetics of revefenacin and its major metabolite in COPD patients. Presented at: American Conference on Pharmacometrics; October 14–19, 2018; San Diego, CA.
  • International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. ICH Harmonised Tripartite Guideline: Guideline for Good Clinical Practice E6(R1); 6 10, 1996 Available from: https://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E6/E6_R1_Guideline.pdf. Accessed 105, 2018.
  • US Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER). Guidance for Industry: Pharmacokinetics in Patients with Impaired Renal Function — Study Design, Data Analysis, and Impact on Dosing and Labeling; 3, 2010 Available from: https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM204959.pdf. Accessed 125, 2018.
  • Bjermer L, Kuna P, Jorup C, Bengtsson T, Rosenborg J. Clinical pharmacokinetics of AZD3199, an inhaled ultra-long-acting beta2-adrenoreceptor agonist (uLABA). Drug Des Devel Ther. 2015;9:753–762. doi:10.2147/DDDT.S66049
  • Borghardt JM, Weber B, Staab A, Kunz C, Kloft C. Model-based evaluation of pulmonary pharmacokinetics in asthmatic and COPD patients after oral olodaterol inhalation. Br J Clin Pharmacol. 2016;82(3):739–753. doi:10.1111/bcp.1297527145733
  • Brutsche MH, Brutsche IC, Munawar M, et al. Comparison of pharmacokinetics and systemic effects of inhaled fluticasone propionate in patients with asthma and healthy volunteers: a randomised crossover study. Lancet. 2000;356(9229):556–561. doi:10.1016/S0140-6736(00)02581-210950233
  • Dalby C, Polanowski T, Larsson T, Borgström L, Edsbäcker S, Harrison TW. The bioavailability and airway clearance of the steroid component of budesonide/formoterol and salmeterol/fluticasone after inhaled administration in patients with COPD and healthy subjects: a randomized controlled trial. Respir Res. 2009;10:104. doi:10.1186/1465-9921-10-3119878590
  • Ferguson G, Pudi KK, Feldmann G, et al. Efficacy and safety of revefenacin (REV), a long-acting muscarinic antagonist for nebulization: results of replicate randomized, double-blind, placebo-controlled, parallel-group phase 3 trials in participants with moderate to very severe COPD. Eur Respir J. 2017;50(Suppl 61):PA1812. doi:10.1183/13993003.00711-2017
  • US Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER). Guidance for Industry: Pharmacokinetics in Patients with Impaired Hepatic Function — Study Design, Data Analysis, and Impact on Dosing and Labeling; 5, 2003 https://www.fda.gov/media/71311/download. Accessed 726, 2019.
  • European Medicines Agency. Guideline on the evaluation of the pharmacokinetics of medicinal products in patients with decreased renal function; 2014; https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-evaluation-pharmacokinetics-medicinal-products-patients-decreased-renal-function_en.pdf. Accessed 726, 2019.
  • European Medicines Agency. Guideline on the Evaluation of the Pharmacokinetics of Medicinal Products in Patients with Impaired Hepatic Function; 2005; https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-evaluation-pharmacokinetics-medicinal-products-patients-impaired-hepatic-function_en.pdf. Accessed 726, 2019.