4. References

  1. DRUGDEX® System (electronic version). Truven Health Analytics, Greenwood Village, Colorado, USA. Available at: http://www.micromedexsolutions.com.libproxy.uthscsa.edu/. Accessed December 6th, 2021.
  2. Clinical Pharmacology [database online]. Tampa, FL: Gold Standard, Inc.; 2021. Available at: http://www.clinicalpharmacology-ip.com.ezproxy.lib.utexas.edu/. Accessed December 6th, 2021.
  3. American Society of Health-System Pharmacists. 2021. AHFS Drug Information® - 2021st Ed. Bethesda, MD. American Society of Health-System Pharmacists®. STAT!Ref Online Electronic Medical Library. Available at:  https://online.statref.com/document/cQfe8yqMRNqgSGqm4Qo8Qj. Accessed December 6th, 2021.  
  4. Ivacaftor (Kalydeco®) package insert. Vertex Pharmaceuticals, Inc., December 2020.
  5. Vertex Pharmaceuticals News & Events Press Release. FDA approves Kalydeco (ivacaftor) as first and only CFTR modulator to treat eligible infants with CF as early as four months of age. Vertex Pharmaceuticals Inc., September 2020.
  6. Lumacaftor/ivacaftor (Orkambi®) package insert. Vertex Pharmaceuticals, Inc., July 2019.
  7. Tezacaftor/ivacaftor tablets; ivacaftor tablets (Symdeko®) package insert. Vertex Pharmaceuticals, Inc., December 2020.
  8. Vertex Pharmaceuticals News & Events Press Release. FDA announces FDA approvals of Trikafta (elexacaftor/ tezacaftor/ ivacaftor and ivacaftor), Symdeko (tezacaftor/ ivacaftor/ and ivacaftor), and Kalydeco (ivacaftor) for use in people with CF with certain rare mutations. Vertex Pharmaceuticals Inc., December 2020.
  9. U.S. Food and Drug Administration. FDA approves new breakthrough therapy for cystic fibrosis. Available at: https://www.fda.gov/news-events/press-announcements/fda-approves-new-breakthrough-therapy-cystic-fibrosis.  Accessed December 6th, 2021.
  10. Elexacaftor/tezacaftor/ivacaftor tablets; ivacaftor tablets (Trikafta®) package insert. Vertex Pharmaceuticals, Inc., October 2021.
  11. Wright CC, Vera YY. Chapter 46. Cystic fibrosis. In: DiPiro JT, Yee GC, Posey LM, et al, eds. Pharmacotherapy: a pathophysiologic approach. 11th ed. New York: McGraw-Hill; 2019. Available at:  https://accesspharmacy-mhmedical-com.ezproxy.lib.utexas.edu/content.aspx?bookid=2577&sectionid=219316881. Accessed December 6th, 2021.
  12. Simon RH. Cystic fibrosis: treatment with CFTR modulators. Post TW, ed. UpToDate. Waltham, MA: UpToDate Inc. https://www.uptodate.com (Accessed on December 6th, 2021.)
  13. Ramsey BW, Davies J, McElvaney NG, et al. A CFTR potentiator in patients with cystic fibrosis and the GG51D mutation. N Engl J Med. 2011;365(18):1663-72.
  14. Davies JC, Wainwright CE, Canny GJ, et al. Efficacy and safety of ivacaftor in patients aged 6 to 11 years with cystic fibrosis with a G551D mutation. Am J Respir Crit Care Med. 2013;187(11):1219-25.
  15. Konstan MW, McKone EF, Moss RB, et al. Assessment of safety and efficacy of long-term treatment with combination lumacaftor and ivacaftor therapy in patients with cystic fibrosis homozygous for the F508del-CFTR mutation (PROGRESS): a phase 3, extension study. Lancet Respir Med. 2017;5(2):107-18.
  16. Heltshe SL, Rowe SM, Skalland M, et al. for the GOAL Investigators of the Cystic Fibrosis Foundation Therapeutics Development Network.  Ivacaftor-treated patients with cystic fibrosis derive long-term benefit despite no short-term clinical improvement. Am J Respir Crit Care Med. 2018;197(11):1483-6.