febuxostat (Uloric)

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Indications

* has not been demonstrated to improve clinical outcomes[5] Contrandications: (caution)

Pregnancy category: C

Dosage

Tabs: 40 mg, 80 mg

Dosage adjustment in renal failure

* CKD stage 3 = 30-60 mL/min/1.73 m2

Pharmacokinetics

Monitor

Adverse effects

* Boxed warning: increased risk of death[11]

Drug interactions

Mechanism of action

Notes

Cost: ~$160/month (2009)

More general terms

References

  1. Prescriber's Letter 16(4): 2009 New Drug: Uloric (Febuxostat) Detail-Document#: http://prescribersletter.com/(5bhgn1a4ni4cyp2tvybwfh55)/pl/ArticleDD.aspx?li=1&st=1&cs=&s=PRL&pt=3&fpt=25&dd=250143&pb=PRL (subscription needed) http://www.prescribersletter.com
  2. Bruce SP. Febuxostat: a selective xanthine oxidase inhibitor for the treatment of hyperuricemia and gout. Ann Pharmacother 2006;40:2187-94 PMID: https://www.ncbi.nlm.nih.gov/pubmed/17132810
  3. Mayer MD et al Pharmacokinetics and pharmacodynamics of febuxostat, a new non-purine selective inhibitor of xanthine oxidase in subjects with renal impairment. Am J Ther 2005;12:22-34. PMID: https://www.ncbi.nlm.nih.gov/pubmed/15662289
  4. Jump up to: 4.0 4.1 Prescriber's Letter 17(7): 2010 Recommended Lab Monitoring for Common Medications Liver Function Test Scheduling Detail-Document#: http://prescribersletter.com/(5bhgn1a4ni4cyp2tvybwfh55)/pl/ArticleDD.aspx?li=1&st=1&cs=&s=PRL&pt=3&fpt=25&dd=260704&pb=PRL (subscription needed) http://www.prescribersletter.com
  5. Jump up to: 5.0 5.1 Geriatric Review Syllabus, 8th edition (GRS8) Durso SC and Sullivan GN (eds) American Geriatrics Society, 2013
    Geriatric Review Syllabus, 9th edition (GRS9) Medinal-Walpole A, Pacala JT, Porter JF (eds) American Geriatrics Society, 2016
  6. Jump up to: 6.0 6.1 Medical Knowledge Self Assessment Program (MKSAP) 17, 18. American College of Physicians, Philadelphia 2015, 2018.
  7. Jump up to: 7.0 7.1 Khanna D et al 2012 American College of Rheumatology guidelines for management of gout. Part 1: Systematic nonpharmacologic and pharmacologic therapeutic approaches to hyperuricemia Arthritis Care & Research, 64(10):1431-1446, October 2012 <PubMed> PMID: https://www.ncbi.nlm.nih.gov/pubmed/23024028 <Internet> http://onlinelibrary.wiley.com/doi/10.1002/acr.21772/abstract
  8. Jump up to: 8.0 8.1 Singh JA, Cleveland JD. Comparative effectiveness of allopurinol versus febuxostat for preventing incident renal disease in older adults: An analysis of Medicare claims data. Ann Rheum Dis 2017 Jun 5 PMID: https://www.ncbi.nlm.nih.gov/pubmed/28584186
  9. Jump up to: 9.0 9.1 FDA Safety Alert. Nov 15, 2017 Febuxostat (Brand Name Uloric): Drug Safety Communication - FDA to Evaluate Increased Risk of Heart-related Death. https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm585281.htm
  10. Jump up to: 10.0 10.1 Kimura K, Hosoya T, Uchida S et al. Febuxostat therapy for patients with stage 3 CKD and asymptomatic hyperuricemia: A randomized trial. Am J Kidney Dis 2018 Dec; 72:798-810. PMID: https://www.ncbi.nlm.nih.gov/pubmed/30177485 Free Article https://www.ajkd.org/article/S0272-6386(18)30834-5/fulltext
  11. Jump up to: 11.0 11.1 FDA Safety Alert. Feb 21, 2019 Uloric (febuxostat): Boxed Warning Added - Due to Increased Risk of Death with Gout Medicine. https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/UCM631824
    DA Safety Announcement. Feb 21, 2019 FDA adds Boxed Warning for increased risk of death with gout medicine Uloric (febuxostat). https://www.fda.gov/Drugs/DrugSafety/ucm631182.htm
  12. Jump up to: 12.0 12.1 Mackenzie IS et al. Long-term cardiovascular safety of febuxostat compared with allopurinol in patients with gout (FAST): A multicentre, prospective, randomised, open-label, non-inferiority trial. Lancet 2020 Nov 9; [e-pub]. PMID: https://www.ncbi.nlm.nih.gov/pubmed/33181081 https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(20)32234-0/fulltext
  13. HIGHLIGHTS OF PRESCRIBING INFORMATION ULORIC. ULORIC (febuxostat) tablets, for oral use https://general.takedapharm.com/ULORICPI