tofacitinib (Xeljanz)

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Introduction

presumptive DMARD

Indications

* not 1st line therapy for rheumatoid arthritis (RA)

* only available ib drug for RA

Contraindications

Pregnancy category: C[7]

Dosage

Storage

  • store in orginal container (reason unclear)[4]

Monitor

Adverse effects

* also elevates HDL cholesterol[6] Box warning:

Drug interactions

Mechanism of action

Management

Notes

  • cost (2014) ~ $30,000/year[6]

More general terms

References

  1. 1.0 1.1 Fleischmann R et al Placebo-controlled trial of tofacitinib monotherapy in rheumatoid arthritis. N Engl J Med 2012 Aug 9; 367:495 PMID: https://www.ncbi.nlm.nih.gov/pubmed/22873530
    van Vollenhoven RF et al Tofacitinib or adalimumab versus placebo in rheumatoid arthritis. N Engl J Med 2012 Aug 9; 367:508 PMID: https://www.ncbi.nlm.nih.gov/pubmed/22873531
    Fox DA. Kinase inhibition - A new approach to the treatment of rheumatoid arthritis. N Engl J Med 2012 Aug 9; 367:565 PMID: https://www.ncbi.nlm.nih.gov/pubmed/22873537
  2. FDA News Release: Nov. 6, 2012 FDA approves Xeljanz for rheumatoid arthritis http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm327152.htm
  3. 3.0 3.1 Burmester GR et al. Tofacitinib (CP-690,550) in combination with methotrexate in patients with active rheumatoid arthritis with an inadequate response to tumour necrosis factor inhibitors: A randomised phase 3 trial. Lancet 2013 Feb 9; 381:451. PMID: https://www.ncbi.nlm.nih.gov/pubmed/23294500
    Miossec P. Kinase inhibition in rheumatoid arthritis: A big advance? Lancet 2013 Feb 9; 381:429. PMID: https://www.ncbi.nlm.nih.gov/pubmed/23294499
  4. 4.0 4.1 Prescriber's Letter 21(6): 2014 Oral Meds to Keep in Original Containers Detail-Document#: http://prescribersletter.com/(5bhgn1a4ni4cyp2tvybwfh55)/pl/ArticleDD.aspx?li=1&st=1&cs=&s=PRL&pt=3&fpt=25&dd=300622&pb=PRL (subscription needed) http://www.prescribersletter.com
  5. 5.0 5.1 Pfizer Drug Warning. May 13, 2014
  6. 6.0 6.1 6.2 6.3 6.4 6.5 Lee EB et al. Tofacitinib versus methotrexate in rheumatoid arthritis. N Engl J Med 2014 Jun 19; 370:2377 PMID: https://www.ncbi.nlm.nih.gov/pubmed/24941177
  7. 7.0 7.1 7.2 7.3 7.4 7.5 7.6 7.7 Medical Knowledge Self Assessment Program (MKSAP) 17, American College of Physicians, Philadelphia 2015
  8. 8.0 8.1 Coblyn JS Baricitinib Might Expand Options for Patients with Refractory Rheumatoid Arthritis NEJM Journal Watch. April 5, 2016 Massachusetts Medical Society (subscription needed) http://www.jwatch.org
  9. 9.0 9.1 Walsh N. FDA Panel Says Yes to Tofacitinib for PsA. Clear efficacy for symptoms, but radiographic progression benefit remains unclear. MedPage Today, August 03, 2017 https://www.medpagetoday.com/Rheumatology/Arthritis/67064
  10. 10.0 10.1 10.2 Gladman D, Rigby W, Azevedo VF et al Tofacitinib for Psoriatic Arthritis in Patients with an Inadequate Response to TNF Inhibitors. N Engl J Med 2017; 377:1525-1536. October 19, 2017 <PubMed> PMID: https://www.ncbi.nlm.nih.gov/pubmed/29045207 <Internet> http://www.nejm.org/doi/full/10.1056/NEJMoa1615977
  11. 11.0 11.1 Winthrop KL, Wouters AG, Choy EH et al. The safety and immunogenicity of live zoster vaccination in patients with rheumatoid arthritis before starting tofacitinib: A randomized phase II trial. Arthritis Rheumatol 2017 Oct; 69:1969 PMID: https://www.ncbi.nlm.nih.gov/pubmed/28845577
    Winthrop KL, Curtis JR, Lindsey S et al Herpes Zoster and Tofacitinib: Clinical Outcomes and the Risk of Concomitant Therapy. Arthritis Rheumatol. 2017 Oct;69(10):1960-1968. PMID: https://www.ncbi.nlm.nih.gov/pubmed/28845604
  12. 12.0 12.1 Brooks M Tofacitinib (Xeljanz) Gets FDA Nod for Ulcerative Colitis. Medscape - May 30, 2018. https://www.medscape.com/viewarticle/897365
    FDA News Release. May 30, 2018 FDA approves new treatment for moderately to severely active ulcerative colitis. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm609225.htm
  13. 13.0 13.1 13.2 FDA Safety Alert. Feb 25, 2018 Xeljanz, Xeljanz XR (tofacitinib): Safety Communication - Safety Trial Finds Increased Risk of Blood Clots in the Lungs and Death with Higher Dose in Rheumatoid Arthritis Patients.
  14. 14.0 14.1 14.2 FDA Safety Alert. July 26, 2019 Xeljanz, Xeljanz XR (tofacitinib): Drug Safety Communication - Due to an Increased Risk of Blood Clots and Death with Higher Dose. https://www.fda.gov/safety/medwatch-safety-alerts-human-medical-products/xeljanz-xeljanz-xr-tofacitinib-drug-safety-communication-due-increased-risk-blood-clots-and-death
    FDA Safety Communiscation. July 26, 2019 FDA approves Boxed Warning about increased risk of blood clots and death with higher dose of arthritis and ulcerative colitis medicine tofacitinib (Xeljanz, Xeljanz XR) https://www.fda.gov/drugs/drug-safety-and-availability/fda-approves-boxed-warning-about-increased-risk-blood-clots-and-death-higher-dose-arthritis-and
  15. 15.0 15.1 15.2 15.3 Curtis JR, Xie F, Yang S et al. Risk for herpes zoster in tofacitinib-treated rheumatoid arthritis patients with and without concomitant methotrexate and glucocorticoids. Arthritis Care Res (Hoboken) 2019 Sep; 71:1249 PMID: https://www.ncbi.nlm.nih.gov/pubmed/30295428 https://onlinelibrary.wiley.com/doi/abs/10.1002/acr.23769
  16. 16.0 16.1 FDA Safety Watch. Feb 4, 2021 Xeljanz, Xeljanz XR (tofacitinib): Drug Safety Communication - Initial Safety Trial Results Find Increased Risk of Serious Heart-related Problems and Cancer with Arthritis and Ulcerative Colitis Medicine. https://www.fda.gov/safety/medical-product-safety-information/xeljanz-xeljanz-xr-tofacitinib-drug-safety-communication-initial-safety-trial-results-find-increased
  17. 17.0 17.1 17.2 17.3 Ytterberg SR et al. Cardiovascular and cancer risk with tofacitinib in rheumatoid arthritis. N Engl J Med 2022 Jan 27; 386:316. PMID: https://www.ncbi.nlm.nih.gov/pubmed/35081280 https://www.nejm.org/doi/10.1056/NEJMoa2109927
  18. HIGHLIGHTS OF PRESCRIBING INFORMATION XELJANZ (tofacitinib) tablets, for oral use. http://labeling.pfizer.com/ShowLabeling.aspx?id=959 https://labeling.pfizer.com/ShowLabeling.aspx?id=959#BOX

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