Formulary drug reviews: Dimethyl fumarate

Hospital Pharmacy

Volumn 48, Issue 8, 2013, Pages 668-679

  Cada, Dennis ^a   Levien, Terri ^b   Baker, Danial ^b  

^a Facts and Comparisons   (United States)

^b WASHINGTON STATE UNIVERSITY   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

4 AMINOPYRIDINE; ALEMTUZUMAB; BETA INTERFERON; BETA1A INTERFERON; CLADRIBINE; DACLIZUMAB; EMPAGLIFLOZIN; FINGOLIMOD; FUMARIC ACID DIMETHYL ESTER; GLATIRAMER; INTERFERON BETA SERINE; LAQUINIMOD; MITOXANTRONE; NATALIZUMAB; OCRELIZUMAB; PAROXETINE; SIMEPREVIR; TERIFLUNOMIDE; TRAMETINIB;

AREA UNDER THE CURVE; ARTICLE; BOOK; DRUG FORMULARY; DRUG HALF LIFE; DRUG INDICATION; DRUG METABOLISM; DRUG UTILIZATION; EXPANDED DISABILITY STATUS SCALE; HOSPITAL PHARMACY; HUMAN; MAXIMUM PLASMA CONCENTRATION; MULTICENTER STUDY (TOPIC); MULTIPLE SCLEROSIS; PHASE 1 CLINICAL TRIAL (TOPIC); PHASE 3 CLINICAL TRIAL (TOPIC); TIME TO MAXIMUM PLASMA CONCENTRATION;

EID: 84884575826     PISSN: 00185787     EISSN: 19451253     Source Type: Journal    
DOI: 10.1310/hpj4808-668     Document Type: Article

References (42)

1. Tecfidera [package insert]. Cambridge, MA: Biogen Idec Inc; March 2013.
2. Temple R. NDA approval letter: Tecfidera (dimethyl fumarate NDA 204063). US Food and Drug Administration Web site. http://www.accessdata.fda.gov/ drugsatfda-docs/ appletter/2013/204063Orig1s000ltr.pdf. Published March 27, 2013. Accessed April 4, 2013.
3. Aubagio [package insert]. Cambridge, MA: Genzyme Corporation; September 2012.
4. Gilenya [package insert]. East Hanover, NJ: Novartis Pharmaceuticals Corporation; May 2012.
5. Goldenberg MM. Multiple sclerosis review. P T. 2012; 37(3):175-184.
6. Rammohan KW, Shoemaker J. Emerging multiple sclerosis oral therapies. Neurology. 2010;74(Suppl 1):S47-S53.
7. Gold R. Oral therapies for multiple sclerosis: A review of agents in phase III development or recently approved. CNS Drugs. 2011;25(1):37-52.
8. Killestein J, Rudick RA, Polman CH. Oral treatment for multiple sclerosis. Lancet Neurol. 2011;10(11):1026-1034.
9. Perumal J, Khan O. Emerging disease-modifying therapies in multiple sclerosis [published online March 18, 2012]. Curr Treat Options Neurol. 2012;14(3):256-263.
10. Fox EJ, Rhoades RW. New treatments and treatment goals for patients with relapsing-remitting multiple sclerosis. Curr Opin Neurol. 2012;25(Suppl):S11- S19.
11. Minagar A. Current and future therapies for multiple sclerosis. Scientifica. 2013;(2013). doi: 10.1155/2013/249101.
12. Thö ne J, Ellrichmann G. Oral available agents in the treatment of relapsing remitting multiple sclerosis: An overview of merits and culprits. Drug Healthc Patient Saf. 2013;5: 37-47.
13. Jeffery DR. Recent advances in treating multiple sclerosis: Efficacy, risks and place in therapy. Ther Adv Chronic Dis. 2013;4(1):45-51.
14. Giovannoni G, Rhoades RW. Individualizing treatment goals and interventions for people with MS. Curr Opin Neurol. 2012;25(Suppl):S20-S27.
15. Miller AE, Rhoades RW. Treatment of relapsing-remitting multiple sclerosis: Current approaches and unmet needs. Curr Opin Neurol. 2012;25(Suppl):S4-S10.
16. Albrecht P, Bouchachia I, Goebels N, et al. Effects of dimethyl fumarate on neuroprotection and immunomodulation. J Neuroinflammation. 2012;9:163.
17. Moharregh-Khiabani D, Linker RA, Gold R, Stangel M. Fumaric acid and its esters: An emerging treatment of multiple sclerosis. Curr Neuropharmacol. 2009;7(1):60-64.
18. Schilling S, Goelz S, Linker R, Luehder F, Gold R. Fumaric acid esters are effective in chronic experimental autoimmune encephalomyelitis and suppress macrophage infiltration. Clin Exp Immunol. 2006;145(1):101-107.
19. Gold R, Linker RA, Stangel M. Fumaric acid and its esters: An emerging treatment for multiple sclerosis with antioxidative mechanism of action. Clin Immunol. 2012;142(1): 44-48.
20. Schimrigk S, Brune N, Hellwig K, et al. Oral fumaric acid esters for the treatment of active multiple sclerosis: An openlabel, baseline-controlled pilot study. Eur J Neurol. 2006; 13(6):604-610.
21. Haiyan P, Elif A, Mireia G, David P, Amy LR, Michael R. The dual function of dimethyl fumarate in multiple sclerosis [abstract]. J Neuroimmunol. 2010;228(1-2):98.
22. Lukashev M, Zeng W, Ryan S, et al. BG00012 (dimethyl fumarate) for the treatment of multiple sclerosis: Evidence for a distinct dual neuroprotective and anti-inflammatory therapeutic modality [abstract]. J Neurology. 2008;255(Suppl 2): 210.
23. Kappos K, Gold R, Miller DH, et al; BG-12 Phase IIb Study Investigators. Efficacy and safety of oral fumarate in patients with relapsing-remitting multiple sclerosis: A multicentre, randomised, double-blind, placebo-controlled phase IIb study [published correction appears in Lancet. 2009;373(9672): 1340]. Lancet. 2008;372(9648):1463-1472.
24. Kappos L, Gold R, Miller DH, et al. Effect of BG-12 on contrast-enhancing lesions in patients with relapsing-remitting multiple sclerosis: Subgroup analyses from the phase 2b study. Mult Scler. 2012;18(3):314-321.
25. MacManus DG, Miller DH, Kappos L, et al. BG-12 reduces evolution of new enhancing lesions to T1-hypointense lesions in patients with multiple sclerosis. J Neurol. 2011; 258(3):449-456.
26. Dimethyl fumarate. ClinicalTrials.gov Web site. http:// www.clinicaltrials.gov. Published March 28, 2012. Accessed March 28, 2012.
27. Gold R, Fox R, Dawson K, O'Neill G, Yang M, Panzara M. Two phase 3 studies to determine the efficacy and safety of BG00012, a novel, oral fumaric acid derivative, in patients with relapsing multiple sclerosis [abstract]. Mult Scler. 2007; 13:S173.
28. Arnold DL, Gold R, Kappos L, et al. Effect of BG-12 on brain atrophy and lesions volume: MRI results from the DEFINE study during first and second year of treatment [abstract]. 64th American Academy of Neurology Annual Meeting; April 21-28, 2012; New Orleans, LA. Abstract IN3-2.002.
29. Agarwal S, Kappos L, Gold R, et al. Effects of BG-12 on quality of life in patients with relapsing-remitting multiple sclerosis: Findings from the DEFINE study [abstract]. 64th American Academy of Neurology Annual Meeting; April 21-28, 2012; New Orleans, LA. Abstract P07-102.
30. Gold R, Kappos L, Arnold DL, et al; DEFINE study Investigators. Placebo-controlled phase 3 study of oral BG-12 for relapsing multiple sclerosis [published correction appears in N Engl J Med. 2012;367(24):2362]. N Engl J Med. 2012; 367(12):1098-1107.
31. Bar-Or A, Gold R, Kappos L, et al. Effect of BG-12 in subgroups of patients with relapsing-remitting multiple sclerosis: Findings from the DEFINE study [abstract]. 64th American Academy of Neurology Annual Meeting; April 21-28, 2012; New Orleans, LA. Abstract P01.130.
32. Giovannoni G, Gold R, Kappos L, et al. BG-12 increases the proportion of patients free of clinical and radiologic disease activity in relapsing-remitting multiple sclerosis: Findings from the DEFINE study [abstract]. 64th American Academy of Neurology Annual Meeting; April 21-28, 2012; New Orleans, LA. Abstract PD5.005.
33. Fox R, Miller D, Phillips JT, et al. Clinical efficacy of BG-12 in relapsing-remitting multiple sclerosis (RRMS): Data from the phase 3 CONFIRM study [abstract]. 64th American Academy of Neurology Annual Meeting; April 21-28; New Orleans, LA. Abstract S01.003.
34. Phillips JT, Fox R, Miller D, et al. Safety and tolerability of BG-12 in patients with relapsing-remitting multiple sclerosis (RRMS): Analyses from the CONFIRM study [abstract]. 64th American Academy of Neurology Annual Meeting; April 21-28, 2012; New Orleans, LA. Abstract S41.005.
35. Miller D, Fox R, Phillips JT, et al. Effects of BG-12 on magnetic resonance imaging (MRI) endpoints in patients with relapsing-remitting multiple sclerosis (RRMS): Data from the phase 3 CONFIRM study [abstract]. 64th American Academy of Neurology Annual Meeting; April 21-28, 2012; New Orleans, LA. Abstract S11.001.
36. Fox R, Miller DH, Phillips JT, et al; CONFIRM Study Investigators. Placebo-controlled phase 3 study of oral BG-12 or glatiramer in multiple sclerosis [published correction appears in N Engl J Med. 2012;367(17):1673]. N Engl J Med. 2012;367(12):1087-1097.
37. Sheikh S, Nestorov I, Russell H, et al. Safety, tolerability, and pharmacokinetics of BG-12 administered with and without aspirin: Key findings from a randomized, double-blind, placebo-controlled trial in healthy volunteers [abstract]. 64th American Academy of Neurology Annual Meeting; April 21-28, 2012; New Orleans, LA. Abstract P04.136.
38. Biogen Idec submits application to FDA for approval of oral BG-12 to treat multiple sclerosis [news release]. Weston, MA: Biogen Idec; February 28, 2012. http://www.biogenidec. com/press-release-details.aspx? ID55981&ReqID51666509. Accessed May 11, 2012.
39. Novartis Pharmaceuticals Corporation. Gilenya REMS document. US Food and Drug Administration Web site. http:// www.fda.gov/downloads/Drugs/DrugSafety/ PostmarketDrug SafetyInformationforPatientsandProviders/UCM227965.pdf. Published February 2012. Accessed April 8, 2013.
40. Dimethyl fumarate oral. Drug Facts and Comparisons. Facts & Comparisons [database online]. St. Louis, MO: Wolters Kluwer Health Inc; 2013. Accessed April 5, 2013.
41. Gold R, Wolinsky JS. Pathophysiology of multiple sclerosis and the place of teriflunomide. Acta Neurol Scand. 2011;124(2):75-84.
42. Claussen MC, Korn T. Immune mechanisms of new therapeutic strategies in MS: Teriflunomide. Clin Immunol. 2012; 142(1):49-56.