dimethyl fumarate (Tecfidera, BG-12)

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Indications

Contraindications

  • not for rapidly evolving severe multiple scleorosis [NGC:NICE]

Pregnancy category: C

Dosage

Capsules: 240 mg

Storage

  • store in orginal container
    • must be protected from light
    • must be used within 90 days once original bottle is opened (U.S. product labeling only)[4] Manitor:
  • CBC: lymphocyte count every 6 months*[6]

* more frequent monitoring after administration in 1st 6 months

Adverse effects

More general terms

References

  1. FDA News Release: March 27, 2013 FDA approves new multiple sclerosis treatment: Tecfidera
  2. Gold R et al. Placebo-controlled phase 3 study of oral BG-12 for relapsing multiple sclerosis. N Engl J Med 2012 Sep 20; 367:1098. PMID: https://www.ncbi.nlm.nih.gov/pubmed/22992073
    Fox RJ et al. Placebo-controlled phase 3 study of oral BG-12 or glatiramer in multiple sclerosis. N Engl J Med 2012 Sep 20; 367:1087. PMID: https://www.ncbi.nlm.nih.gov/pubmed/22992072
  3. Prescriber's Letter 20(5): 2013 New Drug: Tecfidera (Dimethyl Fumarate) Detail-Document#: http://prescribersletter.com/(5bhgn1a4ni4cyp2tvybwfh55)/pl/ArticleDD.aspx?li=1&st=1&cs=&s=PRL&pt=3&fpt=25&dd=290512&pb=PRL (subscription needed) http://www.prescribersletter.com
  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 FDA Drug Safety Communication: Nov 25, 2014 FDA warns about case of rare brain infection PML with MS drug Tecfidera (dimethyl fumarate). http://www.fda.gov/Drugs/DrugSafety/ucm424625.htm
  6. 6.0 6.1 Medical Knowledge Self Assessment Program (MKSAP) 17, American College of Physicians, Philadelphia 2015

Database