dimethyl fumarate (Tecfidera, BG-12)
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Indications
- relapsing multiple sclerosis
Contraindications
- not for rapidly evolving severe multiple scleorosis [NGC:NICE]
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
- lymphopenia
- flushing
- nausea, vomiting, abdominal cramping & diarrhea
- especially at the start of therapy
- GI effects may decrease over time
- case report of progressive multifocal leukoencephalopathy (PML)[5]
More general terms
References
- ↑ FDA News Release: March 27, 2013 FDA approves new multiple sclerosis treatment: Tecfidera
- ↑ 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 - ↑ 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
- ↑ 4.0 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
- ↑ 5.0 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
- ↑ 6.0 6.1 Medical Knowledge Self Assessment Program (MKSAP) 17, American College of Physicians, Philadelphia 2015