Search
dimethyl fumarate (Tecfidera, BG-12)
Indications:
- relapsing multiple sclerosis
Contraindications:
- not for rapidly evolving severe multiple scleorosis [NGC:NICE]
Pregnancy category: C
Dosage:
- 240 mg PO BID-TID
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]
General
ester
neurologic agent
Database Correlations
PUBCHEM cid=637568
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: 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: 22992072
- Prescriber's Letter 20(5): 2013
New Drug: Tecfidera (Dimethyl Fumarate)
Detail-Document#: 290512
(subscription needed) http://www.prescribersletter.com
- Prescriber's Letter 21(6): 2014
Oral Meds to Keep in Original Containers
Detail-Document#: 300622
(subscription needed) http://www.prescribersletter.com
- 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
- Medical Knowledge Self Assessment Program (MKSAP) 17,
American College of Physicians, Philadelphia 2015