Generic Name: dimethyl fumarate
Dosage Form: capsules

Indications and Usage for Tecfidera

Tecfidera is indicated for the treatment of patients with relapsing forms of multiple sclerosis.

Tecfidera Dosage and Administration
Dosing Information
The starting dose for Tecfidera is 120 mg twice a day orally. After 7 days, the dose should be increased to the maintenance dose of 240 mg twice a day orally. Tecfidera should be swallowed whole and intact. Tecfidera should not be crushed or chewed and the capsule contents should not be sprinkled on food. Tecfidera can be taken with or without food. Administration with food may reduce the incidence of flushing. [see Clinical Pharmacology()]12.3.

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Blood Test Prior to Initiation of Therapy
A recent complete blood cell count (CBC) (i.e., within 6 months) is recommended before initiation of therapy to identify patients with pre-existing low lymphocyte counts.

Dosage Forms and Strengths
Tecfidera is available as hard gelatin delayed-release capsules containing 120 mg or 240 mg of dimethyl fumarate. The 120 mg capsules have a green cap and white body, printed with “BG-12 120 mg” in black ink on the body. The 240 mg capsules have a green cap and a green body, printed with “BG-12 240 mg” in black ink on the body.

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Contraindications
None

Warnings and Precautions

Lymphopenia
Tecfidera may decrease lymphocyte counts [see Adverse Reactions()]6.1. In the MS placebo controlled trials, mean lymphocyte counts decreased by approximately 30% during the first year of treatment with Tecfidera and then remained stable. Four weeks after stopping Tecfidera, mean lymphocyte counts increased but did not return to baseline. Six percent (6%) of TEDFIDERA patients and <1% of placebo patients experienced lymphocyte counts <0.5x109/L (lower limit of normal 0.91x109/L). The incidence of infections (60% vs 58%) and serious infections (2% vs 2%) was similar in patients treated with Tecfidera or placebo, respectively. There was no increased incidence of serious infections observed in patients with lymphocyte counts <0.8x109/L or 0.5x109/L.

Before initiating treatment with Tecfidera, a recent CBC (i.e., within 6 months) should be available. A CBC is recommended annually, and as clinically indicated. Withholding treatment should be considered in patients with serious infections until the infection(s) is resolved. Tecfidera has not been studied in patients with pre-existing low lymphocyte counts.

Flushing
Tecfidera may cause flushing (e.g., warmth, redness, itching, and/or burning sensation). In clinical trials, 40% of Tecfidera treated patients experienced flushing. Flushing symptoms generally began soon after initiating Tecfidera and usually improved or resolved over time. In the majority of patients who experienced flushing, it was mild or moderate in severity. Three percent (3%) of patients discontinued Tecfidera for flushing and <1% had serious flushing symptoms that were not life-threatening but led to hospitalization. Administration of Tecfidera with food may reduce the incidence of flushing.

Adverse Reactions
The following important adverse reactions are described elsewhere in labeling