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TECFIDERA is indicated for the treatment of patients with relapsing forms of multiple sclerosis.
DOSAGE AND ADMINISTRATION
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.
Temporary dose reductions to 120 mg twice a day may be considered for individuals who do not tolerate the maintenance dose. Within 4 weeks, the recommended dose of 240 mg twice a day should be resumed. Discontinuation of TECFIDERA should be considered for patients unable to tolerate return to the maintenance dose. The incidence of flushing may be reduced by administration of TECFIDERA with food. Alternatively, administration of non-enteric coated aspirin (up to a dose of 325 mg) 30 minutes prior to TECFIDERA dosing may reduce the incidence or severity of flushing [see CLINICAL PHARMACOLOGY].
Blood Test Prior To Initiation Of Therapy
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 “BG12 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.
Storage And Handling
TECFIDERA is available as hard gelatin delayed-release capsules in two strengths containing either 120 mg or 240 mg of dimethyl fumarate. The green and white 120 mg capsules are printed with “BG-12 120 mg” in black ink. The green 240 mg capsules are printed with “BG-12 240 mg” in black ink. TECFIDERA is available as follows:
30-day Starter Pack, (NDC
7-day bottle 120 mg capsules, quantity 14
23-day bottle 240 mg capsules, quantity 46
120 mg Capsules
7-day bottle of 14 capsules (NDC 64406-005-01)
240 mg Capsules
30-day bottle of 60 capsules (NDC 64406-006-02)
Store at 15°C to 30°C (59 to 86°F). Protect the capsules from light. Store in original container.
Once opened, discard bottles of TECFIDERA after 90 days.
Manufactured by: Biogen Idec Inc. Cambridge, MA 02142. Revised: December: 2014
Last reviewed on RxList: 12/18/2014
This monograph has been modified to include the generic and brand name in many instances.
Additional Tecfidera Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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