dimethyl fumarate (Tecfidera)

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GENERIC NAME: dimethyl fumarate

BRAND NAME: Tecfidera

DRUG CLASS AND MECHANISM: Dimethyl fumarate is an oral disease-modifying agent used for treating relapsing forms of multiple sclerosis (MS). Teriflunomide (Aubagio), Interferon beta-1a (Avonex), interferon beta-1b (Betaseron), glatiramer acetate (Copaxone), interferon beta-1b (Extavia), fingolimod (Gilenya), mitoxantrone (Novantrone), interferon beta-1a (Rebif), and natalizumab (Tysabri) are other disease modifying agents for multiple sclerosis. Although the exact mechanism of how dimethyl fumarate works is unknown, it is thought to have protective effects on the nervous system and anti-inflammatory properties. Dimethyl fumarate prevents the immune cells from attacking the central nervous system. Dimethyl fumarate reduces the number of annual relapses rate. The FDA approved dimethyl fumarate in March 2013.

PRESCRIPTION: Yes

GENERIC AVAILABLE: No

PREPARATIONS: Delayed-release capsules: 120 mg and 240 mg

STORAGE: Capsules should be stored at 15 C to 30 C (59 F to 86 F). The capsules should be stored in the original container and protected from light.

PRESCRIBED FOR: Dimethyl fumarate is used for the treatment of patients (adults) with relapsing forms of multiple sclerosis (MS).

DOSING: The recommended starting dose is one 120 mg capsule orally twice daily with or without food. After 7 days, the dose should be increased to the recommended maintenance dose of 240 mg twice daily. Dimethyl fumarate capsules should not be crushed, chewed, or sprinkled on food. Dosing should only begin after a recently completed (within 6 months) normal CBC (complete blood count).

DRUG INTERACTIONS: No potential drug interactions were identified in clinical studies.

PREGNANCY: Dimethyl fumarate has not been adequately evaluated in pregnant women. Patients who are pregnant or plan on becoming pregnant should let their doctor know. Pregnant patients are encouraged to enroll in the Dimethyl fumarate Pregnancy Registry and can call 1-800-456-2255 for more information.

NURSING MOTHERS: It is not known whether Dimethyl fumarate is secreted into breast milk.

SIDE EFFECTS: The most common side effects associated with dimethyl fumarate treatment are flushing, abdominal pain, diarrhea, and nausea. A decrease in white blood cell count also occurs. Patients should check their baseline white blood cell count or have a recently completed blood cell count (CBC) (within 6 months) before starting treatment. Increase in liver enzymes has also been reported in clinical studies.

REFERENCE: FDA Prescribing Information.


Medically Reviewed by a Doctor on 8/19/2014



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