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Warnings 

Description 

TECFIDERA™ (dimethyl fumarate) delayed-release capsules, for oral use
Initial U.S. Approval: 2013

TECFIDERA contains dimethyl fumarate which is also known by its chemical name, dimethyl (E) butenedioate, (C6H8O4).

Dimethyl fumarate is a white to off-white powder that is highly soluble in water with a molecular mass of 144.13.

TECFIDERA is provided as hard gelatin delayed-release capsules for oral administration, containing 120 mg or 240 mg of dimethyl fumarate consisting of the following inactive ingredients: microcrystalline cellulose, silicified microcrystalline cellulose, croscarmellose sodium, talc, silica colloidal silicon dioxide, magnesium stearate, triethyl citrate, methacrylic acid copolymer – Type A, methacrylic acid copolymer dispersion, simethicone (30% emulsion), sodium lauryl sulphate, and polysorbate 80. The capsule shell, printed with black ink, contains the following inactive ingredients: gelatin, titanium dioxide, FD&C blue 1; brilliant blue FCF, yellow iron oxide and black iron oxide.

Clinical pharmacology

Mechanism of Action:
The mechanism by which dimethyl fumarate (DMF) exerts its therapeutic effect in multiple sclerosis is unknown. DMF and the metabolite, monomethyl fumarate (MMF), have been shown to activate the Nuclear factor (erythroid-derived 2)-like 2 (Nrf2) pathway in vitro and in vivo in animals and humans. The Nrf2 pathway is involved in the cellular response to oxidative stress. MMF has been identified as a nicotinic acid receptor agonist in vitro.

Indications and usage 

INDICATIONS AND USAGE:
TECFIDERA is indicated for the treatment of patients with relapsing forms of multiple sclerosis.

Contraindications

None

Precautions

WARNINGS AND PRECAUTIONS:
TECFIDERA may cause lymphopenia. A recent CBC should be available before initiating treatment with TECFIDERA. A CBC is recommended annually, and as clinically indicated. Consider withholding treatment in patients with serious infections.

Adverse reactions

ADVERSE REACTIONS:
Most common adverse reactions (incidence geq10% and geq2% placebo) were flushing, abdominal pain, diarrhea, and nausea.

To report SUSPECTED ADVERSE REACTIONS, contact Biogen Idec at 1-800-456-2255 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

USE IN SPECIFIC POPULATIONS:
PPregnancy: based on animal data, may cause fetal harm.

See PACKAGE INSERT for PATIENT COUNSELING INFORMATION and Medication Guide.

Dosage and administration 

DOSAGE AND ADMINISTRATION:

  • Starting dose: 120 mg twice a day, orally, for 7 days.
  • Maintenance dose after 7 days: 240 mg twice a day, orally.
  • Swallow TECFIDERA capsules whole and intact. Do not crush, chew, or sprinkle capsule contents on food.
  • Take TECFIDERA with or without food.

How supplied

DOSAGE FORMS AND STRENGTHS:
Delayed-release capsules: 120 mg and 240 mg

Reference

Package insert data:   [Accessed: Jan 2014]
Manufactured by: Biogen Idec Inc., Cambridge, MA 02142, www.TECFIDERA.com or call 1-800-456-2255
This Patient Information has been approved by the U.S. Food and Drug Administration
Issued: 03/2013

PACKAGE LABEL PRINCIPAL DISPLAY PANEL – 240 mg Capsules: Box Label
NDC: 64406-006-02
TECFIDERA®
(dimethyl fumarate)
30-day bottle 240 mg capsules, quantity 60
Manufactured by:
Biogen Idec Inc.
Cambridge, MA 02142 USA

Reference(s)

National Institutes of Health, U.S. National Library of Medicine, DailyMed Database.
Provides access to the latest drug monographs submitted to the Food and Drug Administration (FDA). Please review the latest applicable package insert for additional information and possible updates.  A local search option of this data can be found here.

Disclaimer

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