Dimethyl Fumarate

What is Dimethyl Fumarate?

• Dimethyl Fumarate (TECFIDERA) is a prescription medicine used to treat relapsing forms of multiple sclerosis (MS).

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What are the uses of this medicine?

• This medicine is used to treat relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.

How does this medicine work?

• 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.

Who Should Not Use this medicine ?

This medicine cannot be used in patientsː

• with known hypersensitivity to dimethyl fumarate or to any of the excipients of TECFIDERA

What drug interactions can this medicine cause?

• No formal drug interaction studies have been conducted with TECFIDERA.

Is this medicine FDA approved?

• FDA approved this drug in the year of 2013.

How should this medicine be used?

• Obtain a complete blood cell count (CBC) including lymphocyte count before initiation of therapy.
• Obtain serum aminotransferase, alkaline phosphatase, and total bilirubin levels prior to treatment with TECFIDERA.

Recommended Dosage:

• 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.
• 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.

Administration

• Take TECFIDERA exactly as your doctor tells you to take it
• The recommended starting dose is one 120 mg capsule taken by mouth 2 times a day for 7 days
• The recommended dose after 7 days is one 240 mg capsule taken by mouth 2 times a day
• TECFIDERA can be taken with or without food
• Swallow TECFIDERA whole. Do not crush, chew, or sprinkle capsule contents on food.
• Protect TECFIDERA from light. You can do this by storing the capsules in their original container.
• If you take too much TECFIDERA, call your doctor or go to the nearest hospital emergency room right away.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Delayed-release capsules: 120 mg and 240 mg

This medicine is available in fallowing brand namesː

• TECFIDERA

What side effects can this medication cause?

The most common side effects of this medicine include:

• flushing, redness, itching, or rash
• nausea, vomiting, diarrhea, stomach pain, or indigestion
• Flushing and stomach problems are the most common reactions, especially at the start of therapy, and may decrease over time. Taking TECFIDERA with food may help reduce flushing.

TECFIDERA may cause serious side effects including:

• allergic reaction
• Progressive multifocal leukoencephalopathy (PML)
• decreases in your white blood cell count
• liver problems
• herpes zoster infections (shingles)
• other serious infections

What special precautions should I follow?

• TECFIDERA can cause anaphylaxis and angioedema after the first dose or at any time during treatment. Discontinue and do not restart TECFIDERA if these occur.
• Progressive multifocal leukoencephalopathy (PML) has occurred in patients with MS treated with TECFIDERA. Withhold TECFIDERA at the first sign or symptom suggestive of PML.
• Serious cases of herpes zoster have occurred with TECFIDERA, including disseminated herpes zoster, herpes zoster ophthalmicus, herpes zoster meningoencephalitis, and herpes zoster meningomyelitis. Consider withholding TECFIDERA in cases of serious infection until the infection has resolved.
• TECFIDERA may decrease lymphocyte counts. Obtain a CBC including lymphocyte count before initiating TECFIDERA, after 6 months, and every 6 to 12 months thereafter. Consider interruption of TECFIDERA if lymphocyte counts <0.5 x 109/L persist for more than six months.
• Clinically significant cases of liver injury have been reported in patients treated with TECFIDERA. Obtain serum aminotransferase, alkaline phosphatase, and total bilirubin levels before initiating TECFIDERA and during treatment, as clinically indicated. Discontinue TECFIDERA if clinically significant liver injury induced by TECFIDERA is suspected.

What to do in case of emergency/overdose?

Management for overdosage:

• In the event of overdose, initiate symptomatic supportive treatment as clinically indicated.
• There are no known therapeutic interventions to enhance elimination of TECFIDERA nor is there a known antidote.

Can this medicine be used in pregnancy?

• There are no adequate data on the developmental risk associated with the use of TECFIDERA in pregnant women.
• There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to TECFIDERA during pregnancy. Encourage patients to enroll by calling 1-866-810-1462 or visiting www.tecfiderapregnancyregistry.com.

Can this medicine be used in children?

• Safety and effectiveness in pediatric patients have not been established.

What are the active and inactive ingredients in this medicine?

• Active ingredient: dimethyl fumarate
• 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. Capsule Shell: gelatin, titanium dioxide, FD&C blue 1; brilliant blue FCF, yellow iron oxide and black iron oxide.

Who manufactures and distributes this medicine?

• Manufactured for: Biogen Inc., Cambridge

What should I know about storage and disposal of this medication?

• Store at 15°C to 30°C (59 to 86°F).
• Protect the capsules from light.
• Store in original container.

• Dailymed label info on Dimethyl Fumarate
• FDA Dimethyl Fumarate

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