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Tecfidera

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Overview

What is Tecfidera?

TECFIDERA contains dimethyl fumarate which is also known by its chemical name, dimethyl (E) butenedioate, (CHO). It has the following structure:

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.



What does Tecfidera look like?



What are the available doses of Tecfidera?

Delayed-release capsules

3

What should I talk to my health care provider before I take Tecfidera?

Pregnancy: Based on animal data, may cause fetal harm. ()

How should I use Tecfidera?

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

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. 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 .

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.


What interacts with Tecfidera?

Sorry No Records found


What are the warnings of Tecfidera?

Sorry No Records found


What are the precautions of Tecfidera?

Sorry No Records found


What are the side effects of Tecfidera?

Sorry No records found


What should I look out for while using Tecfidera?

TECFIDERA is contraindicated in patients with known hypersensitivity to dimethyl fumarate or to any of the excipients of TECFIDERA. Reactions have included anaphylaxis and angioedema


What might happen if I take too much Tecfidera?

Sorry No Records found


How should I store and handle Tecfidera?

Store at 25º C (77º F); excursions permitted to 15 to 30º C (59 to 86º F) [see USP Controlled Room Temperature].Do not store unpouched. Insert immediately upon removal from the protective pouch.Store at 25º C (77º F); excursions permitted to 15 to 30º C (59 to 86º F) [see USP Controlled Room Temperature].Do not store unpouched. Insert immediately upon removal from the protective pouch.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 64406-007-03): 120 mg capsules: 240 mg capsules: Store at 15°C to 30°C (59 to 86°F). Protect the capsules from light. Store in original container. 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 64406-007-03): 120 mg capsules: 240 mg capsules: Store at 15°C to 30°C (59 to 86°F). Protect the capsules from light. Store in original container. 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 64406-007-03): 120 mg capsules: 240 mg capsules: Store at 15°C to 30°C (59 to 86°F). Protect the capsules from light. Store in original container. 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 64406-007-03): 120 mg capsules: 240 mg capsules: Store at 15°C to 30°C (59 to 86°F). Protect the capsules from light. Store in original container. 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 64406-007-03): 120 mg capsules: 240 mg capsules: Store at 15°C to 30°C (59 to 86°F). Protect the capsules from light. Store in original container.


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Clinical Information

Chemical Structure

No Image found
Clinical Pharmacology

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 and 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 .

Non-Clinical Toxicology
TECFIDERA is contraindicated in patients with known hypersensitivity to dimethyl fumarate or to any of the excipients of TECFIDERA. Reactions have included anaphylaxis and angioedema

Aminoglutethimide:

Amphotericin B injection and potassium-depleting agents:

Antibiotics:

Anticholinesterases:

Anticoagulants, oral:

Antidiabetics:

Antitubercular drugs:

Cholestyramine:

Cyclosporine:

Digitalis glycosides:

Estrogens, including oral contraceptives:

Hepatic enzyme inducers (eg, barbiturates, phenytoin, carbamazepine, rifampin):

Ketoconazole:

Nonsteroidal anti-inflammatory drugs (NSAIDs):

Skin tests:





TECFIDERA can cause anaphylaxis and angioedema after the first dose or at any time during treatment. Signs and symptoms have included difficulty breathing, urticaria, and swelling of the throat and tongue. Patients should be instructed to discontinue TECFIDERA and seek immediate medical care should they experience signs and symptoms of anaphylaxis or angioedema.

The following important adverse reactions are described elsewhere in labeling:

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Reference

This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

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Professional

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Interactions

Interactions

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