Brand Name
Tecfidera
Generic Name
Dimethyl-Fumarate
View Brand Information FDA approval date: March 27, 2013
Form: Kit, Capsule
What is Tecfidera (Dimethyl-Fumarate)?
TECFIDERA is indicated for the treatment of relapsing forms of multiple sclerosis , to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults. TECFIDERA is indicated for the treatment of relapsing forms of multiple sclerosis , to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.
Approved To Treat
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Brand Information
Tecfidera (dimethyl fumarate)
1INDICATIONS AND USAGE
TECFIDERA is indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.
2DOSAGE 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 “BG-12 120 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.
3CONTRAINDICATIONS
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
4ADVERSE REACTIONS
The following important adverse reactions are described elsewhere in labeling:
- Anaphylaxis and Angioedema
- Progressive multifocal leukoencephalopathy
- Herpes Zoster and Other Serious Opportunistic Infections
- Lymphopenia
- Liver Injury
- Flushing
- Serious Gastrointestinal Reactions
4.1Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.
In placebo-controlled and uncontrolled clinical studies, a total of 2513 patients have received TECFIDERA and been followed for periods up to 13 years with an overall exposure of 11,318 person-years. Approximately 1169 patients have received more than 5 years of treatment with TECFIDERA, and 426 patients have received at least 10 years of treatment with TECFIDERA.
4.2Postmarketing Experience
The following adverse reactions have been identified during post-approval use of TECFIDERA. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Gastrointestinal Disorders: Acute Pancreatitis; Gastrointestinal perforation, ulceration, obstruction, and hemorrhage
Hepatobiliary Disorders: Liver function abnormalities (elevations in transaminases ≥ 3 times ULN with concomitant elevations in total bilirubin > 2 times ULN)
Infections and Infestations: Herpes zoster infection and other serious opportunistic infections
Respiratory, Thoracic, and Mediastinal Disorders: Rhinorrhea
Skin and Subcutaneous: Alopecia
5OVERDOSE
Cases of overdose with TECFIDERA have been reported. The symptoms described in these cases were consistent with the known adverse event profile of TECFIDERA.
There are no known therapeutic interventions to enhance elimination of TECFIDERA nor is there a known antidote. In the event of overdose, initiate symptomatic supportive treatment as clinically indicated.
6DESCRIPTION
TECFIDERA contains dimethyl fumarate which is also known by its chemical name, dimethyl (E) butenedioate, (C
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.
7CLINICAL STUDIES
The efficacy and safety of TECFIDERA were demonstrated in two studies (Studies 1 and 2) that evaluated TECFIDERA taken either twice or three times a day in patients with relapsing-remitting multiple sclerosis (RRMS). The starting dose for TECFIDERA was 120 mg twice or three times a day for the first 7 days, followed by an increase to 240 mg twice or three times a day. Both studies included patients who had experienced at least 1 relapse over the year preceding the trial or had a brain Magnetic Resonance Imaging (MRI) scan demonstrating at least one gadolinium-enhancing (Gd+) lesion within 6 weeks of randomization. The Expanded Disability Status Scale (EDSS) was also assessed and patients could have scores ranging from 0 to 5. Neurological evaluations were performed at baseline, every 3 months, and at the time of suspected relapse. MRI evaluations were performed at baseline, month 6, and year 1 and 2 in a subset of patients (44% in Study 1 and 48% in Study 2).
8HOW SUPPLIED/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 64406-007-03):
- 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.
9PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (
10Principal Display Panel - 120 mg Capsules: No Charge Box Label
NDC 64406-005-08
14 capsules
Tecfidera®
(dimethyl fumarate)
delayed-release capsules
120 mg
Dispense in original Package.
Swallow capsule whole.
Rx only
11Principal Display Panel - 120 mg Capsules: Sample Box Label
NDC 64406-005-10
14 capsules
Tecfidera®
(dimethyl fumarate)
delayed-release capsules
120 mg
Dispense in original Package.
Swallow capsule whole.
Rx only
