Dimethyl Fumarate 240 mg/1
Dimethyl Fumarate · CAPSULE, DELAYED RELEASE · Aurobindo Pharma Limited
Dimethyl fumarate is a prescription medication taken by mouth as a delayed-release capsule that is used to treat relapsing forms of multiple sclerosis. It works by helping to reduce inflammation in the nervous system.
Key Facts
- Brand Name
- Dimethyl Fumarate
- Generic Name
- Dimethyl Fumarate
- NDC Code (Product)
59651-084- Manufacturer
- Aurobindo Pharma Limited
- Strength
- 240 mg/1
- Dosage Form
- CAPSULE, DELAYED RELEASE
- Route
- ORAL
- Marketing Status
- Application #
- ANDA210385
- Marketing Start
- 12/22/2022
Recall History
Biogen MA Inc.
cGMP deviations: one lot of the product was distributed to US Markets despite being rejected during in-process control.
Attix Pharmaceuticals
Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE Dimethyl fumarate delayed-release capsules are 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. Dimethyl fumarate 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 ( 1 )
Dosage & Administration
2 DOSAGE AND ADMINISTRATION Starting dose: 120 mg twice a day, orally, for 7 days ( 2.1 ) Maintenance dose after 7 days: 240 mg twice a day, orally ( 2.1 ) Swallow dimethyl fumarate delayed-release capsules whole and intact. Do not crush, chew, or sprinkle capsule contents on food ( 2.1 ) Take dimethyl fumarate delayed-release capsule with or without food ( 2.1 ) 2.1 Dosing Information The starting dose for dimethyl fumarate delayed-release capsules are 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 dimethyl fumarate delayed-release capsules should be considered for patients unable to tolerate return to the maintenance dose. The incidence of flushing may be reduced by administration of dimethyl fumarate delayed-release capsules with food. Alternatively, administration of non-enteric coated aspirin (up to a dose of 325 mg) 30 minutes prior to dimethyl fumarate delayed-release capsule dosing…
Contraindications
4 CONTRAINDICATIONS Dimethyl fumarate is contraindicated in patients with known hypersensitivity to dimethyl fumarate or to any of the excipients of dimethyl fumarate. Reactions have included anaphylaxis and angioedema [see Warnings and Precautions (5.1) ]. Known hypersensitivity to dimethyl fumarate or any of the excipients of dimethyl fumarate. ( 4 )
Adverse Reactions
6 ADVERSE REACTIONS The following important adverse reactions are described elsewhere in labeling: Anaphylaxis and Angioedema [see Warnings and Precautions (5.1) ]. Progressive multifocal leukoencephalopathy [see Warnings and Precautions (5.2) ]. Herpes Zoster and Other Serious Opportunistic Infections [ see Warnings and Precautions (5.3) ]. Lymphopenia [ see Warnings and Precautions (5.4) ]. Liver Injury [ see Warnings and Precautions (5.5) ]. Flushing [ see Warnings and Precautions (5.6) ]. Most common adverse reactions (incidence ≥10% and ≥2% placebo) were flushing, abdominal pain, diarrhea, and nausea. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact MSN pharmaceuticals Inc. at 1-855-668-2369 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical 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. The most common adverse reactions (incidence ≥10% and ≥2% more than placebo) for dimethyl fumarate were flushing, abdominal pain, diarrhe…
Frequently Asked Questions
What is Dimethyl Fumarate used for?
Dimethyl fumarate is a prescription medication taken by mouth as a delayed-release capsule that is used to treat relapsing forms of multiple sclerosis. It works by helping to reduce inflammation in the nervous system.
Is Dimethyl Fumarate a controlled substance?
Dimethyl Fumarate is not classified as a controlled substance by the DEA.
What is the generic name for Dimethyl Fumarate?
The generic name for Dimethyl Fumarate is Dimethyl Fumarate. There are 9 other brand versions of Dimethyl Fumarate.
What is the NDC code for Dimethyl Fumarate 240 mg/1?
The NDC (National Drug Code) for Dimethyl Fumarate 240 mg/1 is 59651-084, listed by Aurobindo Pharma Limited.
Other Dimethyl Fumarate Dosages
Other Dimethyl Brands
See all →- DIMETHYL FUMARATE240 mg/150090-5288
- TECFIDERA120 mg/164406-005
- Dimethyl fumarate120 mg/182249-745
- dimethyl fumarate240 mg/124979-128
- dimethyl fumarate240 mg/170710-1205
- dimethyl fumarate240 mg/170771-1531
- DIMETHYL FUMARATE240 mg/182009-138
- Dimethyl fumarate240 mg/182249-747
- DIMETHYL FUMARATE120 mg/116729-416
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)