Dimethyl Fumarate 120 mg/1
Dimethyl Fumarate · CAPSULE, DELAYED RELEASE · Aurobindo Pharma Limited
Dimethyl fumarate is an oral medication taken by capsule that is used to treat relapsing forms of multiple sclerosis. It works by reducing inflammation and immune system activity in the nervous system.
Key Facts
- Brand Name
- Dimethyl Fumarate
- Generic Name
- Dimethyl Fumarate
- NDC Code (Product)
59651-083- Manufacturer
- Aurobindo Pharma Limited
- Strength
- 120 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 an oral medication taken by capsule that is used to treat relapsing forms of multiple sclerosis. It works by reducing inflammation and immune system activity 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 120 mg/1?
The NDC (National Drug Code) for Dimethyl Fumarate 120 mg/1 is 59651-083, 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)