Vumerity 231 mg/1
diroximel fumarate · CAPSULE · Biogen Inc.
Vumerity (diroximel fumarate) is an oral capsule used to treat relapsing forms of multiple sclerosis. It works by modifying the immune system's activity to help reduce the frequency of relapses and slow disease progression.
Key Facts
- Brand Name
- Vumerity
- Generic Name
- diroximel fumarate
- NDC Code (Product)
64406-020- Manufacturer
- Biogen Inc.
- Strength
- 231 mg/1
- Dosage Form
- CAPSULE
- Route
- ORAL
- Marketing Status
- Application #
- NDA211855
- Marketing Start
- 10/29/2019
Recall History
Biogen MA Inc.
Failed dissolution specifications: out-of-specification test results observed during the buffer stage dissolution testing.
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 VUMERITY 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. VUMERITY 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 Blood tests are required prior to initiation of VUMERITY ( 2.1 ) Starting dose: 231 mg twice a day, orally, for 7 days ( 2.2 ) Maintenance dose after 7 days: 462 mg (administered as two 231 mg capsules) twice a day, orally ( 2.2 ) Swallow VUMERITY capsules whole and intact. Do not crush, chew, or sprinkle capsule contents on food ( 2.3 ) Avoid administration of VUMERITY with a high-fat, high-calorie meal/snack ( 2.3 ) Avoid co-administration of VUMERITY with alcohol ( 2.3 ) 2.1 Blood Tests Prior to Initiation of VUMERITY Obtain the following prior to treatment with VUMERITY: A complete blood cell count (CBC), including lymphocyte count [see Warnings and Precautions ( 5.4 )] . Serum aminotransferase, alkaline phosphatase, and total bilirubin levels [see Warnings and Precautions ( 5.5 )] . 2.2 Dosing Information The starting dosage for VUMERITY is 231 mg twice a day orally. After 7 days, the dosage should be increased to the maintenance dosage of 462 mg (administered as two 231 mg capsules) twice a day orally. Temporary dosage reductions to 231 mg twice a day may be considered for individuals who do not tolerate the maintenance dosage. Within 4 weeks, the …
Contraindications
4 CONTRAINDICATIONS VUMERITY is contraindicated in patients With known hypersensitivity to diroximel fumarate, dimethyl fumarate, or to any of the excipients of VUMERITY. Reactions may include anaphylaxis and angioedema [see Warnings and Precautions ( 5.1 )]. Taking dimethyl fumarate [see Drug Interactions ( 7.1 )] . Known hypersensitivity to diroximel fumarate, dimethyl fumarate, or to any of the excipients of VUMERITY ( 4 ) Co-administration with dimethyl fumarate ( 4 )
Drug Interactions
7 DRUG INTERACTIONS 7.1 Concomitant Dimethyl Fumarate VUMERITY is contraindicated in patients currently taking dimethyl fumarate, which is also metabolized to monomethyl fumarate. VUMERITY may be initiated the day following discontinuation of dimethyl fumarate [see Contraindications ( 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 Section ( 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 ( 5.6 )] Flushing [see Warnings and Precautions ( 5.6 )] Serious Gastrointestinal Reactions [see Warnings and Precautions ( 5.7 )] Most common adverse reactions (incidence for dimethyl fumarate [which has the same active metabolite as VUMERITY] ≥10% and ≥2% more than placebo) were flushing, abdominal pain, diarrhea, and nausea. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Biogen at 1-800-456-2255 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 pract…
Frequently Asked Questions
What is Vumerity used for?
Vumerity (diroximel fumarate) is an oral capsule used to treat relapsing forms of multiple sclerosis. It works by modifying the immune system's activity to help reduce the frequency of relapses and slow disease progression.
Is Vumerity a controlled substance?
Vumerity is not classified as a controlled substance by the DEA.
What is the generic name for Vumerity?
The generic name for Vumerity is diroximel fumarate. There are no other listed brand versions of diroximel fumarate.
What is the NDC code for Vumerity 231 mg/1?
The NDC (National Drug Code) for Vumerity 231 mg/1 is 64406-020, listed by Biogen Inc..
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)