Vumerity

Last updated on RxList: 2/11/2021
Vumerity Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

What Is Vumerity?

Vumerity (diroximel fumarate) is an immunomodulator 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.

What Are Side Effects of Vumerity?

Side effects of Vumerity include:

Dosage for Vumerity

The starting dose of Vumerity is 231 mg twice a day, orally, for 7 days. The maintenance dose of Vumerity after 7 days is 462 mg (administered as two 231 mg capsules) twice a day, orally.

Vumerity In Children

The safety and effectiveness of Vumerity in pediatric patients has not been established.

What Drugs, Substances, or Supplements Interact with Vumerity?

Vumerity may interact with other medicines such as:

  • dimethyl fumarate

Tell your doctor all medications and supplements you use.

Vumerity During Pregnancy and Breastfeeding

Vumerity is not recommended for use during pregnancy; it may harm a fetus. It is unknown if Vumerity passes into breast milk. Consult your doctor before breastfeeding.

Additional Information

Our Vumerity (diroximel fumarate) Delayed-Release Capsules, for Oral Use Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

QUESTION

What kind of disease is multiple sclerosis? See Answer
Vumerity Consumer Information

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Diroximel fumarate may cause a serious brain infection that can lead to disability or death. Call your doctor right away if you have problems with speech, thought, vision, or muscle movement. These symptoms may start gradually and get worse quickly.

Also call your doctor at once if you have:

  • liver problems--loss of appetite, stomach pain (upper right side), tiredness, dark urine, jaundice (yellowing of the skin or eyes);
  • signs of infection--fever, chills, sweating, cough, shortness of breath, headache, neck stiffness, increased sensitivity to light, nausea, vomiting; or
  • symptoms of herpes virus--flu-like symptoms, cold sores around your mouth, tingly or painful blistering rash, burning pain in your thigh or lower back.

Common side effects may include:

  • indigestion, nausea, vomiting, stomach pain;
  • skin rash, itching, or redness;
  • diarrhea; or
  • flushing (sudden warmth, redness, or tingly feeling).

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Vumerity (Diroximel Fumarate Delayed-release Capsules)

SLIDESHOW

What Is Multiple Sclerosis? MS Symptoms, Causes, Diagnosis See Slideshow
Vumerity Professional Information

SIDE EFFECTS

The following important adverse reactions are described elsewhere in labeling:

  • Anaphylaxis and Angioedema [see WARNINGS AND PRECAUTIONS]
  • Progressive Multifocal Leukoencephalopathy [see WARNINGS AND PRECAUTIONS]
  • Herpes Zoster and Other Serious Opportunistic Infections [see WARNINGS AND PRECAUTIONS]
  • Lymphopenia [see WARNINGS AND PRECAUTIONS]
  • Liver Injury [see WARNINGS AND PRECAUTIONS]
  • Flushing [see WARNINGS AND PRECAUTIONS]

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 data described in the following sections were obtained using dimethyl fumarate delayed-release capsules, which has the same active metabolite as VUMERITY.

Adverse Reactions In Placebo-Controlled Trials With Dimethyl Fumarate

In the two well-controlled studies demonstrating effectiveness, 1529 patients received dimethyl fumarate with an overall exposure of 2244 person-years [see Clinical Studies].

The adverse reactions presented in Table 1 below are based on safety information from 769 patients treated with dimethyl fumarate 240 mg twice a day and 771 placebo-treated patients. The most common adverse reactions (incidence ≥10% and ≥2% more than placebo) for dimethyl fumarate were flushing, abdominal pain, diarrhea, and nausea.

Table 1: Adverse Reactions in Study 1 and 2 Reported for Dimethyl Fumarate at ≥2% Higher Incidence than Placebo

Adverse ReactionsDimethyl Fumarate
240 mg Twice Daily
(N=769)
%
Placebo
(N=771)
%
Flushing406
Abdominal pain1810
Diarrhea1411
Nausea129
Vomiting95
Pruritus84
Rash83
Albumin urine present64
Erythema51
Dyspepsia53
Aspartate aminotransferase increased42
Lymphopenia2<1

Gastrointestinal

Dimethyl fumarate caused GI events (e.g., nausea, vomiting, diarrhea, abdominal pain, and dyspepsia). The incidence of GI events was higher early in the course of treatment (primarily in month 1) and usually decreased over time in patients treated with dimethyl fumarate compared with placebo. Four percent (4%) of patients treated with dimethyl fumarate and less than 1% of placebo patients discontinued due to gastrointestinal events. The incidence of serious GI events was 1% in patients treated with dimethyl fumarate.

Hepatic Transaminases

An increased incidence of elevations of hepatic transaminases in patients treated with dimethyl fumarate was seen primarily during the first six months of treatment, and most patients with elevations had levels <3 times the upper limit of normal (ULN) during controlled trials. Elevations of alanine aminotransferase and aspartate aminotransferase to ≥3 times the ULN occurred in a small number of patients treated with both dimethyl fumarate and placebo and were balanced between groups. There were no elevations in transaminases ≥3 times the ULN with concomitant elevations in total bilirubin >2 times the ULN. Discontinuations due to elevated hepatic transaminases were <1% and were similar in patients treated with dimethyl fumarate or placebo.

Eosinophilia

A transient increase in mean eosinophil counts was seen during the first 2 months of therapy.

Adverse Reactions In Clinical Studies With VUMERITY

In clinical studies assessing safety in patients with RRMS, approximately 700 patients were treated with VUMERITY and approximately 490 patients received more than 1 year of treatment with VUMERITY. The adverse reaction profile of VUMERITY was consistent with the experience in the placebo-controlled clinical trials with dimethyl fumarate.

Postmarketing Experience

The following adverse reaction has been identified during post approval use of dimethyl fumarate. 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.

Liver function abnormalities (elevations in transaminases ≥3 times ULN with concomitant elevations in total bilirubin >2 times ULN) have been reported following dimethyl fumarate administration in post marketing experience [see WARNINGS AND PRECAUTIONS].

Herpes zoster infection and other serious opportunistic infections have been reported with dimethyl fumarate administration in postmarketing experience [see WARNINGS AND PRECAUTIONS].

Read the entire FDA prescribing information for Vumerity (Diroximel Fumarate Delayed-release Capsules)

© Vumerity Patient Information is supplied by Cerner Multum, Inc. and Vumerity Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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