DIROXIMEL FUMARATE

Other

Brand names: Vumerity

Oral

Mechanism of Action

12.1 Mechanism of Action The mechanism by which diroximel fumarate exerts its therapeutic effect in multiple sclerosis is unknown. MMF, the active metabolite of diroximel fumarate, has been shown to activate the nuclear factor (erythroid-derived 2)-like 2 (Nrf2) pathway in vitro and in vivo in animals and humans. The Nrf2 pathway is involved in the cellular response to oxidative stress. MMF has been identified as a nicotinic acid receptor agonist in vitro .

Indications

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

Contraindications

• 4 CONTRAINDICATIONS VUMERITY is contraindicated in patients With known hypersensitivity to diroximel fumarate
• dimethyl fumarate
• dimethyl fumarate
• or to any of the excipients of VUMERITY ( 4 ) Co-administration with dimethyl fumarate ( 4 )

FDA Warnings

5 WARNINGS AND PRECAUTIONS Anaphylaxis and Angioedema: Discontinue and do not restart VUMERITY if these occur
2 ) Herpes Zoster and Other Serious Opportunistic Infections: Consider withholding VUMERITY in cases of serious infection until the infection has resolved
PML is an opportunistic viral infection of the brain caused by the JC virus (JCV) that typically only occurs in patients who are immunocompromised, and that usually leads to death or severe disability
A fatal case of PML occurred in a patient who received dimethyl fumarate for 4 years while enrolled in a clinical trial

Known Side Effects

7 documented side effects by frequency

Diarrhea

1-10%

Fatigue

1-10%

Nausea

1-10%

Headache

1-10%

Itching

1-10%

Falls

0.1-1%

Drug Not Working

0.1-1%

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Formulations

Dosage Forms

Tablet

Route

Oral