• Relapsing forms of multiple sclerosis (MS), including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease.

Contraindicated in:

• Hypersensitivity to diroximel fumarate or dimethyl fumarate
• Concurrent use of dimethyl fumarate
• Moderate or severe renal impairment.

Use Cautiously in:

• Serious infections (treatment may be withheld)
• Persistent lymphopenia (>6 mo) (↑ risk of PML)
• OB: Safety not established in pregnancyUse during pregnancy only if potential maternal benefit justifies potential fetal risk
• Lactation: Safety not established in breastfeedingUse while breastfeeding only if potential maternal benefit justifies potential risk to infant
• Pedi: Safety and effectiveness not established in children.

Derm: flushing, erythema, pruritus, rash.

GI: abdominal pain, diarrhea, nausea, dyspepsia, HEPATOTOXICITY, vomiting.

GU: albuminuria.

Hemat: eosinophilia, lymphopenia.

Neuro: PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY (PML).

Misc: INFECTION (BACTERIAL, VIRAL [ESPECIALLY HERPES ZOSTER], AND FUNGAL), HYPERSENSITIVITY REACTIONS (INCLUDING ANAPHYLAXIS AND ANGIOEDEMA).

Drug-Drug:

• Alcohol may ↓ MMF levels; avoid concurrent use.

• Capsules: 231 mg;

• PO (Adults): 231 mg twice daily for 1 wk, then 462 mg twice daily.

Vumerity

• Activates nuclear factor (Nrf2) pathway involved in cellular response to oxidative stress.

• Decreased incidence/severity of relapse with decreased progression of lesions and disability.

Therapeutic Classification: anti-multiple sclerosis agents

Absorption: Following oral administration, rapidly converted to active metabolite, monomethyl fumarate (MMF), by enzymes in GI tract, blood, and tissue. Absorption decreased by high-fat, high-calorie food.

Distribution: Well distributed to extravascular tissues.

Metabolism/Excretion: MMF is metabolized by the tricarboxylic acid (TCA) cycle. MMF eliminated via exhalation of CO₂. Inactive metabolites eliminated in urine.

Half-life: MMF: 1 hr.

(MMF plasma concentrations)

• Instruct patient to take medication as directed. A starter dose bottle will be initially provided. Avoid administration with alcohol. Advise patient to read Patient Information before starting therapy and with each Rx refill in case of changes.
• Caution patient not to share medication with others, even if they have the same symptoms; may be dangerous.
• May cause flushing (warmth, redness, itching, and/or burning sensation). Usually begins after starting and resolves over time. Administration of diroximel fumarate with food or administration of non-enteric coated aspirin (up to a dose of 325 mg) 30 minutes prior to diroximel fumarate dosing may decrease incidence or severity of flushing.
• Advise patient to notify health care professional promptly if signs and symptoms of PML (new or worsening weakness; trouble using arms or legs; or changes to thinking, eyesight, strength or balance), liver injury (fatigue, anorexia, right upper abdominal discomfort, dark urine, jaundice), infection (herpes zoster or others), or hypersensitivity reactions (difficulty breathing, urticaria, swelling of throat and tongue) occur.
• Advise patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and to consult with health care professional before taking other medications.
• Advise female patients to notify health care professional if pregnancy is planned or suspected or if breastfeeding.
• Emphasize importance of routine lab test to monitor for side effects.

dye-ROX-i-mel FYOO-ma-rate

NDC Code^*

• 64406- Biogen Inc.
  • 64406-020- Vumerity
    • 64406-020-01- 1 BOTTLE, PLASTIC in 1 CARTON (64406-020-01) > 106 CAPSULE in 1 BOTTLE, PLASTIC

• 64406- Biogen Inc.
  • 64406-020- Vumerity
    • 64406-020-03- 1 BOTTLE, PLASTIC in 1 CARTON (64406-020-03) > 120 CAPSULE in 1 BOTTLE, PLASTIC

• 64406- Biogen Inc.
  • 64406-020- Vumerity
    • 64406-020-05- 1 BOTTLE, PLASTIC in 1 CARTON (64406-020-05) > 106 CAPSULE in 1 BOTTLE, PLASTIC