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

Contraindicated in:

• Hypersensitivity.

Use Cautiously in:

• Serious infections (treatment may be withheld)
• Persistent lymphopenia (>6 mo) (↑ risk of progressive multifocal leukoencephalopathy [PML])
• OB: Use during pregnancy only if potential maternal benefit justifies potential fetal risk
• Lactation: Safety not established in breastfeeding
• Pedi: Safety and effectiveness not established in children.

Derm: flushing, erythema, pruritus, rash.

GI: abdominal pain, diarrhea, nausea, ↑ liver enzymes, dyspepsia, HEPATOTOXICITY, vomiting.

Hemat: lymphopenia.

Neuro: PML.

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

Drug-Drug:

• None reported.

(Generic available)

• Extended-release capsules: 120 mg; 240 mg;

• PO (Adults): 120 mg twice daily for one wk, then 240 mg twice daily.

Tecfidera

• 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.

Distribution: Unknown.

Metabolism/Excretion: MMF is metabolized by the tricarboxylic acid cycle. 60% eliminated via exhalation of CO₂. Minor amounts eliminated by renal (16%) and fecal (1%) routes, trace amounts in urine.

Half-life: MMF: 1 hr.

(effects on disability)

• Instruct patient to take dimethyl fumarate as directed. 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 dimethyl fumarate with food or administration of nonenteric coated aspirin (up to a dose of 325 mg) 30 min prior to dimethyl fumarate dosing may decrease incidence or severity of flushing.
• Advise patient to notify health care professional if signs or symptoms of infections or liver injury (fatigue, anorexia, right upper abdominal discomfort, dark urine, jaundice) occur.
• Advise patient to notify health care professional promptly if signs and symptoms of PML (new or worsening weakness; trouble using their arms or legs; or changes to thinking, eyesight, strength or balance) 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.
• Rep: Advise female patient to notify health care professional if pregnancy is planned or suspected, or if breastfeeding. Encourage patients who become pregnant to join the pregnancy registry by calling 1-866-810-1462 or visiting .

dye-METH-il FUE-ma-rate

NDC Code^*

• 64406- Biogen Inc.
  • 64406-005- Tecfidera
    • 64406-005-01- 1 BOTTLE, PLASTIC in 1 CARTON (64406-005-01) > 14 CAPSULE in 1 BOTTLE, PLASTIC

• 64406- Biogen Inc.
  • 64406-006- Tecfidera
    • 64406-006-02- 1 BOTTLE, PLASTIC in 1 CARTON (64406-006-02) > 60 CAPSULE in 1 BOTTLE, PLASTIC

• 64406- Biogen Inc.
  • 64406-007- Tecfidera
    • 64406-007-03- 1 KIT in 1 KIT (64406-007-03) * 14 CAPSULE in 1 BOTTLE, PLASTIC * 46 CAPSULE in 1 BOTTLE, PLASTIC