• 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: Other agents preferred when disease-modifying therapy needed
• Lactation: Safety not established in breastfeeding
• Pedi: Safety and effectiveness not established in children.

Derm: flushing, erythema, pruritus, rash.

GI: abdominal pain, diarrhea, nausea, dyspepsia, GI HEMORRHAGE, GI OBSTRUCTION, GI PERFORATION, GI ULCERATION, HEPATOTOXICITY, ↑ liver enzymes, 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-like 2 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: 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; changes to thinking, eyesight, strength, or balance), GI events (rectal bleeding, bloody diarrhea, vomiting blood, severe abdominal pain, severe vomiting, severe diarrhea), 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 patients to notify health care professional if pregnancy is planned or suspected or if breastfeeding.

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