dimethyl fumarate

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.

Adv. Reactions/Side Effects ⬆ ⬇

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)

Interactions ⬆ ⬇

Drug-drug:

None reported.

Availability ⬆ ⬇

(Generic available)

Extended-release capsules: 120 mg; 240 mg

Route/Dosage ⬆ ⬇

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

US Brand Names ⬆ ⬇

Action ⬆ ⬇

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

Therapeutic effects:

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

Classifications ⬆ ⬇

Therapeutic Classification: anti-multiple sclerosis agents

Pharmacokinetics ⬆ ⬇

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

Time/Action Profile ⬆ ⬇

(effects on disability)

ROUTE	ONSET	PEAK	DURATION
PO	24 wk	60 wk	Unknown

Patient/Family Teaching ⬆ ⬇

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 www.tecfiderapregnancyregistry.com.

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Indications ⬇

Contraind./Precautions ⬆ ⬇