dimethyl fumarate


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dimethyl fumarate

(dye-meth-il fue-ma-rate ) ,

Tecfidera

(trade name),

DMF

(trade name)

Classification

Therapeutic: anti multiple sclerosis agents
Pregnancy Category: C

Indications

Treatment of relapsing forms of multiple sclerosis

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.

Pharmacokinetics

Absorption: Following oral administration rapidly converted to active metabolite monomethyl fumarate (MMF) by enzymes in GI tract, blood, and tissue.
Distribution: Unknown.
Metabolism and Excretion: MMF is metabolized by the tricarboxylic acid (TCA) cycle. 60% eliminated via exhalation of CO2. Minor amounts eliminated by renal (16%) and and fecal (1%) routes, trace amounts in urine.
Half-life: MMF—1 hr

Time/action profile (effects on disability)

ROUTEONSETPEAKDURATION
PO24 wk60 wkUnk

Contraindications/Precautions

Contraindicated in: None noted
Use Cautiously in: Serious infections (treatment may be witheld) Obstetric: Use during pregancy only if potential benefit justifies potential risk to fetus Lactation: Use cautiously if breast feeding Pediatric: Safe and effective use in children has not been established

Adverse Reactions/Side Effects

Gastrointestinal

  • abdominal pain (most frequent)
  • diarrhea (most frequent)
  • nausea (most frequent)
  • dyspepsia
  • ↑ liver enzymes
  • vomiting

Dermatologic

  • flushing (most frequent)
  • erythema
  • prutitus
  • rash

Hematologic

  • lymphopenia

Interactions

Drug-Drug interaction

None noted

Route/Dosage

Oral (Adults) 120 mg twice daily for one week, then 240 mg twice daily

Availability

Extended-release capsules: 120 mg, 240 mg

Nursing implications

Nursing assessment

  • Monitor for signs and symptoms of infections (fever, sore throat). Consider withholding medication until serious infections are resolved.
  • Lab Test Considerations: Monitor CBC within 6 mo of starting therapy, then annually or when clinically indicated.
    • May casue ↓ lymphocyte counts.
    • May cause ↑ hepatic transaminases, mostly during first 6 mo of therapy.
    • May cause transient ↑ mean eosinophil count during first 2 mo of therapy.

Potential Nursing Diagnoses

Deficient knowledge, related to disease process and medication regimen (Patient/Family Teaching)

Implementation

  • Oral: Administer 120 mg twice daily for 7 days then increase to maintenance dose of 240 mg twice daily without regard to food. Swallow capsules whole; do not open, crush, chew, or sprinkle on food. Discard any unused capsules 90 days after opening.

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 may decrease incidence of flushing.
  • 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 patient to notify health care professional if pregnancy is planned or suspected, or if breast feeding. Patients who become pregnant should be encouraged to join the pregnancy registry by calling 1-800-456-2255.

Evaluation/Desired Outcomes

  • Decreased incidence/severity of relapse of multiple sclerosis.
References in periodicals archive ?
EVOLVE-MS-2 was a Phase 3, multicenter, double-blind, active-controlled, five-week study designed to evaluate the Gl tolerability, including duration and severity, of diroximel fumarate 462 mg twice daily compared to dimethyl fumarate 240 mg twice daily in 506 patients with RRMS.
EVOLVE-MS-2 was a Phase 3, multicenter, double-blind, active-controlled, five-week study designed to evaluate the GI tolerability, including duration and severity, of diroximel fumarate 462 mg twice daily compared to dimethyl fumarate 240 mg twice daily in 506 patients with RRMS.
Uncertainty remains as to whether glatiramer acetate, or dimethyl fumarate, is safe for women who choose to breastfeed.
Biaglow, "Postirradiation sensitization of mammalian cells by the thiol-depleting agent dimethyl fumarate," Radiation Research, vol.
Dimethyl fumarate Relapsing MS Activate nuclear factors resulting in anti-inflammatory, antioxidant, and neuroprotective properties.
"In clinical trials, patients treated with dimethyl fumarate had less disease activity when compared to patients on placebo--whether they were in the early stages of MS or had more established disease," said Dr.
The 408 claimants - including 55 children - suffered skin complaints caused by dimethyl fumarate (DMF) in leather sofas manufactured by Chinese companies Linkwise and Eurosofa.
The 408 claimants - including 55 children - will each receive pounds 1800 after suffering skin complaints caused by the "highly sensitising" chemical dimethyl fumarate, known as DMF, in sofas bought from Land of Leather.
Sofas containing the nowbanned substance DMF (dimethyl fumarate) were manufactured by Chinese companies Linkwise and Eurosofa and distributed by Argos and Land of Leather.
Up to 100,000 sofas were sold, containing the "highly sensitising" fungicidal chemical dimethyl fumarate (DMF).
Recent studies reveal that dimethyl fumarate (DMFE) can be used to treat psoriasis (Schmidta et al., 2007), but there are risk factors involved upon ingestion of this compound.
The firm said the rashes had been caused by chemical dimethyl fumarate, used to prevent mould.