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.
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References in periodicals archive ?
The effects of both dimethyl fumarate and laquinimod appear immunomodulatory, but their exact mechanisms of action remain to be proven.
Upon cooling, white crystals of the isomerized product, dimethyl fumarate, were obtained in better yield and purity.
NICE first began to consider the application of dimethyl fumarate - which used to be used on furniture and shoes to prevent mould during storage or transport in a humid climate, until it was banned for causing allergic reactions - for MS last year.
Even so, both studies indicate that dimethyl fumarate, also known as 13G-12, "has a future as an oral therapeutic option for patients with relapsing MS [multiple sclerosis]," said Dr.
The chemical put into the sofas by Chinese firms Linkwise and Eurosofa, a fungicide known as dimethyl fumarate or DMF, has now been banned by the European Union after consumers in at least five European countries suffered skin burns and breathing problems.
Lawyers for claimants say they suffered painful medical complaints due the chemical dimethyl fumarate in leather sofas manufactured by Chinese companies Linkwise and Eurosofa.
A new microtablet formulation that consists solely of dimethyl fumarate has now been through phase II studies and is expected to be licensed in the United Kingdom, she said.
It is thought that when people sat on the sofas their body heat caused the dimethyl fumarate to vaporise and penetrate their clothes.
It has been alleged the imported furniture contained an anti-mould chemical called dimethyl fumarate, which can cause skin burns and other injuries.
The data presented at ECTRIMS were included in Biogen Idec's regulatory submissions for dimethyl fumarate around the world.
After thousands of people complained it was found that a known irritant called dimethyl fumarate, which had been put in the sofas to stop them getting damp, was vaporising and leaching out of the leather and through people's clothes.
It is believed the husband and wife, like the earlier victim, were exposed to the chemical dimethyl fumarate (DMF) The customers are suing Chinese manufacturer Linkwise, potentially along with shops including Argos, Land of Leather and Walmsley.