dimethyl fumarate

(redirected from Tecfidera)

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.
Mentioned in ?
References in periodicals archive ?
announced that the companies have commenced co-promotion of Biogen Japan's multiple sclerosis treatments TECFIDERA (dimethyl fumarate), TYSABRI (natalizumab, genetic recombinant) and AVONEX (interferon beta 1a, genetic recombinant) in Japan as of today.
ALKS 8700 is designed to rapidly and efficiently convert to monomethyl fumarate in the body and to offer differentiated features as compared to the currently marketed dimethyl fumarate, Tecfidera.
In the third quarter of 2017, TECFIDERA revenues comprised $836M in sales in the U.
Meanwhile, the pair will also co-promote Biogen's multiple sclerosis treatments, Avonex (interferon beta-1a), Tysabri (natalizumab) and Tecfidera (dimethyl fumarate), in Japan to certain accounts.
Allen Mitchell serves on an Independent Advisory Committee for Biogen's Tecfidera Pregnancy Registry, and he disclosed personal fees from Biogen, outside submitted work.
He then displayed a list of the 2020 leaders which included Humira, Opdivo, Tecfidera, Entresto, Enbrel, Xtani, Keytruda, Eylea, Prevnar 13, Harvoni, Avastin, Soliris, Eliquid, Remicade etc.
The appeals court decision is expected to trigger a tide of generic rivals that will not only impact Gilenya but other branded MS drugs such as Tecfidera from Biogen Inc.
Tecfidera (dimethyl fumarate) for the treatment of multiple sclerosis (October 2015);
82, followed by the diabetes drug Lantus (insulin glargine) and two multiple sclerosis drugs: Tecfidera (dimethyl fumarate) and Copaxone (glatiramer), Express Scripts said in its "2016 Drug Trend Report.
Biogen is targeting high-priority medicines in its pipeline after concerns over stalling demand for its key MS drug, Tecfidera, in recent quarters.
The company owns royalty interests in 40 products including Humira, Remicade, Lyrica, Prezista, Truvada, Januvia, Tecfidera, Imbruvica, Kalydeco and Orkambi.
Notably, dimethyl fumarate (DMF), a strong inducer of NRF2, was recently approved by the Food and Drug Administration (FDA) with a brand name, Tecfidera, for treatment of recurrent multiple sclerosis (MS) patients [47].