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.
References in periodicals archive ?
decreased by approximately $25 million for TECFIDERA, AVONEX, PLEGRIDY, and TYSABRI combined.
(Nasdaq: BIIB) today announced positive topline results from EVOLVE-MS-2, a large, randomized, double-blind, five-week, Phase 3 study of diroximel fumarate, an investigational, novel oral fumarate with a distinct chemical structure, for relapsing-remitting multiple sclerosis (RRMS), compared to TECFIDERA (dimethyl fumarate).
Piper Jaffray analyst Danielle Brill said Alkermes (ALKS) has scored "back-to-back wins" with its announcement yesterday that it settled the ongoing Vivitrol patent dispute with Amneal (AMRX) and the news this morning that BIIB098 showed a statistically significant improvement on GI tolerability versus Tecfidera in a head-to-head Phase 3 trial.
M2 PHARMA-July 24, 2019-Banner Life Sciences Enrolls First Subject in Randomised, Double-Blind Head-to-Head Study of Bafiertam and Tecfidera for Comparative Assessment of GI Tolerability
Tecfidera (dimethyl fumarate) is the only known drug that may upregulate NRF2.
Prior to joining PaxVax, Meltz worked at Biogen Idec (now Biogen), where he served as the US commercial lead lawyer for Tysabri and Tecfidera (including for its US launch), and as the lead lawyer for global medical affairs.
Multiple sclerosis drug Tecfidera is facing competition from newer treatments such as Roche Holding AG's Ocrevus, and Biogen has been banking on its spinal muscular atrophy treatment, Spinraza, to drive future growth.
Banner Life Sciences LLC , a privately held specialty pharmaceutical company, revealed on Wednesday that it has received tentative approval from the US Food and Drug Administration (FDA) for its new drug application (NDA 505(b)(2)) for BAFIERTAM, a novel fumarate bioequivalent alternative to a prodrug of BAFIERTAM, Tecfidera (dimethyl fumarate) of Biogen Inc.
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.
(F) MS relapse diagnosed; started taking dimethyl fumarate (tecfidera); her gait had worsened.
Allen Mitchell serves on an Independent Advisory Committee for Biogen's Tecfidera Pregnancy Registry, and he disclosed personal fees from Biogen, outside submitted work.