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dimethyl fumarate(dye-meth-il fue-ma-rate ) ,
Pregnancy Category: C
ClassificationTherapeutic: anti multiple sclerosis agents
Treatment of relapsing forms of multiple sclerosis
Activates Nuclear factor (Nrf2) pathway involved in cellular response to oxidative stress.
Decreased incidence/severity of relapse with decreased progression of lesions and disability.
Absorption: Following oral administration rapidly converted to active metabolite monomethyl fumarate (MMF) by enzymes in GI tract, blood, and tissue.
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)
|PO||24 wk||60 wk||Unk|
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
- abdominal pain (most frequent)
- diarrhea (most frequent)
- nausea (most frequent)
- ↑ liver enzymes
- flushing (most frequent)
Drug-Drug interactionNone noted
Oral (Adults) 120 mg twice daily for one week, then 240 mg twice daily
Extended-release capsules: 120 mg, 240 mg
- 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 DiagnosesDeficient knowledge, related to disease process and medication regimen (Patient/Family Teaching)
- 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.
- 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.
- Decreased incidence/severity of relapse of multiple sclerosis.