monomethyl fumarate

Contraindicated in:

Hypersensitivity to monomethyl fumarate, dimethyl fumarate, or diroximel fumarate;
Concurrent use of dimethyl fumarate or diroximel fumarate.

Use Cautiously in:

Serious infections (treatment may be withheld);
Persistent lymphopenia (>6 mo) (↑ risk of progressive multifocal leukoencephalopathy [PML]);
OB: Safety not established in pregnancy;
Lactation: Safety not established in breastfeeding;
Pedi: Safety and effectiveness not established in children.

Adv. Reactions/Side Effects ⬆ ⬇

Derm: flushing, erythema, pruritus, rash

GI: abdominal pain, diarrhea, nausea, dyspepsia, GI HEMORRHAGE, GI OBSTRUCTION, GI PERFORATION, GI ULCERATION, HEPATOTOXICITY, vomiting

GU: albuminuria

Hemat: eosinophilia, lymphopenia

Neuro: PML

Misc: HYPERSENSITIVITY REACTIONS (INCLUDING ANAPHYLAXIS AND ANGIOEDEMA), INFECTION (BACTERIAL, VIRAL [ESPECIALLY HERPES ZOSTER], AND FUNGAL)

Interactions ⬆ ⬇

Drug-drug:

Both dimethyl fumarate and diroximel fumarate are metabolized to monomethyl fumarate; concurrent use contraindicated.

Availability ⬆ ⬇

Delayed-release capsules: 95 mg

Route/Dosage ⬆ ⬇

PO (Adults ): 95 mg twice daily for 7 days, then ↑ to 190 mg twice daily.

US Brand Names ⬆ ⬇

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.

Classifications ⬆ ⬇

Therapeutic Classification: anti-multiple sclerosis agents

Pharmacokinetics ⬆ ⬇

Absorption: Delayed by ingestion of high-fat meals.

Distribution: Well distributed to extravascular tissues.

Metabolism/Excretion: Metabolized by the tricarboxylic acid cycle. 60% eliminated via exhalation of CO₂. Minor amounts eliminated by renal (16%) and fecal (1%) routes.

Half-Life: 30 min.

Time/Action Profile ⬆ ⬇

(plasma concentrations)

ROUTE	ONSET	PEAK	DURATION
PO	unknown	4 hr	12 hr

Patient/Family Teaching ⬆ ⬇

Explain purpose and side effects of monomethyl fumarate to patient. Instruct them to take medication as directed and when to ask for pain medication. Do not share medication with others, even if they have similar symptoms; may be harmful. Keep out of children's reach. Advise patient to read Patient Information before starting therapy and with each Rx refill in case of changes.
Encourage patient to follow up with lab tests to monitor for side effects.
Inform patient that medication may cause flushing. Usually begins at start of therapy and improves or resolves over time. Administration of non-enteric-coated aspirin (up to 325 mg) 30 min before therapy may ↓ the incidence or severity of flushing.
Advise patient to notify health care professional immediately if signs and symptoms of hypersensitivity reactions, PML (progressive weakness on one side of the body or clumsiness of limbs; disturbance of vision; changes in thinking, memory, and orientation leading to confusion and personality changes; may progress gradually over days to wks), infection, or liver injury occur.
Advise patient to report symptoms of GI ulcer or bleeding (epigastic pain, nausea, black tarry stools, rectal bleeding) or obstruction (abdominal pain, bloating, vomiting, constipation).
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.
Rep: May cause fetal harm. Advise women of reproductive potential to notify health care professional if pregnancy is planned or suspected or if breastfeeding. Advise patients that there is a pregnancy registry that monitors pregnancy outcomes in women exposed to monomethyl fumarate during pregnancy, and they can be enrolled by contacting Banner Life Sciences at 1-866-MMF-95MG (1-866-663-9564).

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Indications ⬇

Contraind./Precautions ⬆ ⬇