PO (Adults): 95 mg twice daily for 7 days, then ↑ to 190 mg twice daily.
Delayed-release capsules: 95 mg
Monitor for signs and symptoms of hypersensitivity reactions (difficulty breathing, urticaria, swelling of the throat and tongue) after each dose.
Assess for any new signs or symptoms that may be suggestive of PML, an opportunistic infection of the brain caused by the JC virus, that leads to death or severe disability; withhold dose and notify health care professional promptly. PML symptoms may begin gradually but usually worsen rapidly. Symptoms vary depending on which part of brain is infected (mental function declines rapidly and progressively, causing dementia; speaking becomes increasingly difficult; partial blindness; difficulty walking; rarely, headaches and seizures occur). Diagnosis is usually made via gadolinium-enhanced MRI and CSF analysis. Risk of PML increases with the number of infusions. Withhold monomethyl fumarate at first sign of PML.
Monitor for signs and symptoms of herpes and other opportunistic infections (fever, chills, lesions on skin or mucous membranes, headache, change in mental status) periodically during therapy.
Lab Test Considerations:
Monitor CBC with lymphocyte count prior to starting therapy, after 6 mo of therapy, and every 6–12 mos as clinically indicated. If lymphocyte count <0.5 x 109 /L, consider holding therapy and monitoring lymphocyte count until recovery, even if therapy is discontinued.
Monitor AST, ALT, alkaline phosphatase, and total bilirubin levels before starting therapy and periodically during therapy. Usually resolve when therapy is discontinued. If significant liver injury is suspected, discontinue therapy.
PO Administer twice daily without regard to food. DNC: Swallow capsules whole; do not crush, chew, or mix contents with food.
Administration of non-enteric coated aspirin (up to 325 mg) 30 min before dosing may reduce incidence or severity of flushing.
Instruct patient to take medication as directed. Advise patient to read Patient Information before starting therapy and with each Rx refill in case of changes.
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 reduce 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 weeks), infection, or liver injury occur.
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 females of reproductive potential to notify health care professional if pregnancy is planned or suspected or if breastfeeding.
Encourage patient to follow up with lab tests to monitor for side effects.
Decreased incidence/severity of relapse with decreased progression of lesions and disability.
monomethyl fumarate is a sample topic from the Davis's Drug Guide.
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