Diroximel Fumarate Dosage
Medically reviewed by Drugs.com. Last updated on Nov 20, 2023.
Applies to the following strengths: 231 mg
Usual Adult Dose for:
Additional dosage information:
Usual Adult Dose for Multiple Sclerosis
Initial dose: 231 mg orally twice a day for 7 days
Maintenance dose: 462 mg orally twice a day
Use: For the treatment of relapsing forms of multiple sclerosis, to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease
Renal Dose Adjustments
Mild renal dysfunction: No adjustment recommended
Moderate or severe renal dysfunction: Not recommended
- No data are available on long-term use in patients with moderate or severe renal dysfunction.
Liver Dose Adjustments
Liver dysfunction: No adjustment recommended
- This drug has not been studied in patients with liver dysfunction; however, no effect on exposure to monomethyl fumarate (active metabolite) would be expected.
Patients who do not tolerate the maintenance dose: Temporary dose reductions to 231 mg orally twice a day may be considered.
- The recommended dose of 462 mg orally twice a day should be resumed within 4 weeks.
- Discontinuation of this drug should be considered for patients unable to tolerate return to the maintenance dose.
Patients with herpes zoster or other serious infections: Withholding therapy until the infection has resolved should be considered.
Patients with lymphocyte counts less than 0.5 x 10(9) cells/L persisting for more than 6 months: Interruption of therapy should be considered.
- Lymphocyte counts should be monitored until recovery if this drug is discontinued or interrupted due to lymphopenia.
At first sign/symptom suggestive of progressive multifocal leukoencephalopathy (PML): This drug should be withheld and appropriate diagnostic evaluation should be performed.
- Known hypersensitivity to the active component, any of the ingredients, or dimethyl fumarate
- Taking dimethyl fumarate
Safety and efficacy have not been established in patients younger than 18 years.
Consult WARNINGS section for additional precautions.
Data not available
- Before therapy, obtain a CBC (including lymphocyte count) and serum aminotransferase, alkaline phosphatase, and total bilirubin levels.
- Swallow capsules whole and intact; do not crush or chew and do not sprinkle the capsule contents on food.
- Administration with food may reduce the incidence of flushing.
- If administered with food, avoid a high-fat, high-calorie meal/snack; the meal/snack should contain no more than 700 calories and no more than 30 g fat.
- Avoid coadministration with alcohol.
- Administration of non-enteric coated aspirin (up to a 325 mg dose) 30 minutes before administration of this drug may reduce the incidence and severity of flushing.
Store at 20C to 25C (68F to 77F); excursions permitted to 15C to 30C (59F to 86F).
- Enzyme investigations: Alkaline phosphatase (before and during therapy, as clinically indicated)
- Hematologic: CBC including lymphocyte count (before therapy, 6 months after starting therapy, and then every 6 to 12 months thereafter, as clinically indicated)
- Hepatic: Serum aminotransferase and total bilirubin levels (before and during therapy, as clinically indicated)
- Read the US FDA-approved patient labeling (Patient Information).
- Take this drug as instructed; do not take it with alcohol.
- Discontinue this drug and seek immediate medical care if signs/symptoms of anaphylaxis or angioedema occur.
- It is important to contact your health care provider if any symptoms suggestive of PML develop; typical symptoms associated with PML are diverse, progress over days to weeks, and include progressive weakness on 1 side of the body or clumsiness of limbs, disturbance of vision, and changes in thinking, memory, and orientation leading to confusion and personality changes.
- It is important to contact your physician if any signs/symptoms associated with herpes zoster or other serious opportunistic infections develop.
- Promptly report any symptoms that may indicate liver injury (including fatigue, anorexia, right upper abdominal discomfort, dark urine, jaundice) to your health care provider.
- Contact health care provider if persistent and/or severe flushing or gastrointestinal reactions occur; taking this drug with food (avoid high-fat, high-calorie meal/snack) or taking a non-enteric coated aspirin before taking this drug may help with flushing.
- Inform health care provider if you are pregnant or plan to become pregnant during therapy.
Frequently asked questions
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