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

Comments:

• No data are available on long-term use in patients with moderate or severe renal dysfunction.

Liver Dose Adjustments

Liver dysfunction: No adjustment recommended

Comments:

• This drug has not been studied in patients with liver dysfunction; however, no effect on exposure to monomethyl fumarate (active metabolite) would be expected.

Dose Adjustments

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.

Precautions

CONTRAINDICATIONS:

• 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.

Dialysis

Data not available

Other Comments

Administration advice:

• 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.

Storage requirements:
Store at 20C to 25C (68F to 77F); excursions permitted to 15C to 30C (59F to 86F).

Monitoring:

• 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)

Patient advice:

• 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

• What are the new drugs used for multiple sclerosis (MS)?