Usual Adult Dose for Multiple Sclerosis

Initial dose: 120 mg orally twice a day for 7 days
Maintenance dose: 240 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

Renal dysfunction: No adjustment recommended

Liver Dose Adjustments

Liver dysfunction: No adjustment recommended

Comments:

• This drug should be discontinued if it is suspected to have induced clinically significant liver injury.

Dose Adjustments

For patients who do not tolerate the maintenance dose:

• Temporary dose reductions to 120 mg orally twice a day may be considered.
• The recommended dose of 240 mg orally twice a day should be resumed within 4 weeks.
• Discontinuation of this drug should be considered if unable to tolerate resumption of the maintenance dose.

• If herpes zoster or other serious infections occur: Withholding therapy until resolution should be considered.

• Lymphocyte count less than 0.5 x 10(9) cells/L for more than 6 months: Interruption of therapy should be considered.
• If this drug is discontinued or interrupted due to lymphopenia: Lymphocyte count should be monitored until recovery.

Precautions

CONTRAINDICATIONS:

• Known hypersensitivity to the active component or any of the ingredients

Dialysis

Data not available

Other Comments

Administration advice:

• Before starting therapy, obtain a CBC (including lymphocyte count) and serum aminotransferase, alkaline phosphatase, and total bilirubin levels.
• Administer with or without food.
• Administration with food may reduce the incidence of flushing; alternatively, administration of non-enteric coated aspirin (up to a dose of 325 mg) may reduce the incidence/severity of flushing.
• Swallow whole and intact; do not crush or chew the capsules, and do not sprinkle the capsule contents on food.

• Store at 15C to 30C (59F to 86F).
• Store in original container and protect from light.

• Hematologic: CBC, including lymphocyte count (before starting therapy, after 6 months of therapy, every 6 to 12 months thereafter, and as clinically indicated)
• Hepatic: Serum aminotransferase, alkaline phosphatase, and total bilirubin levels (before starting and during therapy as clinically indicated)
• Infections/Infestations: For signs/symptoms of herpes zoster
• Nervous System: MRI for signs consistent with progressive multifocal leukoencephalopathy (PML)

• Read the US FDA-approved patient labeling (Patient Information).
• Stop this drug and seek medical care if signs/symptoms of anaphylaxis or angioedema develop.
• It is important to contact your physician 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/orientation (leading to confusion, 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 suggestive of liver injury (including fatigue, anorexia, right upper abdominal discomfort, dark urine, jaundice).
• Contact health care provider if persistent and/or severe flushing or gastrointestinal reactions (abdominal pain, diarrhea, nausea) occur.
• Notify your physician if you are pregnant or plan to become pregnant during therapy. Enrollment in the pregnancy registry is encouraged if you become pregnant while taking this drug.

Frequently asked questions

• What are the new drugs used for multiple sclerosis (MS)?
• Is Tecfidera an immunosuppressant?
• Can I stop taking Tecfidera? What happens if I do?
• Can you drink alcohol while taking Tecfidera?
• What causes flushing with Tecfidera?
• How long can you take Tecfidera?
• Gilenya vs Tecfidera. How do they compare?
• Does Tecfidera cause weight gain or loss?
• How long does it take Tecfidera to start working?
• Can Tecfidera cause progressive multifocal leukoencephalopathy (PML)?
• Can Tecfidera cause low lymphocytes?