Tecfidera Dosage/Direction for Use

Treatment should be initiated under supervision of a physician experienced in the treatment of multiple sclerosis.
Posology: The starting dose is 120 mg twice a day. After 7 days, the dose should be increased to the recommended maintenance dose of 240 mg twice a day (see Precautions).
If a patient misses a dose, a double dose should not be taken. The patient may take the missed dose only if they leave 4 hours between doses. Otherwise the patient should wait until the next scheduled dose.
Temporary dose reduction to 120 mg twice a day may reduce the occurrence of flushing and gastrointestinal adverse reactions. Within 1 month, the recommended maintenance dose of 240 mg twice a day should be resumed.
Tecfidera should be taken with food (see Pharmacology: Pharmacokinetics under Actions). For those patients who may experience flushing or gastrointestinal adverse reactions, taking Tecfidera with food may improve tolerability (see Precautions, Interactions and Adverse Reactions).
Special populations: Elderly: Clinical studies of Tecfidera had limited exposure to patients aged 55 years and above, and did not include sufficient numbers of patients aged 65 and over to determine whether they respond differently than younger patients (see Pharmacology: Pharmacokinetics under Actions). Based on the mode of action of the active substance there are no theoretical reasons for any requirement for dose adjustments in the elderly.
Renal and hepatic impairment: Tecfidera has not been studied in patients with renal or hepatic impairment. Based on clinical pharmacology studies, no dose adjustments are needed (see Pharmacology: Pharmacokinetics under Actions). Caution should be used when treating patients with severe renal or severe hepatic impairment (see Precautions).
Paediatric population: The safety and efficacy of Tecfidera in children and adolescents aged 10 to 18 years have not yet been established.
Currently available data are described in Adverse Reactions, Pharmacology: Pharmacodynamics and Pharmacokinetics under Actions, but no recommendation on a posology can be made. There is no relevant use of Tecfidera in children aged less than 10 years for the indication of relapsing remitting multiple sclerosis.
Method of administration: For oral use.
The capsule should be swallowed whole. The capsule or its contents should not be crushed, divided, dissolved, sucked or chewed as the enteric-coating of the microtablets prevents irritant effects on the gut.