TECFIDERA GASTRO-RESISTANT HARD CAPSULES 120 MG

4.1. Therapeutic indications

Tecfidera is indicated for the treatment of adult and paediatric patients aged 13 years and older with relapsing remitting multiple sclerosis (RRMS).

4.3. Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information. Suspected or confirmed Progressive Multifocal Leukoencephalopathy (PML).

4.2. Posology and method of administration

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 section 4.4 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

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 section 5.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). For those patients who may experience flushing or gastrointestinal adverse reactions, taking Tecfidera with food may improve tolerability (see sections 4.4, 4.5 and 4.8 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

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 section 5.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). 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 section 5.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). Caution should be used when treating patients with severe renal or severe hepatic impairment (see section 4.4 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Paediatric population

The posology is the same in adults and in paediatric patients aged 13 years and older.

Currently available data are described in sections 4.4, 4.8, 5.1, and 5.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.

There are limited data available in children between 10 and 12 years old.

The safety and efficacy of Tecfidera in children aged less than 10 years have not yet been established.

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.