INOVELON Film-coated tablet Ref.[9269] Active ingredients: Rufinamide

Treatment with rufinamide should be initiated by a physician specialised in paediatrics or neurology with experience in the treatment of epilepsy.

Inovelon oral suspension and Inovelon film-coated tablets may be interchanged at equal doses. Patients should be monitored during the switch over period.

Posology

Use in children from 1 year to less than 4 years of age

Patients not receiving valproate

Treatment should be initiated at a dose of 10 mg/kg/day administered in two equally divided doses separated by approximately 12 hours. According to clinical response and tolerability, the dose may be increased by up to 10 mg/kg/day every third day to a target dose of 45 mg/kg/day administered in two equally divided doses separated by approximately 12 hours. For this patient population, the maximum recommended dose is 45 mg/kg/day.

Patients receiving valproate

As valproate significantly decreases clearance of rufinamide, a lower maximum dose of Inovelon is recommended for patients being co-administered valproate. Treatment should be initiated at a dose of 10 mg/kg/day administered in two equally divided doses separated by approximately 12 hours. According to clinical response and tolerability, the dose may be increased by up to 10 mg/kg/day every third day to a target dose of 30 mg/kg/day administered in two equally divided doses separated by approximately 12 hours. For this patient population, the maximum recommended dose is 30 mg/kg/day.

If the recommended calculated dose of Inovelon is not achievable, the dose should be given to the nearest whole 100 mg tablet.

Use in children 4 years of age or older and less than 30 kg

Patients <30 kg not receiving valproate

Treatment should be initiated at a daily dose of 200 mg. According to clinical response and tolerability, the dose may be increased by 200 mg/day increments, as frequently as every third day, up to a maximum recommended dose of 1,000 mg/day.

Doses of up to 3,600 mg/day have been studied in a limited number of patients.

Patients <30 kg also receiving valproate

As valproate significantly decreases clearance of rufinamide, a lower maximum dose of Inovelon is recommended for patients <30 kg being co-administered valproate. Treatment should be initiated at a daily dose of 200 mg. According to clinical response and tolerability, after a minimum of 2 days the dose may be increased by 200 mg/day, to the maximum recommended dose of 600 mg/day.

Use in adults, adolescents and children 4 years of age or older of 30 kg or over

Patients >30 kg not receiving valproate

Treatment should be initiated at a daily dose of 400 mg. According to clinical response and tolerability, the dose may be increased by 400 mg/day increments, as frequently as every other day, up to a maximum recommended dose as indicated in the table below.

Doses of up to 4,000 mg/day (in the 30-50 kg range) or 4,800 mg/day (in the over 50 kg) have been studied in a limited number of patients.

Patients >30 kg also receiving valproate

Treatment should be initiated at a daily dose of 400 mg. According to clinical response and tolerability, the dose may be increased by 400 mg/day increments, as frequently as every other day, up to a maximum recommended dose as indicated in the table below.

Elderly

There is limited information on the use of rufinamide in older people. Since the pharmacokinetics of rufinamide are not altered in older people (see section 5.2), dosage adjustment is not required in patients over 65 years of age.

Renal impairment

A study in patients with severe renal impairment indicated that no dose adjustments are required for these patients (see section 5.2).

Hepatic impairment

Use in patients with hepatic impairment has not been studied. Caution and careful dose titration is recommended when treating patients with mild to moderate hepatic impairment. Use in patients with severe hepatic impairment is not recommended.

Discontinuation of rufinamide

When rufinamide treatment is to be discontinued, it should be withdrawn gradually. In clinical trials rufinamide discontinuation was achieved by reducing the dose by approximately 25% every two days (see section 4.4).

In the case of one or more missed doses, individualised clinical judgement is necessary.

Uncontrolled open-label studies suggest sustained long-term efficacy, although no controlled study has been conducted for longer than three months.

Paediatric population

The safety and efficacy of rufinamide in new-born infants or infants and toddlers aged less than 1 year have not been established. No data are available (see section 5.2).

Method of administration

Rufinamide is for oral use.

The tablet should be taken twice daily with water in the morning and in the evening, in two equally divided doses.

Inovelon should be administered with food (see section 5.2). If the patient has difficulty with swallowing, tablets can be crushed and administered in half a glass of water. Alternatively, use the score line to break the tablet into two equal halves.

After an acute overdose, the stomach may be emptied by gastric lavage or by induction of emesis. There is no specific antidote for rufinamide. Treatment should be supportive and may include haemodialysis (see section 5.2).

Multiple dosing of 7,200 mg/day was associated with no major signs or symptoms.

4 years.

Do not store above 30°C.

Aluminium/aluminium blisters, packs of 10, 30, 50, 60 and 100 film-coated tablets.

Not all pack sizes may be marketed.

No special requirements for disposal.

This medicinal product could have potential risk for the environment. Any unused medicinal product or waste material should be disposed of in accordance with local requirements (see section 5.3).