GILENYA Hard capsule Ref.[8575] Active ingredients: Fingolimod

The treatment should be initiated and supervised by a physician experienced in multiple sclerosis.

Posology

In adults, the recommended dose of Gilenya is one 0.5 mg capsule taken orally once daily.

In paediatric patients (10 years of age and above), the recommended dose is dependent on body weight:

• Paediatric patients with body weight ≤40 kg: one 0.25 mg capsule taken orally once daily.
• Paediatric patients with body weight >40 kg: one 0.5 mg capsule taken orally once daily.

Paediatric patients who start on 0.25 mg capsules and subsequently reach a stable body weight above 40 kg should be switched to 0.5 mg capsules.

When switching from a 0.25 mg to a 0.5 mg daily dose, it is recommended to repeat the same first dose monitoring as for treatment initiation.

Gilenya can be taken with or without food.

The capsules should always be swallowed intact, without opening them.

The same first dose monitoring as for treatment initiation is recommended when treatment is interrupted for:

• 1 day or more during the first 2 weeks of treatment.
• more than 7 days during weeks 3 and 4 of treatment.
• more than 2 weeks after one month of treatment.

If the treatment interruption is of shorter duration than the above, the treatment should be continued with the next dose as planned (see section 4.4).

Special populations

Elderly population

Gilenya should be used with caution in patients aged 65 years and over due to insufficient data on safety and efficacy (see section 5.2).

Renal impairment

Gilenya was not studied in patients with renal impairment in the multiple sclerosis pivotal studies. Based on clinical pharmacology studies, no dose adjustments are needed in patients with mild to severe renal impairment.

Hepatic impairment

Gilenya must not be used in patients with severe hepatic impairment (Child-Pugh class C) (see section 4.3). Although no dose adjustments are needed in patients with mild or moderate hepatic impairment, caution should be exercised when initiating treatment in these patients (see sections 4.4 and 5.2).

Paediatric population

The safety and efficacy of Gilenya in children aged below 10 years have not yet been established. No data are available.

There are very limited data available in children between 10–12 years old (see sections 4.4, 4.8 and 5.1).

Method of administration

This medicinal product is for oral use.

Single doses up to 80 times the recommended dose (0.5 mg) were well tolerated in healthy adult volunteers. At 40 mg, 5 of 6 subjects reported mild chest tightness or discomfort which was clinically consistent with small airway reactivity.

Fingolimod can induce bradycardia upon treatment initiation. The decline in heart rate usually starts within one hour of the first dose, and is steepest within 6 hours. The negative chronotropic effect of Gilenya persists beyond 6 hours and progressively attenuates over subsequent days of treatment (see section 4.4 for details). There have been reports of slow atrioventricular conduction, with isolated reports of transient, spontaneously resolving complete AV block (see sections 4.4 and 4.8).

If the overdose constitutes first exposure to Gilenya, it is important to monitor patients with a continuous (real time) ECG and hourly measurement of heart rate and blood pressure, at least during the first 6 hours (see section 4.4).

Additionally, if after 6 hours the heart rate is <45 bpm in adults, <55 bpm in paediatric patients aged 12 years and above, or <60 bpm in paediatric patients aged 10 years to below 12 years, or if the ECG at 6 hours after the first dose shows second degree or higher AV block, or if it shows a QTc interval ≥500 msec, monitoring should be extended at least for overnight and until the findings have resolved. The occurrence at any time of third degree AV block should also lead to extended monitoring including overnight monitoring.

Neither dialysis nor plasma exchange results in removal of fingolimod from the body.

Gilenya 0.25 mg hard capsules: 18 months.

Gilenya 0.5 mg hard capsules: 2 years.

Do not store above 25°C.

Store in the original package in order to protect from moisture.

Gilenya 0.25 mg hard capsules:

PVC/PVDC/aluminium blister packs containing 28 hard capsules.

PVC/PVDC/aluminium perforated unit dose blister packs containing 7x 1 hard capsules.

Gilenya 0.5 mg hard capsules:

PVC/PVDC/aluminium blister packs containing 7, 28 or 98 hard capsules or multipacks containing 84 (3 packs of 28) hard capsules.

PVC/PVDC/aluminium perforated unit dose blister packs containing 7x 1 hard capsules.

Not all pack sizes may be marketed.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.