GILENYA CAPSULE 0.25mg

4.1 Therapeutic indications

Gilenya is indicated as monotherapy for the treatment of adult patients and paediatric patients of 10 years of age and above with the relapsing-remitting form of multiple sclerosis to reduce the frequency of clinical exacerbations and to delay the progression of physical disability.

4.3 Contraindications

Known immunodeficiency syndrome.

Patients with increased risk for opportunistic infections, including immunocompromised patients (including those currently receiving immunosuppressive therapies or those immunocompromised by prior therapies).

Severe active infections, active chronic infections (hepatitis, tuberculosis).

Known active malignancies, except for patients with cutaneous basal cell carcinoma.

Severe liver impairment (Child-Pugh class C).

Patients who in the last 6 months had myocardial infarction, unstable angina pectoris, stroke/transient ischemic attack, decompensated heart failure (requiring inpatient treatment), or New York Heart Association Class III/IV heart failure.

Patients who have concomitant treatment with Class Ia or Class III anti-arrhythmic drugs (see section 4.4 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Patients with second-degree Mobitz type II atrioventricular (AV) block or third-degree AV block, or sick-sinus syndrome, if they do not have a pacemaker (see section 4.4 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Patients with a baseline QTc interval ≥500 msec (see section 4.4 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Known hypersensitivity to fingolimod 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.

4.2 Posology and method of administration

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

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.

Gilenya can be taken with or without food. If a dose is missed treatment should be continued with the next dose as planned.

When switching from a 0.25 mg to a 0.5 mg daily dose, it is recommended to repeat the observation after first dose.

For recommendations related to switching patients from other disease modifying therapies to Gilenya (see section 4.4 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

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

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

Diabetic patients

Gilenya has not been studied in multiple sclerosis patients with concomitant diabetes mellitus. Gilenya should be used with caution in these patients due to a potential increase in the risk of macular oedema (see sections 4.4 and 4.8 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). Regular ophthalmological examinations should be conducted in these patients to detect macular oedema.

Paediatric population (below 10 years of age)

The safety and efficacy of Gilenya in paediatric patients below 10 years of age have not yet been studied.