GILENYA

What it is

GILENYA is indicated for the treatment of adult and paediatric patients of 10 years of age and above with relapsing forms of multiple sclerosis to reduce the frequency of relapses and to delay the progression of disability. The active ingredient is fingolimod hydrochloride. Each capsule contains 560 microgram fingolimod hydrochloride, equivalent to 500 microgram fingolimod. GILENYA is subject to additional monitoring in Australia to allow quick identification of new safety information.

Approved indications

— Relapsing forms of multiple sclerosis in adult and paediatric patients of 10 years of age and above.

Dosing overview

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: one 0.25 mg capsule daily for those with body weight ≤ 40 kg, or one 0.5 mg capsule daily for those with body weight > 40 kg. GILENYA can be taken with or without food.

Key safety warnings

Fingolimod causes a dose-dependent reduction in peripheral lymphocyte count to 20–30% of baseline values because of reversible sequestration of lymphocytes in lymphoid tissues, and may increase the risk of infections, including opportunistic infections, some serious in nature. Cases of cryptococcal infections, including cryptococcal meningitis, have been reported in the post-marketing setting after approximately 2–3 years of treatment, and cryptococcal meningitis may be fatal. Cases of progressive multifocal leukoencephalopathy (PML) have been reported in the post-marketing setting; PML is an opportunistic infection caused by JC virus, which may be fatal or result in severe disability. Initiation of fingolimod treatment results in a decrease in heart rate, with the heart rate decrease starting within an hour of the first dose and being maximal within 6 hours, averaging approximately 8 beats per minute. On initiation of GILENYA treatment, after the first dose, all patients should be observed with hourly pulse and blood pressure measurement for a period of 6 hours for signs and symptoms of bradycardia, and all patients should have an electrocardiogram performed prior to dosing and at the end of the 6-hour monitoring period. Initiation of fingolimod treatment has been associated with atrio-ventricular conduction delays, usually as first-degree atrio-ventricular blocks, with second-degree atrio-ventricular blocks usually Mobitz type I observed in less than 0.5% of patients; these conduction abnormalities typically were transient, asymptomatic, usually did not require treatment and resolved within the first 24 hours on treatment. Increased liver enzymes, mostly alanine aminotransaminase (ALT) elevation, have been reported in multiple sclerosis patients treated with fingolimod, with 3-fold or greater elevation in liver transaminases occurring in 8.5% of patients treated with fingolimod 0.5 mg during clinical trials. Clinically significant liver injury has been reported in patients treated with fingolimod in the post-market setting including cases of acute liver failure requiring liver transplant. Macular oedema can occur with or without visual symptoms, and an ophthalmologic evaluation should be performed before starting fingolimod and at 3–4 months after treatment initiation. Patients with diabetes mellitus or a history of uveitis are at increased risk of macular oedema.

Contraindications

GILENYA is contraindicated in patients who in the last 6 months experienced myocardial infarction, unstable angina, stroke, TIA, decompensated heart failure requiring hospitalisation or Class III/IV heart failure; patients with history or presence of Mobitz Type II second-degree or third-degree atrioventricular block or sick sinus syndrome, unless the patient has a functioning pacemaker; and patients with baseline QTc interval ≥ 500 ms. Concomitant treatment with Class Ia or Class III anti-arrhythmic drugs is contraindicated during GILENYA initiation. GILENYA should not be administered to patients with known hypersensitivity to fingolimod or any of the excipients.

PBS listing

GILENYA 250 micrograms capsules are listed on the PBS with streamlined restriction at an ex-manufacturer price of A$951.05.

Regulatory history

GILENYA fingolimod 0.5 mg capsules were first registered on the ARTG on 2011-02-01 by Novartis Pharmaceuticals. The TGA approved fingolimod for the treatment of relapsing remitting multiple sclerosis and secondary progressive multiple sclerosis with superimposed relapses to delay the progression of physical disability and reduce the frequency of relapse. GILENYA fingolimod 0.25 mg capsules were subsequently added to the ARTG on 2019-04-12. In November 2014, the PBAC recommended extending the listing of fingolimod for relapsing-remitting multiple sclerosis to include patients who have failed treatment with one prior disease-modifying therapy. In July 2019, the PBAC recommended a new Authority Required listing of 250 mcg capsules for relapsing-remitting multiple sclerosis in patients weighing 40 kg or less. In November 2024, the PBAC recommended an amendment to PBS listings to allow nurse practitioners to initiate and continue treatment in consultation with a specialist physician.