RILUKEM

What it is

RILUKEM contains riluzole 50 mg as a film-coated tablet. Riluzole is a benzothiazole. The tablets are white and capsule shaped, debossed with the text 'RLZ' on one side.

Approved indications

— Treatment of patients with amyotrophic lateral sclerosis (ALS).

Dosing overview

The recommended daily dose in adults and elderly patients is 100 mg (50 mg every 12 hours). No significant increase in benefit can be expected from higher daily doses. RILUKEM should not be taken with a fat containing meal, due to reduction in absorption observed when administered with high fat meals.

Key safety warnings

Marked neutropenia has been reported, with absolute neutrophil counts less than 500/mm³ occurring in three cases among approximately 5000 patients treated with riluzole. Patients should be warned to report any febrile illness to their physicians, and febrile illness should prompt physicians to check white blood cell counts and discontinue riluzole in case of neutropenia. Cases of interstitial lung disease have been reported in patients treated with riluzole, some of them severe. If respiratory symptoms develop such as dry cough and/or dyspnoea, chest radiography should be performed, and in case of findings suggestive of interstitial lung disease, riluzole should be discontinued immediately. Elevations of alanine-aminotransferase (ALT) levels to more than 3 times the upper limit of the normal range were observed in about 10% of patients treated with riluzole compared to 3.7% in the placebo group. The increases in ALT usually appeared within 3 months after the start of therapy and were usually transient, with levels returning to below 2 times the upper limit of normal after 2 to 6 months. Because of risks of hepatitis, serum transaminases should be measured before and during therapy with riluzole, with ALT measured every month during the first 3 months of treatment, every 3 months during the remainder of the first year, and periodically thereafter.

Contraindications

Patients with a history of severe hypersensitivity reactions to riluzole or any tablet components. Patients with hepatic disease or hepatic impairment (baseline transaminases greater than 3 times the upper limit of normal). Patients who are pregnant or lactating.

Regulatory history

RILUKEM riluzole 50 mg film-coated tablets were first approved on 16 May 2011. The brand RILUKEM was first listed on the ARTG on 4 June 2014 (ARTG 207453) as a riluzole 50 mg film-coated tablet in blister pack format, and subsequently on 25 March 2022 (ARTG 343970) as a riluzole 50 mg film-coated tablet in bottle format.