RILUZOLE

What it is

Riluzole Sandoz is a film-coated tablet containing 50 mg riluzole, a benzothiazole.

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. Riluzole Sandoz should not be taken with a fat containing meal, due to the reduction in absorption observed when administered with high fat meals.

Key safety warnings

Neutropenia has been reported, with three cases of marked neutropenia (absolute neutrophil count less than 500/mm³) among approximately 5000 patients. 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 to 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. These increases 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 while treatment continued. Because of risks of hepatitis, serum transaminases, including ALT, should be measured before and during therapy with riluzole. ALT should be measured every month during the first 3 months of treatment, every 3 months during the remainder of the first year, and periodically thereafter.

Contraindications

Riluzole is contraindicated in patients who have a history of severe hypersensitivity reactions to riluzole or any of the tablet components. It is contraindicated in patients who have hepatic disease or hepatic impairment (baseline transaminases greater than 3 times the upper limit of normal). Riluzole is contraindicated in patients who are pregnant or lactating.

PBS listing

Riluzole Sandoz 50 mg tablets are listed on the PBS as 2 items with authority required restriction, at an ex-manufacturer price of A$89.04.

Regulatory history

Riluzole Sandoz received initial approval on 16 May 2011. The product was first listed on the ARTG on 8 March 2012.