TEGLUTIK

What it is

TEGLUTIK is indicated for the treatment of patients with amyotrophic lateral sclerosis (ALS). TEGLUTIK is formulated as an oral liquid suspension containing riluzole 50 mg per 10 mL.

Approved indications

— Amyotrophic lateral sclerosis (ALS)

Dosing overview

The recommended daily dose in adults or elderly is 100 mg (50 mg every 12 hours). No significant increase in benefit can be expected from higher daily doses. TEGLUTIK 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 with absolute neutrophil count less than 500/mm³ has been reported rarely. Patients should be warned to report any febrile illness to their physicians, and the report of a 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 normal 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 while treatment was continued. 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

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

PBS listing

TEGLUTIK oral suspension 50 mg per 10 mL is listed on the PBS as 2 items with authority required restriction, at an ex-manufacturer price of A$87.29.

Regulatory history

TEGLUTIK received initial approval on 16 May 2011. An oral liquid suspension formulation (ARTG 292987) was first listed on 21 August 2018.