TIGLUTIK safety data
TIGLUTIK has an established safety profile
For more than 20 years, riluzole has been prescribed to patients diagnosed with amyotrophic lateral sclerosis (ALS). The safety of riluzole, of which TIGLUTIK is the oral suspension formulation, was demonstrated in pooled, placebo-controlled trials (Study 1 and Study 2) of 633 patients with ALS.
Most common adverse reactions with TIGLUTIK oral suspension (incidence greater than or equal to 5% and greater than placebo) were oral hypoesthesia, asthenia, nausea, decreased lung function, hypertension, and abdominal pain.
Below are adverse reactions that occurred in at least 2% of patients treated with riluzole tablets and at a higher rate than placebo.
Adverse reactions compared with placebo (≥2% in riluzole-treated patients)
|Riluzole tablets 50 mg twice-daily (n=313)||Placebo (n=320)|
|Decreased lung function||10%||9%|
|Urinary tract infection||3%||2%|
Pooled clinical results from placebo-controlled Study 1 and Study 2.
TIGLUTIK (riluzole) [package insert]. Berwyn, PA: ITF Pharma; September 2018.