Indication and Important Safety Information
TIGLUTIK is indicated for the treatment of patients with amyotrophic lateral sclerosis (ALS).
Important Safety Information
TIGLUTIK is contraindicated in patients with a history of severe hypersensitivity reactions to riluzole or to any of its components.
Warnings and Precautions
TIGLUTIK can cause liver injury and there have been cases of drug-induced liver injury, some of which were fatal, in patients taking riluzole. Asymptomatic elevations of hepatic transaminases have been reported and, in some patients, have recurred upon re-challenge with riluzole. Maximum increases in ALT occurred within 3 months after starting riluzole. Monitor patients for hepatic injury every month for the first 3 months of treatment, and periodically thereafter; TIGLUTIK should be discontinued if there is evidence of liver dysfunction, for example, elevated bilirubin. Use of TIGLUTIK with other hepatotoxic drugs may increase the risk for hepatotoxicity.
TIGLUTIK can cause neutropenia. Cases of severe neutropenia (absolute neutrophil count less than 500 per mm3) within the first 2 months of riluzole treatment have been reported. Advise patients to report febrile illnesses.
TIGLUTIK can cause interstitial lung disease, including hypersensitivity pneumonitis. Discontinue TIGLUTIK immediately if interstitial lung disease develops.
The most common adverse reactions (incidence greater than or equal to 5% and greater than placebo) of TIGLUTIK were oral hypoesthesia (29%), asthenia (19%), nausea (16%), decreased lung function (10%), hypertension (5%), and abdominal pain (5%).
Coadministration of TIGLUTIK with strong or moderate CYP1A2 inhibitors, such as ciprofloxacin, enoxacin, fluvoxamine, methoxsalen, mexiletine, oral contraceptives, thiabendazole, vemurafenib, and zileuton, may increase the risk of TIGLUTIK-associated adverse reactions.
Coadministration of TIGLUTIK with CYP1A2 inhibitors may result in decreased efficacy of TIGLUTIK.
Use in Specific Populations
Patients with mild or moderate hepatic impairment (Child-Pugh’s score A or B) had increases in AUC compared to patients with normal hepatic function. Thus, patients with mild or moderate hepatic impairment may be at increased risk of adverse reactions. Use of TIGLUTIK is not recommended in patients with baseline elevations of serum aminotransferases greater than 5 times the upper limit of normal or evidence of liver dysfunction.
Japanese patients are more likely to have higher riluzole concentrations, and thus may be at a greater risk of adverse reactions.