Tiglutik Generic Name & Formulations
Riluzole 50mg/10mL (5mg/mL); oral susp.
Oral susp (300mL)—2 (w. supplies)
Amyotrophic lateral sclerosis (ALS).
Tiglutik Dosage and Administration
Take ≥1hr before or 2hrs after a meal. 50mg (10mL) orally or via PEG-tubes every 12hrs.
Tiglutik Boxed Warnings
Monitor for hepatic injury monthly for the first 3 months, and periodically thereafter. Measure serum aminotransferases before and during treatment. If ALT >5×ULN: not recommended. Discontinue if liver dysfunction evident (eg, elevated bilirubin). Risk of neutropenia: monitor for febrile illness. Discontinue immediately if interstitial lung disease develops. Japanese patients (higher drug concentration/adverse reactions). Hepatic impairment. Elderly. Pregnancy. Nursing mothers.
May be potentiated by strong or moderate CYP1A2 inhibitors (eg, ciprofloxacin, enoxacin, fluvoxamine, methoxsalen, mexiletine, oral contraceptives, thiabendazole, vemurafenib, zileuton). May be antagonized by CYP1A2 inducers. Increased risk of hepatotoxicity with concomitant other hepatotoxic agents (eg, allopurinol, methyldopa, sulfasalazine).
Tiglutik Adverse Reactions
Oral hypoesthesia, asthenia, nausea, decreased lung function, hypertension, abdominal pain; elevated ALTs, severe neutropenia, interstitial lung disease, hypersensitivity pneumonitis.
Tiglutik Clinical Trials
Tiglutik Patient Counseling