Miscellaneous neurodegenerative disorders:

Indications for TIGLUTIK:

Amyotrophic lateral sclerosis (ALS).

Adult:

Take ≥1hr before or 2hrs after a meal. 50mg (10mL) orally or via PEG-tubes every 12hrs.

Children:

Not established.

Warnings/Precautions:

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.

Pharmacologic Class:

Benzothiazole.

Interactions:

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).

Adverse Reactions:

Oral hypoesthesia, asthenia, nausea, decreased lung function, hypertension, abdominal pain; elevated ALTs, severe neutropenia, interstitial lung disease, hypersensitivity pneumonitis.

Generic Availability:

NO

How Supplied:

Oral susp (300mL)—2 (w. supplies)

Pricing for TIGLUTIK

300ml of 50mg/10ml bottle of oral suspension (Qty: 2)
Appx. price $3319
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