TIGLUTIK For Oral Administration

TIGLUTIK is an oral suspension developed for people with ALS who have dysphagia. TIGLUTIK has a mildly thick consistency (IDDSI criteria Level 2).¹ It was developed to help overcome the challenges that many patients have swallowing tablets. TIGLUTIK is administered by placing the tip of the oral syringe containing TIGLUTIK 10 mL inside the patient’s cheek. Slowly press the plunger until the oral syringe is empty.

Bottle of Tiglutik (riluzole)

Oral Administration graphic for TIGLUTIK

Approximately 85% of people with ALS develop dysphagia caused by deficits of oropharyngeal motor and sensory neurons.² For many patients, swallowing pills becomes difficult and can lead to significant health implications, including aspirating on pills.³ Before the availability of TIGLUTIK, patients who had difficulty swallowing pills were frequently advised to crush their riluzole tablets. However, no studies appear in medical literature showing that crushing riluzole tablets is safe to do.² In some patients, crushing riluzole tablets may exacerbate dysphagia due to a laryngeal sensory deficit.²

Dysphagia is Common in ALS

Bulbar Onset

Chart - Bulbar Onset

Limb Onset

Chart - Limb Onset

Combined*

Chart - Combined Bulbar and Limb Onset

* Weighted average
Adapted from Onesti E. Frontiers in Neurology 2017;8:94.

TIGLUTIK oral suspension 50 mg (10 mL) is bioequivalent to Rilutek® (riluzole) 50 mg tablets.^4-6

Mean TIGLUTIK 50 mg (10 mL) is bioequivalent to Rilutek 50 mg tablets.

Oral PK Curve

Click here for information to How to Order TIGLUTIK for Your Patients to ensure your patients with ALS get the full dose of riluzole they deserve.

References

International Dysphagia Diet Standardisation Initiative. https://iddsi.org/. Accessed July 1, 2020.
Onesti E, Front Neurol. 2017;8:94.
Nativ-Zeltzer N, Front. Surg. 2019;6:43.
TIGLUTIK® (riluzole) [package insert]. Berwyn, PA: ITF Pharma; March 2020.
Rilutek (riluzole) [package insert]. Cary, NC: Covis Pharmaceuticals, Inc.; July 2016.
Data on file. ITF Pharma. Berwyn, PA; December 2019.

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Indication

TIGLUTIK is indicated for the treatment of patients with amyotrophic lateral sclerosis (ALS).

Important Safety Information

Contraindication

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.

Adverse Reactions

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 inducers 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.

Please see accompanying prescribing information.

Intended for U.S. Residents Only

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