Why TIGLUTIK now?

Why TIGLUTIK (riluzole) now?

For more than 20 years, physicians have relied on riluzole as a foundational therapy for their patients diagnosed and living with amyotrophic lateral sclerosis (ALS). Now TIGLUTIK is available, the first and only oral suspension alternative to riluzole tablets specifically designed for people living with ALS who have or may develop dysphagia.1-3

Unpredictable onset of dysphagia

More than 80% of patients develop dysphagia at some point, and despite being present in about one-third of patients at disease onset, it often goes unrecognized.3

Why wait for dysphagia—when it can strike at any time?

There are hazards around dysphagia and swallowing crushed tablets4:

  • Patients tend to adapt to slowly deteriorating swallowing function by changing or modifying their foods, drinks, and medicine4
  • Dosage errors may result from incomplete delivery of medicine3
  • Using alternative methods to administer oral medications may change how the drug is absorbed by the body, potentially affecting its safety and efficacy3

Prescribe TIGLUTIK at diagnosis

See the clinical trials behind TIGLUTIK

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References

  1. U.S. Food and Drug Administration. Center for Drug Evaluation and Research. Rilutek (riluzole) NDA 20599 S-013 approval package. November 16, 2009.
  2. TIGLUTIK (riluzole) [package insert]. Berwyn, PA: ITF Pharma; September 2018.
  3. Keating GM. Riluzole oral suspension in amyotrophic lateral sclerosis: a guide to its use. Drugs Ther Perspect. 2016;32(7):282-286.
  4. Onesti E, Schettino I, Gori MC, et al. Dysphagia in amyotrophic lateral sclerosis: impact on patient behavior, diet adaptation, and riluzole management. Front Neurol. 2017;8:94. doi:10.3389/fneur2017.00094.
  5. Rilutek (riluzole) [package insert]. Cary, NC: Covis Pharmaceuticals, Inc.; April 2016.
  6. Data on file. ITF Pharma. Berwyn, PA. September 2018.
  7. Barnett N, Parmar P. How to tailor medication formulations for patients with dysphagia. Pharm J. 2016;297(7892). doi: 10.1211/PJ.2016.20201498.

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Indication and Important Safety Information

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 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.

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