FAQs

FAQs about TIGLUTIK (riluzole)

What is TIGLUTIK?

TIGLUTIK is the first and only easy-to-swallow oral suspension alternative to riluzole tablets for the treatment of amyotrophic lateral sclerosis (ALS).1,2

How do my patients take TIGLUTIK?

Patients take 10 mL of oral suspension TIGLUTIK twice a day. This dose includes the same 50 mg found in a riluzole tablet.1,3

How is TIGLUTIK supplied to my patients?

TIGLUTIK 50 mg/10 mL (5 mg/mL) oral suspension is supplied in amber glass bottles closed with child-resistant, tamper-evident screw caps. Each bottle contains 300 mL of oral suspension and is intended for multidose use. TIGLUTIK is supplied in a carton containing two 300 mL bottles, two plastic 10 mL oral dispensers (syringes), two syringe bottle adapters, and two syringe tip caps.1

Can my patient take TIGLUTIK if she is pregnant?

There are no studies of riluzole, the active ingredient in TIGLUTIK, in pregnant women, and case reports have been inadequate to inform on the drug-associated risk. Based on animal data, women should be advised of a possible risk to the fetus associated with use of TIGLUTIK during pregnancy.1

Can my patient breastfeed while she is taking TIGLUTIK?

It is not known if riluzole, the active ingredient in TIGLUTIK, is excreted in human milk. Riluzole or its metabolites have been detected in the milk of lactating rats. Women should be advised that many drugs are excreted in human milk and that the potential for serious adverse reactions in nursing infants from riluzole is unknown.1

Does TIGLUTIK have any contraindications?

TIGLUTIK is contraindicated in patients with a history of severe hypersensitivity reactions to riluzole or to any of its components (anaphylaxis has occurred).1

References

  1. TIGLUTIK (riluzole) [package insert]. Berwyn, PA: ITF Pharma; September 2018.
  2. Keating GM. Riluzole oral suspension in amyotrophic lateral sclerosis: a guide to its use. Drugs Ther Perspect. 2016;32(7):282-286.
  3. Rilutek (riluzole) [package insert]. Cary, NC: Covis Pharmaceuticals, Inc.; April 2016.

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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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