Rx Item-TIGLUTIK- riluzole liquid 50mg/10ml 5mg/ml 1x300ml by ITF Pharma, Inc.

For: Amyotrophic Lateral Sclerosis

Tiglutik (riluzole) is an easy-to-swallow, thickened, oral suspension formulation of the approved drug riluzole for the treatment of amyotrophic lateral sclerosis (ALS). TIGLUTIK (50 mg/10 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 multi-dose use, NDC 70726-0303-2.

TIGLUTIK is supplied in a carton, NDC 70726-0303-1, containing:

Two bottles, each containing 300 mL oral suspension
Two 10 mL oral syringes
Two syringe bottle adapters
Two syringe tip caps
Prescribing Information, including Instructions for Use. These highlights do not include all the information needed to use TIGLUTIK� safely and effectively. See full prescribing information for TIGLUTIK.
TIGLUTIK (riluzole) oral suspension
Initial U.S. Approval: 1995
INDICATIONS AND USAGE

TIGLUTIK is indicated for the treatment of amyotrophic lateral sclerosis (ALS) (1)
DOSAGE AND ADMINISTRATION

Recommended dosage: 50 mg (10 mL), twice daily, taken orally, every 12 hours (2)
Take at least 1 hour before or 2 hours after a meal (2)
Measure serum aminotransferases before and during treatment (2, 5.1)

DOSAGE FORMS AND STRENGTHS

Oral suspension: 50 mg/10 mL (5 mg/mL) in 300 mL multiple-dose bottle (3)
CONTRAINDICATIONS

Patients with a history of severe hypersensitivity reactions to riluzole or to any of its components (4)
WARNINGS AND PRECAUTIONS

Hepatic injury: Use of TIGLUTIK is not recommended in patients with baseline elevations of serum aminotransferases greater than 5 times the upper limit of normal; discontinue TIGLUTIK if there is evidence of liver dysfunction (5.1)
Neutropenia: Advise patients to report any febrile illness (5.2)
Interstitial lung disease: Discontinue TIGLUTIK if interstitial lung disease develops (5.3)

ADVERSE REACTIONS

Most common adverse reactions (incidence greater than or equal to 5% and greater than placebo) were oral hypoesthesia, asthenia, nausea, decreased lung function, hypertension, and abdominal pain (6.1)



To report SUSPECTED ADVERSE REACTIONS, contact ITF Pharma Inc. at 1-800-664-1490 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
DRUG INTERACTIONS

Strong to moderate CYP1A2 inhibitors: Co-administration may increase TIGLUTIK-associated adverse reactions (7.1)
Strong to moderate CYP1A2 inducers: Co-administration may result in decreased efficacy (7.2)
Hepatotoxic drugs: TIGLUTIK-treated patients that take other hepatotoxic drugs may be at increased risk for hepatotoxicity (7.3)

USE IN SPECIFIC POPULATIONS

Pregnancy: Based on animal data, may cause fetal harm (8.1)



See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.

Revised: 9/2018

Rx Item-TIGLUTIK- riluzole liquid 50mg/1
RX70726-0303-2

Rx Item-TIGLUTIK- riluzole liquid 50mg/1
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