Rx Item-Exservan (riluzole) Oral Film BY Aquestive Therapeutics 50MG 60

These highlights do not include all the information needed to use EXSERVAN� safely and effectively. See full prescribing information for EXSERVAN.

EXSERVAN (riluzole) oral film
Initial U.S. Approval: 1995
INDICATIONS AND USAGE

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

Recommended dosage: 50 mg twice daily, taken at least 1 hour before or 2 hours after a meal (2.1)
Measure serum aminotransferases before and during treatment (2.2, 5.1)

DOSAGE FORMS AND STRENGTHS

Oral Film: 50 mg (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 EXSERVAN is not recommended in patients with baseline elevations of serum aminotransferases greater than 5 times upper limit of normal; discontinue EXSERVAN if there is evidence of liver dysfunction (5.1)
Neutropenia: Advise patients to report any febrile illness (5.2)
Interstitial lung disease: Discontinue EXSERVAN 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 Aquestive Therapeutics at 1-877-394-5045 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
DRUG INTERACTIONS

Strong to moderate CYP1A2 inhibitors: Coadministration may increase EXSERVAN-associated adverse reactions (7.1)
Strong to moderate CYP1A2 inducers: Coadministration may result in decreased efficacy (7.2)
Hepatotoxic drugs: EXSERVAN-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: 11/2019

Rx Item-Exservan (riluzole) Oral Film BY
RX10094-350-60

Rx Item-Exservan (riluzole) Oral Film BY
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