EXSERVAN™ is contraindicated in patients with a history of severe hypersensitivity reactions to riluzole or to any of its components (anaphylaxis has occurred).
EXSERVAN™ 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.
The use of EXSERVAN™ is not recommended if patients develop hepatic transaminases levels greater than 5 times the ULN. Discontinue EXSERVAN™ if there is evidence of liver dysfunction (e.g., elevated bilirubin). Concomitant use with other hepatotoxic drugs may increase the risk for hepatotoxicity.
EXSERVAN™ 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.
EXSERVAN™ can cause interstitial lung disease, including hypersensitivity pneumonitis. Discontinue EXSERVAN™ immediately if interstitial lung disease develops.
The most common adverse reactions (incidence greater than or equal to 5% and greater than placebo) of EXSERVAN™ were oral hypoesthesia (38%), asthenia (19%), nausea (16%), decreased lung function (10%), hypertension (5%), and abdominal pain (5%).
Coadministration of EXSERVAN™ with strong or moderate CYP1A2 inhibitors, such as ciprofloxacin, enoxacin, fluvoxamine, methoxsalen, mexiletine, oral contraceptives, thiabendazole, vemurafenib, and zileuton, may increase the risk of EXSERVAN™-associated adverse reactions.
Coadministration of EXSERVAN™ with CYP1A2 inducers may result in decreased efficacy of EXSERVAN™.
EXSERVAN™-treated patients that take other hepatotoxic drugs may be at increased risk for hepatotoxicity.
Based on animal data, riluzole may cause fetal harm. Women should be advised of a possible risk to the fetus associated with use of EXSERVAN™ during pregnancy. Riluzole has been detected in the milk of lactating rats. The risks and benefits of riluzole treatment in breastfeeding women should be carefully considered.
Japanese patients are more likely to have higher riluzole concentrations, and thus may be at a greater risk of adverse reactions.
To report suspected adverse reactions or product complaints, contact Mitsubishi Tanabe Pharma America, Inc. at 1-888-292-0058. You may also report suspected adverse reactions to the FDA at 1-800-FDA-1088 or
www.fda.gov/medwatch.
EXSERVAN™ (riluzole) oral film is indicated for the treatment of amyotrophic lateral sclerosis (ALS).
