Do not use if you are allergic to riluzole or to any of its ingredients.
Before using EXSERVAN™, tell your doctor about all the medicines you take and all your
health conditions, including if you:
- Have liver problems.
- Are taking certain drugs known as strong or moderate CYP1A2 inhibitors such as
ciprofloxacin, enoxacin, fluvoxamine, methoxsalen, mexiletine, oral contraceptives,
thiabendazole, vemurafenib, or zileuton.
- Are pregnant or intend to become pregnant during EXSERVAN™ therapy, or if you are
breastfeeding or intend to breastfeed during EXSERVAN™ therapy.
EXSERVAN™ can cause serious side effects, including:
Liver Problems: Cases of liver injury, some fatal, have occurred in
patients taking riluzole. Consult your doctor promptly if you experience unexplained nausea,
vomiting, stomach (abdominal) pain, fatigue, weight loss (anorexia), jaundice (yellowing of
the skin or whites of the eyes), and/or dark urine.
Low White Blood Cell Counts (Neutropenia): Tell your doctor if you develop
a fever while taking EXSERVAN™.
Serious Lung Problems (Interstitial Lung Disease): Tell your doctor if you
have problems with your lungs or breathing such as dry cough and difficult or labored
breathing. Discontinue EXSERVAN™ immediately if you develop interstitial lung disease.
The most common side effects include numbness in the mouth or tongue, muscle
weakness, nausea, lung problems, high blood pressure, and stomach (abdominal) pain.
These are not all the possible side effects of EXSERVAN™. Consult your doctor for
medical advice about side effects.
To report side effects, contact Mitsubishi Tanabe Pharma America, Inc. at
1-888-292-0058 or the FDA at 1-800-FDA-1088 or
Use EXSERVAN™ as prescribed. The recommended dosage for EXSERVAN™ is 50 mg taken
orally twice daily at least 1 hour before or 2 hours after a meal. Place EXSERVAN™ oral film
strip on the top of the tongue where it will adhere and dissolve. Swallow in a normal manner. Do
cut or split the film or take liquids with EXSERVAN™. Do not chew, spit, or talk while EXSERVAN™
is dissolving. Read the Instructions for Use for EXSERVAN™.
EXSERVAN™ (riluzole) is indicated for the treatment of amyotrophic lateral sclerosis
Please click here to see the full Prescribing Information for