Prescription and Enrollment Form
Download the Prescription and Enrollment Form to get patients started on
Guide to Patient Access
Learn about access information available to your patients from PANTHERx Rare Pharmacy.
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Patient Authorization Form
Use this form to obtain patient authorization to receive access information if the patient did not sign the Prescription and Enrollment Form. The signed Patient Authorization Form can be provided via fax.
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Sample Letter of Medical Necessity
Consider using this sample letter to help your patients with a prescription for
Sample Exceptions Letter
Consider using this sample letter if your patient's coverage is denied because
Sample Appeal Letter
Consider using this sample letter if your patient's coverage is denied because their condition did not meet the plan's criteria for prescribing
EAT-10 Screening Tool
Download a tool to help facilitate discussions about your patients' swallowing abilities.
DownloadThe sample letters are provided by Mitsubishi Tanabe Pharma America for informational purposes for patients who have been prescribed
The mechanism by which riluzole exerts its therapeutic effects in patients with ALS is unknown.1
Coadministration with strong to moderate CYP1A2 inhibitors may increase
Each
There are no studies of riluzole in pregnant women, and case reports have been inadequate to inform the drug-associated risk. Advise patients to notify their healthcare provider if they become pregnant or intend to become pregnant during
There are no data on the presence of riluzole in human milk, the effects on the breastfed infant, or the effects on milk production. Riluzole or its metabolites have been detected in milk of lactating rat. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for
Each EXSERVAN oral film is an orange, rectangular-shaped film that contains 50 mg of riluzole with "R50" printed in white ink on one side. Each film is packaged
NDC 70510-2201-1: 50 mg oral film, carton of 60 pouches.1
Store EXSERVAN oral film pouches at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F).1
Do not administer
Apply
The recommended dosage for
Mitsubishi Tanabe Pharma America, Inc. is committed to advancing treatment options for people living with ALS.
Discover another treatment option to consider in your patients' ALS journeys
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Important Safety Information
Contraindication
Warnings and Precautions
Hepatic Injury
The use of
Neutropenia
Interstitial Lung Disease
Adverse Reactions
The most common adverse reactions (incidence greater than or equal to 5% and greater than placebo) of
Drug Interactions
Coadministration of
Coadministration of
Use in Specific Populations
Based on animal data, riluzole may cause fetal harm. Women should be advised of a possible risk to the fetus associated with use of
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
Indication
Please see the full
Prescribing Information for