EXSERVAN- riluzole film
EXSERVAN is indicated for the treatment of amyotrophic lateral sclerosis (ALS).
The recommended dosage for EXSERVAN is 50 mg taken orally twice daily. EXSERVAN should be taken at least 1 hour before or 2 hours after a meal [see Clinical Pharmacology ( 12.3)].
Measure serum aminotransferases before and during treatment with EXSERVAN [see Warnings and Precautions ( 5.1)].
Instruct patients and/or caregivers to read the “Instruction for Use” carefully for complete directions on how to properly dose and administer EXSERVAN oral films.
Apply EXSERVAN on top of the tongue where it adheres and dissolves. Do not cut or split the film.
Do not administer with liquids. As the film dissolves, saliva should be swallowed in a normal manner, but the patient should refrain from chewing, spitting or talking.
Only one oral film should be taken at a time.
Oral film: 50 mg orange, rectangular-shaped, orally dissolving film with “R50” printed in white on one side.
EXSERVAN is contraindicated in patients with a history of severe hypersensitivity reactions to riluzole or to any of its components (anaphylaxis has occurred) [see Adverse Reactions ( 6.1)].
EXSERVAN can cause liver injury. Cases of drug-induced liver injury, some of which were fatal, have been reported in patients taking riluzole. Asymptomatic elevations of hepatic transaminases have also been reported, and in some patients have recurred upon rechallenge with riluzole.
In clinical studies, the incidence of elevations in hepatic transaminases was greater in riluzole-treated patients than in placebo-treated patients. The incidence of elevations of ALT above 5 times the upper limit of normal (ULN) was 2% in riluzole-treated patients. Maximum increases in ALT occurred within 3 months after starting riluzole. About 50% and 8% of riluzole-treated patients in pooled controlled efficacy studies (Studies 1 and 2) had at least one elevated ALT level above ULN and above 3 times ULN, respectively [see Clinical Studies ( 14)].
Monitor patients for signs and symptoms of 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 [see Drug Interactions ( 7.3)].
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 following clinically significant adverse reactions are described below and elsewhere in the labeling:
- Hepatic Injury [see Warnings and Precautions ( 5.1)]
- Neutropenia [see Warnings and Precautions ( 5.2)]
- Interstitial Lung Disease [see Warnings and Precautions ( 5.3)]
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
Adverse Reactions in Controlled Clinical Trials of Riluzole Tablets
In the placebo-controlled clinical trials in patients with ALS (Study 1 and 2), a total of 313 patients received riluzole tablets 50 mg twice daily [see Clinical Studies ( 14)]. The most common adverse reactions in the riluzole-treated patients (in at least 5% of patients and more frequently than on placebo) were asthenia, nausea, decreased lung function, hypertension, and abdominal pain. The most common adverse reactions leading to discontinuation in the riluzole-treated patients were nausea, abdominal pain, constipation, and elevated ALT.
There was no difference in rates of adverse reactions leading to discontinuation in females and males. However, the incidence of dizziness was higher in females (11%) than in males (4%). The adverse reaction profile was similar in older and younger patients. There were insufficient data to determine if there were differences in the adverse reaction profile in different races.
Table 1 lists adverse reactions that occurred in at least 2% of riluzole treated patients (50 mg twice daily) in pooled Study 1 and 2, and at a higher rate than placebo.
|RILUZOLE Tablets 50 mg twice daily (N=313) %||Placeb o (N=320) %|
|Decreased lung function||10||9|
|Urinary tract infection||3||2|
Additional Adverse Reaction with EXSERVAN
In an open-label pharmacokinetic study in healthy subjects (n=32), oral hypoesthesia was observed in 38% of subjects taking EXSERVAN, compared to no subjects taking riluzole tablets, under fasting conditions.
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