Riluzole

RILUZOLE- riluzole tablet, film coated
Mylan Pharmaceuticals Inc.

1 INDICATIONS AND USAGE

Riluzole tablets are indicated for the treatment of amyotrophic lateral sclerosis (ALS).

2 DOSAGE AND ADMINISTRATION

The recommended dosage for riluzole tablets is 50 mg taken orally twice daily. Riluzole tablets 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 riluzole tablets [see Warnings and Precautions (5.1)].

3 DOSAGE FORMS AND STRENGTHS

Riluzole Tablets, USP are available containing 50 mg of riluzole, USP.

The 50 mg tablets are white, film-coated, capsule shaped, unscored tablets debossed with M on one side of the tablet and RE 50 on the other side.

4 CONTRAINDICATIONS

Riluzole tablets are contraindicated in patients with a history of severe hypersensitivity reactions to riluzole or to any of their components (anaphylaxis has occurred) [see Adverse Reactions (6.1)].

5 WARNINGS AND PRECAUTIONS

5.1 Hepatic Injury

Cases of drug-induced liver injury, some of which were fatal, have been reported in patients taking riluzole tablets. Asymptomatic elevations of hepatic transaminases have also been reported, and in some patients have recurred upon rechallenge with riluzole tablets.

In clinical studies, the incidence of elevations in hepatic transaminases was greater in riluzole tablet-treated patients than placebo-treated patients. The incidence of elevations of ALT above 5 times the upper limit of normal (ULN) was 2% in riluzole tablet-treated patients. Maximum increases in ALT occurred within 3 months after starting riluzole tablets. About 50% and 8% of riluzole tablet-treated patients in pooled 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 riluzole tablets is not recommended if patients develop hepatic transaminase levels greater than 5 times the ULN. Discontinue riluzole tablets if there is evidence of liver dysfunction (e.g., elevated bilirubin).

5.2 Neutropenia

Cases of severe neutropenia (absolute neutrophil count less than 500 per mm3) within the first 2 months of riluzole tablet treatment have been reported. Advise patients to report febrile illnesses.

5.3 Interstitial Lung Disease

Interstitial lung disease, including hypersensitivity pneumonitis, has occurred in patients taking riluzole tablets. Discontinue riluzole tablets immediately if interstitial lung disease develops.

6 ADVERSE REACTIONS

The following 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)]

6.1 Clinical Trials Experience

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

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 tablets group (in at least 5% of patients and more frequently than in the placebo group) were asthenia, nausea, dizziness, decreased lung function, and abdominal pain. The most common adverse reactions leading to discontinuation in the riluzole tablets group 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 tablet-treated patients (50 mg twice daily) in pooled Study 1 and 2, and at a higher rate than placebo.

Table 1. Adverse Reactions in Pooled Placebo-Controlled Trials (Studies 1 and 2) in Patients with ALS

Riluzole Tablets

50 mg twice daily

(N = 313)

Placebo

(N = 320)

Asthenia

19%

12%

Nausea

16%

11%

Decreased lung function

10%

9%

Hypertension

5%

4%

Abdominal pain

5%

4%

Vomiting

4%

2%

Arthralgia

4%

3%

Dizziness

4%

3%

Dry mouth

4%

3%

Insomnia

4%

3%

Pruritus

4%

3%

Tachycardia

3%

1%

Flatulence

3%

2%

Increased cough

3%

2%

Peripheral edema

3%

2%

Urinary Tract Infection

3%

2%

Circumoral paresthesia

2%

0%

Somnolence

2%

1%

Vertigo

2%

1%

Eczema

2%

1%

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