Rilutek

RILUTEK- riluzole tablet
Covis Pharma US, Inc

1 INDICATIONS AND USAGE

RILUTEK is indicated for the treatment of amyotrophic lateral sclerosis (ALS).

2 DOSAGE AND ADMINISTRATION

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

3 DOSAGE FORMS AND STRENGTHS

Tablets: 50 mg film-coated, capsule-shaped, white, with “RPR 202” on one side.

4 CONTRAINDICATIONS

RILUTEK 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)].

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 RILUTEK. Asymptomatic elevations of hepatic transaminases have also been reported, and in some patients have recurred upon rechallenge with RILUTEK.

In clinical studies, the incidence of elevations in hepatic transaminases was greater in RILUTEK-treated patients than placebo-treated patients. The incidence of elevations of ALT above 5 times the upper limit of normal (ULN) was 2% in RILUTEK-treated patients. Maximum increases in ALT occurred within 3 months after starting RILUTEK. About 50% and 8% of RILUTEK-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 RILUTEK is not recommended if patients develop hepatic transaminase levels greater than 5 times the ULN. Discontinue RILUTEK 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 RILUTEK 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 RILUTEK. Discontinue RILUTEK 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 RILUTEK 50 mg twice daily [see Clinical Studies (14)]. The most common adverse reactions in the RILUTEK 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 RILUTEK 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 RILUTEK-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

RILUTEK
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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