RILUZOLE tablet, film coated

Country: Stati Uniti

Lingwa: Ingliż

Sors: NLM (National Library of Medicine)

Ingredjent attiv:

RILUZOLE (UNII: 7LJ087RS6F) (RILUZOLE - UNII:7LJ087RS6F)

Disponibbli minn:

AvKARE

Rotta amministrattiva:

ORAL

Tip ta 'preskrizzjoni:

PRESCRIPTION DRUG

Indikazzjonijiet terapewtiċi:

Riluzole tablets is indicated for the treatment of amyotrophic lateral sclerosis (ALS). Riluzole tablets 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)] . Risk Summary There are no studies of riluzole in pregnant women, and case reports have been inadequate to inform the drug-associated risk. The background risk for major birth defects and miscarriage in patients with amyotrophic lateral sclerosis is unknown. In the U.S. general population, the background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. In studies in which riluzole was administered orally to pregnant animals, developmental toxicity (decreased embryofetal/offspring viability, growth, and functional development) was observed at clinically relevant doses [see Data] . Based on these results, women should be advised of a possible risk to the fetus associated with use of riluzole during pregnancy. Data Animal Data Oral administration of riluzole (3, 9, or 27 mg/kg/day) to pregnant rats during the period of organogenesis resulted in decreases in fetal growth (body weight and length) at the high dose. The mid dose, a no-effect dose for embryofetal developmental toxicity, is approximately equal to the recommended human daily dose (RHDD, 100 mg) on a mg/m 2 basis. When riluzole was administered orally (3, 10, or 60 mg/kg/day) to pregnant rabbits during the period of organogenesis, embryofetal mortality was increased at the high dose and fetal body weight was decreased and morphological variations increased at all but the lowest dose tested. The no-effect dose (3 mg/kg/day) for embryofetal developmental toxicity is less than the RHDD on a mg/m 2 basis. Maternal toxicity was observed at the highest dose tested in rat and rabbit. When riluzole was orally administered (3, 8, or 15 mg/kg/day) to male and female rats prior to and during mating and to female rats throughout gestation and lactation, increased embryofetal mortality and decreased postnatal offspring viability, growth, and functional development were observed at the high dose. The mid dose, a no-effect dose for pre-and postnatal developmental toxicity, is approximately equal to the RHDD on a mg/m 2 basis. Risk Summary It is not known if riluzole is excreted in human milk. Riluzole or its metabolites have been detected in milk of lactating rat. Women should be advised that many drugs are excreted in human milk and that the potential for serious adverse reactions in nursing infants from riluzole is unknown. In rats, oral administration of riluzole resulted in decreased fertility indices and increases in embryolethality [see Nonclinical Toxicology ( 13.1)] . Safety and effectiveness of riluzole tablets in pediatric patients have not been established. In clinical studies of riluzole tablets, 30% of patients were 65 years and over. No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. Patients with mild [Child-Pugh's (CP) score A] or moderate (CP score B) hepatic impairment had increases in AUC compared to patients with normal hepatic function. Thus, patients with mild or moderate hepatic impairment may be at increased of adverse reactions. The impact of severe hepatic impairment on riluzole exposure is unknown. Use of riluzole tablets is not recommended in patients with baseline elevation of elevations of serum aminotransferases greater than 5 times upper limit of normal or evidence of liver dysfunction (e.g., elevated bilirubin) [Clinical Pharmacology ( 12.3)] . Japanese patients are more likely to have higher riluzole concentrations. Consequently, the risk of adverse reactions may be greater in Japanese patients [see Clinical Pharmacology ( 12.3)] .

Sommarju tal-prodott:

Riluzole Tablets, USP 50 mg are white to off-white, film-coated, capsule-shaped and engraved with “795” on one side, plain on the other. Riluzole is supplied in bottles of 60 tablets, NDC 42291-775-60. Store at 20º to 25ºC (68º to 77ºF) [See USP Controlled Room Temperature]. Protect from bright light.

L-istatus ta 'awtorizzazzjoni:

Abbreviated New Drug Application

Karatteristiċi tal-prodott

RILUZOLE- RILUZOLE TABLET, FILM COATED
AVKARE
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HIGHLIGHTS OF PRESCRIBING INFORMATION
RILUZOLE TABLETS, USP
RX ONLY
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
RILUZOLE TABLETS SAFELY
AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR RILUZOLE
TABLETS.
INITIAL U.S. APPROVAL: 1995
INDICATIONS AND USAGE
Riluzole tablets is indicated for the treatment of amyotrophic lateral
sclerosis (ALS) ( 1)
DOSAGE AND ADMINISTRATION
Recommended dosage: 50 mg twice daily, taken at least 1 hour before or
2 hours after a meal ( 2)
Measure serum aminotransferases before and during treatment ( 2,5.1)
DOSAGE FORMS AND STRENGTHS
Tablets: 50 mg ( 3)
CONTRAINDICATIONS
Patients with a history of severe hypersensitivity reactions to
riluzole tablets or to any of its components (
4)
WARNINGS AND PRECAUTIONS
Hepatic injury: Use of riluzole tablets is not recommended in patients
with baseline elevations of serum
aminotransferases greater than 5 times upper limit of normal;
discontinue Riluzole tablets if there is
evidence of liver dysfunction ( 5.1)
Neutropenia: Advise patients to report any febrile illness ( 5.2)
Interstitial lung disease: Discontinue Riluzole tablets if
interstitial lung disease develops ( 5.3)
ADVERSE REACTIONS
Most common adverse reactions (incidence greater than or equal to 5%
and greater than placebo) were
asthenia, nausea, dizziness, decreased lung function, and abdominal
pain ( 6.1)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT AVKARE AT
1-855-361-3993 OR FDA AT 1-
800-FDA-1088 OR _WWW.FDA.GOV/MEDWATCH._
DRUG INTERACTIONS
Strong to moderate CYP1A2 inhibitors: Coadministration may increase
riluzole -associated adverse
reactions ( 7.1)
Strong to moderate CYP1A2 inducers: Coadministration may result in
decreased efficacy ( 7.2)
Hepatotoxic drugs: Riluzole-treated patients that take other
hepatotoxic drugs may be at increased risk
for hepatotoxicity ( 7.3)
USE IN SPECIFIC POPULATIONS
Pregnancy: Based on animal data, may cause fetal harm ( 8.1)
SEE 17 FOR PATIENT COUNSELING INFORMATION.
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