EXSERVAN- riluzole film

Država: Sjedinjene Američke Države

Jezik: engleski

Izvor: NLM (National Library of Medicine)

Aktivni sastojci:

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

Dostupno od:

Aquestive Therapeutics

Administracija rute:

ORAL

Tip recepta:

PRESCRIPTION DRUG

Terapijske indikacije:

EXSERVAN is indicated for the treatment of amyotrophic lateral sclerosis (ALS). 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 )] . 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 us

Proizvod sažetak:

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 in a pouch. NDC 10094-350-60: 50 mg oral film, carton of 60 pouches 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) (see USP Controlled Room Temperature) and protect from bright light.

Status autorizacije:

New Drug Application

Svojstava lijeka

EXSERVAN- RILUZOLE FILM
AQUESTIVE THERAPEUTICS
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
EXSERVAN SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR EXSERVAN.
EXSERVAN (RILUZOLE) ORAL FILM
INITIAL U.S. APPROVAL: 1995
INDICATIONS AND USAGE
EXSERVAN 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 (2.1)
Measure serum aminotransferases before and during treatment (2.2, 5.1)
DOSAGE FORMS AND STRENGTHS
Oral Film: 50 mg (3)
CONTRAINDICATIONS
Patients with a history of severe hypersensitivity reactions to
riluzole or to any of its components (4)
WARNINGS AND PRECAUTIONS
Hepatic injury: Use of EXSERVAN is not recommended in patients with
baseline elevations of serum
aminotransferases greater than 5 times upper limit of normal;
discontinue EXSERVAN if there is evidence of liver
dysfunction (5.1)
Neutropenia: Advise patients to report any febrile illness (5.2)
Interstitial lung disease: Discontinue EXSERVAN 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 oral hypoesthesia,
asthenia, nausea, decreased lung function, hypertension, and abdominal
pain (6.1)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT AQUESTIVE THERAPEUTICS
AT 1-877-394-5045 OR FDA AT
1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH.
DRUG INTERACTIONS
Strong to moderate CYP1A2 inhibitors: Coadministration may increase
EXSERVAN-associated adverse reactions (7.1)
Strong to moderate CYP1A2 inducers: Coadministration may result in
decreased efficacy (7.2)
Hepatotoxic drugs: EXSERVAN-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 AND FDA-APPROVED PATIENT
LABE