EXSERVAN- riluzole film

Χώρα: Ηνωμένες Πολιτείες

Γλώσσα: Αγγλικά

Πηγή: NLM (National Library of Medicine)

Δραστική ουσία:

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

Διαθέσιμο από:

Mitsubishi Tanabe Pharma America, Inc.

Οδός χορήγησης:

ORAL

Τρόπος διάθεσης:

PRESCRIPTION DRUG

Θεραπευτικές ενδείξεις:

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)] . 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 EXSERVAN d

Περίληψη προϊόντος:

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 70510-2201-1: 50 mg oral film, 1 pouch NDC 70510-2201-2: 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.

Καθεστώς αδειοδότησης:

New Drug Application

Αρχείο Π.Χ.Π.

EXSERVAN- RILUZOLE FILM
MITSUBISHI TANABE PHARMA AMERICA, INC.
----------
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
•
•
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
•
•
•
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 MITSUBISHI TANABE
PHARMA AMERICA, INC
AT 1-888-292-0058 OR FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH.
DRUG INTERACTIONS
•
•
•
USE IN SPECIFIC POPULATIONS
•
SEE 17 FOR PATIENT COUNSELING INFORMATION AND FDA-APPROVED PATIENT
LABELING.
REVISED: 4/2021
FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS AND USAGE
2 DOSAGE AND ADMINISTRATION
2.1 Dosage Information
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)
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)
Strong to moderate CYP1A2 inhibitors: Coadministration may increase
EXSERVAN-associated adverse
reactions (7.1)
Strong to moderate CYP1A2 inducers: Coadministration may result in
decreas