INGREZZA- valbenazine capsule INGREZZA- valbenazine kit

Land: USA

Språk: engelska

Källa: NLM (National Library of Medicine)

Aktiva substanser:

VALBENAZINE TOSYLATE (UNII: 5SML1T733B) (VALBENAZINE - UNII:54K37P50KH)

Tillgänglig från:

Neurocrine Biosciences, Inc.

INN (International namn):

VALBENAZINE

Sammansättning:

VALBENAZINE 40 mg

Administreringssätt:

ORAL

Receptbelagda typ:

PRESCRIPTION DRUG

Terapeutiska indikationer:

INGREZZA is indicated for the treatment of adults with: - tardive dyskinesia [see Clinical Studies ( 14.1 )] . - chorea associated with Huntington’s disease [see Clinical Studies ( 14.2 )] . INGREZZA is contraindicated in patients with a history of hypersensitivity to valbenazine or any components of INGREZZA. Rash, urticaria, and reactions consistent with angioedema (e.g., swelling of the face, lips, and mouth) have been reported [see Warnings and Precautions ( 5.2 ) and Adverse Reactions ( 6.2 )]. Risk Summary The limited available data on INGREZZA use in pregnant women are insufficient to inform a drug-associated risk. In animal reproductive studies, no malformations were observed when valbenazine was administered orally to rats and rabbits during the period of organogenesis at doses up to 1.8 or 24 times, respectively, the maximum recommended human dose (MRHD) of 80 mg/day based on mg/m2 body surface area. However, administration of valbenazine to pregnant rats during organogenesis through lactation p

Produktsammanfattning:

INGREZZA (valbenazine) capsules are available as: 40 mg Capsule: White opaque body with a purple cap, printed with ‘VBZ’ and ‘40’ in black ink. 60 mg Capsule:   Dark red opaque body with a purple cap, printed with ‘VBZ’ and ‘60’ in black ink. 80 mg Capsule: Purple opaque body and cap, printed with ‘VBZ’ and ‘80’ in black ink. Storage Store at 15°C to 30°C (59°F to 86°F).

Bemyndigande status:

New Drug Application

Produktens egenskaper

INGREZZA- VALBENAZINE CAPSULE
INGREZZA- VALBENAZINE
NEUROCRINE BIOSCIENCES, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
INGREZZA SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR INGREZZA.
INGREZZA (VALBENAZINE) CAPSULES, FOR ORAL USE
INITIAL U.S. APPROVAL: 2017
WARNING: DEPRESSION AND SUICIDAL IDEATION AND BEHAVIOR IN PATIENTS
WITH
HUNTINGTON’S DISEASE
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
• INCREASES THE RISK OF DEPRESSION AND SUICIDAL THOUGHTS AND
BEHAVIOR IN PATIENTS WITH
HUNTINGTON’S DISEASE (5.1)
• BALANCE RISKS OF DEPRESSION, AND SUICIDAL IDEATION AND BEHAVIOR
WITH THE CLINICAL NEED
FOR TREATMENT OF CHOREA WHEN CONSIDERING THE USE OF INGREZZA (5.1)
• MONITOR PATIENTS FOR THE EMERGENCE OR WORSENING OF DEPRESSION,
SUICIDAL IDEATION, OR
UNUSUAL CHANGES IN BEHAVIOR (5.1)
• INFORM PATIENTS, CAREGIVERS, AND FAMILIES OF THE RISK OF
DEPRESSION AND SUICIDAL
IDEATION AND BEHAVIOR AND INSTRUCT THEM TO REPORT BEHAVIORS OF CONCERN
PROMPTLY TO
THE TREATING PHYSICIAN (5.1)
• EXERCISE CAUTION WHEN TREATING PATIENTS WITH A HISTORY OF
DEPRESSION OR PRIOR SUICIDE
ATTEMPTS OR IDEATION (5.1)
RECENT MAJOR CHANGES
Boxed Warning
8/2023
Indications and Usage (1)
8/2023
Dosage and Administration (2.1)
8/2023
Warnings and Precautions (5.1, 5.2, 5.5, 5.6) 8/2023
INDICATIONS AND USAGE
INGREZZA is a vesicular monoamine transporter 2 (VMAT2) inhibitor
indicated for the treatment of adults
with:
- tardive dyskinesia. (1)
- chorea associated with Huntington’s disease. (1)
DOSAGE AND ADMINISTRATION
Tardive dyskinesia: The initial dosage is 40 mg once daily. After one
week, increase the dose to the
recommended dosage of 80 mg once daily. (2.1)
Chorea associated with Huntington’s disease: The initial dosage is
40 mg once daily. Increase the dose
in 20 mg increments every two weeks to the recommended dosage of 80 mg
once daily. (2.1)
40 mg or 60 mg once daily may be considered depending on response and
tolerability