REXULTI- brexpiprazole tablet REXULTI- brexpiprazole kit

Quốc gia: Hoa Kỳ

Ngôn ngữ: Tiếng Anh

Nguồn: NLM (National Library of Medicine)

Thành phần hoạt chất:

brexpiprazole (UNII: 2J3YBM1K8C) (brexpiprazole - UNII:2J3YBM1K8C)

Sẵn có từ:

Otsuka America Pharmaceutical, Inc.

INN (Tên quốc tế):

brexpiprazole

Thành phần:

brexpiprazole 0.25 mg

Tuyến hành chính:

ORAL

Loại thuốc theo toa:

PRESCRIPTION DRUG

Chỉ dẫn điều trị:

REXULTI is indicated for: - Adjunctive treatment of major depressive disorder (MDD) in adults - Treatment of schizophrenia in adults and pediatric patients ages 13 years and older - Treatment of agitation associated with dementia due to Alzheimer's disease Limitations of Use: REXULTI is not indicated as an as needed ("prn") treatment for agitation associated with dementia due to Alzheimer's disease [see Clinical Studies (14.3)] . REXULTI is contraindicated in patients with a known hypersensitivity to brexpiprazole or any of its components. Reactions have included rash, facial swelling, urticaria, and anaphylaxis. Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to REXULTI during pregnancy. For more information contact the National Pregnancy Registry for Atypical Antipsychotics at 1-866-961-2388 or visit http://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/ . Risk Summary Adequate and well-controlled studies have not

Tóm tắt sản phẩm:

How Supplied REXULTI (brexpiprazole) tablets have markings on one side and are available in the following strengths and package configurations (see below): Storage Store REXULTI tablets 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].

Tình trạng ủy quyền:

New Drug Application

Tờ rơi thông tin

REXULTI- BREXPIPRAZOLE
Otsuka America Pharmaceutical, Inc.
----------
MEDICATION GUIDE
REXULTI ® (REX-UL-TE)
(BREXPIPRAZOLE)
TABLETS, FOR ORAL USE
This Medication Guide has been approved by the U.S.
Food and Drug Administration.
Revised: 5/2023
What is the most important information I should know about REXULTI?
REXULTI may cause serious side effects, including:
•
Increased risk of death in elderly people with dementia-related
psychosis. Medicines like
REXULTI can raise the risk of death in elderly people who have lost
touch with reality
(psychosis) due to confusion and memory loss (dementia). REXULTI is
not approved for the
treatment of people with dementia-related psychosis without agitation
that may happen with
dementia due to Alzheimer's disease.
•
Increased risk of suicidal thoughts and actions. REXULTI and
antidepressant medicines may
increase suicidal thoughts and actions in some people 24 years of age
and younger, especially
within the first few months of treatment or when the dose is changed.
•
Depression and other mental illnesses are the most important causes of
suicidal thoughts
and actions.
How can I watch for and try to prevent suicidal thoughts and actions
in myself or a family
member?
•
Pay close attention to any changes, especially sudden changes in mood,
behaviors,
thoughts, or feelings. This is very important when REXULTI or the
antidepressant
medicine is started or when the dose is changed.
•
Call your healthcare provider right away to report new or sudden
changes in mood,
behavior, thoughts, or feelings, or if you develop suicidal thoughts
or actions.
•
Keep all follow-up visits with your healthcare provider as scheduled.
Call your healthcare
provider between visits as needed, especially if you have concerns
about symptoms.
Call a healthcare provider right away if you or your family member
have any of the following
symptoms, especially if they are new, worse, or worry you:
•
thoughts about suicide or dying
•
new or worsening depression
•
feeling very agitated or restless
•

Đặc tính sản phẩm

REXULTI- BREXPIPRAZOLE TABLET
REXULTI- BREXPIPRAZOLE
OTSUKA AMERICA PHARMACEUTICAL, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
REXULTI SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR REXULTI.
REXULTI® (BREXPIPRAZOLE) TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 2015
WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED
PSYCHOSIS AND SUICIDAL THOUGHTS AND BEHAVIORS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS TREATED WITH
ANTIPSYCHOTIC DRUGS
ARE AT INCREASED RISK OF DEATH. REXULTI IS NOT APPROVED FOR THE
TREATMENT OF
PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS WITHOUT AGITATION ASSOCIATED
WITH
DEMENTIA DUE TO ALZHEIMER'S DISEASE. (5.1)
ANTIDEPRESSANTS INCREASED THE RISK OF SUICIDAL THOUGHTS AND BEHAVIORS
IN PATIENTS
AGED 24 YEARS AND YOUNGER. MONITOR FOR CLINICAL WORSENING AND
EMERGENCE OF
SUICIDAL THOUGHTS AND BEHAVIORS. SAFETY AND EFFECTIVENESS OF REXULTI
HAVE NOT BEEN
ESTABLISHED IN PEDIATRIC PATIENTS WITH MDD. (5.2, 8.4)
RECENT MAJOR CHANGES
Boxed Warning
5/2023
Indications and Usage (1)
5/2023
Dosage and Administration (2.1, 2.3, 2.4, 2.5, 2.6)
5/2023
Warnings and Precautions (5.1, 5.3, 5.4, 5.6, 5.9, 5.14)
5/2023
INDICATIONS AND USAGE
REXULTI is an atypical antipsychotic indicated for:
Use as an adjunctive therapy to antidepressants for the treatment of
major depressive disorder (MDD)
in adults (1, 14.1)
Treatment of schizophrenia in adults and pediatric patients ages 13
years and older (1, 14.2)
Treatment of agitation associated with dementia due to Alzheimer's
disease (1, 14.3)
Limitations of Use: REXULTI is not indicated as an as needed ("prn")
treatment for agitation associated
with dementia due to Alzheimer's disease (1)
DOSAGE AND ADMINISTRATION
Administer REXULTI once daily with or without food. (2, 12.3)
INDICATION
STARTING DOSAGE
RECOMMENDED TARGET
DOSAGE
MAXIMUM DOSAGE
MDD
Adults (2.2)
0.5 mg/day or
1 mg/day
2 mg/day
3 mg/day
Sch