BREXPIPRAZOLE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

BREXPIPRAZOLE (UNII: 2J3YBM1K8C) (BREXPIPRAZOLE - UNII:2J3YBM1K8C)

Available from:

Ajanta Pharma USA Inc.

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Brexpiprazole tablets are indicated for: - Adjunctive treatment of major depressive disorder (MDD) in adults. - Treatment of schizophrenia in adults. Brexpiprazole tablets are 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 brexpiprazole tablets 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 been conducted with brexpiprazole tablets in pregnant women to inform drug-associated risks. However, neonates whose mothers are exposed to antipsychotic drugs, like brexpiprazole tablets, during the third trimester of pregnancy are at risk for extrapyrami

Product summary:

Brexpiprazole tablets have markings on both the side, and are available in the following strengths and package configurations (see below): Store brexpiprazole tablets at 20°C t o 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].

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

Ajanta Pharma USA Inc.
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MEDICATION GUIDE
Brexpiprazole (breks PIP ray zole)
Tablets
What is the most important information I should know about
brexpiprazole tablets?
Brexpiprazole tablets may cause serious side effects, including:
•
Increased risk of death in elderly people with dementia-related
psychosis. Medicines like
brexpiprazole tablets can raise the risk of death in elderly people
who have lost touch with reality
(psychosis) due to confusion and memory loss (dementia). Brexpiprazole
tablets are not approved for
the treatment of people with dementia-related psychosis.
•
Increased risk of suicidal thoughts and actions. Antidepressant
medicines may increase suicidal
thoughts and actions in some children, adolescents, and young adults
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 brexpiprazole tablets 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:
o thoughts about suicide or dying o attempts to commit suicide
o new or worsening depression o new or worsening anxiety
o feeling very agitated or restless o panic attacks
o trouble sleeping (insomnia) o new or worsening irritability
o acting aggressive, being angry, or vi

Summary of Product characteristics

BREXPIPRAZOLE - BREXPIPRAZOLE TABLET
AJANTA PHARMA USA INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
BREXPIPRAZOLE TABLETS
SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
BREXPIPRAZOLE TABLETS.
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. Brexpiprazole tablets are not approved for the
treatment of patients with dementia-
related psychosis. (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 brexpiprazole tablets have not been
established in pediatric patients
with MDD. (5.2, 8.4)
RECENT MAJOR CHANGES
Boxed Warning 12/2021
Warnings and Precautions (5.6) 12/2021
INDICATIONS AND USAGE
Brexpiprazole tablets 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
DOSAGE AND ADMINISTRATION
Administer brexpiprazole tabletsonce daily with or without food.
(2.1,2.2,12.3)
INDICATION
STARTING DOSE
RECOMMENDED
DOSE
MAXIMUM DOSE
MDD Adults (2.1)
0.5 mg/day or
1 mg/day
2 mg/day
3 mg/day
Schizophrenia Adults
(2.2)
1 mg/day
2 to 4 mg/day
4 mg/day
_Moderate to Severe Hepatic Impairment (Child-Pugh score greater than
or equal to 7): _Maximum
recommended dosage is 2 mg once daily for patients with MDD and 3 mg
once daily for patients with
schizophrenia. (2.3)
_Moderate, Severe or End-Stage Renal Impairment (CrCl less than 60
mL/minute): _Maximum
recommended dosage is 2 mg once daily for patients with MDD and 3 mg
once daily for