ABILIFY MYCITE- aripiprazole tablet with sensor

Land: Verenigde Staten

Taal: Engels

Bron: NLM (National Library of Medicine)

Werkstoffen:

ARIPIPRAZOLE (UNII: 82VFR53I78) (ARIPIPRAZOLE - UNII:82VFR53I78)

Beschikbaar vanaf:

Otsuka America Pharmaceutical, Inc.

INN (Algemene Internationale Benaming):

ARIPIPRAZOLE

Samenstelling:

ARIPIPRAZOLE 2 mg

Toedieningsweg:

ORAL

Prescription-type:

PRESCRIPTION DRUG

therapeutische indicaties:

ABILIFY MYCITE, a drug-device combination product comprised of aripiprazole tablets embedded with an Ingestible Event Marker (IEM) sensor intended to track drug ingestion, is indicated for the: - Treatment of adults with schizophrenia. - Treatment of bipolar I disorder Acute treatment of adults with manic and mixed episodes as monotherapy and as adjunct to lithium or valproate. Maintenance treatment of adults as monotherapy and as adjunct to lithium or valproate. - Acute treatment of adults with manic and mixed episodes as monotherapy and as adjunct to lithium or valproate. - Maintenance treatment of adults as monotherapy and as adjunct to lithium or valproate. - Adjunctive treatment of adults with Major Depressive Disorder. Limitations of Use: - The ability of the ABILIFY MYCITE to improve patient compliance or modify aripiprazole dosage has not been established [see Dosage and Administration (2.1)] . - The use of ABILIFY MYCITE to track drug ingestion in "real-time" or during an emergency is not recommended

Product samenvatting:

The ABILIFY MYCITE kit contains aripiprazole tablets embedded with an Ingestible Event Marker (IEM) sensor co-packaged with MYCITE Patches (wearable sensors) (referred to as the patch ). The patch is available as a: The patch has a corresponding IFU within the app . The status of the patch is indicated by a status icon in the app to inform the user that the patch is properly adhered and fully functioning. Figure 9: MYCITE Patch (2-component) ABILIFY MYCITE Kits (2-component patch) ABILIFY MYCITE kits are available in the following strengths and packages: Tablet bottle : Store 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature] . Do not store in conditions where tablets are exposed to humid conditions. MYCITE Patch (Wearable Sensor) : Store between 5°C and 27°C (41°F to 81°F), 15% to 93% relative humidity.

Autorisatie-status:

New Drug Application

Bijsluiter

Otsuka America Pharmaceutical, Inc.
----------
This Medication Guide has been approved by the U.S. Food and
Drug Administration.
Revised: 12/2020
MEDICATION GUIDE
ABILIFY MYCITE® (a BIL ĭ fī - Mi SIHYT)
(aripiprazole tablets with sensor), for oral use
Important:
•
If you are taking ABILIFY MYCITE with other medicines for treatment of
major depressive
disorder (MDD), you should also read the Medication Guides or Patient
Information that comes
with the other medicines.
•
The ABILIFY MYCITE System has 4 parts:
•
Aripiprazole tablet with an Ingestible Event Marker (IEM) sensor
inside it (ABILIFY
MYCITE).
•
MYCITE Patch (wearable sensor) that picks up (detects) the signal from
the IEM sensor
after you take the ABILIFY MYCITE tablet and sends the information to
a smartphone.
•
MYCITE App, which is a smartphone application (app) that is used with
a compatible
smartphone to show information about when you take your ABILIFY MYCITE
tablet.
•
Web-based portal for healthcare providers and caregivers.
•
Download the MYCITE App before using the ABILIFY MYCITE System. Always
follow the
instructions provided within the MYCITE App when using the ABILIFY
MYCITE System.
•
Your healthcare provider should show you how to use the ABILIFY MYCITE
System before you
use it for the first time.
What is the most important information I should know about ABILIFY
MYCITE?
ABILIFY MYCITE may cause serious side effects, including:
•
Increased risk of death in elderly people with dementia-related
psychosis. Medicines like
ABILIFY MYCITE can raise the risk of death in elderly people who have
lost touch with reality
(psychosis) due to confusion and memory loss (dementia). ABILIFY
MYCITE is not approved
for the treatment of people who have lost touch with reality
(psychosis) due to confusion or
memory loss (dementia).
•
Increased risk of suicidal thoughts or actions in children and young
adults. Antidepressant
medicines may increase suicidal thoughts or actions in some children
and young adults within the
first few months of tr

Productkenmerken

ABILIFY MYCITE- ARIPIPRAZOLE TABLET WITH SENSOR
OTSUKA AMERICA PHARMACEUTICAL, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ABILIFY MYCITE SAFELY
AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR ABILIFY MYCITE.
ABILIFY MYCITE (ARIPIPRAZOLE TABLETS WITH SENSOR), FOR ORAL USE
INITIAL U.S. APPROVAL: 2002
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 AN INCREASED RISK OF DEATH. ABILIFY MYCITE IS NOT APPROVED FOR
THE TREATMENT
OF PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS. (5.1)
INCREASED RISK OF SUICIDAL THOUGHTS AND BEHAVIORS IN PEDIATRIC AND
YOUNG ADULT
PATIENTS TAKING ANTIDEPRESSANTS. CLOSELY MONITOR FOR WORSENING AND
EMERGENCE OF
SUICIDAL THOUGHTS AND BEHAVIORS. (5.2)
THE SAFETY AND EFFECTIVENESS OF ABILIFY MYCITE HAVE NOT BEEN
ESTABLISHED IN
PEDIATRIC PATIENTS. (8.4)
INDICATIONS AND USAGE
ABILIFY MYCITE, a drug-device combination product comprised of
aripiprazole tablets embedded with an
Ingestible Event Marker (IEM) sensor intended to track drug ingestion,
is indicated for the:
Treatment of adults with schizophrenia (1)
Treatment of bipolar I disorder (1)
Acute treatment of adults with manic and mixed episodes as monotherapy
and as adjunct to lithium
or valproate
Maintenance treatment of adults as monotherapy and as adjunct to
lithium or valproate
Adjunctive treatment of adults with major depressive disorder (MDD)
(1)
Limitations of Use:
The ability of ABILIFY MYCITE to improve patient compliance or modify
aripiprazole dosage has not been
established. (1)
The use of ABILIFY MYCITE to track drug ingestion in "real-time" or
during an emergency is not
recommended because detection may be delayed or not occur. (1)
DOSAGE AND ADMINISTRATION
INITIAL DOSE
RECOMMENDED
DOSE
MAXIMUM DOSE
Schizophrenia – adults (2.3)
10 to 1