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 * U.S. FULL PRESCRIBING INFORMATION, including BOXED WARNING
 * Important Safety Information




 * Home
 * Maintenance Study
   * Study Design
   * Primary Endpoint
   * Secondary Endpoint
 * Safety Profile
   * Safety Profile
 * Dosing
   * Initiation
   * Dosage Adjustments
 * Pharmacokinetic Profile
   * Pharmacokinetic Profile
 * About the Experts
   * Rebecca Roma, MD
   * Brooke Kempf, MSN, PMHNP-BC




EXPERT INSIGHTS ON ABILIFY MAINTENA® (ARIPIPRAZOLE) FOR APPROPRIATE STABLE
ADULTS WITH BIPOLAR I DISORDER

THIS SITE IS INTENDED FOR U.S. HEALTHCARE PROFESSIONALS.
INDICATIONS: ABILIFY MAINTENA is an atypical antipsychotic indicated for the
treatment of schizophrenia in adults and the maintenance monotherapy treatment
of bipolar I disorder in adults

 * Home
 * Maintenance Study
   * Study Design
   * Primary Endpoint
   * Secondary Endpoint
 * Safety Profile
   * Safety Profile
 * Dosing
   * Initiation
   * Dosage Adjustments
 * Pharmacokinetic Profile
   * Pharmacokinetic Profile
 * About the Experts
   * Rebecca Roma, MD
   * Brooke Kempf, MSN, PMHNP-BC
 * 0


DR ROMA AND MS KEMPF GIVE EXPERT INSIGHTS ON ABILIFY MAINTENA

This program was developed in conjunction with and sponsored by Otsuka America
Pharmaceutical, Inc. and Lundbeck, based on interviews with Rebecca Roma, MD and
Brooke Kempf, MSN, PMHNP-BC.

Each received an honorarium for participation in this program.

Join Dr Roma and Ms Kempf in this clinical data review for ABILIFY MAINTENA, a
long-acting injectable (LAI) option for the maintenance monotherapy treatment of
bipolar I disorder in adults and schizophrenia in adults. Explore efficacy
results and safety data from clinical trials, dosing and administration for
appropriate patients, and the pharmacokinetic profile—each topic featuring
expert insights relevant to your practice.










REBECCA ROMA, MD
Psychiatrist
Roma Evaluation and Consulting
Pittsburgh, Pennsylvania

Dr Roma is paid to speak by Otsuka, and views expressed are her own.




> “Many of my stable patients with bipolar I disorder have very busy lives.
> Since maintenance therapy is essential to keeping their mood episodes under
> control, I utilize ABILIFY MAINTENA as a long-term injectable option for
> maintenance monotherapy treatment of bipolar I disorder in adults. My patients
> with bipolar I disorder usually understand the importance of symptom control,
> and this option helps them maintain control.” – Rebecca Roma, MD




Contraindication: Known hypersensitivity reaction to aripiprazole. Reactions
have ranged from pruritus/urticaria to anaphylaxis.




BROOKE KEMPF, MSN, PMHNP-BC
Psychiatric Mental Health Nurse Practitioner
Hamilton Center Community Mental Health Center
Terre Haute, Indiana

Ms Kempf is paid to speak by Otsuka, and views expressed are her own.

> “In my clinical opinion, prescribers should consider using long-term
> injectables in their appropriate patients' treatment journey. I always
> consider ABILIFY MAINTENA, a long-term injectable with efficacy in bipolar I
> disorder and an established safety profile, as early as possible for my
> appropriate patients.1,2” – Brooke Kempf, MSN, PMHNP-BC



*Establish tolerability with oral aripiprazole before initiating therapy. For
patients already stable on oral aripiprazole or another oral antipsychotic,
after the first ABILIFY MAINTENA injection, continue treatment with the
antipsychotic for 14 consecutive days.

Please see IMPORTANT SAFETY INFORMATION, below.

REFERENCES
1. CALABRESE JR, SANCHEZ R, JIN N, ET AL. EFFICACY AND SAFETY OF ARIPIPRAZOLE
ONCE-MONTHLY IN THE MAINTENANCE TREATMENT OF BIPOLAR I DISORDER: A DOUBLE-BLIND,
PLACEBO-CONTROLLED, 52-WEEK RANDOMIZED WITHDRAWAL STUDY. J CLIN PSYCHIATRY.
2017;78(3):324-331. 2. DATA ON FILE. ABIMAI-178.


FEATURED TOPICS


PIVOTAL MAINTENANCE STUDY

Explore maintenance therapy data in adult patients with bipolar I disorder. more


DOSING AND ADMINISTRATION

Initiate ABILIFY MAINTENA with any oral antipsychotic. more


SAFETY PROFILE

Review adverse reactions in adult patients with schizophrenia. more

EXPANDCOLLAPSE


IMPORTANT SAFETY INFORMATION AND INDICATIONS FOR ABILIFY MAINTENA®
(ARIPIPRAZOLE)


WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS

Elderly patients with dementia-related psychosis treated with antipsychotic
drugs are at increased risk of death (1.6 to 1.7 times) compared to
placebo-treated patients. ABILIFY MAINTENA is not approved for the treatment of
patients with dementia-related psychosis.

Contraindication: Known hypersensitivity reaction to aripiprazole. Reactions
have ranged from pruritus/urticaria to anaphylaxis.

Cerebrovascular Adverse Events, Including Stroke: Increased incidence of
cerebrovascular adverse events (e.g., stroke, transient ischemic attack),
including fatalities, have been reported in clinical trials of elderly patients
with dementia-related psychosis treated with oral aripiprazole.

Neuroleptic Malignant Syndrome (NMS): NMS is a potentially fatal symptom complex
reported in association with administration of antipsychotic drugs including
ABILIFY MAINTENA. Clinical signs of NMS are hyperpyrexia, muscle rigidity,
altered mental status and evidence of autonomic instability. Additional signs
may include elevated creatine phosphokinase, myoglobinuria (rhabdomyolysis), and
acute renal failure. Manage NMS with immediate discontinuation of ABILIFY
MAINTENA, intensive symptomatic treatment, and monitoring.

Tardive Dyskinesia (TD): Risk of TD, and the potential to become irreversible,
are believed to increase with duration of treatment and total cumulative dose of
antipsychotic drugs. TD can develop after a relatively brief treatment period,
even at low doses, or after discontinuation of treatment. Prescribing should be
consistent with the need to minimize TD. If antipsychotic treatment is
withdrawn, TD may remit, partially or completely.

Metabolic Changes: Atypical antipsychotic drugs have caused metabolic changes
including:

 * Hyperglycemia/Diabetes Mellitus: Hyperglycemia, in some cases extreme and
   associated with ketoacidosis, hyperosmolar coma, or death, has been reported
   in patients treated with atypical antipsychotics including aripiprazole.
   Patients with diabetes mellitus should be regularly monitored for worsening
   of glucose control; those with risk factors for diabetes (e.g., obesity,
   family history of diabetes), should undergo baseline and periodic fasting
   blood glucose testing. Any patient treated with atypical antipsychotics
   should be monitored for symptoms of hyperglycemia including polydipsia,
   polyuria, polyphagia, and weakness. Patients who develop symptoms of
   hyperglycemia should also undergo fasting blood glucose testing. In some
   cases, hyperglycemia has resolved when the atypical antipsychotic was
   discontinued; however, some patients required continuation of anti-diabetic
   treatment despite discontinuation of the suspect drug.
 * Dyslipidemia: Undesirable alterations in lipids have been observed in
   patients treated with atypical antipsychotics.
 * Weight Gain: Weight gain has been observed with atypical antipsychotic use.
   Clinical monitoring of weight is recommended.

Pathological Gambling and Other Compulsive Behaviors: Intense urges,
particularly for gambling, and the inability to control these urges have been
reported while taking aripiprazole. Other compulsive urges have been reported
less frequently. Prescribers should ask patients or their caregivers about the
development of new or intense compulsive urges. Consider dose reduction or
stopping aripiprazole if such urges develop.

Orthostatic Hypotension: ABILIFY MAINTENA may cause orthostatic hypotension and
should be used with caution in patients with known cardiovascular disease,
cerebrovascular disease, or conditions which would predispose them to
hypotension.

Falls: Antipsychotics may cause somnolence, postural hypotension, motor and
sensory instability, which may lead to falls causing fractures or other
injuries. For patients with diseases, conditions, or medications that could
exacerbate these effects, complete fall risk assessments when initiating
treatment and recurrently during therapy.

Leukopenia, Neutropenia, and Agranulocytosis: Leukopenia, neutropenia and
agranulocytosis have been reported with antipsychotics. Monitor complete blood
count in patients with pre-existing low white blood cell count (WBC)/absolute
neutrophil count or history of drug-induced leukopenia/neutropenia. Discontinue
ABILIFY MAINTENA at the first sign of a clinically significant decline in WBC
and in severely neutropenic patients.

Seizures: ABILIFY MAINTENA should be used with caution in patients with a
history of seizures or with conditions that lower the seizure threshold.

Potential for Cognitive and Motor Impairment: ABILIFY MAINTENA may impair
judgment, thinking, or motor skills. Instruct patients to avoid operating
hazardous machinery, including automobiles, until they are certain ABILIFY
MAINTENA does not affect them adversely.

Body Temperature Regulation: Use ABILIFY MAINTENA with caution in patients who
may experience conditions that increase body temperature (e.g., strenuous
exercise, extreme heat, dehydration, or concomitant use with anticholinergics).

Dysphagia: Esophageal dysmotility and aspiration have been associated with
ABILIFY MAINTENA. Use caution in patients at risk for aspiration pneumonia.

Alcohol: Advise patients to avoid alcohol while taking ABILIFY MAINTENA.

Concomitant Medication: Dosage adjustments are recommended in patients who are
CYP2D6 poor metabolizers and in patients taking concomitant CYP3A4 inhibitors or
CYP2D6 inhibitors for greater than 14 days. Avoid concomitant use of CYP3A4
inducers with ABILIFY MAINTENA for greater than 14 days. Dosage adjustments are
not recommended for patients with concomitant use of CYP3A4 inhibitors, CYP2D6
inhibitors or CYP3A4 inducers for less than 14 days.

Most Commonly Observed Adverse Reactions: The most commonly observed adverse
reactions with ABILIFY MAINTENA in patients with schizophrenia (incidence ≥5%
and at least twice that for placebo) were increased weight, akathisia, injection
site pain, and sedation.

Injection Site Reactions: In a short-term, clinical trial with ABILIFY MAINTENA
in patients with schizophrenia treated with gluteal administered ABILIFY
MAINTENA, the percent of patients reporting any injection site-related adverse
reaction was 5.4%, and 0.6% for placebo. In an open label study of ABILIFY
MAINTENA administered in the deltoid or gluteal muscle, injection site pain was
observed at approximately equal rates.

Dystonia: Symptoms of dystonia may occur in susceptible individuals during the
first days of treatment and at low doses.

Pregnancy: Neonates exposed to antipsychotic drugs, including ABILIFY MAINTENA,
during the third trimester of pregnancy are at risk for extrapyramidal and/or
withdrawal symptoms. Consider the benefits and risks of ABILIFY MAINTENA and
possible risks to the fetus when prescribing ABILIFY MAINTENA to a pregnant
woman. Advise pregnant women of potential fetal risk.

Lactation: Aripiprazole is present in human breast milk. A decision should be
made whether to discontinue nursing or to discontinue the drug, taking into
account the importance of the drug to the mother and any potential risks to the
infant.

To report SUSPECTED ADVERSE REACTIONS, contact Otsuka America Pharmaceutical,
Inc. at 1-800-438-9927 or FDA at 1-800-FDA-1088 (www.fda.gov/medwatch).


INDICATIONS 

ABILIFY MAINTENA is an atypical antipsychotic indicated for:

 * Treatment of schizophrenia in adults
 * Maintenance monotherapy treatment of bipolar I disorder in adults

Please see FULL PRESCRIBING INFORMATION, including BOXED WARNING.


IMPORTANT SAFETY INFORMATION AND INDICATIONS FOR ABILIFY MAINTENA®
(ARIPIPRAZOLE)


WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS

Elderly patients with dementia-related psychosis treated with antipsychotic
drugs are at increased risk of death (1.6 to 1.7 times) compared to
placebo-treated patients. ABILIFY MAINTENA is not approved for the treatment of
patients with dementia-related psychosis.

Contraindication: Known hypersensitivity reaction to aripiprazole. Reactions
have ranged from pruritus/urticaria to anaphylaxis.

Cerebrovascular Adverse Events, Including Stroke: Increased incidence of
cerebrovascular adverse events (e.g., stroke, transient ischemic attack),
including fatalities, have been reported in clinical trials of elderly patients
with dementia-related psychosis treated with oral aripiprazole.

Neuroleptic Malignant Syndrome (NMS): NMS is a potentially fatal symptom complex
reported in association with administration of antipsychotic drugs including
ABILIFY MAINTENA. Clinical signs of NMS are hyperpyrexia, muscle rigidity,
altered mental status and evidence of autonomic instability. Additional signs
may include elevated creatine phosphokinase, myoglobinuria (rhabdomyolysis), and
acute renal failure. Manage NMS with immediate discontinuation of ABILIFY
MAINTENA, intensive symptomatic treatment, and monitoring.

Tardive Dyskinesia (TD): Risk of TD, and the potential to become irreversible,
are believed to increase with duration of treatment and total cumulative dose of
antipsychotic drugs. TD can develop after a relatively brief treatment period,
even at low doses, or after discontinuation of treatment. Prescribing should be
consistent with the need to minimize TD. If antipsychotic treatment is
withdrawn, TD may remit, partially or completely.

Metabolic Changes: Atypical antipsychotic drugs have caused metabolic changes
including:

 * Hyperglycemia/Diabetes Mellitus: Hyperglycemia, in some cases extreme and
   associated with ketoacidosis, hyperosmolar coma, or death, has been reported
   in patients treated with atypical antipsychotics including aripiprazole.
   Patients with diabetes mellitus should be regularly monitored for worsening
   of glucose control; those with risk factors for diabetes (e.g., obesity,
   family history of diabetes), should undergo baseline and periodic fasting
   blood glucose testing. Any patient treated with atypical antipsychotics
   should be monitored for symptoms of hyperglycemia including polydipsia,
   polyuria, polyphagia, and weakness. Patients who develop symptoms of
   hyperglycemia should also undergo fasting blood glucose testing. In some
   cases, hyperglycemia has resolved when the atypical antipsychotic was
   discontinued; however, some patients required continuation of anti-diabetic
   treatment despite discontinuation of the suspect drug.
 * Dyslipidemia: Undesirable alterations in lipids have been observed in
   patients treated with atypical antipsychotics.
 * Weight Gain: Weight gain has been observed with atypical antipsychotic use.
   Clinical monitoring of weight is recommended.

Pathological Gambling and Other Compulsive Behaviors: Intense urges,
particularly for gambling, and the inability to control these urges have been
reported while taking aripiprazole. Other compulsive urges have been reported
less frequently. Prescribers should ask patients or their caregivers about the
development of new or intense compulsive urges. Consider dose reduction or
stopping aripiprazole if such urges develop.

Orthostatic Hypotension: ABILIFY MAINTENA may cause orthostatic hypotension and
should be used with caution in patients with known cardiovascular disease,
cerebrovascular disease, or conditions which would predispose them to
hypotension.

Falls: Antipsychotics may cause somnolence, postural hypotension, motor and
sensory instability, which may lead to falls causing fractures or other
injuries. For patients with diseases, conditions, or medications that could
exacerbate these effects, complete fall risk assessments when initiating
treatment and recurrently during therapy.

Leukopenia, Neutropenia, and Agranulocytosis: Leukopenia, neutropenia and
agranulocytosis have been reported with antipsychotics. Monitor complete blood
count in patients with pre-existing low white blood cell count (WBC)/absolute
neutrophil count or history of drug-induced leukopenia/neutropenia. Discontinue
ABILIFY MAINTENA at the first sign of a clinically significant decline in WBC
and in severely neutropenic patients.

Seizures: ABILIFY MAINTENA should be used with caution in patients with a
history of seizures or with conditions that lower the seizure threshold.

Potential for Cognitive and Motor Impairment: ABILIFY MAINTENA may impair
judgment, thinking, or motor skills. Instruct patients to avoid operating
hazardous machinery, including automobiles, until they are certain ABILIFY
MAINTENA does not affect them adversely.

Body Temperature Regulation: Use ABILIFY MAINTENA with caution in patients who
may experience conditions that increase body temperature (e.g., strenuous
exercise, extreme heat, dehydration, or concomitant use with anticholinergics).

Dysphagia: Esophageal dysmotility and aspiration have been associated with
ABILIFY MAINTENA. Use caution in patients at risk for aspiration pneumonia.

Alcohol: Advise patients to avoid alcohol while taking ABILIFY MAINTENA.

Concomitant Medication: Dosage adjustments are recommended in patients who are
CYP2D6 poor metabolizers and in patients taking concomitant CYP3A4 inhibitors or
CYP2D6 inhibitors for greater than 14 days. Avoid concomitant use of CYP3A4
inducers with ABILIFY MAINTENA for greater than 14 days. Dosage adjustments are
not recommended for patients with concomitant use of CYP3A4 inhibitors, CYP2D6
inhibitors or CYP3A4 inducers for less than 14 days.

Most Commonly Observed Adverse Reactions: The most commonly observed adverse
reactions with ABILIFY MAINTENA in patients with schizophrenia (incidence ≥5%
and at least twice that for placebo) were increased weight, akathisia, injection
site pain, and sedation.

Injection Site Reactions: In a short-term, clinical trial with ABILIFY MAINTENA
in patients with schizophrenia treated with gluteal administered ABILIFY
MAINTENA, the percent of patients reporting any injection site-related adverse
reaction was 5.4%, and 0.6% for placebo. In an open label study of ABILIFY
MAINTENA administered in the deltoid or gluteal muscle, injection site pain was
observed at approximately equal rates.

Dystonia: Symptoms of dystonia may occur in susceptible individuals during the
first days of treatment and at low doses.

Pregnancy: Neonates exposed to antipsychotic drugs, including ABILIFY MAINTENA,
during the third trimester of pregnancy are at risk for extrapyramidal and/or
withdrawal symptoms. Consider the benefits and risks of ABILIFY MAINTENA and
possible risks to the fetus when prescribing ABILIFY MAINTENA to a pregnant
woman. Advise pregnant women of potential fetal risk.

Lactation: Aripiprazole is present in human breast milk. A decision should be
made whether to discontinue nursing or to discontinue the drug, taking into
account the importance of the drug to the mother and any potential risks to the
infant.

To report SUSPECTED ADVERSE REACTIONS, contact Otsuka America Pharmaceutical,
Inc. at 1-800-438-9927 or FDA at 1-800-FDA-1088 (www.fda.gov/medwatch).


INDICATIONS 

ABILIFY MAINTENA is an atypical antipsychotic indicated for:

 * Treatment of schizophrenia in adults
 * Maintenance monotherapy treatment of bipolar I disorder in adults
   
   

Please see FULL PRESCRIBING INFORMATION, including BOXED WARNING.




This program was developed in conjunction with and sponsored by Otsuka America
Pharmaceutical, Inc. and Lundbeck, based on interviews with Rebecca Roma, MD and
Brooke Kempf, MSN, PMHNP-BC.

 

Each received an honorarium for participation in this program.

 

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