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Efficacy that supports up to 2 months of long-lasting stability1,2*

The efficacy of ABILIFY ASIMTUFII® (aripiprazole) is based on pivotal studies of ABILIFY MAINTENA® (aripiprazole).1

* Stability is defined as delayed time to recurrence of clinical worsening, psychiatric hospitalization, or increased risk of suicide.3

52-Week Maintenance Study Exploratory Analyses

ABILIFY MAINTENA significantly delayed time to recurrence† vs placebo in adults living with bipolar
I disorder over 52 weeks (HR=0.45; 95% CI 0.30–0.68; P<0.0001)3

Primary endpoint: Time from randomization to recurrence† of any mood disorder vs placebo3

Proportion of patients with recurrence at 52 weeks, Graph
Proportion of patients with recurrence at 52 weeks, Graph

This figure is based on a total of 103 recurrences.1

Study design summary: Pivotal 52-week, randomized, double-blind, placebo-controlled, maintenance study in adults living with bipolar I disorder (N=266). The study followed a 4-phase design: conversion to and stabilization on oral aripiprazole (phases 1–2), followed by conversion to and stabilization on ABILIFY MAINTENA 400 mg (phase 3), before entering the double-blind phase (phase 4).3

† Recurrence is defined as clinical worsening, psychiatric hospitalization, or increased risk of suicide.3

CI=confidence interval; HR=hazard ratio.

The pivotal 52-week, randomized, double-blind, placebo-controlled, maintenance study in adults living with bipolar I disorder evaluated time to recurrence* with ABILIFY MAINTENA vs placebo. The maintenance study consisted of four phases:3

* Recurrence was defined as clinical worsening, psychiatric hospitalization, or increased risk of suicide;3 † Including those patients entering the trial on oral aripiprazole;3 ‡ Patients continued oral aripiprazole 10–20mg in the first 14 days following the initial ABILIFY MAINTENA dose;2 § Patients were randomized at baseline to receive either ABILIFY MAINTENA or placebo.3

Recurrence was defined as one, or more, of the following:3

Clinical worsening

  • YMRS total score ≥15 OR
  • MÅDRS total score ≥15 OR
  • CGI-BP-S overall score >4 OR
  • Serious AE of worsening bipolar I disorder OR
  • Discontinuation due to lack of efficacy or due to an AE of worsening bipolar I disorder OR
  • Clinical worsening with the need for addition of a mood stabilizer, antidepressant treatment, antipsychotic medication, and/or increase greater than the allowed benzodiazepine doses for treatment of symptoms of an underlying mood disorder

Psychiatric hospitalization

  • For any mood episode

Increased risk of suicide

  • Score ≥4 on the MÅDRS item 10 OR
  • Answer of YES on question 4 or 5 on the C-SSRS

CGI-BP-S=Clinical Global Impression-Bipolar-Version-Severity; C-SSRS=Columbia-Suicide Severity Rating Scale; MÅDRS=Montgomery-Åsberg Depression Rating Scale; YMRS=Young Mania Rating Scale.

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Are your patients ready for up to 2 months of long-lasting stability?1,2‡

‡ Stability is defined as delayed time to recurrence of clinical worsening, psychiatric hospitalization, or increased risk of suicide;3 or delayed time to relapse, defined as one or more of the following: clinical worsening, psychiatric hospitalizations, risk of suicide, or violent behavior.4

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Exploratory analyses from the pivotal 52-week randomized, double-blind, placebo-controlled, maintenance study of ABILIFY MAINTENA in adults living with bipolar I disorder3,5

75%

reduced risk of recurrence of mixed/​manic mood episodes vs placebo (HR=0.249; 95% CI 0.137-0.451)5§

Delayed time to recurrence for a manic episode (HR=0.259; 95% CI 0.136-0.495)
or mixed episode (HR=0.202; 95% CI 0.044-0.939)5

No substantial difference in the time to depressive episode (HR=0.932; 95% CI 0.497-1.747)5

Data limitation: The pivotal maintenance trial was not designed to assess, nor statistically powered to examine, the combined risk of mixed/manic episodes, excluding depressive episodes. These results require cautious interpretation and may represent chance findings.

§ The HR was used to calculate the reduction in risk of recurrence for patients on ABILIFY MAINTENA vs placebo.5

CI=confidence interval; HR=hazard ratio.

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ABILIFY MAINTENA and ABILIFY ASIMTUFII offer one or two months of sustained
plasma concentrations per dose, respectively.1,2

Learn More About the Pharmacokinetic Data
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A long-acting injectable option like ABILIFY ASIMTUFII can offer flexibility that may potentially help patients maintain stability. — Eric Thomason, MSN, PMHNP-BC, MBA 

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Proven safety for your adult patients.1,2#

Explore the Safety Data

Speakers are paid by Otsuka and Lundbeck and the opinions expressed are their own.
¶ Based on a 32-week pharmacokinetic study of ABILIFY MAINTENA and ABILIFY ASIMTUFII in adult patients with schizophrenia and bipolar I disorder.6
# Based on a 12-week study of ABILIFY MAINTENA vs placebo in patients living with schizophrenia.1

 

IMPORTANT SAFETY INFORMATION and INDICATIONS for ABILIFY ASIMTUFII® (aripiprazole) and 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 ASIMTUFII and ABILIFY MAINTENA are 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 aripiprazole. 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 aripiprazole, 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 antidiabetic 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 or Syncope: ABILIFY ASIMTUFII and 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. Monitoring of orthostatic vital signs should be considered in patients who are vulnerable 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 ASIMTUFII or ABILIFY MAINTENA at the first sign of a clinically significant decline in WBC and in severely neutropenic patients.

Seizures: ABILIFY ASIMTUFII and 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 ASIMTUFII and ABILIFY MAINTENA may impair judgment, thinking, or motor skills. Patients should be cautioned about performing activities that require mental alertness such as operating hazardous machinery or operating a motor vehicle, until they are reasonably certain that therapy with ABILIFY ASIMTUFII or ABILIFY MAINTENA does not affect them adversely.

Body Temperature Regulation: Use ABILIFY ASIMTUFII or 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 aripiprazole. Use caution in patients at risk for aspiration.

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

Concomitant Medications: Dosage reductions are recommended in patients who are CYP2D6 poor metabolizers and/or in patients taking concomitant CYP3A4 inhibitors or CYP2D6 inhibitors for greater than 14 days. Avoid concomitant use of CYP3A4 inducers with ABILIFY ASIMTUFII and 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 of ≥5% and at least twice that for placebo) were increased weight, akathisia, injection site pain, and sedation.

Injection Site Reactions:

  • ABILIFY MAINTENA: In a short-term, clinical trial with ABILIFY MAINTENA in patients with schizophrenia treated with gluteally 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.
  • ABILIFY ASIMTUFII: In an open-label study in patients with schizophrenia or bipolar I disorder, the percent of patients reporting any injection site-related adverse reactions was 19% for ABILIFY ASIMTUFII and 9.0% for ABILIFY MAINTENA. In both treatment groups, the majority of the injection site pain events coincided with the first injection and were reported with decreasing frequency upon subsequent injections. Patient-reported rating of pain was similar in both treatment groups at the last injection.

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 aripiprazole, during the third trimester of pregnancy are at risk for extrapyramidal and/or withdrawal symptoms. There are risks to the mother associated with untreated schizophrenia or bipolar I disorder and with exposure to antipsychotics, including ABILIFY ASIMTUFII and ABILIFY MAINTENA, during pregnancy.

Lactation: Aripiprazole is present in human breast milk. Monitor the breastfed infant for dehydration and lack of appropriate weight gain. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for ABILIFY ASIMTUFII or ABILIFY MAINTENA and any potential adverse effects on the breastfed infant from ABILIFY ASIMTUFII or ABILIFY MAINTENA or from the underlying maternal condition.

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 ASIMTUFII® (aripiprazole) is an atypical antipsychotic indicated for treatment of schizophrenia in adults and maintenance monotherapy treatment of bipolar I disorder in adults.

ABILIFY MAINTENA® (aripiprazole) is an atypical antipsychotic indicated for treatment of schizophrenia in adults and maintenance monotherapy treatment of bipolar I disorder in adults.

Please see FULL PRESCRIBING INFORMATION, including BOXED WARNING, for ABILIFY ASIMTUFII and ABILIFY MAINTENA.

References: 1. ABILIFY ASIMTUFII® (aripiprazole) Prescribing Information. 2. ABILIFY MAINTENA® (aripiprazole) Prescribing Information. 3. 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 4. Kane JM, et al. Aripiprazole intramuscular depot as maintenance treatment in patients with schizophrenia: a 52-week, multicenter, randomized, double-blind, placebo-controlled study. J Clin Psychiatry. 2012;73(11):617–624. 5. Data on file. ABIMAI-178. 6. Harlin M, et al. A randomized, open-label, multiple-dose, parallel-arm study to evaluate the safety, tolerability, and pharmacokinetics of aripiprazole 2-month long-acting injectable in adults with schizophrenia or bipolar I disorder. CNS Drugs. 2023;37:337–350.