Conversation Guide - Abilify Digital Conversation...DISCUSSION POINTS • Determining patients’ attitudes toward their treatment formulations ... schizophrenia and maintenance monotherapy

1Please see IMPORTANT SAFETY INFORMATION on pages 7-9.

INDICATIONSABILIFY MAINTENA is an atypical antipsychotic indicated for:• Treatment of schizophrenia in adults• Maintenance monotherapy treatment of bipolar I disorder in adults

WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSISElderly 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.

LAI=long-acting injectable. Models used for illustrative purposes.

DISCUSSION POINTS

• Determining patients’ attitudes toward their treatment formulations

• Discussing the importance of taking medication

• Considering a once-monthly§ treatment option

• Introducing/Reintroducing an LAI as an alternative to a daily antipsychotic

• Reviewing ABILIFY MAINTENA with appropriate patients as a once-monthly option||

§Some long-acting formulations require overlapping dosing of oral antipsychotic treatment at initiation.4

|| Establish tolerability with oral aripiprazole before initiating therapy. Along with the first injection, patients should take oral aripiprazole or current antipsychotic for 14 consecutive days.

For the treatment of adults with schizophrenia For maintenance monotherapy in adults with bipolar I disorder

Significant delay in time to recurrence of any mood episode vs placebo (P<0.0001)3‡

‡In a 52-week study: N=266 randomized. See clinical study information on page 10.

Significant symptom improvement* vs placebo and delayed time to relapse† vs placebo (P<0.0001)1,2

*In a 12-week study: N=340 randomized. †In a 52-week study: N=403 randomized. See clinical study information on page 10.

aintenancechievable

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Conversation Guide: ABILIFY MAINTENA® (aripiprazole) for Appropriate Patients

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Please see IMPORTANT SAFETY INFORMATION on pages 7-9.

AS YOU MAY KNOW…

Current guidelines remind us that periodic reevaluation of a patient’s treatment plan is a part of good clinical practice.5-8

In addition, shared decision-making with patients may play a role in their consideration of treatment options such as an LAI.9-13

Open-ended questions have been shown to help clinicians engage patients in discussions.13

The questions provided in this brochure have been designed not as medical guidance but as examples of this open-ended style.

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

Determining patients’ attitudes toward their treatment:

• How is your treatment formulation working for you?

• What can I do to help with your treatment?

Determining patients’ attitudes toward their treatment formulations


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DID YOU KNOW?

• Some psychiatrists may assume that certain patients would choose not to receive LAIs14

Important Warning and Precaution Regarding 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.

Discussing the importance of taking their oral or LAI medication:

• What was it like the last time you stopped taking your medication?

• What do you think would happen if you didn’t receive your medication?

Discussing the importance of taking medication


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LET YOUR PATIENTS KNOW…

• ABILIFY MAINTENA® (aripiprazole) can be used as an alternative to a daily antipsychotic

• Establish tolerability with oral aripiprazole prior to initiating treatment with ABILIFY MAINTENA.

Allow up to 2 weeks to fully assess tolerability

• Along with the first injection, treatment with oral aripiprazole or current oral antipsychotic should

be continued for 14 days. Only for administration by a healthcare professional. Dosage adjustments are

required for missed doses

Important Warning and Precaution Regarding 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.

* Some long-acting formulations require overlapping dosing of oral antipsychotic treatment at initiation.4

Considering how a patient would feel about receiving a once-monthly* medication:

• Would it help if you didn’t have to take your antipsychotic every day*?

– What are your thoughts on receiving your medication once a month?

– How do you feel about receiving a month’s worth of medicine with one dose?

Considering a once-monthly treatment option


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Important Warning and Precaution Regarding 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.

Introducing/Reintroducing an LAI as an alternative to a daily antipsychotic

Introducing/Reintroducing LAIs:

• Have you given more thought to receiving your antipsychotic medicine as a once-monthly* injection?

– Since the last time we spoke, what thought have you given to receiving this medicine each month with one injection?

– How do you feel about starting a trial of the once-monthly dosing we talked about?

WHAT IS YOUR EXPERIENCE?Do you feel that patients who initially reject an LAI may become more

receptive to this treatment option if the topic is periodically reintroduced?15

* Some long-acting formulations require overlapping dosing of oral antipsychotic treatment at initiation.4


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Important Warning and Precaution Regarding 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.

Reviewing ABILIFY MAINTENA® (aripiprazole) with appropriate

patients as a once-monthly* option

LET YOUR PATIENTS KNOW…

• ABILIFY MAINTENA is the first and only FDA-approved once-monthly* injectable for both schizophrenia and maintenance monotherapy treatment of bipolar I disorder in adults

* Establish tolerability with oral aripiprazole before initiating therapy. Along with the first injection, patients should take oral aripiprazole or current oral antipsychotic for 14 consecutive days.

Reviewing the topic of a once-monthly treatment:

• If oral aripiprazole is working for you, how about trying a once-monthly option?

– What do you think about an injectable option that can help maintain symptom control and deliver the same active ingredient as a daily tablet?

– What are your thoughts about receiving the medicine you need in your arm or buttock?

– Since your body can tolerate oral aripiprazole, what would you say about giving ABILIFY MAINTENA a try?†

†Establish tolerability with oral aripiprazole before initiating therapy.

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INDICATIONSABILIFY MAINTENA is an atypical antipsychotic indicated for:

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

IMPORTANT SAFETY INFORMATION


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.

(Continued on next page.)

INDICATIONS and IMPORTANT SAFETY INFORMATION for ABILIFY MAINTENA® (aripiprazole)

Please see FULL PRESCRIBING INFORMATION, including BOXED WARNING.

https://www.otsuka-us.com/media/static/Abilify-M-PI.pdf?_ga=2.67192146.2141693713.1524854804-1148943990.1513268143

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• Hyperglycemia/Diabetes Mellitus (continued): 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.

(Continued on next page.)

IMPORTANT SAFETY INFORMATION for ABILIFY MAINTENA® (aripiprazole), continued



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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).

IMPORTANT SAFETY INFORMATION for ABILIFY MAINTENA® (aripiprazole), continued



Please see IMPORTANT SAFETY INFORMATION on pages 7-9.10

Pivotal studies for ABILIFY MAINTENA® (aripiprazole)

12-WEEK SCHIZOPHRENIA STUDY1,16

• A randomized, double-blind, placebo-controlled clinical study of 340 acutely relapsed adult patients with schizophrenia to determine the efficacy and safety of ABILIFY MAINTENA 400 mg (n=168) vs placebo (n=172). All patients had a diagnosis of schizophrenia for ≥1 year at study entry

• In this study, ABILIFY MAINTENA showed significant results in PANSS Total Score vs placebo (at Week 1: P<0.001; at Week 2 and all subsequent time points, including primary efficacy endpoint at Week 10: P<0.0001)

52-WEEK, MULTIPHASE SCHIZOPHRENIA STUDY2

• Open-label phase (Phase 2), patients with a diagnosis of schizophrenia ≥3 years were stabilized on oral aripiprazole 10 mg to 30 mg/day

• Single-blind phase (Phase 3), patients were converted to and stabilized on ABILIFY MAINTENA 400 mg (patients also continued on oral aripiprazole 10 mg to 20 mg for the first 14 days following the initial ABILIFY MAINTENA dose)

• Double-blind, placebo-controlled phase (Phase 4), patients were randomized to either intramuscular (IM) ABILIFY MAINTENA (n=269) or IM placebo (n=134)

• In this study, ABILIFY MAINTENA significantly delayed time to relapse vs placebo (P<0.0001). ABILIFY MAINTENA showed significant difference in PANSS Total Score vs placebo starting at Week 2 in double-blind Phase 4 and at all subsequent time points (at Week 2: P<0.05; at Week 4: P<0.001; at Weeks 6 through 52: P<0.0001)

52-WEEK, MULTIPHASE BIPOLAR I DISORDER STUDY3

• Open-label phase (Phase 2), patients were stabilized on oral aripiprazole 15 mg to 30 mg/day

• Single-blind phase (Phase 3), patients were converted to and stabilized on ABILIFY MAINTENA 400 mg (patients also continued on oral aripiprazole 10 mg to 20 mg for the first 14 days following the initial ABILIFY MAINTENA dose)

• Double-blind, placebo-controlled phase (Phase 4), patients were randomized to either IM ABILIFY MAINTENA (n=133) or IM placebo (n=133)

• In this study, ABILIFY MAINTENA significantly delayed time to recurrence of any mood episode vs placebo (P<0.0001). ABILIFY MAINTENA significantly delayed time to recurrence for a manic and mixed episode. No substantial difference in the time to a depressive episode

PANSS=Positive and Negative Syndrome Scale.

11Please see IMPORTANT SAFETY INFORMATION on pages 7-9.

REFERENCES: 1. Kane JM, Peters-Strickland T, Baker RA, et al. Aripiprazole once-monthly in the acute treatment of schizophrenia: findings from a 12-week, randomized, double-blind, placebo-controlled study. J Clin Psychiatry. 2014;75(11):1254-1260. 2. Kane JM, Sanchez R, Perry PP, 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(5):617-624 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, Aguglia E, Altamura AC, et al. Guidelines for depot antipsychotic treatment in schizophrenia. Eur Neuropsychopharmacol. 1998;8(1):55-66. 5. Lehman AF, Lieberman JA, Dixon LB, et al; Steering Committee on Practice Guidelines. Practice Guideline for the Treatment of Patients With Schizophrenia. 2nd ed. Washington, DC: American Psychiatric Association; 2004. 6. Hirschfeld RMA, Bowden CL, Gitlin MJ, et al; Steering Committee on Practice Guidelines. Practice Guideline for the Treatment of Patients With Bipolar Disorder. 2nd ed. Washington, DC: American Psychiatric Association; 2002. 7. The Management of Bipolar Disorder Working Group. VA/DoD Clinical Practice Guidelines for Management of Bipolar Disorder in Adults. Washington, DC: Department of Veterans Affairs, Department of Defense; 2010. 8. Suppes T, Dennehy EB, Hirschfeld RMA, et al. The Texas Implementation of Medication Algorithms: update to the algorithms for treatment of bipolar I disorder. J Clin Psychiatry. 2005;66(7):870-886. 9. Remington G, Foussias G, Agid O. Progress in defining optimal treatment outcome in schizophrenia. CNS Drugs. 2010;24(1):9-20. 10. Wehring HJ, Thedford S, Koola M, Kelly DL. Patient and health care provider perspectives on long acting injectable antipsychotics in schizophrenia and the introduction of olanzapine long-acting injection. J Cent Nerv Syst Dis. 2011;3:107-123. 11. Gray R, Spilling R, Burgess D, Newey T. Antipsychotic long-acting injections in clinical practice: medication management and patient choice. Br J Psychiatry. 2009;195(52):S51–S56. 12. Srebnik DS, Rutherford LT, Peto T, et al. The content and clinical utility of psychiatric advance directives. Psychiatr Serv. 2005;56(5):592-598. 13. Miller WR, Rollnick S. Motivational Interviewing: Helping People Change. 3rd ed. New York, NY: Guilford Press; 2013:chap 3. 14. Haddad P, Lambert T, Lauriello J, eds. Antipsychotic Long-acting Injections. Oxford, UK: Oxford University Press, Inc; 2011. 15. Kane JM, Garcia-Ribera C. Clinical guideline recommendations for antipsychotic long-acting injections. Br J Psychiatry. 2009;195:s63-s67. 16. Data on file. ABIMAI-062.

Clinical safety profile for ABILIFY MAINTENA® (aripiprazole)

• In an open-label study comparing bioavailability of ABILIFY MAINTENA administered in the deltoid or gluteal muscle, injection site pain was observed in both groups at approximately equal rates

SD=standard deviation.

The following safety information is derived from a 12-week, double-blind study or an open-label study in schizophrenia.

• Most commonly observed adverse reactions (incidence ≥5% for ABILIFY MAINTENA and at least twice that for placebo) were increased weight, akathisia, injection site pain, and sedation

— The mean intensity of injection pain reported by patients using a visual analog scale (0=no pain to 100=unbearably painful) approximately 1 hour after injection was 7.1 (SD 14.5) for the first injection and 4.8 (SD 12.4) at the last visit

ABILIFY MAINTENA HAS BEEN EVALUATED FOR SAFETY IN MORE THAN 2000 ADULT PATIENTS WITH SCHIZOPHRENIA AND IN MORE THAN 800 ADULT PATIENTS WITH BIPOLAR I DISORDER

INJECTION PAIN REPORTED BY PATIENTS WITH SCHIZOPHRENIA

No pain Unbearably painful

Visual Analog Scale

0 10 80706050403020 90 100

7.1 (14.5) ~ 1 hour after first injection

4.8 (12.4) at the last visit

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©2018 Otsuka America Pharmaceutical, Inc. April 2018 09US18EBP0064

Discussing ABILIFY MAINTENA® (aripiprazole) as an LAI treatment option with appropriate patients

INDICATIONSABILIFY MAINTENA is an atypical antipsychotic indicated for:• Treatment of schizophrenia in adults• Maintenance monotherapy treatment of bipolar I disorder in adults



Make ABILIFY MAINTENA your choice for an LAI

Please visit ABILIFYMAINTENAhcp.com for more information.

• For patients who have never taken aripiprazole, establish tolerability with oral aripiprazole prior to initiating treatment with ABILIFY MAINTENA. Due to the half-life of oral aripiprazole, it may take up to 2 weeks to fully assess tolerability

• Along with the first injection, patients should also receive a prescription for oral aripiprazole (10 mg to 20 mg) or current oral antipsychotic for 14 consecutive days

• Please specify either the pre-filled, dual chamber syringe or the vial kit when writing either an electronic or a conventional prescription

*Establish tolerability with oral aripiprazole before initiating therapy. Along with the first injection, patients should take oral aripiprazole or current oral antipsychotic for 14 consecutive days.

The first and only FDA-approved once-monthly* injectable for both schizophrenia and maintenance

monotherapy treatment of bipolar I disorder in adults

Vial Kit

ABILIFY MAINTENA® (aripiprazole)Pre-filled DCS 400 mg #1 Sig: 400 mg IM q month

ABILIFY MAINTENA® (aripiprazole)Vial Kit 400 mg #1

Sig: 400 mg IM q month

Pre-filled, Dual Chamber Syringe

LAI=long-acting injectable.

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Conversation Guide - Abilify Digital Conversation...DISCUSSION POINTS • Determining patients’ attitudes toward their treatment formulations ... schizophrenia and maintenance monotherapy