FOR HEALTHCARE PROFESSIONALS INITIATING APPROPRIATE ...

FOR HEALTHCARE PROFESSIONALS INITIATING APPROPRIATE PATIENTS FROM

ANY ORAL ANTIPSYCHOTIC

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.

ABILIFY MAINTENA® (aripiprazole) INITIATION GUIDE

INDICATIONS

ABILIFY MAINTENA® (aripiprazole) 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 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.

Please see IMPORTANT SAFETY INFORMATION.

12-WEEK STUDY

CLINICAL SAFETYPROFILE

INITIATION AND DOSING

REFERENCES

IMPORTANT SAFETY INFORMATION

PHARMACOKINETICS

SUMMARY

PRESCRIBINGINFORMATION

https://www.otsuka-us.com/media/static/Abilify-M-PI.pdf

Patients without prior exposure received oral aripiprazole to establish tolerability2

*Percentages provided were patient-reported estimations. All patients underwent a 7-day washout period at trial entry.2

PATIENTS WERE RECEIVING A RANGE OF MEDICATIONS PRIOR TO STUDY ENROLLMENT*

Risperidone 21.5%

Quetiapine 15.3%

Olanzapine 8.2%

Aripiprazole 6.5%

Another antipsychotic 22%

No antipsychotic 26.5%

Contraindication: Known hypersensitivity reaction to aripiprazole. Reactions have ranged from pruritus/urticaria to anaphylaxis.Important Warning and Precaution Regarding Cerebrovascular Adverse Events, Including StrokeIncreased 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.


93.5% of patients were treated with an antipsychotic other than aripiprazole or no antipsychotic prior to study entry1

IN A 12-WEEK STUDY OF ADULT PATIENTS WITH SCHIZOPHRENIA

SEE STUDY DESIGN

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CGI-S=Clinical Global Impression-Severity; PANSS=Positive and Negative Syndrome Scale.

* Baseline characteristics: PANSS Total Score ≥80 and PANSS score >4 on each of 4 specific psychotic symptoms (conceptual disorganization, hallucinatory behavior, suspiciousness/persecution, and unusual thought content). Patients were required to remain as inpatients for at least the first 2 weeks of treatment, after which hospitalization status was determined on the basis of the investigator’s judgment of the patient’s clinical status. Those discharged were followed with clinic visits and phone calls.2

A 12-week, randomized, double-blind, placebo-controlled study in which acutely relapsed adult patients* with schizophrenia were randomized to either ABILIFY MAINTENA® (aripiprazole) (n=168) or intramuscular placebo (n=172), and patients received 14 days of oral aripiprazole or oral placebo, respectively. Primary endpoint was mean change in PANSS Total Score from baseline to Week 10. Safety was assessed through the duration of the study.2

• In the short-term study of patients with schizophrenia, patients were given 10 mg of oral aripiprazole for 3 days for sensitivity purposes2

• Patients had a mean PANSS Total Score of 103 (range 82 to 144) and a CGI-S score of 5.2 (markedly ill) at baseline

Study design of a 12-week study of acutely relapsed adult patients with schizophrenia

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.


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ABILIFY MAINTENA® (aripiprazole) achieved statistically significant improvement in PANSS Total Score vs placebo2

ABILIFY MAINTENA

Placebo

-11.7-12.6

Number of patients

0 21-35

-30

-25

-5

-20

-10

-15

12104 6 8

162 162 144 99 99134 126 108167 167 157 81 68140 117 96

Leas

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uar

es m

ean

red

uct

ion

fro

mb

asel

ine

in P

AN

SS T

otal

Sco

re

Weeks from randomization

-26.8Week 10 (P<0.0001) -27.2

Week 12 (P<0.0001)

-8.9Week 1

(P<0.001)

EARLY AND CONTINUEDSYMPTOM IMPROVEMENTFROM WEEK 1 TO WEEK 123

Concomitanttreatment with oral aripiprazoleor placebo for 14 days afterfirst injection3

-5.0

0

Primary endpoint: Mean change in PANSS Total Score from baseline at Week 10

SEE STUDY DESIGN

IN A SHORT-TERM STUDY OF ADULT PATIENTS WITH SCHIZOPHRENIA

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.


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PERCENTAGE OF PATIENTS REPORTING REACTION*

SYSTEM ORGAN CLASS PREFERRED TERM ABILIFY MAINTENA (n=167)

PLACEBO (n=172)

GASTROINTESTINAL DISORDERS

Constipation 10 7

Dry mouth 4 2

Diarrhea 3 2

Vomiting 3 1

Abdominal discomfort 2 1

GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Injection site pain 5 1

INFECTIONS AND INFESTATIONS Upper respiratory tract infection 4 2

INVESTIGATIONSIncreased weight 17 7

Decreased weight 4 2

*Table excludes adverse reactions that had an incidence equal to or less than placebo.

Clinical safety profile of ABILIFY MAINTENA® (aripiprazole)Adverse reactions in ≥2% of patients

FROM A PLACEBO-CONTROLLED, 12-WEEK STUDY IN ADULT PATIENTS WITH SCHIZOPHRENIA

(Continued on following page)


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Clinical safety profile of ABILIFY MAINTENA® (aripiprazole) (cont’d)

MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS

Arthralgia 4 1

Back pain 4 2

Myalgia 4 2

Musculoskeletal pain 3 1

NERVOUS SYSTEM DISORDERS

Akathisia 11 4

Sedation 5 1

Dizziness 4 2

Tremor 3 1

RESPIRATORY, THORACIC, AND MEDIASTINAL Nasal congestion 2 1

PERCENTAGE OF PATIENTS REPORTING REACTION*

SYSTEM ORGAN CLASS PREFERRED TERM ABILIFY MAINTENA (n=167)

PLACEBO (n=172)

• Most commonly observed adverse reactions in patients with schizophrenia (incidence ≥5% for ABILIFY MAINTENA and at least twice that for placebo) were increased weight (16.8% vs 7.0%), akathisia (11.4% vs 3.5%), injection site pain (5.4% vs 0.6%), and sedation (5.4% vs 1.2%)

Adverse reactions in ≥2% of patients (cont’d)

*Table excludes adverse reactions that had an incidence equal to or less than placebo.

FROM A PLACEBO-CONTROLLED, 12-WEEK STUDY IN ADULT PATIENTS WITH SCHIZOPHRENIA


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Recommended starting and maintenance dose of ABILIFY MAINTENA is 400 mg once monthly

Initiating ABILIFY MAINTENA® (aripiprazole) in patients taking any oral antipsychotic

• For patients without a history of aripiprazole use, establish tolerability for up to 2 weeks with oral aripiprazole prior to 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

*Oral aripiprazole (10 mg to 20 mg) or current oral antipsychotic.

• ABILIFY MAINTENA is to be administered by either deep intramuscular deltoid or gluteal injection by a healthcare professional

• After the first injection of ABILIFY MAINTENA, treatment with oral aripiprazole (10 mg to 20 mg) or current oral antipsychotic should be continued for 14 consecutive days

• If there are adverse reactions with the 400 mg dosage, consider reducing the dosage to 300 mg• For additional dosage and administration information, please see FULL PRESCRIBING INFORMATION, including BOXED WARNING

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MAINTAIN ABILIFY MAINTENA once monthly

Do not administer ABILIFY MAINTENA any sooner than 26 days after the previous injection

INITIATE ABILIFY MAINTENA

CONTINUE patient’s current oral antipsychotic* for 14 days 1 2

STEP STEP

For patients known to tolerate aripiprazole:

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Important Warning and Precaution Regarding Metabolic ChangesAtypical 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. Assess fasting plasma glucose before or soon after initiation of antipsychotic medication, and monitor periodically during long-term treatment.

• 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.




Adjustments if the second or third doses are missed:

HOW LONG HAS THE PATIENT GONE WITHOUT AN INJECTION? NEXT STEPS

MORE THAN 4 WEEKS AND LESS THAN 5 WEEKS

Administer an injection as soon as possible.

MORE THAN 5 WEEKSRestart concomitant oral aripiprazole for

14 days with the next administered injection.

Adjustments if the fourth or subsequent doses are missed:

HOW LONG HAS THE PATIENT GONE WITHOUT AN INJECTION? NEXT STEPS

MORE THAN 4 WEEKS AND LESS THAN 6 WEEKS

Administer an injection as soon as possible.

MORE THAN 6 WEEKSRestart concomitant oral aripiprazole for

14 days with the next administered injection.

Dosage adjustments


Important Warning and Precaution Regarding Pathological Gambling and Other Compulsive BehaviorsIntense 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.


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Dosage adjustments (cont’d)

Adjustments based on CYP2D6 metabolism or concomitant medications

FACTORS ADJUSTED DOSE

CYP2D6 POOR METABOLIZERS

Known CYP2D6 poor metabolizers 300 mg

Known CYP2D6 poor metabolizers taking concomitant CYP3A4 inhibitors for greater than 14 days

200 mg*

PATIENTS TAKING 400 mg OF ABILIFY MAINTENA

Receiving strong CYP2D6 or CYP3A4 inhibitors for greater than 14 days 300 mg

Receiving CYP2D6 and CYP3A4 inhibitors for greater than 14 days 200 mg*

Receiving CYP3A4 inducers for greater than 14 days Avoid use

PATIENTS TAKING 300 mg OF ABILIFY MAINTENA

Receiving strong CYP2D6 or CYP3A4 inhibitors for greater than 14 days 200 mg*

Receiving CYP2D6 and CYP3A4 inhibitors for greater than 14 days 160 mg*

Receiving CYP3A4 inducers for greater than 14 days Avoid use

Important Warning and Precaution Regarding 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.


*200 mg and 160 mg dosage adjustments are obtained only by using the 300 mg or 400 mg strength vial kits.

Dosage adjustments are not recommended for patients with concomitant use of CYP3A4 inhibitors, CYP2D6 inhibitors, or CYP3A4 inducers for less than 14 days.

For additional dosage adjustment information, please see FULL PRESCRIBING INFORMATION, including BOXED WARNING.

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400 mg and 300 mg doses may be given via the deltoid and gluteal injection sites

All doses can be given by deltoid or gluteal intramuscular administration

Needle options are conveniently color-coded based on the size of patient and site of administration

2 inches (51 mm) x 21-gauge needle

1.5 inches (38 mm) x 22-gauge needle

1 inch (25 mm) x 23-gauge needledeltoid

gluteal

deltoid

gluteal

Non-obese

Obese

1"

1.5"

2"

Important Warning and Precaution Regarding FallsAntipsychotics 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.


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• Rotate site of injection between the two deltoid or gluteal muscles

• Each box of ABILIFY MAINTENA® (aripiprazole) offers needle options for deltoid and gluteal administration—no additional ordering needed


Median aripiprazole average steady-state* plasma concentrations (Cavg,ss)for daily oral aripiprazole and once-monthly ABILIFY MAINTENA

Doses of ABILIFY MAINTENA® (aripiprazole) provided a range of aripiprazole levels consistent with oral aripiprazole3

Simulations based on pharmacokinetic data in patients with schizophrenia

Daily oral aripiprazole dosing ABILIFY MAINTENA monthly dosing†

113ng/mL

169ng/mL

225ng/mL

338ng/mL

Ari

pip

razo

le c

once

ntr

atio

n (n

g/m

L)

300 mg monthly

218291ng/mL

Ari

pip

razo

le c

once

ntr

atio

n (n

g/m

L)

10 mg/day 15 mg/day 20 mg/day 30 mg/day 400 mg monthly

ng/mL

Recommended starting and maintenance dose of ABILIFY MAINTENA is 400 mg once monthly

*Steady-state concentrations for the typical subject were attained by the fourth dose for both gluteal and deltoid sites of administration.†Data from the gluteal site.

• Following multiple doses, there is a gradual rise of aripiprazole to maximum plasma concentrations (Tmax) at a median of 4 days for the deltoid muscle and 5-7 days for the gluteal muscle

Important Warning and Precaution Regarding Leukopenia, Neutropenia, and AgranulocytosisLeukopenia, 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.


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

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.

Please see FULL PRESCRIBING INFORMATION, including BOXED WARNING.

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IMPORTANT SAFETY INFORMATION for ABILIFY MAINTENA® (aripiprazole) (cont’d)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.



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IMPORTANT SAFETY INFORMATION for ABILIFY MAINTENA® (aripiprazole) (cont’d)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).


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*As measured in mean change in PANSS Total Score.

When transitioning patients from any oral antipsychotic, choose ABILIFY MAINTENA® (aripiprazole)

INDICATIONS

ABILIFY MAINTENA® (aripiprazole) 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 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.


93.5% of patients were treated with an antipsychotic other than aripiprazole or no antipsychotic prior to study entry1

The most commonly observed adverse reactions (incidence ≥5% for ABILIFY MAINTENA and at least twice that for placebo) were:

Patients achieved early and continued improvement in PANSS Total Score from Week 1 to Week 122*

• increased weight (16.8% vs 7.0%) • akathisia (11.4% vs 3.5%)

• injection site pain (5.4% vs 0.6%)• sedation (5.4% vs 1.2%)

In a short-term study of adult patients with schizophrenia

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.

ABILIFY MAINTENA has proven efficacy and demonstrated safety1,212-WEEK STUDY



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References1. Data on file. ABIMAI-122.

2. 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.

3. Data on file. ABIMAI-046.

©2020 Otsuka America Pharmaceutical, Inc. All rights reserved. October 2020 09US20EBP0128


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http://lundbeck.com/us

https://www.otsuka-us.com/discover/oapi


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