Abilifymaintenahcp.com

DOSING AND ADMINISTRATION GUIDE
FOR PATIENTS WITH SCHIZOPHRENIA
Dosing and administration information
IMPORTANT SAFETY INFORMATION (cont'd)
ABILIFY MAINTENA® (aripiprazole) provides options
for ABILIFY MAINTENA® (aripiprazole)
Leukopenia, Neutropenia, and Agranulocytosis: Leukopenia, neutropenia, and agranulocytosis have
Approved for deltoid or gluteal administration
been reported. In patients with a history of clinically significant low white blood cell count (WBC)/ absolute neutrophil count (ANC) or history of drug-induced leukopenia/neutropenia, perform a complete blood count (CBC) frequently during the first few months of therapy. Consider discontinuing ABILIFY MAINTENA at the first sign of a clinically significant decline in WBC in the absence of other causative factors. Monitor patients with clinically significant neutropenia for fever or other symptoms or signs of infection and treat promptly if such symptoms or signs occur. Discontinue ABILIFY MAINTENA in patients with severe neutropenia (ANC <1000/mm3) and follow their WBC counts until recovery.
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: Disruption of the body's ability to reduce core body temperature has been
attributed to antipsychotic agents. Advise patients regarding appropriate care in avoiding overheating and dehydration. Appropriate care is advised for patients who may exercise strenuously, may be exposed to extreme heat, receive concomitant medication with anticholinergic activity, or are subject to dehydration.
Dysphagia: Esophageal dysmotility and aspiration have been associated with ABILIFY MAINTENA;
A single 400 mg, once-monthly* dose is recommended for both initiation and maintenance use caution in patients at risk for aspiration pneumonia. Provide the flexibility of deltoid or gluteal administration options Alcohol: Advise patients to avoid alcohol while taking ABILIFY MAINTENA.
Available in both a pre-filled, dual chamber syringe (DCS) for all-in-one delivery and vial kit Concomitant Medication: Dosage adjustments are recommended in patients who are CYP2D6 poor
300 mg and 400 mg vial kits are available for patients needing dosage adjustments metabolizers and in patients taking concomitant CYP3A4 inhibitors or CYP2D6 inhibitors for greater than 14 days. If the CYP3A4 inhibitor or CYP2D6 inhibitor is withdrawn, the ABILIFY MAINTENA dosage *After the first injection of ABILIFY MAINTENA, treatment with oral aripiprazole or current oral antipsychotic should be continued for 14 consecutive days.
may need to be increased. Avoid the concomitant use of CYP3A4 inducers with ABILIFY MAINTENA ABILIFY MAINTENA® (aripiprazole) is an atypical antipsychotic indicated for the for greater than 14 days because the blood levels of aripiprazole are decreased and may be below the treatment of schizophrenia. effective levels. Dosage adjustments are not recommended for patients with concomitant use of Please specify either DCS or vial kit when writing
CYP3A4 inhibitors, CYP2D6 inhibitors or CYP3A4 inducers for less than 14 days. WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-
for both conventional and electronic prescriptions.
Most Commonly Observed Adverse Reactions: Based on the placebo-controlled trial of
RELATED PSYCHOSIS
ABILIFY MAINTENA in schizophrenia, the most commonly observed adverse reactions associated with the use of ABILIFY MAINTENA (incidence of 5% or greater and aripiprazole incidence at least Elderly patients with dementia-related psychosis treated with antipsychotic drugs are
twice that for placebo) were increased weight (16.8% vs 7.0%), akathisia (11.4% vs 3.5%), WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-
at an increased risk (1.6 to 1.7 times) of death compared to placebo (4.5% vs 2.6%,
injection site pain (5.4% vs 0.6%), and sedation (5.4% vs 1.2%).
RELATED PSYCHOSIS
respectively). Although the causes of death were varied, most of the deaths appeared
Injection Site Reactions: In the data from the short-term, double-blind, placebo-controlled trial with
Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk
to be cardiovascular (e.g., heart failure, sudden death) or infectious (e.g., pneumonia)
ABILIFY MAINTENA in patients with schizophrenia, the percent of patients reporting any injection (1.6 to 1.7 times) of death compared to placebo (4.5% vs 2.6%, respectively). Although the causes of
in nature. ABILIFY MAINTENA is not approved for the treatment of patients with
site-related adverse reaction (all reported as injection site pain) was 5.4% for patients treated with death were varied, most of the deaths appeared to be cardiovascular (e.g., heart failure, sudden death)
gluteal administered ABILIFY MAINTENA and 0.6% for placebo. In an open label study comparing or infectious (e.g., pneumonia) in nature. ABILIFY MAINTENA is not approved for the treatment of
bioavailability of ABILIFY MAINTENA administered in the deltoid or gluteal muscle, injection site pain patients with dementia-related psychosis.
was observed in both groups at approximately equal rates.
Please see IMPORTANT SAFETY INFORMATION on pages 6 and 7.
Dystonia: Symptoms of dystonia may occur in susceptible individuals during the first days of treatment
Please see IMPORTANT SAFETY INFORMATION on pages 6 and 7 and FULL PRESCRIBING INFORMATION, and at low doses. including BOXED WARNING, for ABILIFY MAINTENA.
Pregnancy: Neonates exposed to antipsychotic drugs, including ABILIFY MAINTENA, during the third
trimester of pregnancy are at risk for extrapyramidal and/or withdrawal symptoms. These complications have varied in severity, from being self-limited to requiring intensive care and prolonged hospitalization. ABILIFY MAINTENA should be used during pregnancy only if the potential benefits justify the potential risks to the fetus.
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).
2016 Otsuka America Pharmaceutical, Inc., Rockville, MD.
All rights reserved. Please see FULL PRESCRIBING INFORMATION, including BOXED WARNING, for ABILIFY MAINTENA.
ABILIFY MAINTENA® (aripiprazole) is available in both pre-fil ed,
dual chamber syringe and vial kit options
ION tions for administration
The pre-filled, dual chamber syringe (DCS) features an all-in-one delivery system that
ABILIFY MAINTENA® (aripiprazole) is an atypical antipsychotic indicated for the treatment of schizophrenia. decreases the number of steps required for reconstitution compared with the vial kit
IMPORTANT SAFETY INFORMATION
WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS
Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk
(1.6 to 1.7 times) of death compared to placebo (4.5% vs 2.6%, respectively). Although the causes of
death were varied, most of the deaths appeared to be cardiovascular (e.g., heart failure, sudden death)
or infectious (e.g., pneumonia) in nature. 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): A potential y fatal symptom complex sometimes referred to as
NMS may occur with administration of antipsychotic drugs, including ABILIFY MAINTENA. Rare cases of N Choose from 3 needle options—conveniently color MS occurred during aripiprazole treatment. Signs an-coded based on site of administration and d symptoms of NMS include hyperpyrexia, m uscle ri size of patient gidity, altered mental status, and evidence of autonomic instability (e.g., irregular pulse or blood pressure, Rotate site of injection between 2 deltoid or gluteal muscles tachycardia, diaphoresis, and cardiac dysrhythmia). Additional signs may include elevated creatine 400 mg and 300 mg dosing options phosphokinase, myoglobinuria (rhabdomyolysis), and acute renal failure. The management of NMS should Each box of ABILIFY MAINTENA offers needle options for deltoid and gluteal administration— include: 1) immediate discontinuation of antipsychotic drugs and other drugs not essential to concurrent Administer within 30 minutes after reconstitution of pre-filled DCS no additional ordering needed therapy; 2) intensive symptomatic treatment and medical monitoring; and 3) treatment of any concomitant Room temperature storage* s Following multiple doses, there is a gradual rise of aripiprazole to maximum plasma concentrations erious medical problems for which specific treatments are available. (T ) at a median of 4 days for the deltoid muscle and 5-7 days for the gluteal muscle dive Dyskinesia (TD): The risk of developing TD (a syndrome of abnormal, involuntary movements) and
Vial kits will continue to be available for patients requiring dosages other than
the potential for it to become irreversible are believed to increase as the duration of treatment and the total h muc *—
400 mg or 300 mg
ds at low doses. Prescribing should be consistent with the need to minimize TD. There is no known treatment for established TD, although the syndrome may remit, partial y or completely, if antipsychotic treatment is withdrawn.
Metabolic Changes: Atypical antipsychotic drugs have been associated with metabolic changes that include:
■ Hyperglycemia/Diabetes Mellitus: Hyperglycemia, in some cases extreme and associated with
ketoacidosis, coma, or death, has been reported in patients treated with atypical antipsychotics including aripiprazole. Patients with diabetes should be regularly monitored for worsening of glucose control; those with risk factors for diabetes should undergo baseline and periodic fasting blood glucose testing. Any patient treated with atypical antipsychotics should be monitored for symptoms of hyperglycemia including Sterile water for injection polydipsia, polyuria, polyphagia, and weakness. Patients who develop symptoms of hyperglycemia should Aripiprazole lyophilized powder 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. In general, no dosage adjustments for ABILIFY MAINTENA are required based on age alone,† In an open-label study comparing bioavailability of ABILIFY MAINTENA administered into the deltoid gender, race, smoking status, hepatic function, or renal function ■ vs gluteal muscle, injection site pain was observed at approximately equal rates Dyslipidemia: Undesirable alterations in lipids have been observed in patients treated with
atypical antipsychotics. *DCS: Store below 30°C [86°F]. Do not freeze. Protect the syringe from light by storing in the original package until time of use.
In the short-term, double-blind, placebo-controlled trial, the percentage of patients reporting any Vial kit: Store at 25°C (77°F); excursions permitted between 15°C and 30°C (59°F to 86°F) [see USP Controlled Room Temperature].
■ injection site–related adverse reaction (all reported as injection site pain) was 5.4% for patients Weight Gain: Weight gain has been observed with atypical antipsychotic use. Clinical monitori ng of
The safety and effectiveness of ABILIFY MAINTENA in patients >65 years of age have not been adequately evaluated. See BOXED WARNING and Warning and Precaution Regarding Increased Mortality in Elderly Patients with Dementia-Related Psychosis
treated with gluteal-administered weight is recommended. ABILIFY MAINTENA and 0.6% for placebo in accompanying FULL PRESCRIBING INFORMATION for ABILIFY MAINTENA.
Pathological Gambling and Other Compulsive Behaviors: Intense urges, particularly for gambling,
*Inactive ingredients: carboxymethyl cellulose sodium, mannitol, sodium phosphate monobasic monohydrate, and sodium hydroxide.
and the inability to control these urges have been reported while taking aripiprazole. Other compulsive Important Warning and Precaution Regarding Cerebrovascular Adverse Events, Including Stroke:
urges (e.g., eating, sexual, or shopping) have been reported less frequently. Prescribers should ask patients Increased incidence of cerebrovascular adverse events (e.g., stroke, transient ischemic attack), including or their caregivers specifical y about, and closely monitor for, the development of new or intense compulsive fatalities, have been reported in clinical trials of elderly patients with dementia-related psychosis treated urges. Consider d oKnown hypersensitivity reaction to aripiprazole. Reactions have ranged from se reduction or stopping aripiprazole, if such urges develop.
with oral aripiprazole.
pruritus/urticaria to anaphylaxis. 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 Please see IMPORTANT SAFETY INFORMATION on pages 6 and 7.
predispose them to hypotension.
A single 400 mg, once-monthly dose is recommended for both
initiation and maintenance
For some patients, dosage adjustments are recommended
ABILIFY MAINTENA® (aripiprazole) is to be administered by either deep intramuscular deltoid Dosage adjustments are based on patient's CYP2D6 metabolism or use of
or gluteal injection by a healthcare professional
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 1 CYP2D6 poor metabolizer
2 Receiving CYP2D6 inhibitors
3 Receiving CYP3A4 inhibitors
After the first injection of ABILIFY MAINTENA, treatment with oral aripiprazole (10 mg to 20 mg) for more than 14 days
for more than 14 days
or current oral antipsychotic should be continued for 14 consecutive days The presence of 1 of the above criteria necessitates a 1-step dosage reduction
INITIATING ABILIFY MAINTENA
Once-monthly ABILIFY MAINTENA
The presence of criteria 1 and 3 or 2 and 3 necessitates a 2-step dosage reduction
aOral aripiprazole (10 mg to 20 mg) or current oral antipsychotic.
Concurrent antipsychotic treatment helps achieve or maintain therapeutic concentrations during initiation If there are adverse reactions with the 400 mg dosage, consider reducing the dosage to 300 mg For patients who are CYP2D6 poor metabolizers and in patients taking concomitant CYP3A4 inhibitors or CYP2D6 inhibitors for more than 14 days Do not administer ABILIFY MAINTENA any sooner than 26 days after the previous injection Avoid the concomitant use of CYP3A4 inducers with ABILIFY MAINTENA for more than 14 days In the event of a missed dose, follow the instructions in the chart below
MISSED DOSES
Because dosage adjustments cannot be made with the 400 mg
Which dose was missed?
How much time has passed
Next steps
since the last injection?
or 300 mg DCS, vial kits need to be specifically requested.
>4 weeks and <5 weeks
Administer injection as soon as possible
Second or third dose
Important Warning and Precaution Regarding Tardive Dyskinesia (TD): The risk of developing TD
>5 weeks
Restart concomitant oral aripiprazole for
(a syndrome of abnormal, involuntary movements) and the potential for it to become irreversible 14 days with the next administered injection
are believed to increase as the duration of treatment and the total cumulative dose of antipsychotic increase. The syndrome can develop, although much less commonly, after relatively brief treatment >4 weeks and <6 weeks
Administer injection as soon as possible
periods at low doses. Prescribing should be consistent with the need to minimize TD. There is no known treatment for established TD, although the syndrome may remit, partially or completely, Fourth dose or any dose thereafter
if antipsychotic treatment is withdrawn. >6 weeks
Restart concomitant oral aripiprazole for
14 days with the next administered injection
Important Warning and Precaution Regarding Neuroleptic Malignant Syndrome (NMS): A potentially
fatal symptom complex sometimes referred to as NMS may occur with administration of antipsychotic
drugs, including ABILIFY MAINTENA. Rare cases of NMS occurred during aripiprazole treatment.
Signs and symptoms of NMS include hyperpyrexia, muscle rigidity, altered mental status,
and evidence of autonomic instability (e.g., irregular pulse or blood pressure, tachycardia,
diaphoresis, and cardiac dysrhythmia). Additional signs may include elevated creatine phosphokinase,
myoglobinuria (rhabdomyolysis), and acute renal failure. The management of NMS should include:
1) immediate discontinuation of antipsychotic drugs and other drugs not essential to concurrent
therapy; 2) intensive symptomatic treatment and medical monitoring; and 3) treatment of any
concomitant serious medical problems for which specific treatments are available.
Please see IMPORTANT SAFETY INFORMATION on pages 6 and 7.
DOSING AND ADMINISTRATION GUIDE
INDICATION and IMPORTANT SAFETY INFORMATION
ABILIFY MAINTENA® (aripiprazole) is available in both pre-fil ed,
FOR PATIENTS WITH SCHIZOPHRENIA
Dosing and administration information
for ABILIFY MAINTENA® (aripiprazole)
ABILIFY MAINTENA® (aripiprazole) provides options
for ABILIFY MAINTENA® (aripiprazole)
s have hat
Approved for deltoid or gluteal administration
ABILIFY MAINTENA® (aripiprazole) is an atypical antipsychotic indicated for the treatment of schizophrenia. n raespeos t
t l toion c
e blpoaored w
d cell citoh t
WB iCa)/l kit
absolute neutrophil count (ANC) or history of drug-induced leukopenia/neutropenia, perform a IMPORTANT SAFETY INFORMATION
complete blood count (CBC) frequently during the first few months of therapy. Consider discontinuing WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS
ABILIFY MAINTENA at the first sign of a clinically significant decline in WBC in the absence of other Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk
causative factors. Monitor patients with clinically significant neutropenia for fever or other symptoms or (1.6 to 1.7 times) of death compared to placebo (4.5% vs 2.6%, respectively). Although the causes of
signs of infection and treat promptly if such symptoms or signs occur. Discontinue ABILIFY MAINTENA death were varied, most of the deaths appeared to be cardiovascular (e.g., heart failure, sudden death)
in patients with severe neutropenia (ANC <1000/mm3) and follow their WBC counts until recovery. or infectious (e.g., pneumonia) in nature. ABILIFY MAINTENA is not approved for the treatment of
Seizures: ABILIFY MAINTENA should be used with caution in patients with a history of seizures or
patients with dementia-related psychosis.
with conditions that lower the seizure threshold. Contraindication: Known hypersensitivity reaction to aripiprazole. Reactions have ranged from
Potential for Cognitive and Motor Impairment: ABILIFY MAINTENA may impair judgment, thinking,
pruritus/urticaria to anaphylaxis. or motor skills. Instruct patients to avoid operating hazardous machinery, including automobiles, Cerebrovascular Adverse Events, Including Stroke: Increased incidence of cerebrovascular adverse events
until they are certain ABILIFY MAINTENA does not affect them adversely. (e.g., stroke, transient ischemic attack), including fatalities, have been reported in clinical trials of elderly Body Temperature Regulation: Disruption of the body's ability to reduce core body temperature has been
patients with dementia-related psychosis treated with oral aripiprazole.
attributed to antipsychotic agents. Advise patients regarding appropriate care in avoiding overheating and Neuroleptic Malignant Syndrome (NMS): A potential y fatal symptom complex sometimes referred to as
dehydration. Appropriate care is advised for patients who may exercise strenuously, may be exposed to NMS may occur with administration of antipsychotic drugs, including ABILIFY MAINTENA. Rare cases of extreme heat, receive concomitant medication with anticholinergic activity, or are subject to dehydration. NMS occurred during aripiprazole treatment. Signs and symptoms of NMS include hyperpyrexia, muscle Dysphagia: Esophageal dysmotility and aspiration have been associated with ABILIFY MAINTENA;
A single 400 mg, once-monthly* dose is recommended for both initiation and maintenance rigidity, altered mental status, and evidence of autonomic instability (e.g., irregular pulse or blood pressure, use caution in patients at risk for aspiration pneumonia. tachycardia, diaphoresis, and cardiac dysrhythmia). Additional signs may include elevated creatine Provide the flexibility of deltoid or gluteal administration options 400 mg and 300 mg dosing options phosphokinase, myoglobinuria (rhabdomyolysis), and acute renal failure. The management of NMS should Alcohol: Advise patients to avoid alcohol while taking ABILIFY MAINTENA.
Available in both a pre-filled, dual chamber syringe (DCS) for all-in-one delivery and vial kit include: 1) immediate discontinuation of antipsychotic drugs and other drugs not essential to concurrent Administer within 30 minutes after reconstitution of pre-filled DCS Concomitant Medication: Dosage adjustments are recommended in patients who are CYP2D6 poor
therapy; 2) intensive symptomatic treatment and medical monitoring; and 3) treatment of any concomitant 300 mg and 400 mg vial kits are available for patients needing dosage adjustments Room temperature storage* metabolizers and in patients taking concomitant CYP3A4 inhibitors or CYP2D6 inhibitors for greater serious medical problems for which specific treatments are available. than 14 days. If the CYP3A4 inhibitor or CYP2D6 inhibitor is withdrawn, the ABILIFY MAINTENA dosage *After the first injection of ABILIFY MAINTENA, treatment with oral aripiprazole or current oral antipsychotic should be continued for 14 consecutive days.
Tardive Dyskinesia (TD): The risk of developing TD (a syndrome of abnormal, involuntary movements) and
omi otar p
s w gites o
h AB tIhLIeFr t
ABILIFY MAINTENA® (aripiprazole) is an atypical antipsychotic indicated for the the potential for it to become irreversible are believed to increase as the duration of treatment and the total for greater than 14 days because the blood levels of aripiprazole are decreased and may be below the treatment of schizophrenia. cumulative dose of antipsychotic increase. The syndrome can develop, although much less commonly, after ge adjustments are not recommended for patients with concomitant use of Please specify either DCS or vial kit when writing
relatively brief treatment periods at low doses. Prescribing should be consistent with the need to minimize CYP3A4 inhibitors, CYP2D6 inhibitors or CYP3A4 inducers for less than 14 days. WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-
TD. There is no known treatment for established TD, although the syndrome may remit, partial y for both conventional and electronic prescriptions.
Most Commonly Observed Adverse Reactions: Based on the placebo-controlled trial of
RELATED PSYCHOSIS
or completely, if antipsychotic treatment is withdrawn. ABILIFY MAINTENA in schizophrenia, the most commonly observed adverse reactions associated with the use of ABILIFY MAINTENA (incidence of 5% or greater and aripiprazole incidence at least Elderly patients with dementia-related psychosis treated with antipsychotic drugs are
Metabolic Changes: Atypical antipsychotic drugs have been associated with metabolic changes that include:
twice that for placebo) were increased weight (16.8% vs 7.0%), akathisia (11.4% vs 3.5%), WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-
at an increased risk (1.6 to 1.7 times) of death compared to placebo (4.5% vs 2.6%,
■ Hyperglycemia/Diabetes Mellitus: Hyperglycemia, in some cases extreme and associated with
injection site pain (5.4% vs 0.6%), and sedation (5.4% vs 1.2%).
ketoacidosis, coma, or death, has been reported in patients treated with atypical antipsychotics including RELATED PSYCHOSIS
respectively). Although the causes of death were varied, most of the deaths appeared
aripiprazole. Patients with diabetes should be regularly monitored for worsening of glucose control; those Injection Site Reactions: In the data from the short-term, double-blind, placebo-controlled trial with
Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk
to be cardiovascular (e.g., heart failure, sudden death) or infectious (e.g., pneumonia)
with risk factors for diabetes should undergo baseline and periodic fasting blood glucose testing. Any ABILIFY MAINTENA in patients with schizophrenia, the percent of patients reporting any injection (1.6 to 1.7 times) of death compared to placebo (4.5% vs 2.6%, respectively). Although the causes of
in nature. ABILIFY MAINTENA is not approved for the treatment of patients with
patient treated with atypical antipsychotics should be monitored for symptoms of hyperglycemia including site-related adverse reaction (all reported as injection site pain) was 5.4% for patients treated with death were varied, most of the deaths appeared to be cardiovascular (e.g., heart failure, sudden death)
polydipsia, polyuria, polyphagia, and weakness. Patients who develop symptoms of hyperglycemia should gluteal administered ABILIFY MAINTENA and 0.6% for placebo. In an open label study comparing or infectious (e.g., pneumonia) in nature. ABILIFY MAINTENA is not approved for the treatment of
also undergo fasting blood glucose testing. In some cases, hyperglycemia has resolved when the atypical bioavailability of ABILIFY MAINTENA administered in the deltoid or gluteal muscle, injection site pain patients with dementia-related psychosis.
antipsychotic was discontinued; however, some patients required continuation of anti-diabetic treatment was observed in both groups at approximately equal rates.
despite discontinuation of the suspect drug. D In general, no dosage adjustments for
ystonia: Symptoms of dystonia may o ABILIFY MAINTENA
ccur in susceptible i are required based on age alone,† ndividuals during the first days o Please see IMPORTANT SAFETY INFORMATION on pages 6 and 7.
Please see IMPORTANT SAFETY INFORMATION on pages 6 and 7 and FULL PRESCRIBING INFORMATION, nd at l , race, smoking status, hepatic function, or renal function ■ Dyslipidemia: Undesirable alterations in lipids have been observed in patients treated with
including BOXED WARNING, for ABILIFY MAINTENA.
atypical antipsychotics. *DCS: Store below 30°C [86°F]. Do not freeze. Protect the syringe from light by storing in the original package until time of us Pregnancy: Neonates exposed to antipsychotic drugs, including ABILIFY MAINTENA, dure.
Vial kit: Store at 25°C (77°F); excursions permitted between 15°C and 30°C (59°F to 86°F) [see USP Controlled Room Temperature].
trimester of pregnancy are at risk for extrapyramidal and/or withdrawal symptoms. These complications ■ Weight Gain: Weight gain has been observed with atypical antipsychotic use. Clinical monitoring of
The safety and effectiveness of ABILIFY MAINTENA in patients >65 years of age have not been adequately evaluated. ri ARNING
ri arning and Precaution Regarding Increased Mortality in Elderly Patients with Dementia-Related Psychosis
ty, from being self-limited to requiring intensive care and prolonged hospita l weight is recommended. in accompanying FULL PRESCRIBING INFORMATION for ABILIFY MAINTENA.
ABILIFY MAINTENA should be used during pregnancy only if the potential benefits justify the potential Pathological Gambling and Other Compulsive Behaviors: Intense urges, particularly for gambling,
risks to the fetus.
and the inability to control these urges have been reported while taking aripiprazole. Other compulsive Important Warning and Precaution Regarding Cerebrovascular Adverse Events, Including Stroke:
urges (e.g., eating, sexual, or shopping) have been reported less frequently. Prescribers should ask patients Increased incidence of cerebrovascular adverse events (e.g., stroke, transient ischemic attack), including Lactation: Aripiprazole is present in human breast milk. A decision should be made whether to
or their caregivers specifical y about, and closely monitor for, the development of new or intense compulsive fatalities, have been reported in clinical trials of elderly patients with dementia-related psychosis treated discontinue nursing or to discontinue the drug, taking into account the importance of the drug urges. Consider dose reduction or stopping aripiprazole, if such urges develop.
to the mother and any potential risks to the infant.
with oral aripiprazole.
Orthostatic Hypotension: ABILIFY MAINTENA may cause orthostatic hypotension and should be used with
To report SUSPECTED ADVERSE REACTIONS, contact Otsuka America Pharmaceutical, Inc. caution in patients with known cardiovascular disease, cerebrovascular disease, or conditions which would at 1-800-438-9927 or FDA at 1-800-FDA-1088 (www.fda.gov/medwatch).
Please see IMPORTANT SAFETY INFORMATION on pages 6 and 7.
2016 Otsuka America Pharmaceutical, Inc., Rockville, MD.
predispose them to hypotension.
All rights reserved. Please see , including BOXED WARNING, for ABILIFY MAINTENA.
DOSING AND ADMINISTRATION GUIDE
FOR PATIENTS WITH SCHIZOPHRENIA
Dosing and administration information
IMPORTANT SAFETY INFORMATION (cont'd)
ABILIFY MAINTENA® (aripiprazole) provides options
for ABILIFY MAINTENA® (aripiprazole)
Leukopenia, Neutropenia, and Agranulocytosis: Leukopenia, neutropenia, and agranulocytosis have
Approved for deltoid or gluteal administration
been reported. In patients with a history of clinically significant low white blood cell count (WBC)/ absolute neutrophil count (ANC) or history of drug-induced leukopenia/neutropenia, perform a complete blood count (CBC) frequently during the first few months of therapy. Consider discontinuing ABILIFY MAINTENA at the first sign of a clinically significant decline in WBC in the absence of other causative factors. Monitor patients with clinically significant neutropenia for fever or other symptoms or signs of infection and treat promptly if such symptoms or signs occur. Discontinue ABILIFY MAINTENA in patients with severe neutropenia (ANC <1000/mm3) and follow their WBC counts until recovery.
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: Disruption of the body's ability to reduce core body temperature has been
attributed to antipsychotic agents. Advise patients regarding appropriate care in avoiding overheating and dehydration. Appropriate care is advised for patients who may exercise strenuously, may be exposed to extreme heat, receive concomitant medication with anticholinergic activity, or are subject to dehydration.
Dysphagia: Esophageal dysmotility and aspiration have been associated with ABILIFY MAINTENA;
A single 400 mg, once-monthly* dose is recommended for both initiation and maintenance use caution in patients at risk for aspiration pneumonia. Provide the flexibility of deltoid or gluteal administration options Alcohol: Advise patients to avoid alcohol while taking ABILIFY MAINTENA.
Available in both a pre-filled, dual chamber syringe (DCS) for all-in-one delivery and vial kit Concomitant Medication: Dosage adjustments are recommended in patients who are CYP2D6 poor
300 mg and 400 mg vial kits are available for patients needing dosage adjustments metabolizers and in patients taking concomitant CYP3A4 inhibitors or CYP2D6 inhibitors for greater than 14 days. If the CYP3A4 inhibitor or CYP2D6 inhibitor is withdrawn, the ABILIFY MAINTENA dosage *After the first injection of ABILIFY MAINTENA, treatment with oral aripiprazole or current oral antipsychotic should be continued for 14 consecutive days.
may need to be increased. Avoid the concomitant use of CYP3A4 inducers with ABILIFY MAINTENA ABILIFY MAINTENA® (aripiprazole) is an atypical antipsychotic indicated for the for greater than 14 days because the blood levels of aripiprazole are decreased and may be below the treatment of schizophrenia. effective levels. Dosage adjustments are not recommended for patients with concomitant use of Please specify either DCS or vial kit when writing
CYP3A4 inhibitors, CYP2D6 inhibitors or CYP3A4 inducers for less than 14 days. WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-
for both conventional and electronic prescriptions.
Most Commonly Observed Adverse Reactions: Based on the placebo-controlled trial of
RELATED PSYCHOSIS
ABILIFY MAINTENA in schizophrenia, the most commonly observed adverse reactions associated with the use of ABILIFY MAINTENA (incidence of 5% or greater and aripiprazole incidence at least Elderly patients with dementia-related psychosis treated with antipsychotic drugs are
twice that for placebo) were increased weight (16.8% vs 7.0%), akathisia (11.4% vs 3.5%), WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-
at an increased risk (1.6 to 1.7 times) of death compared to placebo (4.5% vs 2.6%,
injection site pain (5.4% vs 0.6%), and sedation (5.4% vs 1.2%).
RELATED PSYCHOSIS
respectively). Although the causes of death were varied, most of the deaths appeared
Injection Site Reactions: In the data from the short-term, double-blind, placebo-controlled trial with
Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk
to be cardiovascular (e.g., heart failure, sudden death) or infectious (e.g., pneumonia)
ABILIFY MAINTENA in patients with schizophrenia, the percent of patients reporting any injection (1.6 to 1.7 times) of death compared to placebo (4.5% vs 2.6%, respectively). Although the causes of
in nature. ABILIFY MAINTENA is not approved for the treatment of patients with
site-related adverse reaction (all reported as injection site pain) was 5.4% for patients treated with death were varied, most of the deaths appeared to be cardiovascular (e.g., heart failure, sudden death)
gluteal administered ABILIFY MAINTENA and 0.6% for placebo. In an open label study comparing or infectious (e.g., pneumonia) in nature. ABILIFY MAINTENA is not approved for the treatment of
bioavailability of ABILIFY MAINTENA administered in the deltoid or gluteal muscle, injection site pain patients with dementia-related psychosis.
was observed in both groups at approximately equal rates.
Please see IMPORTANT SAFETY INFORMATION on pages 6 and 7.
Dystonia: Symptoms of dystonia may occur in susceptible individuals during the first days of treatment
Please see IMPORTANT SAFETY INFORMATION on pages 6 and 7 an and at low doses. including BOXED WARNING, for ABILIFY MAINTENA.
Pregnancy: Neonates exposed to antipsychotic drugs, including ABILIFY MAINTENA, during the third
trimester of pregnancy are at risk for extrapyramidal and/or withdrawal symptoms. These complications have varied in severity, from being self-limited to requiring intensive care and prolonged hospitalization. ABILIFY MAINTENA should be used during pregnancy only if the potential benefits justify the potential risks to the fetus.
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).
2016 Otsuka America Pharmaceutical, Inc., Rockville, MD.
All rights reserved. Please see FULL PRESCRIBING INFORMATION, including BOXED WARNING, for ABILIFY MAINTENA.

Source: https://www.abilifymaintenahcp.com/Content/files/AbilifyMaintenaHCP_DosingAndAdministrationGuide.pdf