Dosing and administration options

ABILIFY MAINTENA® (aripiprazole) options offer flexibility in dosing and administration. It is available in a pre-filled, dual chamber syringe and vial kit.

Instructions for Use Videos

The following are instructional videos on how to use the 2 delivery systems.

Pre-filled, dual chamber syringe
Vial kit

Dosing and Administration Guide

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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.

Dosing and Administration

ABILIFY MAINTENA® (aripiprazole) provides options for dosing and administration

ADMINISTRATION

  • Two intramuscular (IM) administration sites: deltoid or gluteal
  • Two delivery systems: pre-filled, dual chamber syringe or vial kit
  • All doses can be given by deltoid or gluteal IM administration
  • Only for administration by a healthcare professional

RECOMMENDED STARTING AND MAINTENANCE DOSE

  • 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
  • 400-mg single injection administered monthly
  • Along with 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
  • Consider reducing to 300 mg in patients with adverse reactions
  • Do not administer ABILIFY MAINTENA any sooner than 26 days after previous injection

DOSAGE ADJUSTMENTS

  • Dosage adjustments are required for missed doses
  • Dosage adjustments are recommended for patients who are CYP2D6 poor metabolizers and in patients taking concomitant CYP3A4 inhibitors or CYP2D6 inhibitors for more than 14 days
  • Avoid concomitant use of CYP3A4 inducers with ABILIFY MAINTENA for more than 14 days

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

Important Warning and Precaution Regarding 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.

Choices that offer flexibility in administration

  • Pre-filled, dual chamber syringe reduces the number of steps required for reconstitution compared with the vial kit
  • Administer within 30 minutes after reconstituting pre-filled, dual chamber syringe
  • Vial kits provide the flexibility to choose doses in amounts other than 400 mg or 300 mg in patients requiring dosage adjustments

Specify the choice of delivery system

When writing an electronic or conventional prescription for ABILIFY MAINTENA, remember to specify either the pre-filled, dual chamber syringe or the vial kit.

  • All doses can be given by gluteal or deltoid intramuscular administration. See above for dosing information
  • Both the pre-filled, dual chamber syringe and the vials are stored at room temperature*

*Pre-filled, dual chamber syringe: Store below 30°C (86°F). Do not freeze. Protect the syringe from light by storing in the original package until time of use.

Vial: Store at 25°C (77°F); excursions permitted between 15°C and 30°C (59°F to 86°F). [See USP Controlled Room Temperature.]

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.

Important Warning and Precaution Regarding 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.

Pharmacokinetic Study

ABILIFY MAINTENA® (aripiprazole) keeps blood concentrations of aripiprazole within therapeutic levels throughout the month in adult patients with schizophrenia.1,2

Mean plasma concentration from first gluteal injection to 24 weeks

*Patients received oral aripiprazole 10 mg/day for 14 days prior to the first ABILIFY MAINTENA injection and concomitant oral aripiprazole 10 mg/day for 14 days after the first injection of ABILIFY MAINTENA.1

Cmin,ss=minimum steady-state plasma drug concentration during a dosage interval.1

STUDY DESIGN

Open-label Phase 1b study1:

  • Assessed the safety, tolerability, effectiveness, and pharmacokinetics of ABILIFY MAINTENA administered by gluteal intramuscular injection to patients with schizophrenia
  • Mean steady-state plasma concentration range for once-monthly ABILIFY MAINTENA 400 mg (n=12) was within the concentration range for multiple, consecutive daily doses (14 days) of oral aripiprazole 10 mg to 30 mg1-3
  • Following multiple doses, there is a gradual rise of aripiprazole to maximum plasma concentration (Tmax) at a median of 4 days for the deltoid muscle and 5 to 7 days for the gluteal muscle

Important Warning and Precaution Regarding 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.

Please see FULL PRESCRIBING INFORMATION, including BOXED WARNING.

References: 1. Mallikaarjun S, Kane JM, Bricmont P, et al. Pharmacokinetics, tolerability and safety of aripiprazole once-monthly in adult schizophrenia: an open-label, parallel-arm, multiple-dose study. Schizophr Res. 2013;150(1):281-288. 2. Mallikaarjun S, Salazar DE, Bramer SL. Pharmacokinetics, tolerability, and safety of aripiprazole following multiple oral dosing in normal healthy volunteers. J Clin Pharmacol. 2004;44(2):179-187. 3. Data on file. ABIMAI-046.

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Pre-filled, dual chamber syringe instructions for use

Please see Full Prescribing Information, including BOXED WARNING.

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Vial kit instructions for use

Please see Full Prescribing Information, including BOXED WARNING.

©2018 Otsuka America Pharmaceutical, Inc.         September 2018         09US17EBP0261

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

INDICATIONS

ABILIFY MAINTENA is an atypical antipsychotic indicated for:

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

Please see FULL PRESCRIBING INFORMATION, including BOXED WARNING.