HOW TO INITIATE ABILIFY MAINTENA

ABILIFY MAINTENA® (aripiprazole) is a once-monthly LAI you can initiate 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.

Find out how ABILIFY MAINTENA is initiated and learn additional information on dosing and administration.

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Patient Initiation
Administration
Dosing ADJUSTMENTS
Recommended starting and maintenance dose of ABILIFY MAINTENA is 400 mg once monthly
  • 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
MAINTAINABILIFY MAINTENA once monthlyDo not administer ABILIFY MAINTENA any sooner than 26 days after the previous injectionINITIATEABILIFY MAINTENA CONTINUEpatient’s current oral anti-psychotic* for 14 days 1STEP2STEPFor patients known to tolerate aripiprazole:
MAINTAINABILIFY MAINTENA once monthlyDo not administer ABILIFY MAINTENA any sooner than 26 days after the previous injectionINITIATEABILIFY MAINTENA CONTINUEpatient’s current oral antipsychotic* for 14 days 12STEPSTEPFor patients known to tolerate aripiprazole:

*Oral aripiprazole (10 mg to 20 mg) or current oral antipsychotic.
LAI=long-acting injectable.

  • 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
Contraindication

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

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Review the Initiation Guide before prescribing

This helpful resource has information to get your appropriate patients started on ABILIFY MAINTENA.

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All doses can be given by deltoid or gluteal intramuscular administration

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

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

2 inches (51 mm) x 21-gauge needle1 inch (25 mm) x23-gauge needledeltoidglutealdeltoidglutealNon-obeseObese1"1.5 inches (38 mm) x 22-gauge needle1.5"2"
2 inches (51 mm) x 21-gauge needle1.5 inches (38 mm) x 22-gauge needle1 inch (25 mm) x 23-gauge needledeltoidglutealdeltoidglutealNon-obeseObese1"1.5"2"
  • Rotate site of injection between the 2 deltoid or gluteal muscles
  • Each box of ABILIFY MAINTENA offers needle options for deltoid and gluteal administration—
    no additional ordering needed
  • 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 
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.

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

Adjustments if the second or third doses are missed: 

HOW LONG HAS THE PATIENT GONE WITHOUT AN INJECTION?NEXT STEPSMORE THAN 4 WEEKS AND LESS THAN 5 WEEKSAdminister an injection as soon as possible.Restart concomitant oral aripiprazole for 14 days with the next administered injection.MORE THAN 5 WEEKS
HOW LONG HAS THE PATIENT GONE WITHOUT AN INJECTION?NEXT STEPS28.2%MORE THAN 4 WEEKS AND LESS THAN 5 WEEKSAdminister an injection as soon as possible.Restart concomitant oral aripiprazole for 14 days with the next administered injection.MORE THAN 5 WEEKS

Adjustments if the fourth or subsequent doses are missed: 

HOW LONG HAS THE PATIENT GONE WITHOUT AN INJECTION?NEXT STEPSMORE THAN 4 WEEKS AND LESS THAN 6 WEEKSAdminister an injection as soon as possible.Restart concomitant oral aripiprazole for 14 days with the next administered injection.MORE THAN 6 WEEKS
HOW LONG HAS THE PATIENT GONE WITHOUT AN INJECTION?NEXT STEPS28.2%MORE THAN 4 WEEKS AND LESS THAN 6 WEEKSAdminister an injection as soon as possible.Restart concomitant oral aripiprazole for 14 days with the next administered injection.MORE THAN 6 WEEKS

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

Adjustments based on CYP2D6 metabolism or concomitant medications

FACTORSADJUSTED DOSECYP2D6 POOR METABOLIZERSPATIENTS TAKING 300 MG OF ABILIFY MAINTENAKnown CYP2D6 poor metabolizersReceiving strong CYP2D6 or CYP3A4 inhibitors for greater than 14 daysReceiving strong CYP2D6 or CYP3A4 inhibitors for greater than 14 daysReceiving CYP2D6 and CYP3A4 inhibitors for greater than 14 daysReceiving CYP2D6 and CYP3A4 inhibitors for greater than 14 daysReceiving CYP3A4 inducers for greater than 14 daysReceiving CYP3A4 inducers for greater than 14 days300 mg200 mg†200 mg†160 mg†Avoid useAvoid use300 mg200 mg†Known CYP2D6 poor metabolizers taking concomitant CYP3A4 inhibitors for greater than 14 daysPATIENTS TAKING 400 MG OF ABILIFY MAINTENA
FACTORSADJUSTED DOSECYP2D6 POOR METABOLIZERSPATIENTS TAKING 400 MG OF ABILIFY MAINTENAPATIENTS TAKING 300 MG OF ABILIFY MAINTENAKnown CYP2D6 poor metabolizersReceiving strong CYP2D6 or CYP3A4 inhibitors for greater than 14 daysReceiving strong CYP2D6 or CYP3A4 inhibitors for greater than 14 daysReceiving CYP2D6 and CYP3A4 inhibitors for greater than 14 daysReceiving CYP2D6 and CYP3A4 inhibitors for greater than 14 daysReceiving CYP3A4 inducers for greater than 14 daysReceiving CYP3A4 inducers for greater than 14 days300 mg200 mg†200 mg†160 mg†Avoid useAvoid use300 mg200 mg†Known CYP2D6 poor metabolizers taking concomitant CYP3A4 inhibitors for greater than 14 days

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

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

To learn more about dose adjustments, download the INITIATION GUIDE.

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.

Instructions for use

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

Instruction for use videos

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

Pre-filled, dual chamber syringe

Pre-filled, dual chamber syringe instructions for use

Vial kit

Vial kit instructions for use

Choices that offer flexibility in administration

ABILIFY MAINTENA® Pre-Filled Syringe

Pre-filled, dual chamber syringe

  • 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
ABILIFY MAINTENA® Vial Kits

 

Vial kit

  • 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.

ABILIFY MAINTENA® Pre-Filled Syringe Prescription
ABILIFY MAINTENA® Pre-Filled Syringe Prescription
  • 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 
  • 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.]

Please see FULL PRESCRIBING INFORMATION, including BOXED WARNING.

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

INDICATIONS and IMPORTANT SAFETY INFORMATION for 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

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).

Please see FULL PRESCRIBING INFORMATION, including BOXED WARNING.