Dosage and Administration, Pre-filled Dual Chamber Syringe (2.5)                                        09/2014

Warnings and Precautions, Metabolic Changes (5.5), Orthostatic Hypotension (5.6)    12/2014

ABILIFY MAINTENA is an atypical antipsychotic indicated for the treatment of schizophrenia (1)
DOSAGE AND ADMINISTRATION

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Only to be administered by intramuscular injection in the gluteal muscle by a healthcare professional ( 2.1)

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For patients naïve to aripiprazole, establish tolerability with oral aripiprazole prior to initiating ABILIFY MAINTENA ( 2.1)

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Recommended starting and maintenance dose is 400 mg administered monthly as a single injection. Dose can be reduced to 300 mg in patients with adverse reactions ( 2.1)

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In conjunction with first dose, take 14 consecutive days of concurrent oral aripiprazole (10 mg to 20 mg) or current oral antipsychotic ( 2.1)

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Dosage adjustments are required for missed doses ( 2.2)

(a)

Known CYP2D6 poor metabolizers: Recommended starting and maintenance dose is 300 mg administered monthly as a single injection. ( 2.3)

(b)

ABILIFY MAINTENA comes in two types of kits. See instructions for reconstitution/injection/disposal procedures for 1) Pre-filled Dual Chamber Syringe ( 2.5), and 2) Vials ( 2.6).

Known hypersensitivity to aripiprazole (4)
WARNINGS AND PRECAUTIONS

1.

Cerebrovascular Adverse Reactions in Elderly Patients with Dementia-Related Psychosis: Increased incidence of cerebrovascular adverse reactions (e.g., stroke, transient ischemic attack, including fatalities) ( 5.2)

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Neuroleptic Malignant Syndrome: Manage with immediate discontinuation and close monitoring ( 5.3)

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Tardive Dyskinesia: Discontinue if clinically appropriate ( 5.4)

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Metabolic Changes: Atypical antipsychotic drugs have been associated with metabolic changes that may increase cardiovascular/cerebrovascular risk. These metabolic changes include hyperglycemia, dyslipidemia, and weight gain ( 5.5)

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Hyperglycemia and Diabetes Mellitus: Monitor patients for symptoms of hyperglycemia including polydipsia, polyuria, polyphagia, and weakness. Monitor glucose regularly in patients with and at risk for diabetes ( 5.5)

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Dyslipidemia: Undesirable alterations have been observed in patients treated with atypical antipsychotics ( 5.5)

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Weight Gain: Gain in body weight has been observed; clinical monitoring of weight is recommended

 

( 5.5)

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Orthostatic Hypotension: Use with caution in patients with known cardiovascular or cerebrovascular disease ( 5.6)

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Leukopenia, Neutropenia, and Agranulocytosis: Perform complete blood counts in patients with a history of a clinically significant low white blood cell count (WBC)/absolute neutrophil count (ANC). Consider discontinuation if clinically significant decline in WBC/ANC in the absence of other causative factors ( 5.7)

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Seizures: Use cautiously in patients with a history of seizures or with conditions that lower the seizure threshold ( 5.8)

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Potential for Cognitive and Motor Impairment: Use caution when operating machinery ( 5.9)

Most commonly observed adverse reactions with ABILIFY MAINTENA (incidence ≥5% and at least twice that for placebo) were increased weight, akathisia, injection site pain, and sedation (6.1)

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).

Dosage adjustments for patients taking CYP2D6 inhibitors, CYP3A4 inhibitors, or CYP3A4 inducers for greater than 14 days (2.3):

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Pregnancy: May cause extrapyramidal and/or withdrawal symptoms in neonates with third trimester exposure ( 8.1)

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Nursing Mothers: Discontinue drug or nursing, taking into consideration importance of drug to the mother ( 8.3)