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ABILIFY MAINTENA
Mood disorders
Psychosis
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Drug Name:

ABILIFY MAINTENA Rx

Generic Name and Formulations:
Aripiprazole extended-release injectable suspension 300mg, 400mg; per vial or pre-filled syringe; lyophilized pwd for IM inj after reconstitution.

Company:
Lundbeck Inc. and Otsuka America Pharmaceutical, Inc.

Therapeutic Use:

Indications for ABILIFY MAINTENA:

Maintenance treatment of bipolar I disorder as monotherapy.

Adult:

Treatment-naive: establish tolerability with oral form first. Give by IM inj into the deltoid or gluteal muscle. Initial and maintenance: 400mg once monthly (no sooner than 26 days after the previous inj); may consider reducing to 300mg once monthly if adverse reactions occur. After first Maintena dose, continue with concurrent oral aripiprazole (10–20mg) or other antipsychotic for 14 consecutive days. Dose adjustments for missed dose, CYP2D6 poor metabolizers, concomitant CYP2D6 inhibitors, CYP3A4 inhibitors or inducers for >14 days: see full labeling.

Children:

<18yrs: not established.

Boxed Warning:

Increased mortality in elderly patients with dementia-related psychosis. Suicidal thoughts and behaviors with antidepressant drugs.

Warnings/Precautions:

Elderly with dementia-related psychosis (not approved use); increased risk of death or cerebrovascular events (eg, stroke, TIA). Increased risk of suicidal thoughts and behavior in children, adolescents, and young adults; monitor closely for worsening or unusual changes in behavior in all patients. Cardio- or cerebrovascular disease. Risk of hypotension, aspiration pneumonia, seizures, or diabetes (do baseline fasting blood sugar). Pre-existing low WBCs or history of leukopenia/neutropenia; monitor CBCs during 1st few months of treatment; discontinue if WBCs decline. Exposure to extreme heat. Dehydration. Perform fall risk assessments when initiating and recurrently on long-term therapy. Monitor for hyperglycemia, dyslipidemia, weight gain. Exclude neuroleptic malignant syndrome if fever occurs. Suicidal tendencies. Pathological gambling and other compulsive behaviors: consider dose reduction or discontinuation if develops. CYP2D6 poor metabolizers. Reevaluate periodically. Write ℞ for smallest practical amount. Labor & delivery. Neonates: risk of extrapyramidal and/or withdrawal symptoms post delivery (due to exposure during 3rd-trimester pregnancy). Pregnancy. Nursing mothers: not recommended.

See Also:

ABILIFY

Aripiprazole Oral Solution

Aripiprazole Orally Disintegrating Tablets

ABILIFY MYCITE

Pharmacological Class:

Atypical antipsychotic.

Interactions:

See Adult. Potentiated by CYP3A4 inhibitors (eg, itraconazole, clarithromycin) or CYP2D6 inhibitors (eg, quinidine, fluoxetine, paroxetine). Antagonized by CYP3A4 inducers (eg, carbamazepine, rifampin). Potentiates antihypertensives. Caution with drugs that interfere with temperature regulation (eg, anticholinergics). Monitor with lorazepam.

Adverse Reactions:

Headache, anxiety, insomnia, constipation, nausea, vomiting, somnolence, fatigue, sedation, dizziness, restlessness, akathisia, orthostatic hypotension, blurred vision, tremor, pyrexia, salivary hypersecretion, nasopharyngitis, EPS, neuroleptic malignant syndrome, tardive dyskinesia, weight gain, hyperglycemia, dyslipidemia, others. Inj: local reactions.

Note:

Register patients in National Pregnancy Registry for Atypical Antipsychotics (866) 961-2388.

Generic Availability:

Tabs, soln, orally disintegrating tabs (YES); Maintena, MyCite (NO)

How Supplied:

Tabs 2mg—30; 5mg, 10mg, 15mg, 20mg, 30mg—30, 100; Prefilled Dual Chamber Syringe—1 (w. supplies); Single-use vials—1 (w. supplies); Oral soln, orally disintegrating tabs—contact supplier; MyCite—30 tabs + 7 patches


Data provided by MPR.

Indications for ABILIFY MAINTENA:

Schizophrenia.

Adult:

Treatment-naive: establish tolerability with oral form first. Give by IM inj into the deltoid or gluteal muscle. Initial and maintenance: 400mg once monthly (no sooner than 26 days after the previous inj); may consider reducing to 300mg once monthly if adverse reactions occur. After first Maintena dose, continue with concurrent oral aripiprazole (10–20mg) or other antipsychotic for 14 consecutive days. Dose adjustments for missed dose, CYP2D6 poor metabolizers, concomitant CYP2D6 inhibitors, CYP3A4 inhibitors or inducers for >14 days: see full labeling.

Children:

<18yrs: not established.

Boxed Warning:

Increased mortality in elderly patients with dementia-related psychosis.

Warnings/Precautions:

Elderly with dementia-related psychosis (not approved use); increased risk of death or cerebrovascular events (eg, stroke, TIA). Increased risk of suicidal thoughts and behavior in children, adolescents, and young adults; monitor closely for worsening or unusual changes in behavior in all patients. Cardio- or cerebrovascular disease. Risk of hypotension, aspiration pneumonia, seizures, or diabetes (do baseline fasting blood sugar). Pre-existing low WBCs or history of leukopenia/neutropenia; monitor CBCs during 1st few months of treatment; discontinue if WBCs decline. Exposure to extreme heat. Dehydration. Perform fall risk assessments when initiating and recurrently on long-term therapy. Monitor for hyperglycemia, dyslipidemia, weight gain. Exclude neuroleptic malignant syndrome if fever occurs. Suicidal tendencies. Pathological gambling and other compulsive behaviors: consider dose reduction or discontinuation if develops. CYP2D6 poor metabolizers. Reevaluate periodically. Write ℞ for smallest practical amount. Labor & delivery. Neonates: risk of extrapyramidal and/or withdrawal symptoms post delivery (due to exposure during 3rd-trimester pregnancy). Pregnancy. Nursing mothers: not recommended.

See Also:

ABILIFY

Aripiprazole Oral Solution

Aripiprazole Orally Disintegrating Tablets

ABILIFY MYCITE

Pharmacological Class:

Atypical antipsychotic.

Interactions:

See Adult. Potentiated by CYP3A4 inhibitors (eg, itraconazole, clarithromycin) or CYP2D6 inhibitors (eg, quinidine, fluoxetine, paroxetine). Antagonized by CYP3A4 inducers (eg, carbamazepine, rifampin). Potentiates antihypertensives. Caution with drugs that interfere with temperature regulation (eg, anticholinergics). Monitor with lorazepam.

Adverse Reactions:

Headache, anxiety, insomnia, constipation, nausea, vomiting, somnolence, fatigue, sedation, dizziness, restlessness, akathisia, orthostatic hypotension, blurred vision, tremor, pyrexia, salivary hypersecretion, nasopharyngitis, EPS, neuroleptic malignant syndrome, tardive dyskinesia, weight gain, hyperglycemia, dyslipidemia, others. Inj: local reactions.

Note:

Register patients in National Pregnancy Registry for Atypical Antipsychotics (866) 961-2388.

Generic Availability:

Tabs, soln, orally disintegrating tabs (YES); Maintena, MyCite (NO)

How Supplied:

Tabs 2mg—30; 5mg, 10mg, 15mg, 20mg, 30mg—30, 100; Prefilled Dual Chamber Syringe—1 (w. supplies); Single-use vials—1 (w. supplies); Oral soln, orally disintegrating tabs—contact supplier; MyCite—30 tabs + 7 patches


Data provided by MPR.

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