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Abilify Maintena Generic Name & Formulations
Legal Class
Rx
General Description
Aripiprazole extended-release injectable suspension 300mg, 400mg; per vial or pre-filled syringe; lyophilized pwd for IM inj after reconstitution.
Pharmacological Class
Atypical antipsychotic.
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 kits (1-component patch)—30 tabs + 7 patches; MyCite kits (2-component patch)—Starter kit (30 tabs + 1 pod + 7 strips); Maintenance kit (30 tabs + 7 strips)
Generic Availability
Tabs, soln, orally disintegrating tabs (YES); Maintena, MyCite (NO)
Abilify Maintena Indications
Indications
Maintenance treatment of bipolar I disorder as monotherapy.
Abilify Maintena Dosage and Administration
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.
Abilify Maintena Contraindications
Not Applicable
Abilify Maintena Boxed Warnings
Boxed Warning
Increased mortality in elderly patients with dementia-related psychosis. Suicidal thoughts and behaviors with antidepressant drugs.
Abilify Maintena Warnings/Precautions
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 neuroleptic malignant syndrome, hypotension, aspiration pneumonia, seizures, or diabetes (do baseline fasting blood sugar). Pre-existing low WBC/ANC or history of leukopenia/neutropenia; monitor CBCs during 1st few months of treatment; consider discontinuation if clinically significant decline in WBC occurs. Discontinue if severe neutropenia occurs (ANC <1000/mm3). Exposure to extreme heat. Dehydration. Perform fall risk assessments when initiating and recurrently on long-term therapy. Monitor for hyperglycemia, dyslipidemia, weight gain. 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.
Abilify Maintena Pharmacokinetics
See Literature
Abilify Maintena Interactions
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.
Abilify Maintena Adverse Reactions
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 (consider discontinuation if occurs), weight gain, hyperglycemia, dyslipidemia, others. Inj: local reactions.
Abilify Maintena Clinical Trials
See Literature
Abilify Maintena Note
Notes
Register patients in National Pregnancy Registry for Atypical Antipsychotics (866) 961-2388.
Abilify Maintena Patient Counseling
See Literature
Abilify Maintena Generic Name & Formulations
Legal Class
Rx
General Description
Aripiprazole extended-release injectable suspension 300mg, 400mg; per vial or pre-filled syringe; lyophilized pwd for IM inj after reconstitution.
Pharmacological Class
Atypical antipsychotic.
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 kits (1-component patch)—30 tabs + 7 patches; MyCite kits (2-component patch)—Starter kit (30 tabs + 1 pod + 7 strips); Maintenance kit (30 tabs + 7 strips)
Generic Availability
Tabs, soln, orally disintegrating tabs (YES); Maintena, MyCite (NO)
Abilify Maintena Indications
Indications
Schizophrenia.
Abilify Maintena Dosage and Administration
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.
Abilify Maintena Contraindications
Not Applicable
Abilify Maintena Boxed Warnings
Boxed Warning
Increased mortality in elderly patients with dementia-related psychosis.
Abilify Maintena Warnings/Precautions
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 neuroleptic malignant syndrome, hypotension, aspiration pneumonia, seizures, or diabetes (do baseline fasting blood sugar). Pre-existing low WBC/ANC or history of leukopenia/neutropenia; monitor CBCs during 1st few months of treatment; consider discontinuation if clinically significant decline in WBC occurs. Discontinue if severe neutropenia occurs (ANC <1000/mm3). Exposure to extreme heat. Dehydration. Perform fall risk assessments when initiating and recurrently on long-term therapy. Monitor for hyperglycemia, dyslipidemia, weight gain. 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.
Abilify Maintena Pharmacokinetics
See Literature
Abilify Maintena Interactions
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.
Abilify Maintena Adverse Reactions
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 (consider discontinuation if occurs), weight gain, hyperglycemia, dyslipidemia, others. Inj: local reactions.
Abilify Maintena Clinical Trials
See Literature
Abilify Maintena Note
Notes
Register patients in National Pregnancy Registry for Atypical Antipsychotics (866) 961-2388.
Abilify Maintena Patient Counseling
See Literature
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