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Abilify Mycite Generic Name & Formulations
Legal Class
Rx
General Description
Aripiprazole 2mg, 5mg, 10mg, 15mg, 20mg, 30mg; tabs with ingestible event marker (IEM) sensor.
Pharmacological Class
Atypical antipsychotic.
See Also
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)
Manufacturer
Generic Availability
NO
Abilify Mycite Indications
Indications
Acute and maintenance treatment of manic or mixed episodes in bipolar I disorder as monotherapy; or as an adjunct to lithium or valproate. Adjunct to antidepressants for major depressive disorder (MDD).
Limitations of Use
Ability to improve patient compliance or modify dosage has not been established. Use for real-time drug ingestion tracking or use during emergency is not recommended.
Abilify Mycite Dosage and Administration
Adult
Swallow tabs whole. Apply MyCite Patch (2 types); see full labeling. Bipolar disorder: initially 15mg once daily; may increase to max 30mg/day; adjunct to lithium or valproate: 10–15mg/day; max 30mg/day. Adjunct for MDD: initially 2–5mg/day; may adjust by 5mg/day increments at intervals of ≥1 week; usual range: 2–15mg/day. Concomitant strong CYP3A4 or CYP2D6 inhibitors, or CYP2D6 poor metabolizer: reduce aripiprazole dose by ½. Concomitant strong CYP3A4 inducers: double aripiprazole dose (max 30mg/day) over 1–2 weeks. Adjust dose to normal range when these drugs are withdrawn. Other dose adjustments: see full labeling.
Children
Not established.
Abilify Mycite Contraindications
Not Applicable
Abilify Mycite Boxed Warnings
Boxed Warning
Increased mortality in elderly patients with dementia-related psychosis. Suicidal thoughts and behaviors with antidepressant drugs.
Abilify Mycite 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 Mycite Pharmacokinetics
See Literature
Abilify Mycite 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 Mycite 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 Mycite Clinical Trials
See Literature
Abilify Mycite Note
Notes
Register patients in National Pregnancy Registry for Atypical Antipsychotics (866) 961-2388.
Abilify Mycite Patient Counseling
See Literature
Abilify Mycite Generic Name & Formulations
Legal Class
Rx
General Description
Aripiprazole 2mg, 5mg, 10mg, 15mg, 20mg, 30mg; tabs with ingestible event marker (IEM) sensor.
Pharmacological Class
Atypical antipsychotic.
See Also
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)
Manufacturer
Generic Availability
Tabs, soln, orally disintegrating tabs (YES); Maintena, MyCite (NO)
Abilify Mycite Indications
Indications
Schizophrenia.
Limitations of Use
Ability to improve patient compliance or modify dosage has not been established. Use for real-time drug ingestion tracking or use during emergency is not recommended.
Abilify Mycite Dosage and Administration
Adult
Swallow tabs whole. Apply Mycite Patch (2 types); see full labeling. Initially 10mg or 15mg once daily; may increase after at least 2 weeks; usual range 10–15mg/day; max 30mg/day. Concomitant strong CYP3A4 or CYP2D6 inhibitors, or CYP2D6 poor metabolizer: reduce aripiprazole dose by ½. Concomitant strong CYP3A4 inducers: double aripiprazole dose (max 30mg/day) over 1–2 weeks. Adjust dose to normal range when these drugs are withdrawn. Other dose adjustments: see full labeling.
Children
Not established.
Abilify Mycite Contraindications
Not Applicable
Abilify Mycite Boxed Warnings
Boxed Warning
Increased mortality in elderly patients with dementia-related psychosis. Suicidal thoughts and behaviors with antidepressant drugs.
Abilify Mycite 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 Mycite Pharmacokinetics
See Literature
Abilify Mycite 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 Mycite 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 Mycite Clinical Trials
See Literature
Abilify Mycite Note
Notes
Register patients in National Pregnancy Registry for Atypical Antipsychotics (866) 961-2388.
Abilify Mycite Patient Counseling
See Literature
