Learn about the ABILIFY MYCITE® System - 5

IMPORTANT SAFETY INFORMATION for
ABILIFY MYCITE®
IMPORTANT SAFETY INFORMATION, cont'd
(aripiprazole tablets with sensor)
WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS
Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an
increased risk of death (1.6 to 1.7 times) compared to placebo-treated patients. ABILIFY MYCITE
is not approved for the treatment of patients with dementia-related psychosis
WARNING: SUICIDAL THOUGHTS AND BEHAVIORS
Antidepressants increased the risk of suicidal thoughts and behavior in children, adolescents,
and young adults. Those on antidepressant therapy should be monitored closely for worsening,
and for emergence of suicidal thoughts and behaviors. Advise families and caregivers of the
need for close observation and communication with the prescriber. The safety and effectiveness
of ABILIFY MYCITE have not been established in pediatric patients.
Contraindication: Known hypersensitivity reaction to aripiprazole. Reactions have ranged from
pruritus/urticaria to anaphylaxis.
Cerebrovascular Adverse Events, Including Stroke, in Elderly Patients with Dementia-Related
Psychosis: 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 aripiprazole.
Neuroleptic Malignant Syndrome (NMS): NMS is a potentially fatal symptom complex reported
in association with administration of antipsychotic drugs, including ABILIFY MYCITE. 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 MYCITE, 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 in total cumulative dose of antipsychotic drugs. TD can develop after a
relatively brief treatment period, even at low doses, or after discontinuation. If antipsychotic treatment
is withdrawn, TD may remit, partially or completely. Prescribing should be consistent with the need to
minimize TD.
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.
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Orthostatic Hypotension: ABILIFY MYCITE 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 MYCITE at the first sign of a clinically significant decline in WBC
and in severely neutropenic patients.
Seizures: ABILIFY MYCITE 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 MYCITE may impair judgment, thinking,
or motor skills. Instruct patients to avoid operating hazardous machinery, including automobiles,
until they are certain ABILIFY MYCITE does not affect them adversely.
Body Temperature Regulation: Use ABILIFY MYCITE 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 MYCITE. Use
caution in patients at risk for aspiration pneumonia.
Dosage Adjustments and Cytochrome P450 Considerations: For patients with schizophrenia and
bipolar I disorder taking ABILIFY MYCITE who are:
* Known CYP2D6 poor metabolizers, administer half the recommended dose
* Known CYP2D6 poor metabolizers takin g concomitant strong CYP3A4 inhibitors (e.g., itraconazole,
clarithromycin), administer a quarter the recommended dose.
* Taking strong CYP2D6 (e.g., quinidine, fluoxetine, paroxetine) or CYP3A4 inhibitors, administer half
the recommended dose.
* Taking strong CYP2D6 and CYP3A4 inhibitors, administer a quarter the recommended dose. When
co-administered drug is withdrawn, adjust ABILIFY MYCITE dosage to its original level.
* Taking strong CYP3A4 inducers (e.g., carbamazepine, rifampin), double recommended dose over
1 to 2 weeks. When coadministered drug is withdrawn, reduce ABILIFY MYCITE dosage to original
level over 1 to 2 weeks.
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 ABILIFY MYCITE
if such urges develop.

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Learn about the ABILIFY MYCITE® System

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