Patients to Consider

ARISTADA® (aripiprazole lauroxil) is a long-acting injectable that provides multiple options for dosing strength and dosing interval to help support your efforts to individualize care1

These are hypothetical patients living with schizophrenia.

Reference: 1. ARISTADA [package insert]. Waltham, MA: Alkermes, Inc; 2017.

    • 1064 mg
    • Gluteal
    • Every 2 months
    Name: Matt
    Sex: Male
    Age: 24

    History: Matt has been dealing with schizophrenia for the last couple of years. His primary symptoms have included persistent auditory hallucinations and paranoid delusions. He lives at home with his parents, who, along with his case manager, have brought up the option of long-acting treatment. Matt has previously been on oral medications and tolerates aripiprazole.

    "Receiving medication every 2 months allows me not to have to think about it every day."

    ARISTADA® (aripiprazole lauroxil) treatment:

    • Dose: 1064-mg IM injection
    • Dosing interval: Every 2 months
    • Injection site: Gluteal
    • 882 mg
    • Gluteal
    • 6 weeks
    Name: Alex
    Sex: Male
    Age: 20

    History: Alex began experiencing auditory hallucinations, paranoid delusions, and social and emotional withdrawal during his freshman year of college.

    "I couldn't think straight because of the voices. I couldn't stand it."

    He was eventually hospitalized for 5 days, was diagnosed with schizophrenia, and his doctor decided to explore ARISTADA® (aripiprazole lauroxil) as a treatment option while he was in the hospital. After following the full Prescribing Information and dosing instructions, his doctor decided to prescribe the 882-mg dose. The 6-week dosing interval works for him.

    ARISTADA treatment:

    • Dose: 882-mg IM injection
    • Dosing interval: Every 6 weeks
    • Injection site: Gluteal
    • 882 mg
    • Gluteal
    • Monthly
    Name: Lisa
    Sex: Female
    Age: 32

    History: Lisa had her first psychotic break and was diagnosed with schizophrenia at age 26. Initially she experienced changes in perception, thought process, and thought content. Lisa eventually began experiencing somatic delusions.

    "My thoughts were so cluttered that I had a really hard time talking to others. At one point I was convinced that my heart was missing."

    Lisa was afraid of seeking treatment when these symptoms began, but she reluctantly agreed to start treatment. She has tried several schizophrenia medications and tolerates aripiprazole. Lisa was started on ARISTADA® (aripiprazole lauroxil) 4 months ago, and she just received her fourth monthly injection.

    ARISTADA treatment:

    • Dose: 882-mg IM injection
    • Dosing interval: Monthly
    • Injection site: Gluteal
    • 662 mg
    • Gluteal
    • Monthly
    Name: Bill
    Sex: Male
    Age: 48

    History: Bill has been on oral antipsychotics for schizophrenia since his initial episode at age 28. He had suffered paranoid delusions of being controlled by the government and that his thoughts were being transmitted to everyone he met by telepathic means. Coworkers noted his blunt affect, passivity, and social withdrawal. After a recent discussion with his nurse practitioner to evaluate alternative treatment options, Bill was started on ARISTADA® (aripiprazole lauroxil).

    "I had never heard about a long-acting shot, and when she told me about it, it seemed like it might be worth a try."

    ARISTADA treatment:

    • Dose: 662-mg IM injection
    • Dosing interval: Monthly
    • Injection site: Gluteal
    • 441 mg
    • Gluteal or deltoid
    • Monthly
    Name: Maria
    Sex: Female
    Age: 44

    History: Maria was diagnosed with schizophrenia 2 months after her divorce, when she presented with visual hallucinations, avolition, apathy, and alogia.

    "My friends thought it was all due to the divorce, but then I started seeing all those things that weren’t there."

    She then moved in with her mother and has done fairly well living with a caregiver who closely monitors her behavior and her adherence to her oral medication. However, her mother felt that Maria should consider a long-acting option. Maria and her mother recently met with Maria’s physician, who prescribed ARISTADA® (aripiprazole lauroxil).

    ARISTADA treatment:

    • Dose: 441-mg IM injection
    • Dosing interval: Monthly
    • Injection site: Deltoid

Indication

ARISTADA® (aripiprazole lauroxil) is indicated for the treatment of schizophrenia.

Important Safety Information

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. ARISTADA is not approved for the treatment of patients with dementia-related psychosis.

Contraindication: Known hypersensitivity reaction to aripiprazole. Reactions have ranged from pruritus/urticaria to anaphylaxis.

Cerebrovascular Adverse Reactions, Including Stroke: Increased incidence of cerebrovascular adverse reactions (e.g., stroke, transient ischemic attack), including fatalities, have been reported in placebo-controlled trials of elderly patients with dementia-related psychosis treated with risperidone, aripiprazole, and olanzapine. ARISTADA is not approved for the treatment of patients with dementia-related psychosis.

Neuroleptic Malignant Syndrome (NMS): A potentially fatal symptom complex sometimes referred to as NMS may occur with administration of antipsychotic drugs, including ARISTADA. Clinical manifestations of NMS include hyperpyrexia, muscle rigidity, altered mental status, and evidence of autonomic instability (irregular pulse or blood pressure, tachycardia, diaphoresis, and cardiac dysrhythmia). Additional signs may include elevated creatine phosphokinase, myoglobinuria (rhabdomyolysis), and acute renal failure. The management of NMS should include: 1) immediate discontinuation of antipsychotic drugs and other drugs not essential to concurrent therapy; 2) intensive symptomatic treatment and medical monitoring; and 3) treatment of any concomitant serious medical problems for which specific treatments are available.

Tardive Dyskinesia (TD): The risk of developing TD (a syndrome of abnormal, involuntary movements) and the potential for it to become irreversible are believed to increase as the duration of treatment and the total cumulative dose of antipsychotic increase. The syndrome can develop, although much less commonly, after relatively brief treatment periods at low doses. Prescribing should be consistent with the need to minimize TD. Discontinue ARISTADA if clinically appropriate. TD may remit, partially or completely, if antipsychotic treatment is withdrawn.

Metabolic Changes: Atypical antipsychotic drugs have been associated with metabolic changes that include:

  • Hyperglycemia/Diabetes Mellitus: Hyperglycemia, in some cases extreme and associated with ketoacidosis, coma, or death, has been reported in patients treated with atypical antipsychotics. There have been reports of hyperglycemia in patients treated with oral aripiprazole. Patients with diabetes should be regularly monitored for worsening of glucose control; those with risk factors for 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 require continuation of antidiabetic 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.

Pathological Gambling and Other Compulsive Behaviors: Compulsive or uncontrollable urges to gamble have been reported with use of aripiprazole. Other compulsive urges less frequently reported include sexual urges, shopping, binge eating and other impulsive or compulsive behaviors which may result in harm for the patient and others if not recognized. Closely monitor patients and consider dose reduction or stopping ARISTADA if a patient develops such urges.

Orthostatic Hypotension: Aripiprazole may cause orthostatic hypotension which can be associated with dizziness, lightheadedness, and tachycardia. Monitor heart rate and blood pressure, and warn patients with known cardiovascular or cerebrovascular disease and risk of dehydration and syncope.

Falls: Antipsychotics including ARISTADA may cause somnolence, postural hypotension, or motor and sensory instability, which may lead to falls and subsequent injury. Upon initiating treatment and recurrently, complete fall risk assessments as appropriate.

Leukopenia, Neutropenia, and Agranulocytosis: Leukopenia, neutropenia, and agranulocytosis have been reported. Patients with a history of clinically significant low white blood cell count (WBC)/absolute neutrophil count (ANC) and history of drug-induced leukopenia/neutropenia should have frequent complete blood count (CBC) during the first few months of receiving ARISTADA. Consider discontinuation of ARISTADA at the first sign of a clinically significant decline in WBC count in the absence of other causative factors. Monitor patients with clinically significant neutropenia for fever or other symptoms or signs of infection and treat promptly if such symptoms or signs occur. Discontinue ARISTADA in patients with severe neutropenia (absolute neutrophil count <1000/mm3) and follow their WBC until recovery.

Seizures: ARISTADA 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: ARISTADA may impair judgment, thinking, or motor skills. Patients should be cautioned about operating hazardous machinery, including automobiles, until they are certain ARISTADA does not affect them adversely.

Body Temperature Regulation: Disruption of the body’s ability to reduce core body temperature has been attributed to antipsychotic agents. Advise patients regarding appropriate care in avoiding overheating and dehydration. Appropriate care is advised for patients who may exercise strenuously, may be exposed to extreme heat, receive concomitant medication with anticholinergic activity, or are subject to dehydration.

Dysphagia: Esophageal dysmotility and aspiration have been associated with antipsychotic drug use; use caution in patients at risk for aspiration pneumonia.

Concomitant Medication: Decreasing the ARISTADA dosage is recommended in patients taking strong CYP3A4 inhibitors and/or strong CYP2D6 inhibitors for longer than 2 weeks. Increasing the ARISTADA dosage from 441 mg to 662 mg is recommended in patients taking CYP3A4 inducers for longer than 2 weeks. No ARISTADA dosage changes are recommended for patients taking CYP450 modulators for less than 2 weeks.

Most Commonly Observed Adverse Reaction: The most common adverse reaction (≥5% incidence and at least twice the rate of placebo reported by patients treated with ARISTADA 441 mg and 882 mg monthly) was akathisia.

Injection-Site Reactions: Injection-site reactions were reported by 4%, 5%, and 2% of patients treated with 441 mg ARISTADA (monthly), 882 mg ARISTADA (monthly), and placebo, respectively. Most of these were injection-site pain and associated with the first injection and decreased with each subsequent injection. Other injection-site reactions (induration, swelling, and redness) occurred at less than 1%.

Dystonia: Symptoms of dystonia, prolonged abnormal contractions of muscle groups, may occur in susceptible individuals during the first days of treatment and at low doses.

Pregnancy/Nursing: May cause extrapyramidal and/or withdrawal symptoms in neonates with third trimester exposure. Advise patients to notify their healthcare provider of a known or suspected pregnancy. Inform patients that there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to ARISTADA during pregnancy. Aripiprazole is present in human breast milk. The benefits of breastfeeding should be considered along with the mother’s clinical need for ARISTADA and any potential adverse effects on the infant from ARISTADA or from the underlying maternal condition.

Please see full Prescribing Information, including Boxed Warning.