The following is Hara E. Oyedeji’s perspective and does not represent the perspective of all healthcare professionals. The information included is not a substitute for professional medical advice. Intended for US healthcare providers only.
As nurse practitioners (NPs), we work with patients in treating and managing chronic conditions. In behavioral and mental health conditions, such as schizophrenia, I believe only the patient really understands their lived experience and how they feel day to day.
This is why I like to think of adult patients as the “captains of their own ships” on their treatment journeys. This doesn’t mean they do it alone; rather, they help steer the ship while their crew (which could include physicians, nurses, pharmacists, psychologists, psychiatrists, family, and caregivers) offer critical and expert clinical experience, support, and guidance to help keep the ship on course, especially when navigating unexpected weather or rough waters.
I have treated many adults living with schizophrenia, a chronic, complex brain disorder with symptoms that may include, but are not limited to, delusions, hallucinations, disorganized speech, trouble with thinking, and lack of motivation.1 While schizophrenia is a lifelong disease, with an appropriate treatment plan, symptoms may improve.1
I believe the role NPs play on the “crew” is that of trusted medical advisor, using our professional clinical knowledge to help educate and inform patients about all their treatment options so the “captain” can make informed, shared decisions about their treatment journey.
Understanding Long-Acting Injectable Antipsychotics and Factors I’ve Considered for Treating My Patients
There are a range of treatment options for schizophrenia, including antipsychotic medications, which may be available in oral forms or as long-acting injectables, which are designed to release medication slowly over an extended period of time.2,3 In addition, psychological and social treatments are also important treatment components.4
While LAI antipsychotics are FDA-approved for the treatment of adults with schizophrenia, they are commonly reserved for use in later or more severe cases of the condition.5
In my experience, I’ve found that if the clinical benefits and risks are explained clearly and appropriate patients take an active role with their treatment team in making treatment decisions, they are often open to trying LAIs. I believe NPs are in the position to help educate and guide patients when it comes to treatment plans. Choice and trust between the patient and treatment team, as well as ensuring that patients are educated on appropriate treatment options, can all have an impact on the patient’s experience.
Choice, Trust, and Ongoing Communication With HCPs Are Important for People Living With Schizophrenia
It’s important for patients to be informed about treatment options so they have input and choice when it comes to making treatment decisions alongside their healthcare providers. After discussing the benefits and risks with patients, I have found that LAIs can be an effective option for the treatment of schizophrenia in some of my patients living with schizophrenia. Certainly, individual results may vary, so it’s important to consider all of a patient’s needs and goals when making treatment decisions.
One LAI option I may consider for appropriate adult patients is ARISTADA® (aripiprazole lauroxil). ARISTADA is a prescription medicine used to treat schizophrenia in adults. ARISTADA is given by intramuscular injection by a healthcare professional following an initiation regimen. This medication is available in 5 dosing regimens, including monthly (441 mg, 662 mg, 882 mg), every 6 weeks (882 mg), and every 2 months (1064 mg). It is not known if ARISTADA is safe and effective in children under 18 years of age. Elderly people with dementia-related psychosis are at increased risk of death when treated with antipsychotic medicines including ARISTADA. ARISTADA is not for the treatment of people who have lost touch with reality (psychosis) due to confusion and memory loss (dementia). Patients should not receive ARISTADA if they are allergic to aripiprazole or any of the ingredients in ARISTADA.6,7
I’ve found that some patients appreciate the dosing options available with LAIs and work with their healthcare teams to select an appropriate dose. By talking to my patients, listening, and empathizing, I find that I can build collaborative, trusting relationships, and play an active clinical role as they steer the ship on their treatment journey.
Hara Oyedeji received compensation from Alkermes, Inc. for her contributions to this article. This article is sponsored by Alkermes, Inc.
Please continue reading for Important Safety Information, including Boxed Warning for ARISTADA INITIO® (aripiprazole lauroxil) and ARISTADA below.
INDICATION and IMPORTANT SAFETY INFORMATION for ARISTADA INITIO® (aripiprazole lauroxil) and ARISTADA® (aripiprazole lauroxil) extended-release injectable suspensions, for intramuscular use
INDICATION
ARISTADA INITIO, in combination with oral aripiprazole, is indicated for the initiation of ARISTADA when used for the treatment of schizophrenia in adults.
ARISTADA is indicated for the treatment of schizophrenia in adults.
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 INITIO and ARISTADA are 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 INITIO and ARISTADA are not approved for the treatment of patients with dementia-related psychosis.
Potential for Dosing and Medication Errors: Medication errors, including substitution and dispensing errors, between ARISTADA INITIO and ARISTADA could occur. ARISTADA INITIO is intended for single administration in contrast to ARISTADA which is administered monthly, every 6 weeks, or every 8 weeks. Do not substitute ARISTADA INITIO for ARISTADA because of differing pharmacokinetic profiles.
Neuroleptic Malignant Syndrome (NMS): A potentially fatal symptom complex may occur with administration of antipsychotic drugs, including ARISTADA INITIO and 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 antipsychotics 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 aripiprazole 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 INITIO and 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 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 ARISTADA INITIO and/or ARISTADA at the first sign of a clinically significant decline in WBC and in severely neutropenic patients.
Seizures: Use with caution in patients with a history of seizures or with conditions that lower the seizure threshold.
Potential for Cognitive and Motor Impairment: ARISTADA INITIO and ARISTADA may impair judgment, thinking, or motor skills. Patients should be cautioned about operating hazardous machinery, including automobiles, until they are certain therapy with ARISTADA INITIO and/or 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: ARISTADA INITIO is only available at a single strength as a single-dose pre-filled syringe, so dosage adjustments are not possible. Avoid use in patients who are known CYP2D6 poor metabolizers or taking strong CYP3A4 inhibitors, strong CYP2D6 inhibitors, or strong CYP3A4 inducers, antihypertensive drugs or benzodiazepines.
Depending on the ARISTADA dose, adjustments may be recommended if patients are 1) known as CYP2D6 poor metabolizers and/or 2) taking strong CYP3A4 inhibitors, strong CYP2D6 inhibitors, or strong CYP3A4 inducers for greater than 2 weeks. Avoid use of ARISTADA 662 mg, 882 mg, or 1064 mg for patients taking both strong CYP3A4 inhibitors and strong CYP2D6 inhibitors. (See Table 4 in the ARISTADA full Prescribing Information.)
Commonly Observed Adverse Reactions: In pharmacokinetic studies the safety profile of ARISTADA INITIO was generally consistent with that observed for ARISTADA. 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: In pharmacokinetic studies evaluating ARISTADA INITIO, the incidences of injection site reactions with ARISTADA INITIO were similar to the incidence observed with ARISTADA. 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 INITIO and/or 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 INITIO and/or ARISTADA and any potential adverse effects on the infant from ARISTADA INITIO and/or ARISTADA or from the underlying maternal condition.
To report SUSPECTED ADVERSE REACTIONS, contact Alkermes at 1-888-238-8008 or FDA at 1-800-FDA-1088 or https://www.fda.gov/medwatch.
Please see full Prescribing Information, including Boxed Warning, for ARISTADA INITIO and ARISTADA.
Hara E. Oyedeji Bio:
Hara E. Oyedeji, PMHNP-BC, CRNP, MSN, MSed, is a nurse practitioner with more than 10 years specializing in behavioral health. She serves as the medical director for an outpatient mental health clinic, Greater Chesapeake Health & Wellness, in addition to working in her own private practice, Fortitude Behavioral Health, both located in Baltimore, Maryland.
References:
1. What is schizophrenia? American Psychiatric Association. Accessed July 19, 2023. https://www.psychiatry.org/patients-families/schizophrenia/what-is-schizophrenia
2. American Psychiatric Association. Practice Guideline for the Treatment of Patients With Schizophrenia. 3rd ed. American Psychiatric Association; 2020. doi 10.1176/appi.ajp.2020.177901
3. Depot medication. Royal College of Psychiatrists. Reviewed April 2018. Accessed December 21, 2023. https://www.rcpsych.ac.uk/mental-health/treatments-and-wellbeing/depot-medication
4. Schizophrenia. Mayo Clinic. Accessed November 6, 2023. https://www.mayoclinic.org/diseases-conditions/schizophrenia/diagnosis-treatment/drc-20354449
5. Schwartz S, Carilli C, Mian T, et al. Attitudes and perceptions about the use of long-acting injectable antipsychotics among behavioral health practitioners. Mental Health Clinician. 2022;12 (4): 232–240.
6. ARISTADA [prescribing information]. Waltham, MA: Alkermes, Inc.
7. ARISTADA Medication Guide. Alkermes, Inc.
Alkermes® is a registered trademark of Alkermes, Inc. ARISTADA® and ARISTADA INITIO® are registered trademarks of Alkermes Pharma Ireland Limited, used by Alkermes, Inc. under license.
©2024. Alkermes, Inc. All rights reserved. ARI-005115
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