Medical Editor: John P. Cunha, DO, FACOEP
What Is Aristada Initio?
What Are Side Effects of Aristada Initio?
Common side effects of Aristada Initio include:
- feeling the urge to move constantly (akathisia),
- injection site reactions (pain, redness, swelling, a hard lump),
- weight gain,
- insomnia, or
- increased blood creatine phosphokinase (CPK)
Dosage for Aristada Initio
The dose of Aristada Initio is one 675 mg injection of Aristada Initio and one 30 mg dose of oral aripiprazole in conjunction with the first Aristada injection. Aristada Initio is only to be used as a single dose and is not for repeated dosing.
What Drugs, Substances, or Supplements Interact with Aristada Initio?
Aristada Initio may interact with itraconazole, clarithromycin, quinidine, fluoxetine, paroxetine, carbamazepine, rifampin, medications to treat high blood pressure, and benzodiazepines. Tell your doctor all medications and supplements you use. Tell your doctor if you are pregnant or plan to become pregnant before using Aristada Initio.
Aristada Initio During Pregnancy and Breastfeeding
It may cause extrapyramidal and/or withdrawal symptoms in neonates in women exposed during the third trimester of pregnancy. There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to Aristada Initio during pregnancy. Aristada Initio passes into breast milk but its effects on nursing infants are unknown. Consult your doctor before breastfeeding.
Our Aristada Initio (aripiprazole lauroxil) Extended-Release Injectable Suspension, for Intramuscular Use Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
The following are discussed in more details in other sections of the labeling:
- Increased Mortality in Elderly Patients with Dementia-related Psychosis [see BOXED WARNING, WARNINGS AND PRECAUTIONS]
- Cerebrovascular Adverse Reactions, Including Stroke [see BOXED WARNING, WARNINGS AND PRECAUTIONS]
- Neuroleptic Malignant Syndrome [see WARNINGS AND PRECAUTIONS]
- Tardive Dyskinesia [see WARNINGS AND PRECAUTIONS]
- Metabolic Changes [see WARNINGS AND PRECAUTIONS]
- Pathological Gambling and Other Compulsive Behaviors [see WARNINGS AND PRECAUTIONS]
- Orthostatic Hypotension [see WARNINGS AND PRECAUTIONS]
- Falls [see WARNINGS AND PRECAUTIONS]
- Leukopenia, Neutropenia, and Agranulocytosis [see WARNINGS AND PRECAUTIONS]
- Seizures [see WARNINGS AND PRECAUTIONS]
- Potential for Cognitive and Motor Impairment [see WARNINGS AND PRECAUTIONS]
- Body Temperature Regulation [see WARNINGS AND PRECAUTIONS]
- Dysphagia [see WARNINGS AND PRECAUTIONS]
Clinical Studies Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The safety of ARISTADA INITIO, in combination with oral aripiprazole, for the initiation of ARISTADA when used for the treatment of schizophrenia in adults has been established and is based on clinical trials of ARISTADA (aripiprazole lauroxil) including 1019 adult patients with schizophrenia.
ARISTADA INITIO has been evaluated for safety in 170 adult patients in clinical trials in schizophrenia.
In pharmacokinetic studies, the safety profile of ARISTADA INITIO was generally consistent with that observed for ARISTADA.
ARISTADA (Aripiprazole Lauroxil) Trials In Adults With Schizophrenia
Commonly Observed Adverse Reactions With Aripiprazole Lauroxil
The most common adverse reaction (incidence ≥5% and at least twice the rate of placebo in patients treated with aripiprazole lauroxil was akathisia.
Adverse Reactions Occurring at An Incidence Of 2% Or More In Aripiprazole Lauroxil-Treated Patients
Adverse reactions associated with the use of aripiprazole lauroxil (incidence of 2% or greater, rounded to the nearest percent and aripiprazole lauroxil incidence greater than placebo) that occurred were: injection site pain, increased weight, increased blood creatinine phosphokinase, akathisia, headache, insomnia, and restlessness.
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 aripiprazole lauroxil.
ARISTADA (Aripiprazole Lauroxil)
Injection site reactions were reported by 4% of patients treated with 441 mg aripiprazole lauroxil and 5% of patients treated with 882 mg aripiprazole lauroxil compared to 2% of patients treated with placebo. Most of these were injection site pain (3%, 4% and 2% in the 441 mg aripiprazole lauroxil, 882 mg aripiprazole lauroxil and placebo groups, respectively). Other injection site reactions (induration, swelling and redness) occurred at less than 1%.
In a schizophrenia efficacy study in aripiprazole lauroxil-treated patients, the incidence of other EPS-related events, excluding akathisia and restlessness, was 5% and 7% for patients on 441 mg and 882 mg, respectively, versus 4% for placebo-treated patients.
Symptoms of dystonia, prolonged abnormal contractions of muscle groups, may occur in susceptible individuals during the first few days of treatment. Dystonic symptoms include: spasm of the neck muscles, sometimes progressing to tightness of the throat, swallowing difficulty, difficulty breathing, and/or protrusion of the tongue. While these symptoms can occur at low doses, they occur more frequently and with greater severity with high potency and at higher doses of first generation antipsychotic drugs. An elevated risk of acute dystonia is observed in males and younger age groups.
Other Adverse Reactions Observed In Clinical Studies With Aripiprazole Lauroxil
The following listing does not include reactions: 1) already listed in previous tables or elsewhere in labeling, 2) for which a drug cause was remote, 3) which were so general as to be uninformative, 4) which were not considered to have significant clinical implications, or 5) which occurred at a rate equal to or less than placebo.
Cardiac - angina pectoris, tachycardia, palpitations
Gastrointestinal disorders - constipation, dry mouth
General disorders - asthenia
Musculoskeletal - muscular weakness
Nervous system disorders - dizziness
Psychiatric disorders - anxiety, suicide
Adverse Reactions Reported In Clinical Trials With Oral Aripiprazole
The following is a list of additional adverse reactions that have been reported in clinical trials with oral aripiprazole and not reported above for ARISTADA INITIO or aripiprazole lauroxil.
Blood and Lymphatic System Disorders: thrombocytopenia
Cardiac Disorders: bradycardia, atrial flutter, cardiorespiratory arrest, atrioventricular block, atrial fibrillation, myocardial ischemia, myocardial infarction, cardiopulmonary failure
Eye Disorders: photophobia, diplopia
Gastrointestinal Disorders: gastroesophageal reflux disease
General Disorders and Administration Site Conditions: peripheral edema, chest pain, face edema
Hepatobiliary Disorders: hepatitis, jaundice
Immune System Disorders: hypersensitivity
Injury, Poisoning, and Procedural Complications: fall, heat stroke
Investigations: weight decreased, hepatic enzyme increased, blood glucose increased, blood lactate dehydrogenase increased, gamma glutamyl transferase increased, blood prolactin increased, blood urea increased, blood creatinine increased, blood bilirubin increased, electrocardiogram QT prolonged, glycosylated hemoglobin increased
Metabolism and Nutrition Disorders: anorexia, hypokalemia, hyponatremia, hypoglycemia
Musculoskeletal and Connective Tissue Disorders: muscle tightness, rhabdomyolysis, mobility decreased
Nervous System Disorders: memory impairment, cogwheel rigidity, hypokinesia, bradykinesia, akinesia, myoclonus, coordination abnormal, speech disorder, choreoathetosis
Psychiatric Disorders: aggression, loss of libido, delirium, libido increased, anorgasmia, tic, homicidal ideation, catatonia, sleep walking
Renal and Urinary Disorders: urinary retention, nocturia
Reproductive System and Breast Disorders: erectile dysfunction, gynaecomastia, menstruation irregular, amenorrhea, breast pain, priapism
Respiratory, Thoracic, and Mediastinal Disorders: nasal congestion, dyspnea
Skin and Subcutaneous Tissue Disorders: rash, hyperhidrosis, pruritus, photosensitivity reaction, alopecia, urticaria
Vascular Disorders: hypotension, hypertension
The following adverse reactions have been identified during post-approval use of oral aripiprazole. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or to establish a causal relationship to drug exposure: occurrences of allergic reaction (anaphylactic reaction, angioedema, laryngospasm, pruritus/urticaria, or oropharyngeal spasm), pathological gambling, hiccups and blood glucose fluctuation.
Read the entire FDA prescribing information for Aristada Initio (Aripiprazole Lauroxil Injectable Suspension)