Aristada Initio

Aristada Initio is FDA-approved for the initiation or re-initiation of treatment with Aristada in adults with schizophrenia. It is used to quickly achieve therapeutic levels of aripiprazole when starting or restarting treatment, thereby allowing the patient to transition directly to Aristada, the long-acting maintenance form of aripiprazole lauroxil.

Aristada Initio is contraindicated in patients with a known hypersensitivity to aripiprazole or any of the excipients in the formulation. Hypersensitivity reactions can include anaphylaxis, angioedema, and other severe allergic reactions. It should also be used with caution in patients with a history of cardiovascular disease, as antipsychotics can sometimes cause changes in heart rhythm (QT prolongation).

Patients receiving Aristada Initio should be advised that this medication is part of a comprehensive treatment plan for schizophrenia, which may include regular follow-up appointments, psychosocial support, and other therapies. It is important to attend all scheduled appointments to ensure the medication is administered properly and on time. Patients should be informed about the potential side effects of the medication and encouraged to report any unusual symptoms, especially signs of movement disorders, changes in mood, or symptoms of an allergic reaction. Additionally, patients should avoid alcohol and be cautious when driving or operating machinery, as the medication may cause drowsiness or impair coordination.

Common side effects of Aristada Initio include injection site reactions, such as pain, swelling, or redness, as well as drowsiness, dizziness, and headache. Some patients may experience weight gain, restlessness (akathisia), or gastrointestinal symptoms like nausea and constipation. Serious side effects, though rare, can include neuroleptic malignant syndrome (NMS), tardive dyskinesia (involuntary movements), and significant changes in blood sugar levels. Patients should seek immediate medical attention if they experience symptoms such as high fever, severe muscle stiffness, confusion, or uncontrollable muscle movements.

Aristada Initio carries a risk of neuroleptic malignant syndrome (NMS), a potentially life-threatening condition characterized by high fever, muscle rigidity, and altered mental status. The medication may also increase the risk of tardive dyskinesia, a serious movement disorder that can become permanent. Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death, and therefore, Aristada Initio is not approved for use in this population. Patients should be monitored for metabolic changes, such as elevated blood sugar or cholesterol levels, as well as for signs of suicidal thoughts or behavior, particularly when starting or adjusting the dose.

Aristada Initio may interact with other medications that affect the central nervous system, such as other antipsychotics, sedatives, or alcohol, increasing the risk of drowsiness and impaired coordination. It can also interact with medications that influence the metabolism of aripiprazole, such as strong CYP3A4 inhibitors (e.g., ketoconazole) or CYP3A4 inducers (e.g., carbamazepine), which can alter the levels of aripiprazole in the blood. Patients should inform their healthcare provider of all medications and supplements they are taking to avoid potential interactions.

Alternative treatments for schizophrenia include other long-acting injectable antipsychotics, such as paliperidone palmitate (Invega Sustenna) or risperidone (Risperdal Consta), as well as oral antipsychotics like olanzapine (Zyprexa) or quetiapine (Seroquel). The choice of treatment will depend on the patient's specific symptoms, treatment history, and response to previous medications.