Aristada

Schizophrenia Treatment

Aristada is an atypical antipsychotic medication specifically indicated for the treatment of schizophrenia in adults. It is used as a long-term maintenance treatment to help manage the chronic symptoms of the disorder.

The medication is intended to help reduce or control various symptoms associated with schizophrenia, such as:

• Hallucinations: Seeing or hearing things that do not exist.
• Delusions: Firmly held false beliefs that are not based in reality.
• Disorganized thinking: Difficulty concentrating or maintaining a clear train of thought.
• Negative symptoms: Such as a lack of motivation, social withdrawal, or decreased emotional expression.

Because Aristada is a long-acting injection administered by a healthcare professional, it is often used to ensure a steady level of medication remains in the body for extended periods. This can be helpful for individuals who prefer not to take daily pills or those who have experienced a return of symptoms when missing doses of oral medications.

Mechanism of Action

Aristada belongs to a class of drugs known as atypical antipsychotics. It is a prodrug, which means that after it is injected, the body must chemically convert it into its active form, aripiprazole, before it can begin to work.

The medication works by influencing the activity of neurotransmitters, which are natural chemicals that carry signals between nerve cells in the brain. It primarily targets two specific neurotransmitters:

• Dopamine: This chemical is involved in how the brain processes rewards, emotions, and perceptions of reality.
• Serotonin: This chemical helps regulate mood, sleep, and cognitive functions.

The exact way aripiprazole works is not fully understood. However, researchers believe it acts as a stabilizer. It can partially activate or block dopamine and serotonin receptors depending on the levels of those chemicals in the brain. By balancing this activity, the medication helps manage symptoms related to thinking, feelings, and behavior.

Extended-Release Delivery

Aristada is an extended-release formulation. Once injected into the muscle, the medication is released slowly into the bloodstream. This delivery method allows the drug to maintain a steady level in the body over several weeks or months, depending on the specific dose and schedule.

Common Side Effects

Many people using Aristada experience mild side effects. These may include:

• Restlessness or a constant urge to move (akathisia)
• Pain, swelling, or redness at the site of the injection
• Headache
• Feeling sleepy or tired
• Weight gain
• Nausea or constipation
• Difficulty sleeping (insomnia)

Serious Side Effects

Contact a healthcare provider immediately if you experience any of the following serious side effects:

• Uncontrolled movements: Repetitive or involuntary muscle movements, especially in the face, tongue, or jaw (tardive dyskinesia).
• Neuroleptic Malignant Syndrome (NMS): A rare but life-threatening reaction that causes high fever, stiff muscles, confusion, and sweating.
• Impulse control problems: New or intense urges to gamble, shop, eat, or engage in other impulsive behaviors that you cannot control.
• Metabolic changes: High blood sugar (hyperglycemia), which may lead to diabetes, or increases in cholesterol and triglyceride levels.
• Blood pressure changes: A sudden drop in blood pressure when standing up, which can cause dizziness or fainting.
• Low white blood cell count: A decrease in the cells that fight infection, which may require regular blood tests.
• Seizures: An increased risk of convulsions or fits.
• Difficulty swallowing: Problems with the muscles used for swallowing, which could lead to food or liquid entering the lungs.
• Heat sensitivity: Difficulty cooling down after exercise or exposure to high temperatures.

Boxed Warning: Dementia-Related Psychosis

Elderly patients with dementia-related psychosis who are treated with antipsychotic drugs are at an increased risk of death. Aristada is not approved for the treatment of patients with dementia-related psychosis.

Impulse Control Problems

Reports indicate that patients taking aripiprazole products may experience intense, uncontrollable urges. These behaviors may include:

• Compulsive gambling
• Binge eating or compulsive eating
• Compulsive shopping
• Increased sexual urges

Because patients may not recognize these behaviors as abnormal, it is important for caregivers to monitor for new or intense urges. These behaviors typically stop if the medication is reduced or discontinued.

Serious Neurological Reactions

Neuroleptic Malignant Syndrome (NMS): This is a rare but potentially fatal condition. Symptoms may include high fever, muscle stiffness, confusion, and changes in pulse or blood pressure.

Tardive Dyskinesia: This medication may cause involuntary, repetitive body movements, particularly in the face, tongue, or jaw. The risk of developing this condition increases with long-term use and may be permanent.

Metabolic and Physical Precautions

• Metabolic Changes: Antipsychotic medications can cause high blood sugar (hyperglycemia), weight gain, and increased levels of cholesterol or triglycerides. Regular monitoring of blood sugar and weight is often recommended.
• Orthostatic Hypotension: Some individuals may experience a sudden drop in blood pressure when standing up, leading to dizziness or fainting.
• Seizures: There is a risk of seizures, particularly in patients with a history of seizure disorders or conditions that lower the seizure threshold.
• Body Temperature Regulation: This medication may interfere with the body's ability to reduce its core temperature. Caution is advised during strenuous exercise or exposure to extreme heat.

Cognitive and Motor Impairment

Aristada may cause drowsiness or impair judgment and motor skills. Caution should be exercised when driving or operating heavy machinery until the effects of the medication are fully understood.

Pregnancy

The use of Aristada during the third trimester of pregnancy may lead to complications for the newborn. Infants exposed to antipsychotic medications like Aristada late in pregnancy may experience withdrawal symptoms or extrapyramidal symptoms after birth. These symptoms can include:

• Agitation or irritability
• Muscle stiffness or weakness
• Tremors
• Sleepiness
• Difficulty breathing
• Feeding problems

Healthcare providers may monitor newborns for these signs if exposure occurred during the final months of pregnancy. There is a pregnancy exposure registry that monitors outcomes for individuals who take psychiatric medications during pregnancy. Patients are encouraged to discuss their treatment plan with their doctor if they are pregnant or planning to become pregnant.

Breastfeeding

Aripiprazole, the active medication in Aristada, has been found in human breast milk. It is not fully known how this may affect a nursing infant or the production of breast milk. When deciding whether to breastfeed while using Aristada, it is important to consider the clinical need for the medication and the potential benefits of breastfeeding for the child. Patients should talk to their healthcare provider to evaluate the best course of action for their specific situation.

Available Forms

Aristada is supplied as an extended-release injectable suspension. This medication is intended for intramuscular administration only and must be injected by a healthcare provider.

The medication is available in the following formulations:

• Extended-Release Injectable Suspension: A long-acting formulation administered into the deltoid muscle of the arm or the gluteal muscle of the buttocks.
• Aristada Initio: A specific formulation of the injectable suspension used for the initiation of treatment.

FDA Approval and Indications

Aristada (aripiprazole lauroxil) was approved by the FDA in October 2015. It is indicated for the treatment of schizophrenia in adults. As a long-acting injectable, it is administered by a healthcare professional into the arm or buttocks every four to eight weeks, depending on the dose prescribed.

Boxed Warning

The FDA requires a boxed warning for Aristada because elderly patients with dementia-related psychosis who are treated with antipsychotic drugs are at an increased risk of death. Aristada is not approved for the treatment of patients with dementia-related psychosis.

Safety Communications and Regulatory Actions

The FDA has issued specific safety communications and updated labeling for aripiprazole products, including Aristada, regarding the following risks:

• Impulse-Control Problems: In 2016, the FDA warned that aripiprazole can lead to new or worsening compulsive urges, such as gambling, binge eating, shopping, and sexual urges. These behaviors may occur even in patients without a prior history of such impulses and typically resolve when the medication is stopped or the dose is lowered.
• CNS Depression: The FDA has issued general warnings regarding the serious risks of combining central nervous system (CNS) depressants, which can lead to extreme sedation and respiratory distress.
• Adverse Event Monitoring: The FDA Adverse Event Reporting System (FAERS) identified impulse control disorders as a potential signal of serious risk in early 2016, leading to subsequent safety labeling changes for the drug class.

Factors Influencing Cost

Aristada is a brand-name medication, and there is currently no generic version available. The total price of treatment can vary based on several factors:

• Dosage and Schedule: Aristada is available in multiple strengths and can be administered once monthly, every six weeks, or every two months. The specific regimen prescribed by a healthcare provider will affect the overall cost.
• Insurance Coverage: Many commercial insurance plans, as well as Medicare and Medicaid, cover Aristada. However, the out-of-pocket cost will depend on the specific plan's copayments, deductibles, and whether the drug is on the plan's preferred formulary.
• Administration Fees: Because Aristada must be administered by a healthcare professional as an intramuscular injection, patients may incur additional costs for the office visit or the administration procedure itself.

Financial Assistance Programs

The manufacturer may offer financial assistance to eligible patients to help manage the cost of the medication. This may include:

• Copay Savings Cards: These may reduce out-of-pocket expenses for patients with commercial insurance.
• Patient Assistance Programs: These programs are often available for individuals who are uninsured or underinsured and meet specific income requirements.

Patients should consult their insurance provider or a healthcare professional to determine the exact cost and explore available savings options.