Abilify Maintena

Schizophrenia

Abilify Maintena is approved for the treatment of schizophrenia in adults. It helps manage symptoms of the condition, which may include:

• Hallucinations (hearing or seeing things that are not there)
• Delusions (strong beliefs in things that are not true)
• Disorganized thinking or behavior
• Social withdrawal or lack of emotion

Bipolar I Disorder

This medication is also used as a maintenance treatment for bipolar I disorder in adults. In this context, it is intended for patients who have already been stabilized on oral aripiprazole or other medications. Its primary goals in treating bipolar I disorder include:

• Helping to prevent or delay the return of manic episodes
• Maintaining mood stability over a long period

Long-Acting Treatment

Unlike daily oral medications, Abilify Maintena is an extended-release suspension. It is administered once a month by a healthcare professional. This delivery method is often used for individuals who have difficulty remembering to take daily pills or for those who benefit from a more consistent level of medication in their system.

Mechanism of Action

Abilify Maintena belongs to a class of medications known as atypical antipsychotics. While the exact way it works is not fully understood, it is believed to help regulate the activity of dopamine and serotonin. These are natural substances, called neurotransmitters, that allow brain cells to communicate with each other.

In the brain, this medication is thought to act as a stabilizer. It can help increase chemical activity when levels are too low or decrease activity when levels are too high. By balancing these neurotransmitters, the medication helps improve thinking, mood, and behavior.

Extended-Release Delivery

Abilify Maintena is an extended-release injectable suspension, which means it is designed to stay in the body for a long period. This delivery method differs from daily oral medications in several ways:

• Slow Release: After the medication is injected into the muscle, it dissolves slowly and enters the bloodstream gradually over several weeks.
• Consistent Levels: The slow-release process helps maintain a steady level of the medication in the body, which can help provide continuous symptom control.
• Long-Term Action: Because the medication remains active in the system for a long time, it is typically administered by a healthcare professional only once every month.

Common Side Effects

Many people using Abilify Maintena experience mild side effects. These often include:

• Pain, redness, or swelling at the injection site
• Weight gain
• Restlessness or an urgent need to move (akathisia)
• Drowsiness or fatigue
• Dizziness
• Nausea, constipation, or dry mouth
• Headache
• Anxiety or trouble sleeping

Serious Side Effects

While less common, some side effects can be severe and require medical attention. These include:

• Uncontrolled body movements: This includes tardive dyskinesia, which involves repetitive, involuntary movements of the face, tongue, or other body parts.
• Neuroleptic Malignant Syndrome (NMS): A rare but life-threatening reaction characterized by high fever, stiff muscles, confusion, and sweating.
• Metabolic changes: High blood sugar (hyperglycemia), increased cholesterol or fats in the blood, and significant weight gain.
• Impulse control problems: Unusual and intense urges to gamble, shop, eat, or engage in sexual activity that the person may not be able to control.
• Low white blood cell count: This can increase the risk of infections.
• Seizures: An increased risk of convulsions.
• Orthostatic hypotension: A sudden drop in blood pressure when standing up, which may cause fainting or dizziness.
• Difficulty swallowing: This may lead to food or liquid entering the lungs.
• Temperature regulation issues: Difficulty cooling down after exercise or exposure to high heat.

Increased Risk of Death in Elderly Patients

Abilify Maintena is not approved for the treatment of patients with dementia-related psychosis. Clinical trials have shown that elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death compared to those receiving a placebo.

Impulse Control Problems

There have been reports of intense urges, particularly for gambling, and the inability to control these urges while taking aripiprazole. Other compulsive behaviors reported include increased sexual urges, binge eating, and compulsive shopping. These urges may stop when the medication is discontinued or the dose is reduced.

Neuroleptic Malignant Syndrome (NMS)

A potentially fatal condition called Neuroleptic Malignant Syndrome has been reported with antipsychotic drugs. Symptoms may include high fever, muscle rigidity, altered mental status, and evidence of autonomic instability, such as irregular pulse or blood pressure.

Tardive Dyskinesia

This medication may cause tardive dyskinesia, a condition involving involuntary, repetitive muscle movements, often in the face, tongue, or jaw. The risk of developing this condition and the likelihood that it will become irreversible are believed to increase with the duration of treatment and the total cumulative dose.

Metabolic Changes

Antipsychotic medications can cause metabolic changes, including:

• High Blood Sugar (Hyperglycemia): In some cases, this can lead to ketoacidosis, coma, or death. Patients with diabetes or those at risk for diabetes should have their blood sugar monitored.
• High Cholesterol and Triglycerides: Changes in lipid levels may occur during treatment.
• Weight Gain: Significant weight gain has been observed in patients using this medication.

Other Serious Precautions

• Orthostatic Hypotension: This medication may cause a drop in blood pressure when rising from a sitting or lying position, which can lead to dizziness or fainting.
• Seizures: Use with caution in patients with a history of seizures or conditions that lower the seizure threshold.
• Cognitive and Motor Impairment: Drowsiness and impaired judgment or motor skills may occur. Caution is advised when operating heavy machinery or driving.
• Body Temperature Regulation: The medication may interfere with the body's ability to reduce its core temperature, increasing the risk of overheating during strenuous exercise or exposure to extreme heat.

Pregnancy

It is not fully known how Abilify Maintena affects human pregnancy. However, taking antipsychotic medications during the last three months (third trimester) of pregnancy may cause problems in the newborn after delivery. These complications can include:

• Withdrawal symptoms
• Breathing difficulties
• Feeding problems
• Tremors or muscle stiffness
• Excessive sleepiness or agitation

If you become pregnant while receiving this medication, it is important to talk to your healthcare provider. Do not stop the treatment without medical guidance, as untreated mental health conditions can also pose risks to both the parent and the baby. There is a pregnancy registry available to monitor the health of individuals who take psychiatric medications during pregnancy.

Breastfeeding

Aripiprazole, the active ingredient in Abilify Maintena, is known to pass into breast milk. Because of the potential for serious side effects in a nursing infant, a decision should be made whether to discontinue breastfeeding or to discontinue the medication. Healthcare providers typically weigh the importance of the drug to the parent's health against the potential risks to the infant when making this recommendation.

Available Forms

Abilify Maintena is provided as a long-acting injectable suspension. It is available in two primary delivery systems:

• Extended-release injectable suspension: This form consists of a vial containing a sterile powder that must be mixed with sterile water before administration.
• Pre-filled dual-chamber syringe: This system contains both the medication powder and the sterile water in separate chambers within a single syringe for reconstitution.

This medication is intended for intramuscular use only and is typically administered into the deltoid or gluteal muscle.

FDA Approval History

Abilify Maintena was first approved by the U.S. Food and Drug Administration (FDA) in February 2013 for the treatment of schizophrenia in adults. In 2017, the FDA expanded its approved indications to include the maintenance treatment of bipolar I disorder in adults as a monotherapy.

Boxed Warning

The FDA requires a boxed warning for Abilify Maintena, which is the most serious type of warning for prescription medications. This warning states that elderly patients with dementia-related psychosis who are treated with antipsychotic drugs are at an increased risk of death. Abilify Maintena is not approved for the treatment of patients with dementia-related psychosis.

Impulse-Control Warnings

In 2016, the FDA issued a safety communication warning that aripiprazole, the active ingredient in Abilify Maintena, can lead to new or worsening impulse-control problems. These compulsive behaviors may include:

• Uncontrollable gambling
• Binge eating
• Compulsive shopping
• Increased sexual urges

According to the FDA, these urges typically stop when the medication is discontinued or the dose is reduced. Patients and caregivers are advised to monitor for these behavioral changes, as they may not be recognized as abnormal without close observation.

Administration Requirements

As a regulatory requirement for safety and efficacy, Abilify Maintena must be administered only by a healthcare professional. It is provided as an extended-release injectable suspension and is typically administered once every month.

Weight Gain as a Side Effect

Weight gain is a documented side effect associated with Abilify Maintena. Clinical data indicates that while many people experience some change in weight, the amount gained can vary significantly between individuals. While aripiprazole is often associated with less weight gain than some other atypical antipsychotics, it remains a common concern for those using the long-acting injectable form.

Why Weight Gain Occurs

Antipsychotic medications can influence the body's metabolism and appetite regulation. Some individuals may experience increased hunger or changes in how their body processes energy while receiving these injections. Because Abilify Maintena is a long-acting medication, these effects may persist throughout the duration of the treatment cycle.

Monitoring and Management

Because of the potential for weight changes, healthcare providers generally implement a monitoring plan that includes:

• Regular Weigh-ins: Tracking weight and body mass index (BMI) during scheduled injection appointments.
• Metabolic Screening: Periodic blood tests to monitor cholesterol levels and blood sugar, as weight gain can sometimes be linked to other metabolic changes.
• Lifestyle Adjustments: Guidance on maintaining a balanced diet and regular physical activity to help manage weight.

It is important to discuss any significant or rapid weight changes with a healthcare provider. They can help determine if the weight gain is related to the medication and provide strategies for management or discuss alternative treatment options if necessary.