Common questions about Abilify Maintena (FAQ)
Q: What is the main reason doctors prescribe Abilify Maintena?
According to official guidance, Abilify Maintena is indicated for the treatment of schizophrenia in adults. It is also approved for the maintenance monotherapy treatment of bipolar I disorder in adults. These are the conditions the drug has been approved to address.
Q: Is Abilify Maintena the same as the daily Abilify pill?
No, the two are not the same. Abilify Maintena is an extended-release injectable suspension, meaning the active ingredient is released slowly over a long time. The daily pill (oral aripiprazole) is a different dosage form that must be taken every day.
Q: Can Abilify Maintena be used for depression?
Official documents indicate that Abilify Maintena is not approved for the treatment of Major Depressive Disorder. Its specific approved indications are limited to schizophrenia and the maintenance treatment of bipolar I disorder.
Q: What are the most commonly reported side effects of Abilify Maintena?
Based on clinical trials, the most commonly reported side effects include weight gain, injection site pain, sedation (sleepiness), and akathisia. Akathisia is an inner sense of restlessness and a compelling need to move.
Q: Is weight gain a potential side effect of Abilify Maintena?
Yes, weight gain is a reported metabolic change associated with this type of medication. For this reason, official guidance notes that regular weight monitoring is recommended during treatment.
Q: Do you need to take any other medication with Abilify Maintena?
Yes, initially. The prescribing information requires the continuation of the oral antipsychotic medication for the first 14 days after the initial injection. This is done to ensure the level of the active ingredient in the blood begins to rise as the long-acting injection starts to work.
Q: How long does it usually take to notice the effects of Abilify Maintena?
The 14-day oral overlap period is a required step because the injection takes time to build up to effective therapeutic levels in the bloodstream. This initial period ensures adequate medication concentration while the drug's long-acting effects start.
Q: Can Abilify Maintena cause movement problems or muscle stiffness?
Yes, movement disorders are a known risk with this class of medication. Regulatory documents warn of serious conditions like Tardive Dyskinesia (uncontrolled movements) and Neuroleptic Malignant Syndrome (NMS), which can involve muscle rigidity.
Q: Is it common to feel tired or sedated after getting the injection?
Yes, sedation (feeling sleepy or tired) is identified in clinical trials as one of the most common side effects of the medication.
Q: Can Abilify Maintena interact with common over-the-counter pain relievers?
The official prescribing information notes that certain medications, including some over-the-counter products, can affect how the body processes the active ingredient. Because these interactions could change the concentration of the drug in the blood, official guidance advises that patients discuss all over-the-counter items with their prescriber.
Q: Are there any specific foods or drinks to avoid while using this medicine?
The official guidance states that patients should avoid alcohol consumption while on this medication, as alcohol can increase central nervous system side effects like dizziness and drowsiness. There are no specific food restrictions, though the oral form of aripiprazole can be taken with or without food.
Q: Why do official documents warn about Abilify Maintena and elderly patients with dementia?
This medication carries a Boxed Warning that notes an increased risk of death in elderly patients when this class of drug is used to treat psychosis related to dementia. Due to this serious safety risk, Abilify Maintena is not approved for the treatment of this condition.
Q: Does Abilify Maintena affect blood sugar levels?
Yes, official documentation indicates that treatment can lead to metabolic changes, including elevated blood sugar (hyperglycemia) and potentially diabetes. Due to this risk, monitoring of blood sugar levels is recommended before and throughout treatment.
Q: What is the clinical evidence or research behind Abilify Maintena's use?
The clinical evidence supporting the drug's approved uses, such as schizophrenia and bipolar I disorder maintenance, is detailed in the clinical studies section of the official prescribing information. This includes data from controlled clinical trials.
Q: Is Abilify Maintena safe to use during pregnancy?
Regulatory data are insufficient to definitively determine the risk to a developing baby. However, exposure during the third trimester may lead to extrapyramidal symptoms (uncontrolled movements) or withdrawal symptoms in newborns after delivery.
Q: Can Abilify Maintena cause any issues with heart rhythm?
The medication may cause orthostatic hypotension, which is a drop in blood pressure upon standing up, leading to dizziness or fainting. Official guidance indicates that the drug should be used with caution in people who have known cardiovascular disease.
Q: What are the age restrictions for using Abilify Maintena?
Abilify Maintena is indicated for use in adults. The official prescribing information states that its safety and effectiveness have not been established in patients who are under 18 years of age.
Q: Do patients typically need a starter dose before switching to the long-acting injection?
Yes, there is an initiation requirement. The initiation requirement is that the oral antipsychotic should be continued for 14 consecutive days after the first injection to allow the long-acting drug to reach effective levels in the bloodstream.
Q: What is the difference in how the long-acting injection and the oral pill work in the body?
Both the injectable and oral forms share the exact same mechanism of action at the molecular level. The key difference is that the long-acting injection is formulated to be slowly absorbed into the bloodstream, which provides a stable, prolonged concentration of the drug over a monthly period.
Q: Is Abilify Maintena considered a stimulant?
No, Abilify Maintena is not classified as a stimulant. It belongs to a class of medications known as atypical antipsychotics.
Q: What are the major contraindications for Abilify Maintena (who should not use it)?
Official documents state that the medication is contraindicated (should not be used) in patients who have a known hypersensitivity reaction to aripiprazole. Hypersensitivity reactions can include severe symptoms like anaphylaxis.
Q: Can Abilify Maintena make existing anxiety worse?
Anxiety is listed in the official documents as one of the potential adverse reactions reported by patients during clinical trials.
Q: Does the medicine lose effectiveness over time?
Studies have examined the long-term use of the medication and demonstrated its sustained efficacy for approved indications. In a randomized-withdrawal maintenance trial, the drug was superior to placebo in delaying the time to relapse.
Q: Is it normal to have some soreness or redness at the injection site?
Yes, injection site pain is identified in clinical trials as one of the most common side effects associated with the medication.
Q: Are there any reported interactions between Abilify Maintena and nicotine products?
The prescribing information notes the importance of informing a doctor about all substances consumed, which includes nicotine products, supplements, and other medicines. This is because substances that induce or inhibit certain liver enzymes may change the concentration of the drug in the body.
Q: What is akathisia, and is it a known issue with this drug?
Yes, akathisia is a known side effect reported in clinical trials. It is described as an inner sense of restlessness and a compelling need to move.
Q: Are there any studies looking at the long-term effects of Abilify Maintena?
Yes, the prescribing information contains data from long-term clinical trials. This research includes a randomized-withdrawal maintenance trial that evaluated the drug's sustained effect in delaying the time to relapse.
Q: Does Abilify Maintena have a risk of causing compulsive behaviors?
Yes, the official guidance notes a potential risk of intense, uncontrollable urges (compulsive behaviors). These reported urges include pathological gambling, as well as compulsive sexual urges, shopping, and eating.
Q: What are the symptoms of an allergic reaction to Abilify Maintena?
Symptoms of hypersensitivity (allergic reaction) have ranged from milder signs like pruritus (itching) and urticaria (hives) to severe reactions like anaphylaxis. Anaphylaxis is a serious medical event that can involve difficulty breathing or swelling of the mouth, face, or tongue.
Q: Why is it important to tell the doctor about all other medications before starting?
Official documents emphasize that providing a full list of medications is necessary because certain drugs can act as inhibitors or inducers of CYP enzymes in the liver. This can change the concentration of aripiprazole in the body, which may require a dose adjustment from the prescriber.
Q: Does using Abilify Maintena require frequent lab tests?
Yes, regulatory documents recommend regular monitoring due to potential metabolic changes. Recommended lab tests and monitoring include checking weight, blood sugar (glucose), lipid levels, and white blood cell count (WBC).
Q: Is Abilify Maintena approved for use in children or adolescents?
No, the official prescribing information states that the medication is not approved for use in children or adolescents. The safety and effectiveness of the long-acting injectable have not been established in patients under 18 years of age.
Q: What is the typical duration of treatment with Abilify Maintena?
The medication is approved for the maintenance treatment of bipolar I disorder, indicating that it is designed for long-term use. Treatment duration is determined based on the needs of the individual patient.
Q: Does this medication have a black box warning, and what does it relate to?
Yes, the medication carries a Boxed Warning regarding an increased risk of death when this class of drug is used in elderly patients to treat psychosis related to dementia. The drug is not approved for that specific condition.
Q: Can Abilify Maintena affect a person's ability to drive?
Yes, the medication may impair judgment, thinking, or motor skills. Official guidance states that caution should be exercised when driving or operating complex machinery until the patient is certain how the medication affects them.
Q: Is a headache a common side effect after the first injection?
Headache is listed in the official prescribing information as an adverse reaction reported in clinical trials. It is not identified among the very most common side effects, but it is a reported potential reaction.
Q: What is the difference in treatment focus between schizophrenia and bipolar disorder when using this medicine?
Official indications specify two different roles for the drug. It is approved for the treatment of schizophrenia and for the maintenance monotherapy treatment of bipolar I disorder in adults.
Q: Can Abilify Maintena interact with commonly prescribed cholesterol medications?
The prescribing information notes that certain medications, including some commonly prescribed drugs, can affect the CYP enzymes that process aripiprazole in the body. If a cholesterol medication is a known CYP inhibitor or inducer, a doctor may need to adjust the dose of Abilify Maintena.
Q: Do patients report changes in their sleep patterns while on Abilify Maintena?
Yes, changes in sleep patterns are reported in clinical trials. Both drowsiness (somnolence) and insomnia (difficulty sleeping) are listed as potential side effects.
Q: Is there a risk of withdrawal symptoms if treatment is discontinued?
The potential for withdrawal symptoms upon discontinuation is implied in the regulatory text, which warns that newborns exposed during late pregnancy may experience these effects. The regulatory text states that any discontinuation plan should be determined by a healthcare provider.
Q: Are there any known interactions with herbal supplements or vitamins?
The prescribing information indicates the necessity of reporting all medicines, including herbal supplements and vitamins, to a doctor. This is because some supplements can affect the liver enzymes responsible for processing the drug, potentially changing the drug's concentration in the blood.
Q: How does the medicine affect liver function over time?
The liver plays a central role in how the drug is cleared, as it is metabolized by liver enzymes CYP2D6 and CYP3A4. While official guidance states no dose adjustment is needed solely for pre-existing liver impairment, the metabolism by these enzymes is critical to the drug's overall behavior in the body.
Q: What is the meaning of the injection being 'stabilized' on oral aripiprazole first?
The 14-day oral overlap period is required because the long-acting injection needs time to slowly build up to an effective level in the bloodstream. Continuing the oral medication during this period is intended to maintain the patient's protection from symptoms while the full therapeutic effect of the injection is established.
Q: Can Abilify Maintena be used for managing tics?
Abilify Maintena is not approved for the management of tics or Tourette's Disorder. Its approved indications are limited to the treatment of schizophrenia and the maintenance treatment of bipolar I disorder.
Q: Does the official guidance mention any potential sexual side effects?
Yes, the official guidance notes the potential for unusual and uncontrollable compulsive urges. These reported urges have included compulsive sexual urges, as well as pathological gambling, shopping, and eating.
Q: Why is close monitoring needed at the start of treatment?
Close monitoring is recommended during the initial treatment period to observe the patient's transition through the 14-day oral overlap and to check for early signs of potential side effects. This includes regularly checking for the emergence of metabolic side effects, such as weight changes or high blood sugar.
