The approval of medicines called second-generation antipsychotics has allowed bipolar I and some conditions that come with it to be treated. A person who has bipolar I disorder can go through various mood swings, also known as episodes. Taking a medicine that can help lower the number of mood episodes can help people with bipolar I manage their symptoms.
Abilify Maintena (a-BIL-i-fy main-TEN-a) was approved in 2013 and is the first and only once-monthly treatment for the maintenance of bipolar I symptoms. Maintenance (ongoing) treatment for bipolar I disorder can allow people to have more time without a mood episode. Abilify Maintena is given in the muscle once a month by a health care provider. It is different from Abilify, which is usually taken once a day by mouth.
How Does It Work for Bipolar I?
Bipolar disorder is a condition that causes severe changes in mood and energy that can cause unpredictable high (manic), low (depressive), and mixed (both high and low) mood swings. There are two types of bipolar disorders: bipolar I and bipolar II. A person with bipolar I has experienced at least 1 episode of mania (also called a manic episode). Each person with bipolar I disorder has differences in how severe or less severe their high and low mood swings are and for how long they last. There is no cure for bipolar disorder, but medicines are used to help control symptoms and improve quality of life.
The active ingredient in Abilify Maintena is aripiprazole, which is a second-generation antipsychotic that is used to treat psychiatric conditions, including bipolar I. Second-generation antipsychotics are different from first-generation antipsychotics because they are less likely to produce movement-related side effects (extrapyramidal symptoms) such as restlessness and tremor.
The exact way that Abilify Maintena works is not known, but the medicine is designed to alter chemicals (serotonin and dopamine) in the brain that affect mood.
How Do I Take It?
Abilify Maintena is given to you by your health care provider once a month. Your health care provider may be able to give you the shot in their office, or you can go to a Local Care Center to receive medicine. It comes as a 300-milligram and 400-milligram shot. Because it is an injection, your health care provider will inject the medicine either in your arm or your butt. The 400-milligram dose is usually what you start with, but your health care provider may switch you to the 300-milligram dose if you have side effects from the medicine.
Depending on whether you are taking an antipsychotic by mouth for your bipolar I disorder, including Abilify or generic aripiprazole, you may need to take an antipsychotic pill before and/or after your Abilify Maintena shot.
If you are currently takingan antipsychotic medicine by mouth for your bipolar I disorder, your health care provider may ask you to keep taking the antipsychotic medicine for up to 14 days after your first Abilify Maintena shot. This will allow the medicine levels in your blood to stay consistent when you are starting your Abilify Maintena treatment.
If you have never taken an antipsychotic medicine by mouth, your health care provider may ask you to take aripiprazole (Abilify) for 2 weeks before your first Abilify Maintena injection, to make sure that your body can tolerate the medicine without having major side effects. After your first shot of Abilify Maintena, your health care provider may ask you to take aripiprazole (Abilify) by mouth for up to 2 weeks after. This will allow the medicine levels in your blood to stay consistent when you are starting your Abilify Maintena treatment.
Abilify Maintena cannot be taken within 26 days of your previous shot. If you miss your dose of Abilify Maintena, call your health care provider right away. Try to keep all appointments with your health care provider to receive your monthly Abilify Maintena dose.
How Was It Studied for Bipolar I?
One clinical study was done to see if Abilify Maintena was safe and effective for managing bipolar I, compared to a placebo containing no medicine. The study included people who were diagnosed with bipolar I disorder and had experienced one or more manic or mixed episodes that required hospitalization or treatment with a mood stabilizer or antipsychotic medicine. People also had to have manic symptoms at the time of the study.
People in the study were 18 to 65 years of age, with the average age being 41. The study included White Americans, African Americans, Asian Americans, Native Americans, or those classified as “Other,” where their race wasn’t specified. About 54% of the people in the study were White Americans and about 58% of people were women.
The study looked to see how long it took for a mood episode to occur, which was defined by one of the following
- Going to the hospital for a mood episode
- Using score systems to see how severe manic or depressive symptoms were
- Side effects showing that bipolar I symptoms were getting worse
- Stopping the study because the medicine was not working, because of a side effect or because bipolar I symptoms were worsening
- Bipolar I symptoms becoming worse and more medicine being needed to manage the symptoms
- Increased suicide risk
What Benefits Were Seen?
Compared to a placebo, fewer people who took Abilify Maintena had a mood episode. That means more people who used Abilify Maintena had a stable mood for a longer period of time.
Abilify Maintena was effective regardless of age, sex, or race. Your results may differ from what was seen in clinical studies.
How Long Does It Take to Work?
Abilify Maintena is an extended-release medicine, meaning that it is designed to be released slowly in the body over time, providing a longer-lasting effect. Because of this, you may not see the effects of the medicine right away. When you start treatment with Abilify Maintena, your health care provider may either ask you to stay on your current antipsychotic medicine that you were taking by mouth or prescribe you aripiprazole (Abilify) to take by mouth for 2 weeks after your first Abilify Maintena shot. This is because Abilify Maintena may take some time to start working, so taking an antipsychotic medicine by mouth after your first dose of Abilify Maintena can help manage your bipolar I symptoms until Abilify Maintena fully kicks in. If it has been a few months and your symptoms have not improved, tell your health care provider.
How Can I Manage Side Effects?
The most common side effects seen in clinical studies with Abilify Maintena are below.
- A movement disorder that makes it hard for you to sit still (akathisia)
- Weight gain
- Anxiety
- Involuntary movements that you cannot control (extrapyramidal symptoms), including shakiness, stiffness, or jerkiness
- Pain where you got the shot
Along with the side effects above, other side effects were seen in clinical studies when people who were also taking an oral antipsychotic medicine started taking Abilify Maintena.
- Trouble sleeping
- Restlessness
- Tiredness
- Infection in the nose or throat, sore throat, or common cold symptoms
Talk to your health care provider if you are having extrapyramidal symptoms, akathisia, or if you’re feeling restless due to Abilify Maintena. Your health care provider may lower the dose of your medicine, prescribe you medicine to treat your symptoms, or switch you to another medicine.
Abilify Maintena can change your metabolism, which can cause you to gain weight, and can cause your blood sugar and cholesterol to increase. Your health care provider may monitor your weight and may also monitor your sugar and cholesterol levels while taking Abilify Maintena.
Anxiety may occur while you are taking Abilify Maintena. Talk to your health care provider if your anxiety symptoms are not going away or are getting worse. Taking steps such as limiting your caffeine intake, getting enough sleep, and relaxing with things like exercise or yoga may help.
Because Abilify Maintena is given to you as a shot, you may have pain at the injection site. This should go away within a few hours to a few days after you’ve gotten your shot. Using over-the-counter pain relievers such as Tylenol or ibuprofen can help, along with ice packs and a warm compress. Talk to your health care provider if you are still in pain after your shot or if the pain gets worse.
Abilify Maintena may cause trouble sleeping, also known as insomnia. Talk to your health care provider if you are having problems falling asleep or staying asleep while on Abilify Maintena.
You may have tiredness while taking Abilify Maintena. It is important not to drive or do other activities that require alertness or coordination until you know how Abilify Maintena affects you.
Infection in the nose or throat, sore throat, or the common cold may happen while you’re on Abilify. Taking over-the-counter medicines may help manage your symptoms. Talk to your health care provider if your symptoms do not improve or get worse.
What Type of Drug Interactions Can Happen?
Other medicines may alter the blood levels of Abilify Maintena, and vice versa. This may increase the risk of side effects from Abilify Maintena or can cause it to not work as well. Talk to your health care provider about all the prescription medicines, over-the-counter medicines, and supplements that you are taking. Your health care provider will decide if they will need to modify any of the medicines that you are taking or modify the dose of Abilify Maintena that you are taking.
Certain medicines can increase the level of Abilify Maintena in the blood. This can include ketoconazole, which is a medicine for fungal infections, and paroxetine and fluoxetine, which are medicines for mood conditions such as depression and anxiety.
Certain medicines can decrease the level of Abilify Maintena in the blood. This can include carbamazepine, which is a medicine used for nerve pain, seizures, and bipolar disorder.
Abilify Maintena may increase the level of blood pressure medicines in the blood. This can cause your blood pressure to decrease more than usual. Your health care provider may monitor your blood pressure and/or change the dose of your medicines.
Abilify Maintena, when taken with a medicine called a benzodiazepine (lorazepam, temazepam, and others), can cause drowsiness and a sudden decrease in your blood pressure when you stand up (orthostatic hypotension). Your health care provider may monitor your blood pressure and/or change the dose of your medicines. Tell your health care provider if you become drowsy. Do not drive or do other activities that require alertness or coordination if you are drowsy.
Is There a Cost Savings Program?
There is a savings card available from the drugmaker that may allow you to pay as little as $10 per month on your prescription. Whether you are eligible depends on your insurance coverage. You can find out more at https://www.abilifymaintena.com/bipolar-I/support-savings or by calling 833-742-0795.
