How Long-Acting Injectables May Help People Living With Schizophrenia Or Bipolar I Disorder 

At mindbodygreen, we're forever believers that managing mental health looks different for everyone, and what works for one person may not work for another. It is important that people living with mental health disorders know that there is no one-size-fits-all approach. When it comes to mental health disorders, like bipolar I and schizophrenia, it is important for patients to understand all available treatment options.

Our society has come a long way in terms of how we talk about and approach mental illness—and yet, less than 10% of patients who have a mental disorder receive effective treatment.¹ This is particularly concerning when it comes to conditions like schizophrenia and bipolar I disorder.

Schizophrenia is a serious mental illness that affects how a person thinks, feels, and behaves.² People with schizophrenia may seem like they have lost touch with reality, which can be distressing for them and for their families and friends. Symptoms of this illness tend to present in early adulthood, although certain indicators can show up earlier—like troubled relationships, reduced motivation, and struggles in school.³ It's important to note that symptoms must persist for six months in order for a diagnosis to be made.³

Bipolar I disorder is a recurrent, lifelong mood disorder.⁴ This mental illness is characterized by recurrent manic and depressive episodes that may last weeks or months.⁴ And those diagnosed tend to experience functional and cognitive impairment that, understandably, impacts quality of life.⁵

The need for multiple treatment options

Nearly 4.8 million American adults live with bipolar I disorder, while about 2.8 million Americans live with schizophrenia.⁶⁻⁷ No doubt, they're two very different conditions, but those diagnosed with bipolar I disorder or schizophrenia face similar situations—including the challenge of finding the right treatment options to manage their illness.

Having multiple treatment options is important because not every patient is the same. Treatment types and plans that may work for some people may not work for others depending on their lifestyle, schedule, occupation, family, and more. 

For patients with schizophrenia, following a treatment plan—especially when patients don't take their medications as prescribed—can be a struggle. According to research, about 40-50% of patients with schizophrenia experience issues with following a treatment plan, and 60% of patients stop medication use after two to three months.⁸⁻⁹ This matters because not following a treatment plan when taking antipsychotic medications is a strong predictor of further relapse.¹⁰

Similarly, of those diagnosed with bipolar I disorder, about half have issues with their treatment plans long term.¹¹ Considering that 90% of people with bipolar disorder experience recurrences during their lifetime, arriving at a long-term treatment plan can be pivotal.¹²

When it comes to treating mental illness, there is no "one size fits all" method. But taking your medication as prescribed is easier said than done—which is why long-acting injectables (also known as LAIs) are changing the conversation surrounding treatment.¹⁵

Approved in 2023 by the Food and Drug Administration (FDA), ABILIFY ASIMTUFII® is an extended-release injectable suspension for the treatment of schizophrenia in adults and the only FDA-approved once-every-two-month maintenance monotherapy treatment of bipolar I disorder in adults. Please read full INDICATIONS and IMPORTANT SAFETY INFORMATION below, including BOXED WARNING for Increased Risk of Death in Elderly People with Dementia-Related Psychosis.

ABILIFY ASIMTUFII is administered by a health care professional (to appropriate patients) through intramuscular injection in the gluteal muscle. It's intended for dosing once every two months, meaning the injection can occur on a less frequent basis when compared to other treatment options. Ensure with your doctor that you can tolerate aripiprazole prior to starting treatment.

As a longer-duration dosing option, ABILIFY ASIMTUFII provides health care providers, patients, and caregivers another way to address these diseases. It starts with speaking to a health care professional to determine if an LAI is the right fit. 

The efficacy and safety of ABILIFY ASIMTUFII is based on the pivotal studies of ABILIFY MAINTENA® (aripiprazole). ABILIFY MAINTENA is the first and only FDA-approved once-monthly maintenance treatment for bipolar I in adults. Some patients with bipolar I disorder and their caregivers may consider trying ABILIFY MAINTENA as a potential treatment option. This treatment is administered by a health care professional via intramuscular injection once a month. People should continue to take their current oral antipsychotic medication for two weeks after their first injection of ABILIFY MAINTENA or ABILIFY ASIMTUFII (if starting from an oral antipsychotic). Please read full INDICATIONS and IMPORTANT SAFETY INFORMATION below, including BOXED WARNING for Increased Risk of Death in Elderly People with Dementia-Related Psychosis. To learn more about the pivotal studies of ABILIFY MAINTENA, visit abilifymaintena.com or abilifyasimtufii.com.

For patients living with schizophrenia or bipolar I disorder, maintaining treatment may be a struggle, but with treatment options such as long-acting injectables like ABILIFY ASIMTUFII and ABILIFY MAINTENA, we have a wide array of treatment options. All patients and their caregivers should speak with their health care professionals about the treatments available to them, in order to determine if an LAI is the right fit for them and their lifestyles.

To learn more, visit https://www.abilifyasimtufii.com/.

INDICATIONS and IMPORTANT SAFETY INFORMATION for

ABILIFY ASIMTUFII® (aripiprazole) and ABILIFY MAINTENA® (aripiprazole) 

INDICATIONS:

ABILIFY ASIMTUFII is a prescription medicine given by injection by a health care professional: 

● for the treatment of schizophrenia in adults

● alone as maintenance treatment of bipolar I disorder in adults

ABILIFY MAINTENA is a prescription medicine given by injection by a health care professional: 

● for the treatment of schizophrenia in adults

● alone as maintenance treatment of bipolar I disorder in adults

Increased risk of death in elderly people with dementia-related psychosis.

ABILIFY ASIMTUFII and ABILIFY MAINTENA increase the risk of death in elderly people who have lost touch with reality (psychosis) due to confusion and memory loss (dementia). ABILIFY ASIMTUFII and ABILIFY MAINTENA are not for the treatment of people with dementia-related psychosis. 

Do not receive ABILIFY ASIMTUFII or ABILIFY MAINTENA if you are allergic to aripiprazole or any of the ingredients in ABILIFY ASIMTUFII or ABILIFY MAINTENA.

ABILIFY ASIMTUFII or ABILIFY MAINTENA may cause serious side effects, including:

● Increased risk of stroke and ministroke has been reported in clinical studies with oral aripiprazole of elderly people with dementia-related psychosis and can lead to death.

● Neuroleptic malignant syndrome (NMS), a serious condition that can lead to death. Call your health care provider or go to the nearest emergency room right away if you have some or all of the following signs and symptoms of NMS: high fever, confusion, changes in pulse, heart rate, and blood pressure, stiff muscles, and increased sweating.

● Uncontrolled body movements (tardive dyskinesia). 

ABILIFY ASIMTUFII and ABILIFY MAINTENA may cause movements that you cannot control in your face, tongue, or other body parts. Tardive dyskinesia may not go away, even if you stop receiving ABILIFY ASIMTUFII or ABILIFY MAINTENA. Tardive dyskinesia may also start after you stop receiving ABILIFY ASIMTUFII or ABILIFY MAINTENA.

● Problems with your metabolism such as:

● High blood sugar (hyperglycemia) and diabetes: Increases in blood sugar can happen in some people who are treated with ABILIFY ASIMTUFII or ABILIFY MAINTENA. Extremely high blood sugar can lead to coma or death. If you have diabetes or risk factors for diabetes such as being overweight or a family history of diabetes, your health care provider should check your blood sugar before you start treatment with ABILIFY ASIMTUFII or ABILIFY MAINTENA, and during treatment.

Call your health care provider if you have any of these symptoms of high blood sugar during treatment with ABILIFY ASIMTUFII or ABILIFY MAINTENA:

● feel very thirsty

● need to urinate more than usual

● feel very hungry

● feel weak or tired

● feel sick to your stomach

● feel confused or your breath smells fruity

● Increased fat levels (cholesterol and triglycerides) in your blood.

● Unusual and uncontrollable (compulsive) urges. 

Some people receiving ABILIFY ASIMTUFII or ABILIFY MAINTENA have had unusual strong urges to gamble and gambling that cannot be controlled (compulsive gambling). Other compulsive urges include sexual urges, shopping, and eating or binge eating. If you or your family members notice that you are having unusual urges or behaviors, talk to your health care provider.

● Decreased blood pressure (orthostatic hypotension). You may feel lightheaded or faint when you rise too quickly from a sitting or lying position.

● Falls. ABILIFY ASIMTUFII and ABILIFY MAINTENA may make you sleepy or dizzy, may cause a decrease in your blood pressure when changing position (orthostatic hypotension), and can slow your thinking and motor skills, which may lead to falls that can cause fractures or other injuries.

● Low white blood cell count. Your health care provider may do blood tests during the first few months of treatment.

● Seizures (convulsions)

● Sleepiness, drowsiness, feeling tired, difficulty thinking and doing normal activities. Do not drive a car, operate machinery, or do other dangerous activities until you know how ABILIFY ASIMTUFII or ABILIFY MAINTENA affects you.

ABILIFY ASIMTUFII or ABILIFY MAINTENA may make you feel drowsy and affect your judgment, thinking, or motor skills. 

● Problems controlling your body temperature so that you feel too warm. 

Do not become too hot or dehydrated during treatment with ABILIFY ASIMTUFII or ABILIFY MAINTENA. Do not exercise too much. In hot weather, stay inside in a cool place if possible. Stay out of the sun. Do not wear too much clothing or heavy clothing. Drink plenty of water.

● Difficulty swallowing that can cause food or liquid to get into your lungs.

Do not drink alcohol during treatment with ABILIFY ASIMTUFII or ABILIFY MAINTENA.

Before receiving ABILIFY ASIMTUFII or ABILIFY MAINTENA, tell your health care provider about all your medical conditions, including if you:

● have never taken aripiprazole before

● have or had diabetes or high blood sugar or a family history of diabetes or high blood sugar.

● Your health care provider should check your blood sugar before you start receiving ABILIFY ASIMTUFII or ABILIFY MAINTENA and during your treatment.

● have or had high levels of total cholesterol, LDL cholesterol, or triglycerides, or low levels of HDL cholesterol

● have or had low or high blood pressure

● have or had heart problems or a stroke

● have or had a low white blood cell count

● have or had seizures (convulsions)

● have problems that may affect you receiving an injection in your buttocks (ABILIFY ASIMTUFII and ABILIFY MAINTENA) or arm (ABILIFY MAINTENA) 

● are pregnant or plan to become pregnant. ABILIFY ASIMTUFII or ABILIFY MAINTENA may harm your unborn baby.

If you become pregnant during treatment with ABILIFY ASIMTUFII or ABILIFY MAINTENA, talk to your health care provider about the risk to your unborn baby and about registering with the National Pregnancy Registry for Atypical Antipsychotics. You can register by calling 1-866-961-2388 or visit https://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/.

● are breastfeeding or plan to breastfeed. ABILIFY ASIMTUFII or ABILIFY MAINTENA can pass into your milk and may harm your baby.

Talk to your health care provider about the best way to feed your baby if you receive ABILIFY ASIMTUFII or ABILIFY MAINTENA. 

ABILIFY ASIMTUFII or ABILIFY MAINTENA and other medicines may affect each other causing possible serious side effects. Do not start or stop any medicines during treatment with ABILIFY ASIMTUFII or ABILIFY MAINTENA without talking to your health care provider first.

The most common side effects of ABILIFY ASIMTUFII or ABILIFY MAINTENA include weight gain, restlessness or feeling like you need to move (akathisia), injection site pain, or sleepiness (sedation).

It is important to contact your health care provider if you experience prolonged, abnormal muscle spasms or contractions, which may be signs of a condition called dystonia.

These are not all the possible side effects of ABILIFY ASIMTUFII or ABILIFY MAINTENA. 

If you have any questions about your health or medicines, talk to your health care provider.

You are encouraged to report side effects of ABILIFY ASIMTUFII and ABILIFY MAINTENA.   

Please contact Otsuka America Pharmaceutical Inc. at 1-800-438-9927 or the FDA at 1-800-FDA-1088 (www.fda.gov/medwatch1).

Please see FULL PRESCRIBING INFORMATION, including BOXED WARNING, and MEDICATION GUIDE for ABILIFY ASIMTUFII and ABILIFY MAINTENA.

Sponsored by © 2023 Otsuka America Pharmaceutical, Inc. and Lundbeck