Exploring Treatment Options for Bipolar I Disorder and Schizophrenia

Bipolar I disorder and schizophrenia are chronic mental illnesses that require continuous management and can interrupt the daily lives of those who live with the conditions. Up to 90% of the 4.8 million Americans with bipolar I disorder experience recurrence of mood episodes, and of the 2.8 million Americans living with schizophrenia, some of them find medication adherence challenging. 

Bipolar I disorder is a recurrent, lifelong mood disorder that results in functional and cognitive impairment, such as periods of unusually intense emotions and changes in sleep patterns and activity levels. This illness is characterized by recurrent manic and depressive episodes that may last weeks.

According to the National Institute of Mental Health (NIMH), schizophrenia is a mental illness that affects how a person thinks, feels, and behaves. People with schizophrenia may seem like they have lost touch with reality, which can be distressing for them, as well as their families and friends. Symptoms of schizophrenia usually first appear in early adulthood and must persist for at least six months for a diagnosis to be made. 

Many patients and their loved ones are unaware of the full spectrum of treatment options available for those with bipolar I disorder and schizophrenia. According to the National Institute on Minority Health and Health Disparities (NIMHD), less than half of all Americans who have a mental disorder get proper treatment. It has been suggested that fewer than 10% of patients with a mental disorder receive effective treatment. The high prevalence of mental disorders paired with the lack of adequate treatment heightens the need for greater awareness of available treatment options for both patients, as well as the general population.

“While society has made strides in prioritizing mental health conversations in recent years, there’s still much work to be done in terms of providing patients with a wide variety of treatment options so they can identify the approach that works best for them,” said Dr. Gus Alva, board-certified psychiatrist by the American Board of Psychiatry and Neurology. “It is essential to explore treatment plans that are well suited to the daily lives of patients and those supporting them.”

Long-acting injectables, also known as LAIs, provide continuous delivery of antipsychotic medication, which may offer an additional treatment option to maintain stability for individuals living with bipolar I disorder or schizophrenia. For those already stable on oral medication, an LAI could serve as a viable alternative to a daily pill, allowing individuals to focus more on everyday life. 

“It’s common for individuals with mental illness to experience relapse and recurrence, so an LAI may offer a medication regimen to eliminate the everyday reminder of their disease,” said Dr. Alva. “Patients’ conditions, lifestyles, and personal preferences are critical in determining the most suitable treatment approach.”

In April of 2023, the FDA approved ABILIFY ASIMTUFII^® (aripiprazole), an extended-release injectable suspension for the treatment of schizophrenia in adults and for the maintenance monotherapy treatment of bipolar I disorder in adults. Administered by a health care professional to recommended patients, a dose is given every two months via intramuscular injection in the gluteal muscle. Patients should continue to take their current oral antipsychotic medication for two weeks after their first injection of ABILIFY ASIMTUFII. ABILIFY ASIMTUFII is the only FDA-approved two-month LAI for bipolar I disorder. It’s important to note that individual experiences may vary. Please read full INDICATIONS and IMPORTANT SAFETY INFORMATION below, including BOXED WARNING for Increased Risk of Death in Elderly People with Dementia-Related Psychosis.

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 disorder in adults. This treatment is administered by a health care professional via intramuscular injection once a month. Patients should continue to take their current oral antipsychotic medication for two weeks after their first injection of ABILIFY MAINTENA.

By offering a longer-duration dosing option, ABILIFY ASIMTUFII provides health care providers, patients, and their loved ones with another way to address these diseases. All patients should speak with their health care professional about the treatments available to them in order to determine if an LAI is the right fit for them and their lifestyles.

Visit www.abilifyasimtufii.com or www.abilifymaintena.com to learn more.

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 healthcare 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 healthcare professional: 

• for the treatment of schizophrenia in adults
• alone as maintenance treatment of bipolar I disorder in adults

It is not known if ABILIFY ASIMTUFII or ABILIFY MAINTENA is safe and effective in children under 18 years of age.

IMPORTANT SAFETY INFORMATION:

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 healthcare 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 healthcare provider should check your blood sugar before you start treatment with ABILIFY ASIMTUFII or ABILIFY MAINTENA, and during treatment.

Call your healthcare 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. 
  • Weight gain.  You and your healthcare provider should check your weight regularly during treatment.
• 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 healthcare 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 healthcare 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 judgement, 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 healthcare 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 healthcare 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 healthcare 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 http://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 healthcare provider about the best way to feed your baby if you receive ABILIFY ASIMTUFII or ABILIFY MAINTENA. 

Tell your healthcare provider about all the medicines you take, including prescription medicine and over-the-counter medicines, vitamins, and herbal supplements.  

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 healthcare 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 healthcare 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 healthcare 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 FDA at 1-800-FDA-1088 (www.fda.gov/medwatch).

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

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