Cariprazine

Important warning for older adults with dementia:

Older adults with dementia (loss of memory and brain function) may have an increased chance of death if treated with antipsychotic medications such as cariprazine. Older adults with dementia may also have a greater chance of having a stroke or mini-stroke during treatment with antipsychotics.

Cariprazine is not approved by the Food and Drug Administration (FDA) for the treatment of behavior disorders in older adults with dementia. Talk to the doctor who prescribed this medication if you, a family member, or someone you care for has dementia and is being treated with cariprazine.

Important warning for people who have depression:

Children, teenagers, and young adults who take antidepressants to treat depression or other mental illnesses may be more likely to become suicidal.

This is especially of concern at the beginning of your treatment and any time that your dose is increased or decreased. You, your family, or your caregiver should call your doctor right away if you experience any of the following symptoms: new or worsening depression; thinking about harming or killing yourself, or planning or trying to do so; extreme worry; agitation; panic attacks; difficulty falling asleep or staying asleep; aggressive behavior; irritability; acting without thinking; severe restlessness; and frenzied abnormal excitement. Be sure that your family or caregiver knows which symptoms may be serious so they can call the doctor if you are unable to seek treatment on your own.

You will be given the Medication Guide. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also visit https://www.fda.gov/Drugs/DrugSafety/ ucm085729.htm to obtain the Medication Guide.

Talk to your doctor about the risks of taking cariprazine.

Cariprazine is used to treat schizophrenia (a mental illness that affects how a person thinks, feels and behaves), bipolar disorder (a disease that causes depression, mania, and other abnormal moods), and major depressive disorder. Cariprazine is in a class of medications called atypical antipsychotics. It works by changing the activity of certain natural substances in the brain.

Cariprazine comes as a capsule to take by mouth. Take once a day with or without food. Take cariprazine at around the same time every day.

Take cariprazine exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Your doctor will probably start you on a low dose of cariprazine and gradually increase your dose depending on how well the medication works for you, and the side effects you experience.

Cariprazine may help control your symptoms but will not cure your condition. It may take several weeks or longer before you feel the full benefit of cariprazine. Continue to take cariprazine even if you feel well. Do not stop taking cariprazine without talking to your doctor. Talk to your doctor if you do not feel like you are getting better during your treatment with cariprazine.

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

Before taking cariprazine,

• tell your doctor or pharmacist if you are allergic to this drug, any part of this drug, or any other drugs, foods or substances. Tell your doctor or pharmacist about the allergy and what symptoms you had
• tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, and nutritional supplements you are taking or plan to take. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
• the following nonprescription or herbal products may interact with cariprazine: St. John's wort. Be sure to let your doctor and pharmacist know that you are taking this medication before you start taking cariprazine. Do not start this medication while taking cariprazine without discussing with your healthcare provider.
• tell your doctor if you or anyone in your family has or has ever had pre-diabetes or diabetes. Also, tell your doctor if you have a low number of white blood cells, or if you have ever developed a low number of white blood cells as a side effect of a medication that you took. Tell your doctor if you have or have ever had seizures; a stroke; a ministroke; a heart attack; heart failure; irregular heartbeat; low or high blood pressure; high levels of cholesterol and other fatty substances in the blood; trouble keeping your balance; difficulty swallowing; or heart, liver, or kidney disease. Also tell your doctor if you have severe vomiting, diarrhea or signs of dehydration now, or if you develop these symptoms at any time during your treatment.
• tell your doctor if you are pregnant, if you plan to become pregnant, or are breastfeeding. If you become pregnant while taking cariprazine, call your doctor.
• you should know that cariprazine may make you drowsy, and may affect your ability to think clearly, make decisions, and react quickly. Do not drive a car or operate machinery during your treatment with cariprazine until you know how this medication affects you.
• you should know that you may experience hyperglycemia (increases in your blood sugar) while you are receiving this medication, even if you do not already have diabetes. Tell your doctor immediately if you have any of the following symptoms during your treatment: extreme thirst, frequent urination, extreme hunger, blurred vision, or weakness. It is very important to call your doctor as soon as you have any of these symptoms, because high blood sugar can cause a serious condition called ketoacidosis. Ketoacidosis may become life-threatening if it is not treated at an early stage. Symptoms of ketoacidosis include: dry mouth, nausea and vomiting, shortness of breath, breath that smells fruity, and decreased consciousness.
• you should know that cariprazine may cause dizziness, lightheadedness, and fainting when you get up too quickly from a lying position. This is more common when you first start taking cariprazine. To avoid this problem, get out of bed slowly, resting your feet on the floor for a few minutes before standing up.
• you should know that cariprazine may make it harder for your body to cool down when it gets very hot. Tell your doctor if you plan to do vigorous exercise or be exposed to extreme heat. Be sure to drink plenty of water and call your doctor if you experience any of the following symptoms: feeling very hot, sweating heavily, not sweating even though it is hot, dry mouth, excessive thirst, or decreased urination.

Unless your doctor tells you otherwise, continue your normal diet.

Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

Cariprazine may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• extreme tiredness
• restlessness, anxiety, agitation
• difficulty falling asleep or staying asleep
• dizziness, feeling unsteady, or having trouble keeping your balance
• increased appetite, weight gain
• nausea, indigestion, constipation
• increased saliva or drooling

Some side effects can be serious. If you experience any of these symptoms or those listed in the IMPORTANT WARNING or SPECIAL PRECAUTIONS section, call your doctor immediately or get emergency medical treatment:

• seizures
• unusual movements of your body or face that you cannot control
• loss of ability to move
• falling down
• fever, sweating, confusion, fast breathing, fast or irregular heartbeat, and severe muscle stiffness
• muscle weakness or aching
• tightness in the throat
• tongue that sticks out of the mouth
• rash, itching, hives; swelling of the face, throat, tongue, lips, or eyes
• dark or cola-colored urine
• swelling in legs and feet
• decreased urination

Cariprazine may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (https://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).

Dispose of unneeded medications in a way so that pets, children, and other people cannot take them. Do not flush this medication down the toilet. Use a medicine take-back program. Talk to your pharmacist about take-back programs in your community. Visit the FDA's Safe Disposal of Medicines website https://goo.gl/c4Rm4p for more information.

Keep all medication out of sight and reach of children as many containers are not child-resistant. Always lock safety caps. Place the medication in a safe location – one that is up and away and out of their sight and reach. https://www.upandaway.org

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

Symptoms of overdose may include the following:

• sedation
• feeling lightheaded, dizzy or faint when standing up from a sitting or lying down position

Keep all appointments with your doctor and the laboratory. Your doctor may order certain lab tests to check your body's response to cariprazine.

Keep a written list of all of the prescription and nonprescription (over-the-counter) medicines, vitamins, minerals, and dietary supplements you are taking. Bring this list with you each time you visit a doctor or if you are admitted to the hospital. You should carry the list with you in case of emergencies.

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