Cariprazine (kar-IP-ra-zeen)

Treats schizophrenia, bipolar disorder (including mania and depression), and depression.

Brand Name(s):

Vraylar

When This Medicine Should Not Be Used:

How to Use This Medicine:

Capsule

• Take your medicine as directed. Your dose may need to be changed several times to find what works best for you.
• Some side effects may not happen right away and can start a few weeks after you start using this medicine or if your dose increases. Do not change your dose or stop using your medicine without first checking with your doctor.
• This medicine should come with a Medication Guide. Ask your pharmacist for a copy if you do not have one.
• Missed dose: Take a dose as soon as you remember. If it is almost time for your next dose, wait until then and take a regular dose. Do not take extra medicine to make up for a missed dose.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Some medicines can affect how cariprazine works. Tell your doctor if you are using carbamazepine, itraconazole, ketoconazole, or rifampin.

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant or planning to become pregnant. This medicine may cause unwanted effects to newborn babies if used during the later part of pregnancy. Tell your doctor right away if you think you have become pregnant.
• Tell your doctor if you are breastfeeding, or if you have kidney disease, liver disease, diabetes, high cholesterol, trouble swallowing, or a history of seizures. Tell your doctor if you have heart or blood vessel problems, including low blood pressure, heart failure, heart rhythm problems, or a history of heart attack or stroke.
• This medicine may cause the following problems:
  • Increased risk of stroke
  • Neuroleptic malignant syndrome (a nerve and muscle problem), which can be life-threatening
  • Tardive dyskinesia (a muscle problem that may become permanent)
  • High blood sugar or cholesterol levels
  • Increased risk of seizures
• This medicine can make you dizzy, drowsy, or lightheaded. You may also have trouble thinking or controlling body movements, which may lead to falls, fractures or other injuries. Do not drive or do anything else that could be dangerous until you know how this medicine affects you. Stand or sit up slowly if you feel lightheaded or dizzy.
• This medicine may make it more difficult for your body to cool down. Be careful to not become overheated during exercise or hot weather, because you could have heat stroke.
• This medicine lowers the number of white blood cells. This weakens your immune system, so you may get infections more easily. Wash your hands often. Avoid people who are sick.
• For some children, teenagers, and young adults, this medicine may increase mental or emotional problems. This may lead to thoughts of suicide and violence. Talk with your doctor right away if you have any thoughts or behavior changes that concern you. Tell your doctor if you or anyone in your family has a history of bipolar disorder or suicide attempts.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Fever, chills, cough, sore throat, body aches
• Increased hunger or thirst, frequent urination
• Jerky muscle movements that you cannot control (often in your face, tongue, or jaw), problems with balance or walking, restlessness
• Lightheadedness, dizziness, fainting
• Seizures, tremors
• Sweating, confusion, uneven heartbeat, muscle stiffness
• Unusual changes in behavior, thoughts or attempts of killing oneself

If you notice these less serious side effects, talk with your doctor:

• Constipation, diarrhea, nausea, vomiting, stomach pain
• Headache, trouble sleeping
• Toothache
• Weight gain

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088