Pronunciation:

kar-IP-ra-zeen

Brand Names:

• Vraylar

Dosage Forms:

• Capsule

Warnings:

Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Cariprazine is not approved for the treatment of patients with dementia-related psychosis. Antidepressants increased the risk of suicidal thoughts and behaviors in pediatric and young adult patients in short-term studies. Closely monitor all antidepressant-treated patients for clinical worsening, and for the emergence of suicidal thoughts and behaviors. The safety and effectiveness of cariprazine have not been established in pediatric patients .

Classifications:

Therapeutic—

Antipsychotic

Uses of This Medicine:

Cariprazine is used to treat schizophrenia or mania and depression related with bipolar disorder. It is also used to treat major depressive disorder (MDD). Cariprazine changes some of the chemicals in the brain that cause psychotic disorders. This medicine should not be used to treat behavioral problems in older adults with dementia.

This medicine is available only with your doctor's prescription.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of cariprazine in the pediatric population. Safety and efficacy have not been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of cariprazine in the elderly. However, elderly patients are more likely to have age-related kidney, liver, or heart problems, which may require caution and an adjustment in the dose for patients receiving cariprazine.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Bromopride
• Metoclopramide

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Boceprevir
• Buprenorphine
• Carbamazepine
• Clarithromycin
• Cobicistat
• Conivaptan
• Fentanyl
• Fosphenytoin
• Idelalisib
• Indinavir
• Itraconazole
• Ketoconazole
• Lopinavir
• Methadone
• Nefazodone
• Nelfinavir
• Phenytoin
• Posaconazole
• Rifampin
• Ritonavir
• Saquinavir
• St John's Wort
• Telaprevir
• Telithromycin
• Voriconazole

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Blood vessel or circulation problems or
• Dehydration or
• Heart attack, history of or
• Heart disease or
• Heart failure or
• Heart rhythm problems or
• Hypovolemia (low amount of blood) or
• Stroke, history of—Use with caution. May cause side effects to become worse.

• Diabetes or
• Hyperglycemia (high blood sugar) or
• Hypotension (low blood pressure) or
• Leukopenia (low white blood cells) or
• Neuroleptic malignant syndrome (NMS), history of or
• Seizures, history of or
• Tardive dyskinesia (movement disorder), history of or
• Trouble with swallowing—Use with caution. May make these conditions worse.

• Kidney disease, severe or
• Liver disease, severe—Use is not recommended in patients with these conditions.

Proper Use of This Medicine:

Take this medicine exactly as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. To do so may increase the chance of side effects.

This medicine comes with a Medication Guide. Read and follow these instructions carefully. Ask your doctor if you have any questions.

You may take this medicine with or without food.

Dosing—

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (capsules):
  • For the treatment of depressive episodes related with bipolar disorder and depression:
    • Adults—At first, 1.5 milligrams (mg) once a day. Your doctor will adjust your dose as needed and tolerated. However, the dose is usually not more than 3 mg per day.
    • Children—Use and dose must be determined by your doctor.
  • For the treatment of schizophrenia and manic or mixed episodes with bipolar disorder:
    • Adults—At first, 1.5 milligrams (mg) once a day. Your doctor will adjust your dose as needed and tolerated. However, the dose is usually not more than 6 mg per day.
    • Children—Use and dose must be determined by your doctor.

Missed dose—

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage—

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using This Medicine:

It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly. Blood tests may be needed to check for unwanted effects.

Tell your doctor if you are pregnant or planning to become pregnant. This medicine may cause unwanted effects (eg, muscle problems, withdrawal symptoms) to newborn babies if used during the later part of pregnancy. Tell your doctor right away if you think you have become pregnant.

This medicine may cause some people to be agitated, irritable, or display other abnormal behaviors. It may also cause some people to have suicidal thoughts and tendencies or to become more depressed. Make sure the doctor knows if you have trouble sleeping, get upset easily, have a big increase in energy, or start to act reckless. Also tell the doctor if you have sudden or strong feelings, such as feeling nervous, angry, restless, violent, or scared. If you or your caregiver notice any of these side effects, tell your doctor right away.

Check with your doctor right away if you have convulsions (seizures), difficulty with breathing, a fast heartbeat, a high fever, high or low blood pressure, increased sweating, loss of bladder control, severe muscle stiffness, unusually pale skin, or tiredness. These could be symptoms of a serious condition called neuroleptic malignant syndrome (NMS).

This medicine may cause tardive dyskinesia (a movement disorder). Check with your doctor right away if you have lip smacking or puckering, puffing of the cheeks, rapid or worm-like movements of the tongue, uncontrolled chewing movements, or uncontrolled movements of the arms and legs.

For diabetic patients: This medicine may cause high blood sugar levels (hyperglycemia). Check with your doctor right away if you have increased thirst or increased urination. Diabetic patients should check their blood and urine sugar levels more often than normal while taking this medicine.

This medicine may increase your weight. Your doctor may need to check your weight on a regular basis while you are using this medicine. Talk to your doctor about ways to prevent weight gain.

Cariprazine can temporarily lower the number of white blood cells in your blood, increasing the chance of getting an infection. If you can, avoid people with infections. Check with your doctor right away if you think you are getting an infection, or if you have a fever or chills, cough or hoarseness, lower back or side pain, or painful or difficult urination.

Dizziness, lightheadedness, or fainting may occur, especially when you get up suddenly from a lying or sitting position. These symptoms are more likely to occur when you begin taking this medicine, or when the dose is increased. Getting up slowly may help. If this problem continues or gets worse, check with your doctor.

This medicine may cause dizziness, drowsiness, trouble with thinking, or trouble with 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.

This medicine may make it more difficult for your body to cool down. It might reduce how much you sweat. Your body could get too hot if you do not sweat enough. If your body gets too hot, you might feel dizzy, weak, tired, or confused. You might vomit or have an upset stomach. Do not get too hot while you are exercising. Avoid places that are very hot. Call your doctor if you are too hot and can not cool down.

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.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

Blurred vision

chills

dizziness

drooling

fever

headache

inability to move the eyes

inability to sit still

increased blinking or spasms of the eyelid

loss of balance control

muscle trembling, jerking, or stiffness

need to keep moving

nervousness

pounding in the ears

restlessness

shuffling walk

slow or fast heartbeat

sticking out of the tongue

stiffness of the limbs

trouble with breathing, speaking, or swallowing

twisting movements of the body

uncontrolled movements, especially of the face, neck, arms, or legs

unusual facial expressions

Less common

Bladder pain

bloody or cloudy urine

confusion

decreased urine output

difficult, burning, or painful urination

dizziness

fast, pounding, or irregular heartbeat or pulse

frequent urge to urinate

increased thirst

loss of consciousness

lower back or side pain

muscle aches, pain, or cramps

nausea

seizures

sore throat

stuffy or runny nose

swelling of the face, ankles, or hands

thoughts or attempts at killing oneself

unusual tiredness or weakness

vomiting

Rare

Burning feeling in the chest or stomach

dark urine

difficulty in speaking

double vision

general tiredness and weakness

inability to move the arms, legs, or facial muscles

inability to speak

indigestion

light-colored stools

muscle spasms or stiffness

slow speech

stomach upset

tenderness in the stomach area

upper right abdominal or stomach pain

yellow eyes and skin

Incidence not known

Blistering, peeling, or loosening of the skin

confusion

cough

diarrhea

drooling

high fever

increased sweating

itching

joint pain

lip smacking or puckering

muscle trembling, jerking, or stiffness

puffing of the cheeks

rapid or worm-like movements of the tongue

red skin lesions, often with a purple center

red, irritated eyes

severe muscle stiffness

sores, ulcers, or white spots in the mouth or on the lips

uncontrolled chewing movements

unusually pale skin

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Decreased appetite

difficulty having a bowel movement

sleepiness or unusual drowsiness

stomach pain

trouble sleeping

Less common

Anxiety

back pain

belching

difficulty with moving

dry mouth

heartburn

indigestion

irritability

pain in the arms or legs

rash

shaking

weight gain

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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