Cariprazine, Oral

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KEY POINTS

• This medicine is taken by mouth to treat the symptoms of schizophrenia or bipolar disorder. Take it exactly as directed.
• Older adults with dementia are at greater risk for side effects, including death.
• This medicine may cause unwanted side effects. Tell your healthcare provider if you have any side effects that are serious, continue, or get worse.
• This medicine may interact with many other medicines. Tell all healthcare providers who treat you about all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take.

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What are other names for this medicine?

Type of medicine: antipsychotic; dopamine D3/D2 receptor partial agonist

Generic and brand names: cariprazine, oral; Vraylar

What is this medicine used for?

This medicine is taken by mouth to treat the symptoms of schizophrenia or bipolar disorder.

This medicine may be used to treat other conditions as determined by your healthcare provider.

What should my healthcare provider know before I take this medicine?

Before taking this medicine, tell your healthcare provider if you have ever had:

• An allergic reaction to any medicine
• A low white blood cell count
• A stroke or transient ischemic attack (TIA)
• Alzheimer's disease or dementia
• Diabetes
• Heart disease, a heart attack, or heart failure
• High cholesterol or high triglycerides
• Low or high blood pressure
• Liver or kidney disease
• Problems with dehydration
• Seizures
• Trouble swallowing

Tell your healthcare provider if you are taking or planning to take any other prescription or nonprescription medicines during treatment with this medicine.

Pregnancy and breast-feeding: Tell your healthcare provider if you are pregnant, plan to become pregnant, are breast-feeding, or plan to breast-feed. It is not known if this medicine can harm an unborn baby. Using this medicine in the last 3 months of pregnancy may cause muscle movement problems or medicine withdrawal symptoms in your newborn. If you become pregnant while taking this medicine, talk to your healthcare provider about registering with the National Pregnancy Registry for Atypical Antipsychotics. It is not known if this medicine passes into your breast milk. Do not breast-feed while taking this medicine without your healthcare provider’s approval.

How do I use it?

Check the label on the medicine for directions about your specific dose. Take this medicine exactly as directed by your healthcare provider. Usually your healthcare provider will start you with a small dosage and increase it gradually over several days. Do not increase the dosage on your own. Do not stop taking this medicine without your healthcare provider's approval.

Check with your healthcare provider before using this medicine in children under age 18.

You may take this medicine with or without food.

What if I miss a dose?

If you miss a dose, take it as soon as you remember unless it is almost time for the next scheduled dose. In that case, skip the missed dose and take the next one as directed. Do not take a double dose. If you are not sure of what to do if you miss a dose, or if you miss more than one dose, contact your healthcare provider.

What if I overdose?

If you or anyone else has intentionally taken too much of this medicine, call 911 or go to the emergency room right away. If you pass out, have seizures, weakness or confusion, or have trouble breathing, call 911. If you think that you or anyone else may have taken too much of this medicine, call the poison control center. Do this even if there are no signs of discomfort or poisoning. The poison control center number is 800-222-1222.

Symptoms of an acute overdose may include: drowsiness, severe dizziness, restlessness, aggressiveness, slurred speech, confusion, fast or irregular heartbeat, uncontrolled muscle movements, trouble breathing.

What should I watch out for?

Older adults with dementia are at greater risk for side effects, including death. Talk with your provider about this.

This medicine can cause low blood pressure, especially when you start taking it, or if you take it with alcohol or sedatives. Low blood pressure may make you feel lightheaded or dizzy. Getting up slowly when sitting or lying down may help. Take care to avoid falling.

This medicine can cause drowsiness, dizziness, and problems with judgment. Do not drive or operate machinery until you are fully alert.

While taking this medicine, be careful when you exercise, especially when it is hot. This medicine affects your body's ability to cool down, and you may get too hot. If you get too hot, you might vomit, feel dizzy, have a fast heartbeat, get very stiff muscles, or be confused. Contact your provider right away if you have these symptoms.

Using this medicine for a long time may cause muscle spasms, twitching in the face and body, and uncontrolled tongue or jaw movement. Talk to your healthcare provider about this.

This medicine may lower the number of certain types of blood cells in your body. Tell your healthcare provider if you have any signs of infection, such as fever, cough, or sore throat. This medicine may also increase the total cholesterol and triglyceride levels in your blood. You will need blood tests regularly to see how this medicine affects you. Keep all appointments for tests.

This medicine may also cause you to gain weight. Talk with your provider about this.

This medicine increases the effects of alcohol and other drugs that slow down your nervous system. Do not drink alcohol while you are taking this medicine. Do not take other medicines unless your healthcare provider tells you to.

Adults over the age of 65 may be at greater risk for side effects. Talk with your healthcare provider about this.

If you need emergency care, surgery, lab tests, or dental work, tell the healthcare provider or dentist you are taking this medicine.

This medicine may increase the risk of diabetes, especially if you are overweight or have a family history of diabetes. If you have diabetes, this medicine may affect your blood sugar level and change the amount of insulin or other diabetes medicines you may need. Talk to your healthcare provider about this.

What are the possible side effects?

Along with its needed effects, your medicine may cause some unwanted side effects. Some side effects may be very serious. Some side effects may go away as your body adjusts to the medicine. Tell your healthcare provider if you have any side effects that continue or get worse.

Life-threatening (Report these to your healthcare provider right away. If you cannot reach your healthcare provider right away, get emergency medical care or call 911 for help.): Allergic reaction (hives; itching; rash; trouble breathing; chest pain or tightness in your chest; swelling of your lips, tongue, and throat); sudden weakness, numbness, or tingling, especially on one side of your body; sudden or severe headache; sudden trouble with vision, speech, balance, or walking.

Serious (Report these to your healthcare provider right away.): Seizures; increased thirst; increased urination; trouble urinating; extreme hunger; uncontrolled muscle movements; shaking; fever; sweating; stiff muscles; confusion; memory problems; swelling in the feet or legs; trouble standing or walking; severe dizziness or fainting; slow, fast, or irregular heartbeat; unexplained fever, sore throat, or cough; trouble swallowing or breathing; severe drowsiness.

Other: Drowsiness, tiredness, dizziness, restlessness, headache, constipation, dry mouth, stomach pain, weight gain, trouble sleeping, back pain, blurry vision.

What products might interact with this medicine?

When you take this medicine with other medicines, it can change the way this or any of the other medicines work. Nonprescription medicines, vitamins, natural remedies, and certain foods may also interact. Using these products together might cause harmful side effects. Talk to your healthcare provider if you are taking:

• ACE inhibitors such as benazepril (Lotensin), captopril, enalapril (Vasotec), fosinopril, lisinopril (Prinivil, Zestril), quinapril (Accupril), and ramipril (Altace)
• Alpha blockers such as alfuzosin (Uroxatral), doxazosin (Cardura), prazosin (Minipress), and terazosin
• Angiotensin receptor blockers (ARBs) such as azilsartan (Edarbi), candesartan (Atacand), eprosartan (Teveten), irbesartan (Avapro), losartan (Cozaar), olmesartan (Benicar), telmisartan (Micardis), and valsartan (Diovan)
• Antianxiety medicines such as alprazolam (Xanax), buspirone, clonazepam (Klonopin), clorazepate (Gen-Xene, Tranxene), diazepam (Valium), lorazepam (Ativan), and oxazepam
• Antibiotics such as clarithromycin (Biaxin), rifabutin (Mycobutin), rifampin (Rifadin), rifapentine (Priftin), and telithromycin (Ketek)
• Antidepressants such as amitriptyline, citalopram (Celexa), escitalopram (Lexapro), fluvoxamine (Luvox), imipramine (Tofranil), nefazodone, and nortriptyline (Pamelor)
• Antifungal medicines such as itraconazole (Sporanox), ketoconazole (Nizoral), posaconazole (Noxafil), and voriconazole (Vfend)
• Antipsychotic medicines such as asenapine (Saphris), chlorpromazine, clozapine (Clozaril, FazaClo), fluphenazine, haloperidol (Haldol), iloperidone (Fanapt), paliperidone (Invega), perphenazine, pimozide (Orap), quetiapine (Seroquel), thioridazine, trifluoperazine, and ziprasidone (Geodon)
• Antiseizure medicines such as carbamazepine (Carbatrol, Epitol, Equetro, Tegretol), phenobarbital, phenytoin (Dilantin, Phenytek), and primidone (Mysoline)
• Antiviral medicines such as ombitasvir/paritaprevir/ritonavir/dasabuvir (Viekira) and ombitasvir/paritaprevir/ritonavir (Technivie)
• Beta blockers such as acebutolol (Sectral), atenolol (Tenormin), bisoprolol (Zebeta), carvedilol (Coreg), labetalol (Trandate), metoprolol (Lopressor, Toprol), nadolol (Corgard), nebivolol (Bystolic), pindolol, and sotalol (Betapace, Sorine)
• Calcium channel blockers such as diltiazem (Cardizem, Cartia, Tiazac), felodipine, isradipine (DynaCirc), nicardipine (Cardene), nifedipine (Adalat CC, Procardia), and verapamil (Calan, Covera, Verelan)
• Cancer medicines such as ceritinib (Zykadia), enzalutamide (Xtandi), idelalisib (Zydelig), and mitotane (Lysodren)
• Clonidine (Catapres, Kapvay)
• Conivaptan (Vaprisol)
• Cough, cold, or allergy medicines such as chlorpheniramine (Chlor-Trimeton) and diphenhydramine (Benadryl)
• Diuretics (water pills) such as amiloride, bumetanide, chlorothiazide (Diuril), furosemide (Lasix), hydrochlorothiazide (Microzide), spironolactone (Aldactone), torsemide (Demadex), and triamterene (Dyrenium)
• Doxepin (Silenor)
• HIV medicines such as atazanavir (Reyataz), cobicistat (Tybost), darunavir (Prezista), elvitegravir/cobicistat/emtricitabine/tenofovir (Stribild), indinavir (Crixivan), lopinavir/ritonavir (Kaletra), nelfinavir (Viracept), ritonavir (Norvir), and saquinavir (Invirase)
• Lumacaftor/ivacaftor (Orkambi)
• MAO inhibitors such as isocarboxazid (Marplan), phenelzine (Nardil), selegiline (Eldepryl, Emsam, Zelapar), and tranylcypromine (Parnate) (Do not take this medicine and an MAO inhibitor within 14 days of each other.)
• Muscle relaxants such as baclofen (Gablofen, Lioresal), carisoprodol (Soma), cyclobenzaprine (Amrix), methocarbamol (Robaxin), orphenadrine (Norflex), and tizanidine (Zanaflex)
• Natural remedies such as gotu kola, kava, St. John's wort, and valerian
• Pain medicines such as codeine, fentanyl (Abstral, Actiq, Duragesic, Fentora, Sublimaze), hydrocodone (Hysingla, Zohydro), hydromorphone (Dilaudid, Exalgo), meperidine (Demerol), methadone (Dolophine, Methadose), morphine (Kadian, MS Contin), oxycodone (OxyContin, Roxicodone), oxycodone/acetaminophen (Percocet, Roxicet), pentazocine (Talwin), tapentadol (Nucynta), and tramadol (ConZip, Ultram)
• Propranolol (Hemangeol, Inderal, InnoPran)
• Sleeping pills such as butabarbital (Butisol), flurazepam, temazepam (Restoril), triazolam (Halcion), zaleplon (Sonata), and zolpidem (Ambien, Edluar, Intermezzo)

Do not drink alcohol while you are taking this medicine.

If you are not sure if your medicines might interact, ask your pharmacist or healthcare provider. Keep a list of all your medicines with you. List all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take. Be sure that you tell all healthcare providers who treat you about all the products you are taking.

How should I store this medicine?

Store this medicine at room temperature. Keep the container tightly closed. Protect it from heat, high humidity, and bright light.

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This advisory includes selected information only and may not include all side effects of this medicine or interactions with other medicines. Ask your healthcare provider or pharmacist for more information or if you have any questions.

Ask your pharmacist for the best way to dispose of outdated medicine or medicine you have not used. Do not throw medicine in the trash.

Keep all medicines out of the reach of children.

Do not share medicines with other people.