Brexpiprazole, Oral

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KEY POINTS

• This medicine is taken by mouth to treat symptoms of schizophrenia and depression. Take it exactly as directed.
• This medicine may increase suicidal thoughts or actions in some people. It may also increase the risk of death in older adults with dementia.
• 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

Generic and brand names: brexpiprazole, oral; Rexulti

What is this medicine used for?

This medicine is taken by mouth to treat the symptoms of schizophrenia. It may be used along with other medicines to treat major depression.

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 or blood vessel disease or a heart attack
• High cholesterol or high triglycerides
• High or low blood pressure
• Lactose intolerance (The tablets contain lactose.)
• Liver or kidney problems
• Problems with dehydration
• Seizures
• Severe depression or thoughts of suicide
• Trouble swallowing

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. You and your healthcare provider should decide if you will take this medicine or breastfeed.

How do I use it?

Read the Medication Guide that comes in the medicine package when you start taking this medicine and each time you get a refill.

Check the label on the medicine for directions about your specific dose. Take this medicine exactly as your healthcare provider prescribes. Do not take more or less or take it longer than prescribed. Continue to take this medicine even if you feel better. 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. Taking it with meals may lessen the chance the drug will upset your stomach.

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 double doses. 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: fast, slow, or irregular heartbeat, nausea, vomiting, tremor, drowsiness, fainting, trouble breathing, confusion, seizures.

What should I watch out for?

Antidepressant medicines may increase suicidal thoughts or actions, especially in some children, teenagers, and young adults. This may happen within the first few months of treatment or when the dose changes. Call your healthcare provider right away if you notice: new or increased thoughts of suicide, or changes in mood or behavior such as becoming depressed, irritable, or anxious.

Older adults with dementia are at greater risk for severe side effects or death if they take this medicine. 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 or take other medicines unless your healthcare provider approves.

You may feel dizzy or faint when you get up quickly after sitting or lying down. Getting up slowly may help.

This medicine may cause dizziness, drowsiness, or blurred vision. Do not drive or operate machinery until you are fully alert and can see clearly.

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 also cause you to gain weight. Talk with your healthcare provider about this.

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.

You may need to have blood tests regularly and checkups while taking this medicine. Keep all appointments.

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 developing 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; 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.): Chest pain; high fever; heavy sweating; sore throat; cough; trouble breathing; irregular or fast heartbeat; severe dizziness or fainting; loss of balance; movements that you can’t control; muscle twitching, shaking, or stiffness; seizures; symptoms of high blood sugar (confusion, shaking, weakness, strong hunger, urinating more than usual, nausea, breath that smells fruity); thoughts of suicide; new or sudden changes in mood or behavior; new or worsening depression; confusion; ongoing or severe trouble sleeping; trouble swallowing or speaking; vision changes; unusual drowsiness, tiredness, or weakness.

Other: Headache, pain at the spot where an injection has been given, weakness, trouble sleeping, nausea, diarrhea, drowsiness, constipation, lightheadedness, dizziness, restlessness, runny nose, increased or decreased appetite, dry mouth, drooling, weight gain, muscle or joint pain.

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 captopril, enalapril (Vasotec), lisinopril (Prinivil, Zestril), ramipril (Altace), and others
• Alpha blockers such as alfuzosin (Uroxatral), doxazosin (Cardura), prazosin (Minipress), and terazosin
• Angiotensin receptor blockers (ARBs) such as candesartan (Atacand), irbesartan (Avapro), losartan (Cozaar), valsartan (Diovan), and others
• Antianxiety medicines such as alprazolam (Xanax), buspirone, diazepam (Valium), lorazepam (Ativan), and others
• Antibiotics such as clarithromycin (Biaxin), isoniazid, rifampin (Rifadin), telithromycin (Ketek), and others
• Antidepressants such as fluoxetine (Prozac), fluvoxamine (Luvox), imipramine (Tofranil), nefazodone, and others
• Antifungal medicines such as fluconazole (Diflucan), itraconazole (Sporanox), ketoconazole (Nizoral), voriconazole (Vfend), and others
• Antihistamines such as azelastine (Astelin, Astepro), chlorpheniramine (Chlor-Trimeton), diphenhydramine (Benadryl), hydroxyzine (Vistaril), and others
• Antiseizure medicines such as carbamazepine (Carbatrol, Epitol, Equetro, Tegretol), phenobarbital, phenytoin (Dilantin, Phenytek), primidone (Mysoline), and others
• Antiviral medicines such as ombitasvir/paritaprevir/ritonavir/dasabuvir (Viekira) and ombitasvir/paritaprevir/ritonavir (Technivie)
• Beta blockers such as atenolol (Tenormin), carvedilol (Coreg), metoprolol (Lopressor, Toprol), sotalol (Betapace, Sorine), and others
• Bosentan (Tracleer)
• Bupropion (Aplenzin, Forfivo, Wellbutrin, Buproban, Zyban)
• Cancer medicines such as abiraterone (Zytiga), enzalutamide (Xtandi), imatinib (Gleevec), nilotinib (Tasigna), and others
• Celecoxib (Celebrex)
• Cimetidine (Tagamet)
• Cinacalcet (Sensipar)
• Clonidine (Catapres, Kapvay)
• Conivaptan (Vaprisol)
• Cyclosporine (Gengraf, Neoral, Sandimmune)
• Darifenacin (Enablex)
• Dexamethasone
• Diabetes medicines such as glipizide (Glucotrol), insulin, metformin (Fortamet, Glucophage, Riomet), pioglitazone (Actos), and others
• Diuretics (water pills) such as bumetanide, furosemide (Lasix), hydrochlorothiazide (Microzide), torsemide (Demadex), and others
• Doxepin (Silenor)
• Duloxetine (Cymbalta)
• Eliglustat (Cerdelga)
• Heart medicines such as amiodarone (Cordarone, Pacerone), diltiazem (Cardizem, Cartia, Tiazac), nicardipine (Cardene), quinidine, and others
• HIV medicines such as atazanavir (Reyataz), indinavir (Crixivan), lopinavir/ritonavir (Kaletra), ritonavir (Norvir), and others
• Lithium (Lithobid)
• Lorcaserin (Belviq)
• Lumacaftor/ivacaftor (Orkambi)
• Malaria medicines such as artemether/lumefantrine (Coartem), chloroquine, quinine, and others
• 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.)
• Metoclopramide (Metozolv, Reglan)
• Mifepristone (Korlym, Mifeprex)
• Migraine medicines such as dihydroergotamine (D.H.E. 45, Migranal), ergonovine, ergotamine (Ergomar), sumatriptan (Alsuma, Imitrex, Sumavel), and others
• Muscle relaxants such as cyclobenzaprine (Amrix), dantrolene (Dantrium), methocarbamol (Robaxin), tizanidine (Zanaflex), and others
• Natural remedies such as gotu kola, kava, St. John's wort, and valerian
• Nausea medicines such as aprepitant (Emend), netupitant/palonosetron (Akynzeo), and promethazine
• Other antipsychotic medicines such as chlorpromazine, haloperidol (Haldol), thioridazine, ziprasidone (Geodon), and others
• Pain medicines such as codeine, hydrocodone (Hysingla, Zohydro), oxycodone (OxyContin, Roxicodone), tramadol (ConZip, Ultram), and others
• Parkinson’s disease medicines such as apomorphine (Apokyn), bromocriptine (Cycloset, Parlodel), levodopa/carbidopa (Duopa, Rytary, Sinemet), ropinirole (Requip), and others
• Paroxetine (Brisdelle, Paxil, Pexeva)
• Propranolol (Hemangeol, Inderal, InnoPran)
• Sleeping pills such as temazepam (Restoril), triazolam (Halcion), zaleplon (Sonata), zolpidem (Ambien, Edluar, Intermezzo), and others
• Stimulants such as dextroamphetamine (Dexedrine), methamphetamine (Desoxyn), methylphenidate (Concerta, Daytrana, Metadate, Ritalin), modafinil (Provigil), and others
• Tetrabenazine (Xenazine)

Do NOT eat or drink products that contain grapefruit, Seville oranges, and tangelos at any time while you are taking this medicine. These fruits and juices affect the way this medicine works and increase your risk of serious side effects. Talk with your healthcare provider or pharmacist about this.

Do not drink alcohol while you are taking this medicine unless your healthcare provider approves.

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.

Keep all medicines out of the reach of children.

Do not share medicines with other people.