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Rexulti

(brexpiprazole)

How does this medication work? What will it do for me?

Brexpiprazole belongs to the group of medications known as antipsychotics. It is used to treat adults with schizophrenia.

Brexpiprazole may also be used in addition to antidepressants to treat major depressive disorder for adults who have not had enough of a response from other treatments.

Brexpiprazole does not cure these conditions, but helps to manage symptoms by affecting the actions of certain chemical messengers in the brain.

This medication may be available under multiple brand names and/or in several different forms. Any specific brand name of this medication may not be available in all of the forms or approved for all of the conditions discussed here. As well, some forms of this medication may not be used for all of the conditions discussed here.

Your doctor may have suggested this medication for conditions other than those listed in these drug information articles. If you have not discussed this with your doctor or are not sure why you are taking this medication, speak to your doctor. Do not stop taking this medication without consulting your doctor.

Do not give this medication to anyone else, even if they have the same symptoms as you do. It can be harmful for people to take this medication if their doctor has not prescribed it.

How should I use this medication?

For schizophrenia, the recommended starting dose of brexpiprazole is 1 mg taken by mouth once daily for 4 days. On day 5 to day 7, the dose should be increased to 2 mg once daily. After day 7, your doctor may increase your dose up to 4 mg taken by mouth once daily, if you are tolerating the medication.

For major depressive disorder, the recommended starting dose of brexpiprazole is 0.5 mg to 1 mg taken by mouth once daily. After 7 days your doctor may increase your dose to the maximum dose of 2 mg once daily, depending on how well you are tolerating and responding to the medication.

Brexpiprazole may be taken with or without food.

Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.

It is important to take this medication exactly as prescribed by your doctor. If you miss a dose, take it as soon as possible and continue with your regular schedule. If it is almost time for your next dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.

Store this medication at room temperature, protect it from light and moisture, and keep it out of the reach of children.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

What form(s) does this medication come in?

0.25 mg
Each light brown, film-coated, round, shallow convex, bevelled-edged tablet with the markings "BRX" and "0.25" contains 0.25 mg of brexpiprazole. Nonmedicinal ingredients: lactose monohydrate, corn starch, microcrystalline cellulose, hydroxypropyl cellulose, low-substituted hydroxypropyl cellulose, magnesium stearate, hypromellose, talc, titanium dioxide, ferric oxide yellow, ferric oxide red, and ferrosoferric oxide.

0.5 mg
Each light orange, film-coated, round, shallow convex, bevelled-edged tablet with the markings "BRX" and "0.5" contains 0.5 mg of brexpiprazole. Nonmedicinal ingredients: lactose monohydrate, corn starch, microcrystalline cellulose, hydroxypropyl cellulose, low-substituted hydroxypropyl cellulose, magnesium stearate, hypromellose, talc, titanium dioxide, ferric oxide yellow, and ferric oxide red.

1 mg
Each light yellow, film-coated, round, shallow convex, bevelled-edged tablet with the markings "BRX" and "1" contains 1 mg of brexpiprazole. Nonmedicinal ingredients: lactose monohydrate, corn starch, microcrystalline cellulose, hydroxypropyl cellulose, low-substituted hydroxypropyl cellulose, magnesium stearate, hypromellose, talc, titanium dioxide, and ferric oxide yellow.

2 mg
Each light green, film-coated, round, shallow convex, bevelled-edged tablet with the markings "BRX" and "2" contains 2 mg of brexpiprazole. Nonmedicinal ingredients: lactose monohydrate, corn starch, microcrystalline cellulose, hydroxypropyl cellulose, low-substituted hydroxypropyl cellulose, magnesium stearate, hypromellose, talc, titanium dioxide, ferric oxide yellow, and ferrosoferric oxide.

3 mg
Each light purple, film-coated, round, shallow convex, bevelled-edged tablet with the markings "BRX" and "3" contains 3 mg of brexpiprazole. Nonmedicinal ingredients: lactose monohydrate, corn starch, microcrystalline cellulose, hydroxypropyl cellulose, low-substituted hydroxypropyl cellulose, magnesium stearate, hypromellose, talc, titanium dioxide, ferric oxide red, and ferrosoferric oxide.

4 mg
Each white, film-coated, round, shallow convex, bevelled-edged tablet with the markings "BRX" and "4" contains 4 mg of brexpiprazole. Nonmedicinal ingredients: lactose monohydrate, corn starch, microcrystalline cellulose, hydroxypropyl cellulose, low-substituted hydroxypropyl cellulose, magnesium stearate, hypromellose, talc, and titanium dioxide.

Who should not take this medication?

Do not take this medication if you are allergic to brexpiprazole or any ingredients of the medication.

Who should NOT take this medication?

Do not take this medication if you are allergic to brexpiprazole or any ingredients of the medication.

What side effects are possible with this medication?

Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.

The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.

The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

  • back or muscle pain
  • cold-like symptoms (e.g., runny nose, sore throat, stuffy nose)
  • diarrhea
  • drowsiness
  • dry mouth
  • fatigue
  • headache
  • heartburn
  • increased appetitie
  • new or worsening constipation
  • nasal stuffiness
  • restlessness
  • skin rash
  • stomach pain
  • tremors
  • trouble sleeping
  • weakness
  • weight gain

Although most of the side effects listed below don't happen very often, they could lead to serious problems if you do not seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

  • anxiety
  • difficulty swallowing
  • dizziness when rising from a sitting or lying position
  • muscle twitching or abnormal movements of the face or tongue
  • signs of muscle damage (e.g., unexplained muscle pain, tenderness or weakness, or brown or discoloured urine)
  • sleep apnea (episodes of stopped breathing while sleeping)
  • sleepwalking or eating while asleep
  • symptoms of an infection (e.g., sore throat, fever, chills, cough)
  • symptoms of high blood sugar (excessive thirst or hunger, excessive urination, weight loss, tiredness)

Stop taking the medication and seek immediate medical attention if any of the following occur:

  • long-lasting (greater than 4 hours) and painful erection of the penis
  • seizures
  • signs of a blood clot in blood vessels, such as chest pain, abnormal heart rhythm, pain and swelling in one leg muscle
  • signs of stroke (e.g., sudden weakness or numbness of the face, arms, or legs and speech or vision problems)
  • symptoms of a hypersensitivity reaction (e.g., fever, rash, peeling skin, facial swelling, flu-like symptoms, swollen glands, shortness of breath, yellow skin or eyes, leg swelling, dry cough, chest pain, thirst, decreased urination)
  • symptoms of a severe allergic reaction (hives; difficulty breathing; difficulty swallowing; swelling of the face, mouth, throat, or tongue)
  • thoughts of suicide or self-harm
  • very stiff muscles with high fever, rapid or irregular heartbeat, sweating, confusion, or reduced consciousness

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.

Are there any other precautions or warnings for this medication?

Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.

Abnormal heart rhythms: This medication can cause an abnormal heart rhythm problem called QT prolongation. If you have a history of QT prolongation, slow or irregular heartbeat, irregular heart rhythm, heart failure, heart attack, heart disease, are taking other medications known to cause QT prolongation, or have a family history of sudden cardiac death at less than 50 years of age, discuss with your doctor how this medication may affect your medical condition, or how your medical condition may affect the dosing and effectiveness of this medication. Your doctor will perform tests at regular intervals to monitor for any changes in your heart rhythm.

Blood clots: This medication may increase the chance of blood clot formation, causing reduction of blood flow to organs or the extremities.

If you have a history of clotting you may be at increased risk of experiencing blood clot-related problems such as heart attack, stroke, or clots in the deep veins of your leg. Discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

If you experience symptoms such as sharp pain and swelling in the leg, difficulty breathing, chest pain, blurred vision, or difficulty speaking, contact your doctor immediately.

Body temperature: Brexpiprazole, like other antipsychotic medications, may interfere with your body's ability to regulate body temperature. People who exercise vigorously, who are exposed to extreme heat, are dehydrated, or are taking anticholinergic medications (e.g., benztropine, oxybutynin) are more at risk. Contact your doctor as soon as possible if you feel very hot and are unable to cool down.

Take care to avoid overheating during strenuous exercise or in hot temperatures, and avoid becoming dehydrated by drinking enough fluids.

Cholesterol: Brexpiprazole may cause increased levels of cholesterol and other lipids in the bloodstream. If you are at risk of developing high cholesterol or you have high cholesterol levels before starting this medication, discuss with your doctor whether any special monitoring is needed.

Compulsive behaviour: This medication has been known to cause changes in behaviour. People who have a history of a gambling disorder may be at an increased risk of compulsive gambling. You may notice other compulsive behaviours, such binge eating, increased or inappropriate sexual thoughts or urges, or inappropriate spending. If you experience any of these behaviours or urges or notice compulsive behaviour in a family member who is taking this medication, contact your doctor.

Diabetes: Brexpiprazole may increase blood sugar for people with diabetes or those who are at risk for diabetes. If you have diabetes, monitor your blood sugar frequently as recommended by your doctor. If you experience symptoms of high blood sugar (e.g., increased urination, increased thirst, increased eating, and weakness) while taking this medication, contact your doctor.

Drowsiness/reduced alertness: Brexpiprazole may cause drowsiness or lightheadedness, which could interfere with your ability to do activities requiring alertness, such as driving a car. Avoid these activities if the medication affects you in this way. Avoid alcohol while taking brexpiprazole as it may increase your drowsiness.

Hypersensitivity reaction: Several severe allergic reactions have been reported by people taking brexpiprazole. These rare reactions often start with a skin reaction, such as a severe rash. Get immediate medical attention if you have symptoms of a severe allergic reaction, including fever, swollen glands, yellowing of the skin or eyes, decreased urination, or flu-like symptoms with skin rash or blistering.

Infection: Brexpiprazole can reduce the number of cells that fight infection in the body (white blood cells). If you experience an increase in the number of colds or other infections, talk to your doctor.

Kidney function: People with decreased kidney function may require lower doses of this medication. If you have kidney problems, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Lactose: This medication contains lactose and should not be taken by people with rare problems of galactose intolerance or problems absorbing glucose or galactose.

Low blood pressure: Some people taking brexpiprazole may experience sudden blood pressure drops when getting up from a sitting or lying position. These blood pressure drops could lead to dizziness, lightheadedness, and falls. If you experience this problem, try getting up more slowly. If it persists or if you faint, contact your doctor.

If you have or have had heart disease, stroke, or "mini-stroke," or are at risk of experiencing low blood pressure (e.g., dehydration, taking medications for high blood pressure), discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Liver function: Liver disease or reduced liver function may cause this medication to build up in the body, causing side effects. If you have liver problems, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed. Your doctor may want to test your liver function regularly with blood tests while you are taking this medication.

Neuroleptic malignant syndrome (NMS): This medication may cause a potentially fatal reaction called neuroleptic malignant syndrome (NMS). If you develop symptoms of NMS, such as muscle stiffness, fever, confusion, sweating, or irregular heartbeat, stop taking this medication and seek immediate medical attention.

Seizures: Some people taking brexpiprazole have experienced seizures. If you have a history of seizures, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed. If you experience a seizure while taking this medication, get immediate medical attention.

Suicidal or agitated behaviour: People taking this medication may feel agitated (restless, anxious, aggressive, emotional, and feeling not like themselves), or they may want to hurt themselves or others. These symptoms may occur within several weeks after starting this medication. If you experience these side effects or notice them in a family member who is taking this medication, contact your doctor immediately. You should be closely monitored by your doctor for emotional and behaviour changes while taking this medication.

Swallowing problems: People taking brexpiprazole may have difficulty swallowing. People taking this or other antipsychotic medications should be closely monitored by their doctor for swallowing problems while they are using this medication. If you experience difficulty swallowing while taking this medication, contact your doctor.

Tardive dyskinesia: People taking this medication may develop tardive dyskinesia, a syndrome of uncontrolled body movements. This syndrome may be irreversible. If you develop uncontrolled or unusual body movements, contact your doctor as soon as possible.

Pregnancy: This medication should not be used during pregnancy unless the benefits outweigh the risks. If you become pregnant while taking this medication, contact your doctor immediately.

If you take this medication in the last 3 months of pregnancy, your baby may experience withdrawal symptoms after they are born, including breathing problems, difficulty feeding, or irritability. If you have been taking this medication during pregnancy, make sure you let everyone involved in caring for you and your baby know.

Breast-feeding: It is not known if this medication passes into breast milk. If you are breast-feeding and are taking brexpiprazole, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

Children: The safety and effectiveness of brexpiprazole have not been established for children less than 18 years of age.

Seniors: Seniors taking similar medications for dementia-related psychosis have a higher risk of stroke and death compared to seniors who are not taking the medication. Brexpiprazole is not approved for use by seniors with dementia-related psychosis.

What other drugs could interact with this medication?

There may be an interaction between brexpiprazole and any of the following:

  • abiraterone acetate
  • acetylcholinesterase inhibitors (e.g., donepezil, galantamine, rivastigmine)
  • alcohol
  • alpha agonists (e.g., clonidine, methyldopa)
  • amiodarone
  • amphetamines (e.g., dextroamphetamine, lisdexamfetamine)
  • angiotensin converting enzyme inhibitors (ACEIs; captopril, ramipril)
  • angiotensin receptor blockers (ARBs; e.g., candesartan, irbesartan, losartan)
  • antihistamines (e.g., cetirizine, doxylamine, diphenhydramine, hydroxyzine, loratadine)
  • antimalarial medications (e.g., chloroquine, quinine)
  • anti-Parkinson medications (e.g., amantadine, apomorphine, bromocriptine, levodopa, pramipexole, ropinirole)
  • anti-psychotics (e.g., chlorpromazine, clozapine, haloperidol, olanzapine, quetiapine, risperidone)
  • apalutamide
  • aprepitant
  • azelastine
  • "azole" antifungals (e.g., itraconazole, ketoconazole, voriconazole)
  • barbiturates (e.g., butalbital, pentobarbital, phenobarbital)
  • benzodiazepines (e.g., alprazolam, diazepam, lorazepam)
  • beta-adrenergic blockers (e.g., atenolol, propranolol, sotalol)
  • bosentan
  • brimonidine
  • bromocriptine
  • buprenorphine
  • bupropion
  • buspirone
  • cabergoline
  • calcium channel blockers (e.g., amlodipine, diltiazem, nifedipine, verapamil)
  • cannabis
  • chloral hydrate
  • chloroquine
  • cinacalcet
  • cladribine
  • cobicistat
  • conivaptan
  • darifenacin
  • dexmethylphenidate
  • diabetes medications (e.g., acarbose, canagliflozin, chlorpropamide, glyburide, insulin, linagliptin, lixisenatide, metformin, rosiglitazone)
  • diuretics (water pills; e.g., furosemide, hydrochlorothiazide, triamterene)
  • domperidone
  • dronedarone
  • entacapone
  • enzalutamide
  • eplerenone
  • ergot alkaloids (e.g., ergotamine, dihydroergotamine)
  • esketamine
  • grapefruit juice
  • HIV non-nucleoside reverse transcriptase inhibitors (NNRTIs; e.g., efavirenz, etravirine, nevirapine)
  • HIV protease inhibitors (e.g., atazanavir, indinavir, ritonavir, saquinavir)
  • hydralazine
  • iron sucrose
  • lithium
  • lemborexant
  • linezolid
  • lithium
  • lumacaftor and ivacaftor
  • macrolide antibiotics (e.g., clarithromycin, erythromycin)
  • methadone
  • methylphenidate
  • metoclopramide
  • mifepristone
  • mirabegron
  • mirtazapine
  • mitotane
  • modafinil
  • monoamine oxidase inhibitors (MAOIs; e.g., moclobemide, rasagiline, selegiline, tranylcypromine)
  • muscle relaxants (e.g., baclofen, cyclobenzaprine, methocarbamol, orphenadrine)
  • nabilone
  • narcotic pain relievers (e.g., codeine, fentanyl, morphine, oxycodone, tapentadol, tramadol)
  • nilotinib
  • nitrates (e.g., isosorbide dinitrate, isosorbide mononitrate, nitroglycerine)
  • obinutuzumab
  • paclitaxel
  • pomalidomide
  • protein kinase inhibitors (e.g., ceritinib, crizotinib, dabrafenib, dasatinib, imatinib, nilotinib)
  • proton pump inhibitors (e.g., lansoprazole, omeprazole)
  • quinidine
  • quinolone antibiotics (e.g., ciprofloxacin, moxifloxacin, norfloxacin)
  • rifabutin
  • rifampin
  • rotigotine
  • sacubitril
  • St. John's wort
  • scopolamine
  • seizure medications (e.g., carbamazepine, clobazam, levetiracetam, phenobarbital, phenytoin, primidone, topiramate, valproic acid, zonisamide)
  • selective serotonin reuptake inhibitors (SSRIs; e.g., citalopram, fluoxetine, paroxetine, sertraline)
  • serotonin antagonists (anti-emetic medications; e.g., granisetron, ondansetron)
  • serotonin/norepinephrine reuptake inhibitors (SNRIs; e.g., desvenlafaxine, duloxetine, venlafaxine)
  • terbinafine
  • tetrabenazine
  • thalidomide
  • tocilizumab
  • trazodone
  • tricyclic antidepressants (e.g., clomipramine, desipramine, imipramine)
  • tryptophan
  • zolpidem
  • zopiclone

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

  • stop taking one of the medications,
  • change one of the medications to another,
  • change how you are taking one or both of the medications, or
  • leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with this medication. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

All material copyright MediResource Inc. 1996 – 2024. Terms and conditions of use. The contents herein are for informational purposes only. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition. Source: www.medbroadcast.com/drug/getdrug/Rexulti

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