Abilify Maintena

This medication is given as an intramuscular (into the muscle) injection at your doctor's office or clinic once a month. The usual monthly dose is 400 mg. Your doctor may adjust this dose depending on how well you tolerate the medication. After the first injection of aripiprazole, you will need to continue taking aripiprazole tablets (or another oral antipsychotic) by mouth for 14 days until the aripiprazole injection has reached the right concentration in your body.

Many things can affect the dose of a 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 this medication be given exactly as recommended by your doctor. If you miss an appointment to receive aripiprazole injection, contact your doctor as soon as possible to reschedule your appointment.

Store this medication at room temperature, protect it from light, 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.

300 mg
Each vial or dual chamber syringe contains 300 mg of aripiprazole as a lyophilized powder for reconstitution. Nonmedicinal ingredients:** **carboxymethyl-cellulose-sodium, mannitol, sodium phosphate monobasic monohydrate, and sodium hydroxide. Diluent: sterile water for injection.

400 mg
Each vial or dual chamber syringe contains 400 mg of aripiprazole as a lyophilized powder for reconstitution. Nonmedicinal ingredients:** carboxymethyl-cellulose-sodium, mannitol, sodium phosphate monobasic monohydrate, and sodium hydroxide. Diluent: sterile water for injection.

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

• anxiety

• constipation

• diarrhea

• dizziness

• drowsiness

• hair loss

• headache

• hiccups

• increased frequency of colds

• nausea

• pain at the injection site

• restlessness

• skin rash (on its own)

• sleep walking or eating while asleep

• sweating

• tremors

• trouble sleeping

• vomiting

• weight changes

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:

• difficulty speaking

• difficulty swallowing

• dizziness when rising from a sitting or lying position

• impulsive behaviour (e.g., gambling, binge eating, spending)

• movement problems (abnormal body movements, restlessness, shaking, or stiffness)

• muscle twitching or abnormal movements of the face or tongue

• signs of liver problems (e.g., nausea, vomiting, diarrhea, loss of appetite, weight loss, yellowing of the skin or whites of the eyes, dark urine, pale stools)

• sleep apnea (interruption of breathing 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)

• uncontrollable and/or inappropriate sexual thoughts or behaviour

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 severe allergic reaction (hives; difficulty breathing; difficulty swallowing; swelling of the face, mouth, throat, or tongue)

• symptoms of a severe skin reaction (e.g., fever, rash, hives, yellowing skin or eyes, swelling of the legs, chest pain, dark urine)

• 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.

Before you begin taking 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 take 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.

**Alcohol and other medications that cause drowsiness: **Do not combine this medication with alcohol or other medications (e.g., antidepressants, sleeping pills, anxiety medications) that cause drowsiness since additional drowsiness can occur and be dangerous.

Blood clots: This medication may increase the chance of blood clot formation, causing reduced 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: Aripiprazole, 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.

**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, see your doctor; if you notice compulsive behaviour in a family member taking this medication, ensure that they see their doctor.

Diabetes: Aripiprazole 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: Aripiprazole may cause drowsiness or lightheadedness, which could interfere with your ability to do activities requiring alertness, such as driving a car. It can also impair judgement. Avoid these activities if the medication affects you in this way. Avoid alcohol while taking aripiprazole as it may increase your drowsiness.

Hypersensitivity reaction: A serious allergic skin reaction called hypersensitivity syndrome has been reported by some people using aripiprazole. This type of reaction can affect organ function and should be treated as an emergency. Get immediate medical attention if you have symptoms of a severe allergic reaction, including fever, swollen glands, yellowing of the skin or eyes, or flu-like symptoms with skin rash or blistering.

Infection: Aripiprazole 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.

Low blood pressure: Some people taking aripiprazole 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, "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.

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: People taking aripiprazole have had 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 have 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 aripiprazole 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 involuntary, uncontrolled body movements. This syndrome may be irreversible. If you develop uncontrolled or unusual body movements or muscle twitching, 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.

Breast-feeding: This medication passes into breast milk. If you are a breast-feeding mother and are taking aripiprazole, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

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

**Seniors: **Seniors taking this medication for dementia-related psychosis have a higher risk of strokes and death compared to seniors who are not taking the medication. Aripiprazole is not approved or recommended for seniors for this purpose.

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

• abiraterone

• alcohol

• alpha-agonists (e.g., clonidine, methyldopa)

• alpha-blockers (e.g., alfuzosin, doxazosin, tamsulosin)

• 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)

• anti-Parkinson medications (e.g., amantadine, apomorphine, bromocriptine, levodopa, pramipexole, ropinirole, rotigotine)

• anti-psychotics (e.g., chlorpromazine, clozapine, haloperidol, olanzapine, quetiapine, risperidone)

• apalutamide

• aprepitant

• azelastine

• "azole" antifungals (e.g., fluconazole, ketoconazole, voriconazole)

• barbiturates (e.g., butalbital, pentobarbital, phenobarbital)

• benzodiazepines (e.g., alprazolam, diazepam, lorazepam)

• beta-adrenergic blockers (e.g., atenolol, propranolol, sotalol)

• bicalutamide

• bosentan

• brimonidine

• buprenorphine

• bupropion

• calcium channel blockers (e.g., amlodipine, diltiazem, nifedipine, verapamil)

• cannabis

• chloral hydrate

• cinacalcet

• cobicistat

• conivaptan

• darifenacin

• deferasirox

• diabetes medications (e.g., glyburide, insulin, metformin, rosiglitazone)

• diuretics (water pills; e.g., furosemide, hydrochlorothiazide, triamterene)

• donepezil

• dronedarone

• eliglustat

• entacapone

• enzalutamide

• everolimus

• galantamine

• general anesthetics (medications used to put people to sleep before surgery)

• grapefruit juice

• hepatitis C antivirals (e.g., asunaprevir, ombitasvir, paritaprevir)

• HIV non-nucleoside reverse transcriptase inhibitors (e.g., efavirenz, etravirine)

• HIV protease inhibitors (e.g., atazanavir, indinavir, ritonavir, saquinavir)

• lithium

• lumacaftor and ivacaftor

• macrolide antibiotics (e.g., clarithromycin, erythromycin)

• MAO inhibitors (e.g., moclobemide, selegiline, tranylcypromine, phenelzine)

• methadone

• methylphenidate

• metoclopramide

• mifepristone

• mirabegron

• mirtazapine

• mitotane

• modafinil

• muscle relaxants (e.g., baclofen, cyclobenzaprine, methocarbamol, orphenadrine)

• nabilone

• narcotic pain relievers (e.g., codeine, fentanyl, morphine, oxycodone)

• protein kinase inhibitors (e.g., ceritinib, dabrafenib, idelalisib, imatinib, lapatinib, nilotinib, pazopanib)

• quinidine

• quinine

• rifabutin

• rifampin

• rivastigmine

• 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/norepinephrine reuptake inhibitors (SNRIs; e.g., desvenlafaxine, duloxetine, venlafaxine)

• siltuximab

• sodium oxybate

• suvorexant

• tapentadol

• terbinafine

• tetrabenazine

• thalidomide

• tocilizumab

• tramadol

• trazodone

• tricyclic antidepressants (e.g., clomipramine, desipramine, imipramine)

• "triptan" migraine medications (e.g., naratriptan, sumatriptan)

• 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/Abilify-Maintena