Description and Brand Names

US Brand Name

1. Abilify
2. Abilify Asimtufii
3. Abilify Maintena

Descriptions

Aripiprazole injection is used to treat agitation caused by schizophrenia or bipolar mania.

Aripiprazole extended-release injection is used to treat schizophrenia (a mental disorder) and bipolar disorder (manic-depressive illness). It works in the brain to change how certain chemicals affect patients. Aripiprazole is an antipsychotic agent.

This medicine is to be given only by or under the immediate supervision of your doctor.

This product is available in the following dosage forms:

• Powder for Suspension, Extended Release
• Suspension, Extended Release

Before Using

Drug information provided by: Merative, Micromedex®

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.

Pediatric

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

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of this medicine in elderly patients. However, elderly patients are more likely to have age-related liver, kidney, or heart problems, which may require caution and an adjustment in the dose for patients receiving aripiprazole injection. This medicine should not be used to treat behavioral problems in elderly patients who have dementia or Alzheimer disease.

Breastfeeding

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.

Drug Interactions

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 receiving 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.

• Bepridil
• Bromopride
• Cisapride
• Dronedarone
• Fluconazole
• Ketoconazole
• Levoketoconazole
• Mavorixafor
• Mesoridazine
• Metoclopramide
• Pimozide
• Piperaquine
• Posaconazole
• Saquinavir
• Sparfloxacin
• Terfenadine
• Thioridazine
• Ziprasidone

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.

• Abametapir
• Abiraterone Acetate
• Adagrasib
• Alfentanil
• Alfuzosin
• Alprazolam
• Amiodarone
• Amisulpride
• Amitriptyline
• Anagrelide
• Apalutamide
• Apomorphine
• Arsenic Trioxide
• Asenapine
• Astemizole
• Atazanavir
• Avacopan
• Azithromycin
• Bedaquiline
• Bentazepam
• Benzhydrocodone
• Boceprevir
• Bromazepam
• Buprenorphine
• Bupropion
• Buserelin
• Butalbital
• Butorphanol
• Calcium Oxybate
• Cannabidiol
• Cannabis
• Carbamazepine
• Celecoxib
• Ceritinib
• Cetirizine
• Chlordiazepoxide
• Chloroquine
• Chlorpromazine
• Ciprofloxacin
• Citalopram
• Clarithromycin
• Clobazam
• Clofazimine
• Clomipramine
• Clonazepam
• Clorazepate
• Clothiapine
• Cloxazolam
• Clozapine
• Cobicistat
• Codeine
• Conivaptan
• Crizotinib
• Cyclobenzaprine
• Dabrafenib
• Daridorexant
• Darunavir
• Dasatinib
• Degarelix
• Delamanid
• Delorazepam
• Desipramine
• Deslorelin
• Desvenlafaxine
• Deutetrabenazine
• Dexmedetomidine
• Diazepam
• Dihydrocodeine
• Disopyramide
• Dofetilide
• Dolasetron
• Domperidone
• Donepezil
• Doxepin
• Doxylamine
• Droperidol
• Duloxetine
• Ebastine
• Efavirenz
• Encorafenib
• Entrectinib
• Enzalutamide
• Eribulin
• Erythromycin
• Escitalopram
• Esketamine
• Estazolam
• Etrasimod
• Famotidine
• Fedratinib
• Felbamate
• Fentanyl
• Fexinidazole
• Fingolimod
• Flecainide
• Flibanserin
• Flunitrazepam
• Fluoxetine
• Flurazepam
• Formoterol
• Foscarnet
• Fosnetupitant
• Fosphenytoin
• Fostemsavir
• Gabapentin
• Gabapentin Enacarbil
• Galantamine
• Gatifloxacin
• Gemifloxacin
• Gepirone
• Givinostat
• Glasdegib
• Gonadorelin
• Goserelin
• Granisetron
• Halazepam
• Halofantrine
• Haloperidol
• Histrelin
• Hydrocodone
• Hydromorphone
• Hydroquinidine
• Hydroxychloroquine
• Hydroxyzine
• Ibutilide
• Idelalisib
• Iloperidone
• Imipramine
• Indinavir
• Inotuzumab Ozogamicin
• Itraconazole
• Ivabradine
• Ivosidenib
• Josamycin
• Ketamine
• Ketazolam
• Lacosamide
• Lapatinib
• Lefamulin
• Lemborexant
• Lenvatinib
• Leuprolide
• Levocetirizine
• Levofloxacin
• Levorphanol
• Lofexidine
• Lonafarnib
• Lopinavir
• Loprazolam
• Lorazepam
• Lormetazepam
• Loxapine
• Lumacaftor
• Lumefantrine
• Macimorelin
• Magnesium Oxybate
• Mavacamten
• Medazepam
• Mefloquine
• Meperidine
• Metaclazepam
• Methadone
• Metronidazole
• Mibefradil
• Midazolam
• Mifepristone
• Mirtazapine
• Mitotane
• Mizolastine
• Mobocertinib
• Morphine
• Morphine Sulfate Liposome
• Moxifloxacin
• Nafarelin
• Nalbuphine
• Nefazodone
• Nelfinavir
• Netupitant
• Nilotinib
• Nitrazepam
• Nordazepam
• Norfloxacin
• Octreotide
• Ofloxacin
• Olanzapine
• Oliceridine
• Omaveloxolone
• Ondansetron
• Osilodrostat
• Osimertinib
• Oxaliplatin
• Oxazepam
• Oxycodone
• Oxymorphone
• Ozanimod
• Pacritinib
• Paliperidone
• Panobinostat
• Paroxetine
• Pasireotide
• Pazopanib
• Pentamidine
• Periciazine
• Perphenazine
• Phenobarbital
• Phenytoin
• Pimavanserin
• Pinazepam
• Pipamperone
• Pitolisant
• Ponesimod
• Potassium Oxybate
• Prazepam
• Pregabalin
• Primidone
• Probucol
• Procainamide
• Prochlorperazine
• Promethazine
• Propafenone
• Protriptyline
• Quazepam
• Quetiapine
• Quinidine
• Quinine
• Quizartinib
• Ranolazine
• Relugolix
• Remifentanil
• Remimazolam
• Ribociclib
• Rifampin
• Rifapentine
• Rilpivirine
• Risperidone
• Ritonavir
• Ropeginterferon Alfa-2b-njft
• Selpercatinib
• Sertindole
• Sertraline
• Sevoflurane
• Siponimod
• Sodium Oxybate
• Sodium Phosphate
• Sodium Phosphate, Dibasic
• Sodium Phosphate, Monobasic
• Solifenacin
• Sorafenib
• Sotalol
• St John’s Wort
• Sufentanil
• Sulpiride
• Sunitinib
• Tacrolimus
• Tamoxifen
• Tapentadol
• Telaprevir
• Telavancin
• Telithromycin
• Temazepam
• Terbinafine
• Tetrabenazine
• Tetrazepam
• Tolterodine
• Topiramate
• Toremifene
• Tramadol
• Trazodone
• Triazolam
• Triclabendazole
• Trimipramine
• Triptorelin
• Troleandomycin
• Tucatinib
• Vandetanib
• Vardenafil
• Vemurafenib
• Venlafaxine
• Vilanterol
• Vinflunine
• Voclosporin
• Voriconazole
• Vorinostat
• Zolpidem
• Zuclopenthixol
• Zuranolone

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. 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 is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

• Grapefruit Juice

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 disease or
• Dehydration or
• Heart attack or stroke, history of or
• Heart disease or
• Heart failure, history of or
• Heart rhythm problems or
• Hypotension (low blood pressure) or
• Hypovolemia (decrease in the volume of blood) or
• Ischemic heart disease, history of or
• Trouble with swallowing—Use with caution. May cause side effects to become worse.

• Depression or
• Diabetes, or family history of or
• Dyslipidemia (high cholesterol or fats in the blood) or
• Hyperglycemia (high blood sugar) or
• Neuroleptic malignant syndrome (NMS), history of or
• Neutropenia (low white blood cells) or
• Reduced white blood cell count, history of or
• Seizures, history of—Use with caution. May make these conditions worse.

Proper Use

A nurse or other trained health professional will give you this medicine in a hospital or clinic. It will be given as a shot into a muscle in your arm or buttock.

This injection is given together with the oral medicine for the first dose. The second dose and the injections that follow are given instead of the oral medicine. Be sure to keep all appointments for the injections.

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

Missed Dose

This medicine needs to be given on a fixed schedule. If you miss a dose or forget to use your medicine, call your doctor or pharmacist for instructions.

Be sure to keep all appointments for the injections

Side Effects

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 or nurse immediately if any of the following side effects occur:

More common

1. Difficulty with speaking
2. drooling
3. loss of balance control
4. muscle trembling, jerking, or stiffness
5. restlessness
6. shuffling walk
7. stiffness of the limbs
8. twisting movements of the body
9. uncontrolled movements, especially of the face, neck, and back

Less common

1. Blurred vision
2. dizziness
3. fast, pounding, or irregular heartbeat or pulse
4. headache
5. inability to move the eyes
6. increased blinking or spasms of the eyelid
7. nervousness
8. pounding in the ears
9. sticking out the tongue
10. trouble breathing or swallowing
11. unusual facial expressions

Rare

1. Fast heartbeat
2. high fever
3. increased sweating
4. lip smacking or puckering
5. loss of bladder control
6. muscle spasm or jerking of all extremities
7. puffing of the cheeks
8. rapid or worm-like movements of the tongue
9. seizures
10. severe muscle stiffness
11. sudden loss of consciousness
12. tiredness
13. uncontrolled chewing movements
14. uncontrolled movements of the arms and legs
15. unusually pale skin

Incidence not known

1. Black, tarry stools
2. chest pain or tightness
3. cough
4. hives or welts, itching, or skin rash
5. itching, puffiness, or swelling of the eyelids or around the eyes, face, lips, or tongue
6. large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
7. redness of the skin
8. sore throat
9. sores, ulcers, or white spots on the lips or in the mouth
10. swollen glands
11. unusual bleeding or bruising
12. unusual tiredness or weakness

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of overdose

1. Infection from breathing foreign substance into the lungs
2. seizure that will not stop
3. unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness

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

1. Belching
2. difficulty having a bowel movement
3. dry mouth
4. fear
5. fever
6. heartburn
7. hyperventilation
8. inability to sit still
9. indigestion
10. irritability
11. lightheadedness
12. need to keep moving
13. runny nose
14. shaking
15. stomach discomfort, upset, or pain
16. trouble sleeping
17. weight gain

Less common

1. Accidental injury
2. bloating or swelling of the face, arms, hands, lower legs, or feet
3. body aches or pain
4. congestion
5. difficulty with moving
6. hoarseness
7. increased appetite
8. joint pain
9. muscle aching or cramping
10. muscle pains or stiffness
11. sneezing
12. stuffy nose
13. swollen joints
14. tender, swollen glands in the neck
15. tingling of the hands or feet
16. tremor
17. unusual weight gain or loss
18. voice changes

Incidence not known

1. Hiccups

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.

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