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Abilify Maintena
aripiprazole monthly injection
Black Box Warnings .
Dementia-Related Psychosis
not approved for dementia-related psychosis; incr. mortality risk in elderly patients on antipsychotic tx for dementia-related psychosis; most deaths due to cardiovascular or infectious events
Adult Dosing .
Dosage forms: INJ (pre-filled syringe): 300 mg per 1.5 mL, 400 mg per 2 mL; INJ (vial): 300 mg per 1.5 mL, 400 mg per 2 mL
schizophrenia
- [1-day initiation regimen]
- Dose: 400 mg IM qmo; Start: after establishing tolerability with PO aripiprazole; give 400 mg IM x2 plus aripiprazole 20 mg PO x1; Info: may decr. dose to 300 mg IM qmo; in CYP2D6 poor metabolizers, start 300 mg IM x2 plus aripiprazole 20 mg PO x1, then 300 mg IM qmo; see pkg insert for missed dose recommendations; periodically reassess need for tx; D/C if ANC <1000; consider D/C if unexplained decr. in WBC
- [14-day initiation regimen]
- Dose: 400 mg IM qmo; Start: after establishing tolerability with PO aripiprazole; overlap PO antipsychotic tx x14 days; Info: may decr. dose to 300 mg IM qmo; in CYP2D6 poor metabolizers, give 300 mg IM qmo; see pkg insert for missed dose recommendations; periodically reassess need for tx; D/C if ANC <1000; consider D/C if unexplained decr. in WBC
bipolar I disorder, maintenance tx
- [1-day initiation regimen]
- Dose: 400 mg IM qmo; Start: after establishing tolerability with PO aripiprazole; give 400 mg IM x2 plus aripiprazole 20 mg PO x1; Info: may decr. dose to 300 mg IM qmo; in CYP2D6 poor metabolizers, start 300 mg IM x2 plus aripiprazole 20 mg PO x1, then 300 mg IM qmo; see pkg insert for missed dose recommendations; periodically reassess need for tx; D/C if ANC <1000; consider D/C if unexplained decr. in WBC
- [14-day initiation regimen]
- Dose: 400 mg IM qmo; Start: after establishing tolerability with PO aripiprazole; overlap PO antipsychotic tx x14 days; Info: may decr. dose to 300 mg IM qmo; in CYP2D6 poor metabolizers, give 300 mg IM qmo; see pkg insert for missed dose recommendations; periodically reassess need for tx; D/C if ANC <1000; consider D/C if unexplained decr. in WBC
renal dosing
- [see below]
- CrCl >15: no adjustment; CrCl <15: not defined
- HD/PD: not defined
hepatic dosing
- [no adjustment]
Peds Dosing .
Peds dosing is currently unavailable or not applicable for this drug.
Contraindications / Cautions .
- hypersensitivity to drug or ingredient
- caution: CYP2D6 poor metabolizers
- caution: patients <25 yo (depression use)
- caution: elderly patients
- caution: psychosis, dementia-associated
- caution: cerebrovascular disease
- caution: cardiovascular disease
- caution: MI history
- caution: ischemic heart disease
- caution: heart failure
- caution: hypovolemia
- caution: dehydration
- caution: hypotension
- caution: aspiration pneumonia risk
- caution: seizure history
- caution: seizure risk
- caution: diabetes mellitus
- caution: diabetes mellitus risk
- caution: environmental temperature, high
- caution: leukopenia
- caution: leukopenia history, drug-induced
- caution: neutropenia
- caution: neutropenia history, drug-induced
- caution: PKU (phenylalanine-containing form)
Drug Interactions .
Overview
aripiprazole monthly injection
atypical antipsychotic
- CYP2D6 substrate
- CYP3A4 substrate
- CNS depression
- decreases central histamine effects
- extrapyramidal effects
- hyperglycemic effects
- hyperthermia
- hypotensive effects
- lowers seizure threshold
- drug interactions apply only to Abilify Maintena; see other aripiprazole products for potentially relevant interactions
- aripiprazole is a substrate of CYP2D6 and CYP3A4; drug interaction guidance may vary with CYP450 inhibitors if patient is CYP2D6 poor metabolizer (PM)
Avoid/Use Alternative
- adagrasib
- aldesleukin
- amifampridine
- apalutamide
- aripiprazole bimonthly injection
- aripiprazole lauroxil
- aripiprazole monthly injection
- aripiprazole oral
- asenapine
- atazanavir
- benztropine
- brexpiprazole
- bupropion
- butalbital
- carbamazepine
- cariprazine
- ceritinib
- chloramphenicol
- clarithromycin
- clonidine
- clozapine
- cobicistat
- codeine
- dacomitinib
- doxylamine
- encorafenib
- enzalutamide
- ethanol (alcoholic beverage)
- ethanol injection
- fluoxetine
- fosphenytoin
- haloperidol
- hydrocodone
- idelalisib
- iloperidone
- iohexol
- isocarboxazid
- itraconazole
- ivosidenib
- kava
- ketoconazole
- kratom
- levoketoconazole
- lofexidine
- lonafarnib
- lopinavir/ritonavir
- lumacaftor/ivacaftor
- lumateperone
- lurasidone
- mavorixafor
- metaxalone
- metoclopramide
- midazolam
- mifepristone
- milsaperidone
- mitotane
- nefazodone
- nelfinavir
- olanzapine
- oxybate
- paliperidone
- paroxetine
- pentobarbital
- phenelzine
- phenobarbital
- phenytoin
- pitolisant
- posaconazole
- primidone
- promethazine
- quetiapine
- quinidine (antiarrhythmic)
- quinidine (CYP2D6 inhibitor)
- relacorilant
- ribociclib
- rifabutin
- rifampin
- risperidone
- ritonavir
- ropeginterferon alfa-2b
- scopolamine
- St. John's wort
- terbinafine
- thalidomide
- tipranavir
- tradipitant
- tranylcypromine
- trimethobenzamide
- tucatinib
- voriconazole
- ziprasidone
- zuranolone
Monitor/Modify Tx
- acarbose
- acebutolol
- alfentanil
- alfuzosin
- aliskiren
- alogliptin
- alprazolam
- alprostadil intracavernous
- amantadine
- amifostine
- amiloride
- amitriptyline
- amlodipine
- amoxapine
- apomorphine
- apraclonidine ophthalmic
- aprocitentan
- articaine
- atenolol
- avanafil
- azilsartan medoxomil
- baclofen intrathecal
- benazepril
- berberine
- betaxolol
- betaxolol ophthalmic
- bethanechol
- bexagliflozin
- bisoprolol
- bortezomib
- brimonidine ophthalmic
- brimonidine topical
- bromocriptine
- bumetanide
- bupivacaine
- bupivacaine liposomal
- buprenorphine
- butorphanol
- cabergoline
- canagliflozin
- candesartan cilexetil
- cannabis
- captopril
- carteolol ophthalmic
- carvedilol
- chlordiazepoxide
- chloroprocaine
- chlorothiazide
- chlorpromazine
- chlorthalidone
- cilostazol
- clevidipine
- clobazam
- clofarabine
- clomipramine
- clonazepam
- clorazepate
- coenzyme Q-10
- colesevelam
- dapagliflozin
- daridorexant
- denileukin diftitox
- desflurane
- desipramine
- dexmedetomidine
- dexmedetomidine injection
- diazepam
- dihydrocodeine
- diltiazem
- dinutuximab
- dipyridamole
- doxazosin
- doxepin
- dronabinol
- droperidol
- dulaglutide
- duloxetine
- empagliflozin
- enalapril
- enalaprilat
- entacapone
- entrectinib
- eplerenone
- epoprostenol
- ertugliflozin
- esketamine
- esmolol
- estazolam
- eszopiclone
- ethacrynic acid
- ethanol (in some formulations)
- etomidate
- etripamil nasal
- exenatide
- felodipine
- fenoldopam
- fentanyl
- ferumoxytol
- flaxseed
- flibanserin
- fluphenazine
- flurazepam
- fosinopril
- foslevodopa
- furosemide
- gabapentin
- gabapentin enacarbil
- garlic
- gilteritinib
- glimepiride
- glipizide
- glyburide
- guanfacine
- hydralazine
- hydrochlorothiazide
- hydromorphone
- hydroxyzine
- ifosfamide
- iloprost
- imipramine
- indapamide
- insulin
- iopamidol
- irbesartan
- iron sucrose
- isoflurane
- isosorbide dinitrate
- isosorbide mononitrate
- isradipine
- ketamine
- labetalol
- landiolol
- lemborexant
- levobunolol ophthalmic
- levodopa
- levorphanol
- lidocaine
- linagliptin
- liraglutide
- lisinopril
- lithium
- lixisenatide
- lorazepam
- losartan
- loxapine
- lubiprostone
- magnesium sulfate
- maraviroc
- meperidine
- mepivacaine
- metformin
- methadone
- methohexital
- methyldopa
- methylene blue injection
- metolazone
- metoprolol
- miglitol
- milrinone
- minoxidil
- mirtazapine
- moexipril
- molindone
- morphine
- nadolol
- nalbuphine
- nateglinide
- nattokinase
- naxitamab
- nebivolol
- nelarabine
- niacin (vitamin B3)
- nicardipine
- nifedipine
- nimodipine
- nisoldipine
- nitric oxide
- nitrite
- nitroglycerin
- nitroprusside
- nortriptyline
- obinutuzumab
- oliceridine
- olmesartan medoxomil
- opicapone
- opium
- oxazepam
- oxybutynin
- oxycodone
- oxymorphone
- palopegteriparatide
- pentamidine
- pentazocine
- perindopril
- perphenazine
- phenoxybenzamine
- phentolamine
- pindolol
- pioglitazone
- pramipexole
- pramlintide
- prazosin
- pregabalin
- procarbazine
- prochlorperazine
- propafenone
- propofol
- propranolol
- protriptyline
- quazepam
- quinapril
- ramipril
- rasagiline
- remifentanil
- remimazolam
- repaglinide
- riociguat
- ropinirole
- ropivacaine
- rosiglitazone
- rotigotine transdermal
- sacubitril
- safinamide
- saxagliptin
- selegiline
- selegiline transdermal
- semaglutide
- sevoflurane
- sildenafil
- silodosin
- sitagliptin
- sodium ferric gluconate complex
- sotagliflozin
- sotalol
- sparsentan
- spironolactone
- sufentanil
- suvorexant
- tadalafil
- tagraxofusp
- tamsulosin
- tapentadol
- taurine
- telmisartan
- temazepam
- terazosin
- thioridazine
- thiothixene
- timolol
- timolol ophthalmic
- tirzepatide
- tizanidine
- tolcapone
- torsemide
- tramadol
- trandolapril
- trazodone
- treprostinil
- triamterene
- triazolam
- trifluoperazine
- trimipramine
- valsartan
- vardenafil
- verapamil
- vosoritide
- yohimbe
- zaleplon
- ziconotide
- zolpidem
Caution Advised
- 5-HTP
- acetazolamide
- aclidinium inhaled
- allopurinol
- almotriptan
- atropine
- baclofen
- belladonna alkaloids
- bosentan
- botulinum toxin
- brivaracetam
- brompheniramine
- buspirone
- busulfan
- cannabidiol
- carbinoxamine
- carisoprodol
- cenobamate
- cetirizine
- chamomile, German
- chlophedianol
- chlorambucil
- chlorcyclizine
- chloroquine
- chlorpheniramine
- chlorzoxazone
- citalopram
- clemastine
- clidinium
- cyclobenzaprine
- cyproheptadine
- dabrafenib
- dantrolene
- darifenacin
- desvenlafaxine
- deutetrabenazine
- dexbrompheniramine
- dexchlorpheniramine
- dichlorphenamide
- dicyclomine
- difelikefalin
- difenoxin
- dimenhydrinate
- diphenhydramine
- diphenoxylate
- disopyramide
- domperidone
- doxepin topical
- efavirenz
- eletriptan
- elinzanetant
- escitalopram
- eslicarbazepine acetate
- ethosuximide
- etravirine
- felbamate
- fenfluramine
- fesoterodine
- fexinidazole
- flavoxate
- fluvoxamine
- frovatriptan
- galantamine
- ganaxolone
- glofitamab
- glycopyrrolate
- glycopyrrolate inhaled
- glycopyrronium topical
- homatropine
- hydroxychloroquine
- hyoscyamine
- ipratropium inhaled
- lacosamide
- lamotrigine
- levetiracetam
- levocetirizine
- levomilnacipran
- linvoseltamab
- lorlatinib
- magnesium citrate
- mavacamten
- meclizine
- melatonin
- meprobamate
- methocarbamol
- methscopolamine
- methsuximide
- metyrapone
- metyrosine
- milnacipran
- mitapivat
- modafinil
- mosunetuzumab
- mycophenolate mofetil
- nafcillin
- naltrexone
- naratriptan
- orphenadrine
- oxcarbazepine
- pacritinib
- passion flower
- perampanel
- pexidartinib
- pheniramine
- pimozide
- polyethylene glycol
- polyethylene glycol/electrolytes
- pyrilamine
- ramelteon
- repotrectinib
- revefenacin inhaled
- rifapentine
- rivastigmine
- rizatriptan
- rufinamide
- selinexor
- sertraline
- sodium picosulfate
- sofpironium topical
- solifenacin
- sotorasib
- stiripentol
- sulfate bowel prep
- sumatriptan
- tasimelteon
- tetrabenazine
- thiotepa
- tiagabine
- tiotropium inhaled
- tolterodine
- topiramate
- treosulfan
- trihexyphenidyl
- triprolidine
- trospium
- umeclidinium inhaled
- valbenazine
- valerian
- valproic acid
- venlafaxine
- vigabatrin
- vilazodone
- viloxazine
- zolmitriptan
- zonisamide
Adverse Reactions .
Serious Reactions
- hypersensitivity reaction
- anaphylaxis
- drug reaction with eosinophilia and systemic symptoms
- neuroleptic malignant syndrome
- extrapyramidal symptoms
- tardive dyskinesia
- dystonia
- stroke
- TIA
- syncope
- hypotension, orthostatic
- seizures
- hyperglycemia
- diabetes mellitus
- dysphagia, severe
- aspiration
- hyperthermia
- hypothermia
- pancreatitis
- blood dyscrasia
- leukopenia
- neutropenia
- agranulocytosis
- rhabdomyolysis
- suicidality
- depression exacerbation
Common Reactions
- headache
- dyslipidemia
- weight gain
- extrapyramidal symptoms
- akathisia
- somnolence
- injection site reaction (IM use)
- insomnia
- hyperglycemia
- anxiety
- fatigue
- nausea
- vomiting
- restlessness
- constipation
- dizziness
- tremor
- fever (peds patients)
- URI
- blurred vision
- sialorrhea (peds patients)
- appetite changes
- xerostomia
- arthralgia
- myalgia
- diarrhea (peds patients)
- impaired body temperature regulation
- compulsive behaviors
Safety/Monitoring .
Monitoring Parameters
fasting glucose at baseline if diabetes risk factors, then periodically; CBC with diff frequently during initial tx if pre-existing or history of leukopenia/neutropenia; weight; consider orthostatic vital signs if hypotension risk
Look/Sound-Alike Drug Names
ARIPiprazole confused with: lansoprazole; omeprazole; RABEprazole
Pregnancy/Lactation .
Pregnancy
Clinical Summary
weigh risk/benefit during pregnancy, especially in 3rd trimester; risk of teratogenicity not expected based on limited human data, though risk of neonatal extrapyramidal and withdrawal symptoms based on human data with antipsychotics
Pregnancy Registry
encourage patients to enroll in National Pregnancy Registry for Atypical Antipsychotics at 1-866-961-2388 or www.womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/
Lactation
Clinical Summary
weigh risk/benefit while breastfeeding, monitor infant for dehydration and poor wt. gain; possible risk of infant harm based on limited human data; decr. milk production based on human data and decr. prolactin levels
Pharmacology .
Metabolism: for aripiprazole: liver; CYP450: 2D6, 3A4 substrate; Info: active metabolite; CYP2D6 poor metabolizers have 60% increased active drug exposure
Excretion: for aripiprazole: feces 55% (18% unchanged), urine 25% (<1% unchanged); Half-life: 75h (IR form, CYP2D6 extensive metabolizers), 146h (IR form, CYP2D6 poor metabolizers), 29.9-46.5 days (1-mo IM form), 21 days (bimonthly IM form)
Subclass: Antipsychotics, 2nd generation ; Bipolar Disorder
Mechanism of Action
for aripiprazole: exact mechanism of action unknown; partially agonizes dopamine D2 and serotonin 5-HT1A receptors, antagonizes serotonin 5-HT2A receptors
Formulary .
No Formulary Selected
Manufacturer/Pricing .
Manufacturer: Otsuka America Pharmaceutical Co. and Lundbeck Inc.
DEA/FDA: Rx
Retail Price
Estimated prices only. For current pricing, visit GoodRx.
intramuscular powder for injection, extended release:
- 300 mg (1 syringe, dual chamber): $1,837.00
- 400 mg (1 syringe, dual chamber): $2,446.00
intramuscular powder for injection, extended release:
- 300 mg (1 vial): $1,837.00
- 400 mg (1 vial): $2,446.00
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