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Aristada
aripiprazole lauroxil
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): 441 mg per 1.6 mL, 662 mg per 2.4 mL, 882 mg per 3.2 mL, 1064 mg per 3.9 mL
Special Note
- [equivalency or interchangeability info]
- Info: Aristada not interchangeable with Aristada Initio due to different pharmacokinetic profiles
schizophrenia
- [qmo dosing regimen]
- Dose: 441-882 mg IM qmo; Start: may give 1st dose within 10 days of concurrent Aristada Initio and aripiprazole 30 mg PO x1, otherwise overlap PO aripiprazole x21 days; Info: for patients stable on PO aripiprazole; see pkg insert for conversion from PO aripiprazole and for missed dose recommendations; space doses at least 14 days apart; decr. dose in CYP2D6 poor metabolizers; periodically reassess need for tx; D/C if ANC <1000; consider D/C if unexplained decr. in WBC
- [q6wk dosing regimen]
- Dose: 882 mg IM q6wk; Start: may give 1st dose within 10 days of concurrent Aristada Initio and aripiprazole 30 mg PO x1, otherwise overlap PO aripiprazole x21 days; Info: for patients stable on PO aripiprazole; see pkg insert for conversion from PO aripiprazole and for missed dose recommendations; space doses at least 14 days apart; decr. dose in CYP2D6 poor metabolizers; periodically reassess need for tx; D/C if ANC <1000; consider D/C if unexplained decr. in WBC
- [q2mo dosing regimen]
- Dose: 1064 mg IM q2mo; Start: may give 1st dose within 10 days of concurrent Aristada Initio and aripiprazole 30 mg PO x1, otherwise overlap PO aripiprazole x21 days; Info: for patients stable on PO aripiprazole; see pkg insert for conversion from PO aripiprazole and for missed dose recommendations; space doses at least 14 days apart; decr. dose in CYP2D6 poor metabolizers; 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: 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: neutropenia
- caution: leukopenia history, drug-induced
- caution: neutropenia history, drug-induced
Drug Interactions .
Overview
aripiprazole lauroxil
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 Aristada and Aristada Initio (aripiprazole lauroxil, injectable prodrug of aripiprazole); 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 combo with Aristada Initio if also combined with strong CYP2D6 inhibitor, strong CYP3A4 inhibitor and/or major CYP3A4 inducer as dose adjustment not possible; Aristada Initio not interchangeable with Aristada due to different pharmacokinetic profiles
Avoid/Use Alternative
- acebutolol
- adagrasib
- aldesleukin
- aliskiren
- alprazolam
- amifampridine
- amiloride
- amlodipine
- apalutamide
- aprocitentan
- aripiprazole bimonthly injection
- aripiprazole lauroxil
- aripiprazole monthly injection
- aripiprazole oral
- asenapine
- atazanavir
- atenolol
- azilsartan medoxomil
- benazepril
- betaxolol
- bisoprolol
- brexpiprazole
- bumetanide
- bupropion
- butalbital
- candesartan cilexetil
- captopril
- carbamazepine
- cariprazine
- carvedilol
- ceritinib
- chloramphenicol
- chlordiazepoxide
- chlorothiazide
- chlorthalidone
- clarithromycin
- clevidipine
- clobazam
- clonazepam
- clonidine
- clorazepate
- clozapine
- cobicistat
- codeine
- dacomitinib
- diazepam
- diltiazem
- doxazosin
- doxylamine
- enalapril
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- encorafenib
- enzalutamide
- eplerenone
- esmolol
- estazolam
- ethacrynic acid
- ethanol (alcoholic beverage)
- ethanol injection
- felodipine
- fenoldopam
- fluoxetine
- flurazepam
- fosinopril
- fosphenytoin
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- haloperidol
- hydralazine
- hydrochlorothiazide
- hydrocodone
- idelalisib
- iloperidone
- indapamide
- irbesartan
- isocarboxazid
- isradipine
- itraconazole
- ivosidenib
- kava
- ketoconazole
- kratom
- labetalol
- levoketoconazole
- lisinopril
- lofexidine
- lonafarnib
- lorazepam
- losartan
- lumacaftor/ivacaftor
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- lurasidone
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- metaxalone
- methyldopa
- metoclopramide
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- midazolam
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- milsaperidone
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- olanzapine
- olmesartan medoxomil
- oxazepam
- oxybate
- paliperidone
- paroxetine
- pentobarbital
- perindopril
- phenelzine
- phenobarbital
- phenoxybenzamine
- phentolamine
- phenytoin
- pindolol
- pitolisant
- posaconazole
- prazosin
- primidone
- promethazine
- propranolol
- quazepam
- quetiapine
- quinapril
- quinidine (antiarrhythmic)
- quinidine (CYP2D6 inhibitor)
- ramipril
- remimazolam
- ribociclib
- rifabutin
- rifampin
- risperidone
- ritonavir
- ropeginterferon alfa-2b
- scopolamine
- spironolactone
- St. John's wort
- telmisartan
- temazepam
- terazosin
- terbinafine
- thalidomide
- timolol
- tipranavir
- torsemide
- tradipitant
- trandolapril
- tranylcypromine
- triamterene
- triazolam
- trimethobenzamide
- tucatinib
- valsartan
- verapamil
- voriconazole
- ziprasidone
- zuranolone
Monitor/Modify Tx
- acarbose
- alfentanil
- alfuzosin
- alogliptin
- alprostadil intracavernous
- amantadine
- amifostine
- amitriptyline
- amoxapine
- apomorphine
- apraclonidine ophthalmic
- articaine
- avanafil
- baclofen intrathecal
- berberine
- betaxolol ophthalmic
- bethanechol
- bexagliflozin
- bortezomib
- brimonidine ophthalmic
- brimonidine topical
- bromocriptine
- bupivacaine
- bupivacaine liposomal
- buprenorphine
- butorphanol
- cabergoline
- canagliflozin
- cannabis
- carteolol ophthalmic
- chloroprocaine
- chlorpromazine
- cilostazol
- clofarabine
- clomipramine
- coenzyme Q-10
- colesevelam
- dapagliflozin
- daridorexant
- denileukin diftitox
- desflurane
- desipramine
- dexmedetomidine
- dexmedetomidine injection
- dihydrocodeine
- dinutuximab
- dipyridamole
- doxepin
- dronabinol
- droperidol
- dulaglutide
- duloxetine
- empagliflozin
- entacapone
- entrectinib
- epoprostenol
- ertugliflozin
- esketamine
- eszopiclone
- ethanol (in some formulations)
- etomidate
- etripamil nasal
- exenatide
- fentanyl
- ferumoxytol
- flaxseed
- flibanserin
- fluphenazine
- fluvoxamine
- foslevodopa
- gabapentin
- gabapentin enacarbil
- garlic
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- hydromorphone
- hydroxyzine
- ifosfamide
- iloprost
- imipramine
- insulin
- iohexol
- iopamidol
- iron sucrose
- isoflurane
- isosorbide dinitrate
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- ketamine
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- levobunolol ophthalmic
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- lidocaine
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- lithium
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- lubiprostone
- magnesium sulfate
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- nitric oxide
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- nortriptyline
- obinutuzumab
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- pentamidine
- pentazocine
- perphenazine
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- pramipexole
- pramlintide
- pregabalin
- procarbazine
- prochlorperazine
- propafenone
- propofol
- protriptyline
- rasagiline
- remifentanil
- repaglinide
- riociguat
- ropinirole
- ropivacaine
- rosiglitazone
- rotigotine transdermal
- sacubitril
- safinamide
- saxagliptin
- selegiline
- selegiline transdermal
- semaglutide
- sevoflurane
- sildenafil
- silodosin
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- sodium ferric gluconate complex
- sotagliflozin
- sotalol
- sparsentan
- sufentanil
- suvorexant
- tadalafil
- tagraxofusp
- tamsulosin
- tapentadol
- taurine
- thioridazine
- thiothixene
- timolol ophthalmic
- tirzepatide
- tizanidine
- tolcapone
- tramadol
- trazodone
- treprostinil
- trifluoperazine
- trimipramine
- vardenafil
- vosoritide
- yohimbe
- zaleplon
- ziconotide
- zolpidem
Caution Advised
- 5-HTP
- acetazolamide
- aclidinium inhaled
- allopurinol
- almotriptan
- atropine
- baclofen
- belladonna alkaloids
- benztropine
- 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
- 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
- akathisia
- weight gain
- headache
- injection site reaction
- insomnia
- parkinsonism
- restlessness
- dystonia
- CPK incr.
- anxiety
- dizziness
- constipation
- xerostomia
- dyslipidemia
- hyperglycemia
- 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
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 lauroxil: liver; CYP450: 2D6, 3A4 substrate
Excretion: for aripiprazole lauroxil: feces 55% (18% unchanged), urine 25% (<1% unchanged); Half-life: 53.9-57.2 days
Subclass: Antipsychotics, 2nd generation
Mechanism of Action
for aripiprazole lauroxil: prodrug converted to 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: Alkermes, Inc.
DEA/FDA: Rx
Retail Price
Estimated prices only. For current pricing, visit GoodRx.
intramuscular suspension, extended release:
- 441 mg (1 syringe, 1.6 mL): $1,452.00
intramuscular suspension, extended release:
- 662 mg (1 syringe, 2.4 mL): $2,174.00
intramuscular suspension, extended release:
- 882 mg (1 syringe, 3.2 mL): $2,893.00
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