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Caplyta
lumateperone
Black Box Warnings .
Dementia-Related Psychosis
not approved for dementia-related psychosis; incr. mortality risk in elderly patients w/ dementia-related psychosis treated w/ antipsychotics
Suicidality
incr. suicidality risk in patients <24 yo in short-term studies; monitor closely for clinical worsening, suicidality, or unusual behavior changes; not approved in peds patients
Adult Dosing .
Dosage forms: CAP: 10.5 mg, 21 mg, 42 mg
schizophrenia
- [42 mg PO qd]
- Info: D/C if ANC <1000; consider D/C if unexplained decr. in WBC
bipolar disorder, depressive episode
- [monotherapy]
- Dose: 42 mg PO qd; Info: for bipolar I or bipolar II disorder; D/C if ANC <1000; consider D/C if unexplained decr. in WBC
- [valproate or lithium adjunct]
- Dose: 42 mg PO qd; Info: for bipolar I or bipolar II disorder; D/C if ANC <1000; consider D/C if unexplained decr. in WBC
renal dosing
- [not defined]
- renal impairment: not defined
- HD/PD: not defined
hepatic dosing
- [adjust dose amount]
- Child-Pugh Class B or C: 21 mg qd
Peds Dosing .
- Dosage forms: --
Contraindications / Cautions .
- hypersensitivity to drug or ingredient
- caution: elderly patients
- caution: hepatic impairment, Child-Pugh Class B-C
- caution: psychosis, dementia-associated
- caution: cerebrovascular dz
- caution: cardiovascular dz
- caution: MI history
- caution: ischemic heart dz
- caution: heart failure
- caution: electrolyte abnormalities
- caution: long QT syndrome, congenital
- caution: QT prolongation
- caution: QT prolongation family history
- caution: torsades de pointes history
- caution: ventricular arrhythmia
- caution: bradycardia
- caution: hypotension, orthostatic
- caution: hypovolemia
- caution: dehydration
- caution: environmental temperature, high
- caution: diabetes mellitus
- caution: diabetes mellitus risk
- caution: leukopenia
- caution: leukopenia history, drug-induced
- caution: neutropenia
- caution: neutropenia history, drug-induced
- caution: seizure history
- caution: aspiration pneumonia risk
Drug Interactions .
Overview
lumateperone
atypical antipsychotic
- CYP3A4 substrate
- CNS depression
- dopamine antagonist
- extrapyramidal effects
- hyperglycemic effects
- hyperthermia
- hypotensive effects
- lowers seizure threshold
- myelosuppressive effects
- prolongs QT interval (conditional)
Contraindicated
- pimozide
- thioridazine
Avoid/Use Alternative
- amifampridine
- apalutamide
- apomorphine
- aripiprazole bimonthly injection
- aripiprazole lauroxil
- aripiprazole monthly injection
- arsenic trioxide
- artemether/lumefantrine
- bosentan
- brigatinib
- butalbital
- carbamazepine
- cenobamate
- ceritinib
- cisapride
- cladribine oral
- clobazam
- codeine
- dabrafenib
- darolutamide
- deferiprone
- domperidone
- doxylamine
- echinacea
- enasidenib
- encorafenib
- felbamate
- fosphenytoin
- glycerol phenylbutyrate
- hydrocodone
- kratom
- lofexidine
- lurasidone
- metaxalone
- netupitant
- odevixibat
- pacritinib
- pentobarbital
- repotrectinib
- rufinamide
- sotalol
- toremifene
- tovorafenib
- tranylcypromine
- trimethobenzamide
- valganciclovir
- vemurafenib
- vinblastine
- vorasidenib
Monitor/Modify Tx
- abemaciclib
- acalabrutinib
- acebutolol
- adagrasib
- ado-trastuzumab emtansine
- afamitresgene autoleucel
- albendazole
- alemtuzumab
- alfentanil
- alprazolam
- amifostine
- amiloride
- amiodarone
- amitriptyline
- amlodipine
- amoxapine
- aprepitant
- asciminib
- asenapine
- atazanavir
- atenolol
- atidarsagene autotemcel
- atorvastatin
- auranofin
- avacopan
- axicabtagene ciloleucel
- azacitidine
- azathioprine
- azilsartan medoxomil
- baclofen intrathecal
- balsalazide
- baricitinib
- belantamab mafodotin
- belinostat
- belumosudil
- benazepril
- bendamustine
- berberine
- berotralstat
- betaxolol ophthalmic
- bethanechol
- betibeglogene autotemcel
- bexagliflozin
- bosutinib
- brentuximab vedotin
- brimonidine ophthalmic
- brimonidine topical
- bupivacaine
- bupivacaine liposomal
- buprenorphine
- bupropion
- busulfan
- butorphanol
- cabazitaxel
- cabergoline
- cabozantinib
- candesartan cilexetil
- cannabis
- capivasertib
- captopril
- carboplatin
- carfilzomib
- cariprazine
- carmustine
- carvedilol
- chloroprocaine
- chloroquine
- chlorpromazine
- chlorthalidone
- chlorzoxazone
- cidofovir
- cilostazol
- ciltacabtagene autoleucel
- cimetidine
- ciprofloxacin
- cladribine injection
- clarithromycin
- clevidipine
- clofazimine
- clomipramine
- clorazepate
- clotrimazole oropharyngeal
- clozapine
- cobicistat
- coenzyme Q-10
- colchicine
- colesevelam
- conivaptan
- copanlisib
- cyclophosphamide
- cyclosporine
- cytarabine
- dacarbazine
- danazol
- dapsone
- daratumumab
- daridorexant
- darunavir
- dasatinib
- daunorubicin
- decitabine
- deferasirox
- degarelix
- denileukin diftitox
- desflurane
- desipramine
- deuruxolitinib
- dexmedetomidine
- dexmedetomidine injection
- dexrazoxane
- diazepam
- dihydrocodeine
- diltiazem
- dinutuximab
- diosmin
- dipyridamole
- disopyramide
- docetaxel
- dofetilide
- donepezil
- dordaviprone
- dostarlimab
- doxazosin
- doxepin
- doxorubicin
- dronabinol
- dronedarone
- droperidol
- dulaglutide
- duloxetine
- duvelisib
- eflornithine
- elivaldogene autotemcel
- elranatamab
- empagliflozin
- enalapril
- enalaprilat
- enfortumab vedotin
- entacapone
- entrectinib
- epcoritamab
- epirubicin
- eplerenone
- epoprostenol
- eribulin
- ertugliflozin
- erythromycin
- esketamine
- esmolol
- estazolam
- eszopiclone
- ethacrynic acid
- ethanol (in some formulations)
- ethinyl estradiol (contraceptive)
- etomidate
- etoposide
- everolimus
- exagamglogene autotemcel
- exenatide
- fam-trastuzumab deruxtecan
- fedratinib
- felodipine
- fenoldopam
- fentanyl
- ferumoxytol
- finerenone
- flaxseed
- flecainide
- flibanserin
- floxuridine
- fluconazole
- flucytosine
- fludarabine
- fluorouracil
- fluphenazine
- flurazepam
- fluvoxamine
- fosaprepitant
- foscarnet
- fosinopril
- foslevodopa
- fostamatinib
- furosemide
- gabapentin
- gabapentin enacarbil
- gemcitabine
- gemtuzumab ozogamicin
- gepotidacin
- gilteritinib
- givinostat
- givosiran
- glasdegib
- glecaprevir
- glimepiride
- glipizide
- glofitamab
- glyburide
- goldenseal
- goserelin
- grazoprevir
- guanfacine
- haloperidol
- histrelin
- hydralazine
- hydrochlorothiazide
- hydromorphone
- hydroxyurea
- hydroxyzine
- ibritumomab tiuxetan
- ibrutinib
- ibutilide
- idarubicin
- idecabtagene vicleucel
- idelalisib
- ifosfamide
- iloprost
- iloprost inhaled
- imatinib
- imetelstat
- imipramine
- indapamide
- inotuzumab ozogamicin
- insulin
- interferon beta 1a
- interferon beta 1b
- interferon gamma 1b
- iohexol
- iopamidol
- irbesartan
- irinotecan
- iron sucrose
- isatuximab
- isavuconazonium
- isoflurane
- isoniazid
- isosorbide dinitrate
- isosorbide mononitrate
- isradipine
- istradefylline
- itraconazole
- ivacaftor
- ixabepilone
- ketamine
- ketoconazole
- labetalol
- landiolol
- lapatinib
- larotrectinib
- lazertinib
- leflunomide
- lemborexant
- lenacapavir
- lenalidomide
- letermovir
- leuprolide
- levobunolol ophthalmic
- levodopa
- levofloxacin
- levoketoconazole
- levorphanol
- lidocaine
- lifileucel
- linagliptin
- linezolid
- linvoseltamab
- liraglutide
- lisinopril
- lisocabtagene maraleucel
- lixisenatide
- lomitapide
- lomustine
- loncastuximab tesirine
- lorazepam
- losartan
- lovastatin
- lovotibeglogene autotemcel
- loxapine
- lubiprostone
- lurbinectedin
- lutetium Lu 177 dotatate
- lutetium Lu 177 vipivotide tetraxetan
- lymphocyte immune globulin, anti-thymocyte globulin
- macimorelin
- magnesium sulfate
- maraviroc
- maribavir
- mavorixafor
- melphalan
- meperidine
- mepivacaine
- mercaptopurine
- mesalamine
- mesalamine rectal
- metformin
- methadone
- methohexital
- methotrexate
- methyldopa
- methylene blue injection
- metolazone
- metoprolol
- midostaurin
- mifepristone
- miglitol
- milrinone
- minoxidil
- mirtazapine
- mitomycin
- mitoxantrone
- moexipril
- mogamulizumab
- molindone
- momelotinib
- morphine
- mosunetuzumab
- moxifloxacin
- mycophenolate mofetil
- mycophenolic acid
- nadolol
- nalbuphine
- nateglinide
- nattokinase
- naxitamab
- nebivolol
- nefazodone
- nelarabine
- nelfinavir
- niacin (vitamin B3)
- nicardipine
- nifedipine
- nilotinib
- nimodipine
- niraparib
- nirogacestat
- nisoldipine
- nitric oxide
- nitrite
- nitroglycerin
- nitroprusside
- nortriptyline
- obecabtagene autoleucel
- obinutuzumab
- ofatumumab
- olanzapine
- olaparib
- oliceridine
- olmesartan medoxomil
- olsalazine
- ondansetron
- opicapone
- opium
- osilodrostat
- osimertinib
- oxaliplatin
- oxazepam
- oxybutynin
- oxycodone
- oxymorphone
- paclitaxel
- palbociclib
- paliperidone
- palonosetron
- palopegteriparatide
- panobinostat
- pasireotide
- pazopanib
- peginterferon alfa 2a
- peginterferon beta 1a
- pemetrexed
- penicillamine
- pentamidine
- pentazocine
- pentostatin
- peppermint
- perindopril
- perphenazine
- phenoxybenzamine
- phentolamine
- pibrentasvir
- pindolol
- pirtobrutinib
- polatuzumab vedotin
- pomalidomide
- ponatinib
- posaconazole
- pralatrexate
- pramipexole
- pramlintide
- prazosin
- pregabalin
- procainamide
- procarbazine
- prochlorperazine
- proguanil
- propafenone
- propofol
- propranolol
- protriptyline
- pyrimethamine
- quazepam
- quercetin
- quetiapine
- quinapril
- quinidine (antiarrhythmic)
- quinidine (CYP2D6 inhibitor)
- quinine
- ramipril
- ranolazine
- rasagiline
- remdesivir
- remifentanil
- remimazolam
- repaglinide
- resveratrol
- revumenib
- ribavirin
- ribociclib
- riociguat
- risperidone
- ritlecitinib
- ritonavir
- rituximab
- romidepsin
- ropinirole
- ropivacaine
- rosiglitazone
- rotigotine transdermal
- rucaparib
- ruxolitinib
- ruxolitinib topical
- sacituzumab govitecan
- sacubitril
- safinamide
- satralizumab
- saxagliptin
- selegiline
- selegiline transdermal
- selinexor
- selpercatinib
- semaglutide
- sevoflurane
- sildenafil
- silodosin
- sirolimus
- sirolimus albumin-bound
- sitagliptin
- sodium ferric gluconate complex
- sotagliflozin
- sparsentan
- spironolactone
- streptozocin
- succimer
- sufentanil
- sulfasalazine
- suvorexant
- tadalafil
- tafasitamab
- tagraxofusp
- talazoparib
- talquetamab
- tamsulosin
- tapentadol
- tarlatamab
- taurine
- teclistamab
- telavancin
- telmisartan
- temazepam
- temozolomide
- temsirolimus
- teplizumab
- terazosin
- teriflunomide
- tetrabenazine
- thioguanine
- thiotepa
- thiothixene
- ticagrelor
- timolol
- timolol ophthalmic
- tipranavir
- tirzepatide
- tisagenlecleucel
- tizanidine
- tofacitinib
- tolcapone
- tolvaptan
- topotecan
- torsemide
- trabectedin
- tramadol
- trandolapril
- trastuzumab
- trazodone
- treosulfan
- treprostinil
- triamterene
- triazolam
- triclabendazole
- trifluoperazine
- trifluridine
- trimethoprim
- trimipramine
- triptorelin
- trofinetide
- tucatinib
- upadacitinib
- valproic acid
- valsartan
- vancomycin
- vardenafil
- venetoclax
- verapamil
- viloxazine
- vincristine
- vinorelbine
- vonoprazan
- voriconazole
- vosoritide
- voxelotor
- xanomeline
- yohimbe
- zaleplon
- ziconotide
- zidovudine
- zileuton
- ziv-aflibercept
- zolpidem
Caution Advised
- 5-HTP
- acetazolamide
- aclidinium inhaled
- almotriptan
- atropine
- baclofen
- belladonna alkaloids
- benztropine
- botulinum toxin
- brivaracetam
- brompheniramine
- buspirone
- cannabidiol
- carbinoxamine
- carisoprodol
- cetirizine
- chamomile, German
- chasteberry
- chlophedianol
- chlorpheniramine
- clemastine
- clidinium
- cyclobenzaprine
- cyproheptadine
- dantrolene
- darifenacin
- desvenlafaxine
- deutetrabenazine
- dexbrompheniramine
- dexchlorpheniramine
- dichlorphenamide
- dicyclomine
- difelikefalin
- difenoxin
- dimenhydrinate
- diphenhydramine
- diphenoxylate
- doxepin topical
- eletriptan
- escitalopram
- ethosuximide
- fenfluramine
- fesoterodine
- flavoxate
- fluoxetine
- frovatriptan
- galantamine
- ganaxolone
- glycopyrrolate
- glycopyrrolate inhaled
- glycopyrronium topical
- homatropine
- hyoscyamine
- ipratropium inhaled
- lacosamide
- lamotrigine
- lasmiditan
- levetiracetam
- levocetirizine
- levomilnacipran
- magnesium citrate
- meclizine
- melatonin
- meprobamate
- meropenem
- methocarbamol
- methscopolamine
- methsuximide
- metyrapone
- metyrosine
- milnacipran
- naltrexone
- naratriptan
- orphenadrine
- paroxetine
- passion flower
- pheniramine
- polyethylene glycol
- polyethylene glycol/electrolytes
- pyrilamine
- ramelteon
- revefenacin inhaled
- rizatriptan
- scopolamine
- sertraline
- sodium picosulfate
- sofpironium topical
- solifenacin
- sulfate bowel prep
- sumatriptan
- tasimelteon
- tiagabine
- tiotropium inhaled
- tolterodine
- trihexyphenidyl
- triprolidine
- trospium
- umeclidinium inhaled
- vaborbactam
- valbenazine
- valerian
- venlafaxine
- vigabatrin
- vilazodone
- zolmitriptan
- zonisamide
Adverse Reactions .
Serious Reactions
- suicidality
- stroke
- TIA
- syncope
- hypotension, orthostatic
- neuroleptic malignant syndrome
- extrapyramidal symptoms
- tardive dyskinesia
- dystonia
- hyperglycemia
- diabetes mellitus
- leukopenia
- neutropenia
- agranulocytosis
- seizures
- hyperthermia
- dysphagia, severe
- aspiration
Common Reactions
- somnolence
- headache
- dyslipidemia
- nausea
- dizziness
- xerostomia
- CPK incr.
- diarrhea
- fatigue
- vomiting
- LFTs incr.
- appetite decr.
- abdominal pain
- URI
- impaired body temperature regulation
Safety/Monitoring .
Monitoring Parameters
fasting lipid panel, weight at baseline, then periodically; fasting glucose at baseline if diabetes risk factors, then periodically; CBC w/ diff frequently during initial tx if pre-existing or history of leukopenia/neutropenia; orthostatic vital signs if hypotension risk
Pregnancy/Lactation .
Pregnancy
Clinical Summary
weigh risk/benefit during pregnancy, esp. in 3rd trimester; no human data available, though risk of neonatal extrapyramidal and withdrawal symptoms based on human data w/ other antipsychotics; no known risk of teratogenicity based on animal data at 2.4x MRHD, though possible risk of fetal harm, incl. decr. fetal weight at >4.9x MRHD
Pregnancy Registry
encourage patients to enroll in National Pregnancy Registry for Atypical Antipsychotics at 1-866-961-2388 or www.womensmentalhealth.org
Lactation
Clinical Summary
weigh risk/benefit while breastfeeding; no human data available to assess risk of infant harm, though drug excreted into milk; no human data available to assess effects on milk production
Pharmacology .
Metabolism: glucuronidation; CYP450: 1A2, 2C8, 3A4 substrate; UGT: 1A1, 1A4, 2B15 substrate
Excretion: urine 58% (<1% unchanged), feces 29%; Half-life: 18h
Subclass: Antipsychotics, 2nd generation ; Bipolar Disorder
Mechanism of Action
exact mechanism of action unknown; antagonizes dopamine D2 receptors, serotonin 5-HT2A receptors, others
Formulary .
No Formulary Selected
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