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Invega Trinza
paliperidone palmitate
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): 273 mg per 0.875 mL, 410 mg per 1.315 mL, 546 mg per 1.75 mL, 819 mg per 2.625 mL
schizophrenia
- [conversion from paliperidone palmitate 78 mg/mo IM]
- Dose: 273 mg IM q3mo; Start: at next scheduled dose after at least 4mo tx with 1-mo IM paliperidone palmitate form (last 2 doses same strength); Max: 819 mg/dose; Info: may adjust dose q3mo; see pkg insert for missed dose recommendations and conversion to oral paliperidone; periodically reassess need for tx; D/C if ANC <1000; consider D/C if unexplained decr. in WBC
- [conversion from paliperidone palmitate 117 mg/mo IM]
- Dose: 410 mg IM q3mo; Start: at next scheduled dose after at least 4mo tx with 1-mo IM paliperidone palmitate form (last 2 doses same strength); Max: 819 mg/dose; Info: may adjust dose q3mo; see pkg insert for missed dose recommendations and conversion to oral paliperidone; periodically reassess need for tx; D/C if ANC <1000; consider D/C if unexplained decr. in WBC
- [conversion from paliperidone palmitate 156 mg/mo IM]
- Dose: 546 mg IM q3mo; Start: at next scheduled dose after at least 4mo tx with 1-mo IM paliperidone palmitate form (last 2 doses same strength); Max: 819 mg/dose; Info: may adjust dose q3mo; see pkg insert for missed dose recommendations and conversion to oral paliperidone; periodically reassess need for tx; D/C if ANC <1000; consider D/C if unexplained decr. in WBC
- [conversion from paliperidone palmitate 234 mg/mo IM]
- Dose: 819 mg IM q3mo; Start: at next scheduled dose after at least 4mo tx with 1-mo IM paliperidone palmitate form (last 2 doses same strength); Max: 819 mg/dose; Info: may adjust dose q3mo; see pkg insert for missed dose recommendations and conversion to oral paliperidone; periodically reassess need for tx; D/C if ANC <1000; consider D/C if unexplained decr. in WBC
renal dosing
- [see below]
- CrCl 50-79: adjust dose using 1-mo IM paliperidone palmitate form prior to conversion; CrCl <50: avoid use
- HD/PD: not defined
hepatic dosing
- [see below]
- Child-Pugh Class A or B: no adjustment; Child-Pugh Class C: not defined
Peds Dosing .
Peds dosing is currently unavailable or not applicable for this drug.
Contraindications / Cautions .
- hypersensitivity to drug or ingredient
- hypersensitivity to risperidone
- CrCl <50
- long QT syndrome, congenital
- arrhythmia history
- caution: bradycardia
- caution: hypokalemia
- caution: hypomagnesemia
- caution: QT prolongation
- caution: QT prolongation family history
- caution: MI, recent
- caution: CHF
- caution: CNS depressant use, concurrent
- caution: alcohol use, concurrent
- caution: elderly patients
- caution: leukopenia
- caution: leukopenia history, drug-induced
- caution: neutropenia
- caution: neutropenia history, drug-induced
- caution: CrCl 50-79
- caution: cardiovascular disease
- caution: cerebrovascular disease
- caution: psychosis, dementia-associated
- caution: dementia with Lewy bodies
- caution: Parkinson disease
- caution: diabetes mellitus
- caution: diabetes mellitus risk
- caution: hypovolemia
- caution: dehydration
- caution: hypotension risk
- caution: seizure history
- caution: seizure risk
- caution: aspiration pneumonia risk
- caution: environmental temperature, high
Drug Interactions .
Overview
paliperidone
atypical antipsychotic
- CYP3A4 substrate
- P-gp substrate
- CNS depression
- decreases central histamine effects
- dopamine antagonist
- extrapyramidal effects
- hyperglycemic effects
- hyperprolactinemic effects
- hyperthermia
- hypotensive effects
- lowers seizure threshold
- prolongs QT interval (known)
Contraindicated
- cisapride
- domperidone
- dronedarone
- levoketoconazole
- pimozide
- thioridazine
Avoid/Use Alternative
- adagrasib
- aldesleukin
- amifampridine
- amiodarone
- anagrelide
- apalutamide
- apomorphine
- aripiprazole bimonthly injection
- aripiprazole lauroxil
- aripiprazole monthly injection
- aripiprazole oral
- arsenic trioxide
- artemether/lumefantrine
- asenapine
- azithromycin
- bedaquiline
- benztropine
- bromocriptine
- butalbital
- cabergoline
- cabozantinib
- carbamazepine
- ceritinib
- chloroquine
- ciprofloxacin
- citalopram
- clarithromycin
- clofazimine
- clonidine
- codeine
- crizotinib
- danshen
- degarelix
- desflurane
- desipramine
- dexmedetomidine
- dexmedetomidine injection
- diazepam
- dicloxacillin
- disopyramide
- dofetilide
- donepezil
- dordaviprone
- doxylamine
- droperidol
- efavirenz
- encorafenib
- entrectinib
- enzalutamide
- ephedra
- epirubicin
- eribulin
- erythromycin
- ethanol (alcoholic beverage)
- ethanol injection
- etrasimod
- fexinidazole
- flecainide
- fluorouracil
- fluoxetine
- foscarnet
- fosfomycin injection
- fosphenytoin
- gepotidacin
- gilteritinib
- givinostat
- glasdegib
- goserelin
- grapefruit
- haloperidol
- histrelin
- hydrocodone
- hydroxychloroquine
- hydroxyzine
- ibutilide
- iloperidone
- inotuzumab ozogamicin
- isocarboxazid
- isoflurane
- ivabradine
- ivosidenib
- kava
- kratom
- lefamulin
- leuprolide
- levofloxacin
- lofexidine
- lonafarnib
- loperamide
- lopinavir/ritonavir
- lorlatinib
- lumacaftor/ivacaftor
- lumateperone
- lurasidone
- macimorelin
- metaxalone
- methadone
- metoclopramide
- midazolam
- mifepristone
- milsaperidone
- mitotane
- mobocertinib
- moxifloxacin
- nilotinib
- olanzapine
- oliceridine
- ondansetron
- osimertinib
- oxaliplatin
- oxybate
- ozanimod
- pacritinib
- palonosetron
- pasireotide
- pazopanib
- pentamidine
- pentobarbital
- phenelzine
- phenobarbital
- phenytoin
- pimavanserin
- pitolisant
- ponesimod
- primidone
- procainamide
- promethazine
- propafenone
- quetiapine
- quinidine (antiarrhythmic)
- quinidine (CYP2D6 inhibitor)
- quinine
- quizartinib
- rasagiline
- revumenib
- ribociclib
- rifabutin
- rifampin
- rifapentine
- rilpivirine
- romidepsin
- ropeginterferon alfa-2b
- rucaparib
- safinamide
- scopolamine
- selegiline
- selegiline transdermal
- selpercatinib
- sertraline
- sevoflurane
- siponimod
- solifenacin
- sorafenib
- sotalol
- St. John's wort
- taletrectinib
- telavancin
- tetrabenazine
- thalidomide
- tipranavir
- toremifene
- tradipitant
- tramadol
- tranylcypromine
- trazodone
- triclabendazole
- trifluridine
- trimethobenzamide
- triptorelin
- turmeric
- vandetanib
- vemurafenib
- ziftomenib
- ziprasidone
- zuranolone
Monitor/Modify Tx
- acarbose
- acebutolol
- albuterol
- albuterol inhaled
- alfentanil
- alfuzosin
- aliskiren
- alogliptin
- alprazolam
- alprostadil intracavernous
- amantadine
- amifostine
- amiloride
- amisulpride
- amitriptyline
- amlodipine
- amoxapine
- apraclonidine ophthalmic
- aprocitentan
- arformoterol inhaled
- articaine
- asciminib
- atenolol
- avanafil
- azilsartan medoxomil
- baclofen intrathecal
- benazepril
- berberine
- berotralstat
- betaxolol
- betaxolol ophthalmic
- bethanechol
- bexagliflozin
- bisoprolol
- bortezomib
- brexpiprazole
- brimonidine ophthalmic
- brimonidine topical
- bumetanide
- bupivacaine
- bupivacaine liposomal
- buprenorphine
- bupropion
- butorphanol
- canagliflozin
- candesartan cilexetil
- cannabis
- captopril
- cariprazine
- carteolol ophthalmic
- carvedilol
- chlordiazepoxide
- chloroprocaine
- chlorothiazide
- chlorpromazine
- chlorthalidone
- cilostazol
- clevidipine
- clobazam
- clofarabine
- clomipramine
- clonazepam
- clorazepate
- clozapine
- coenzyme Q-10
- colesevelam
- dapagliflozin
- daridorexant
- dasatinib
- denileukin diftitox
- deutetrabenazine
- dihydrocodeine
- diltiazem
- dinutuximab
- dipyridamole
- doxazosin
- doxepin
- dronabinol
- dulaglutide
- duloxetine
- eliglustat
- empagliflozin
- enalapril
- enalaprilat
- entacapone
- eplerenone
- epoprostenol
- ertugliflozin
- escitalopram
- esketamine
- esmolol
- estazolam
- eszopiclone
- ethacrynic acid
- ethanol (in some formulations)
- etomidate
- etripamil nasal
- exenatide
- felodipine
- fenoldopam
- fentanyl
- ferumoxytol
- fingolimod
- flaxseed
- flibanserin
- fluconazole
- fluphenazine
- flurazepam
- formoterol inhaled
- fosinopril
- foslevodopa
- fostemsavir
- furosemide
- gabapentin
- gabapentin enacarbil
- garlic
- gemtuzumab ozogamicin
- gepirone
- glimepiride
- glipizide
- glyburide
- granisetron
- guanfacine
- hydralazine
- hydrochlorothiazide
- hydromorphone
- ifosfamide
- iloprost
- imipramine
- indapamide
- insulin
- iohexol
- iopamidol
- irbesartan
- iron sucrose
- isosorbide dinitrate
- isosorbide mononitrate
- isradipine
- ketamine
- labetalol
- landiolol
- lapatinib
- lemborexant
- lenvatinib
- levalbuterol inhaled
- levobunolol ophthalmic
- levodopa
- levorphanol
- lidocaine
- linagliptin
- liraglutide
- lisinopril
- lithium
- lixisenatide
- lorazepam
- losartan
- loxapine
- lubiprostone
- magnesium sulfate
- maraviroc
- mavorixafor
- mefloquine
- meperidine
- mepivacaine
- metformin
- methohexital
- methyldopa
- methylene blue injection
- metolazone
- metoprolol
- metronidazole
- midostaurin
- 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
- ofloxacin
- olmesartan medoxomil
- olodaterol inhaled
- opicapone
- opium
- osilodrostat
- oxazepam
- oxybutynin
- oxycodone
- oxymorphone
- palopegteriparatide
- pentazocine
- perindopril
- perphenazine
- phenoxybenzamine
- phentolamine
- pindolol
- pioglitazone
- posaconazole
- pralsetinib
- pramipexole
- pramlintide
- prazosin
- pregabalin
- primaquine
- procarbazine
- prochlorperazine
- propofol
- propranolol
- protriptyline
- quazepam
- quinapril
- ramipril
- ranolazine
- relugolix
- remifentanil
- remimazolam
- repaglinide
- riociguat
- risperidone
- ropinirole
- ropivacaine
- rosiglitazone
- rotigotine transdermal
- sacituzumab govitecan
- sacubitril
- salmeterol inhaled
- saxagliptin
- sebetralstat
- semaglutide
- sildenafil
- silodosin
- sitagliptin
- sodium ferric gluconate complex
- sotagliflozin
- sparsentan
- spironolactone
- sufentanil
- sunitinib
- suvorexant
- tacrolimus
- tadalafil
- tagraxofusp
- tamsulosin
- tapentadol
- taurine
- tazemetostat
- telmisartan
- temazepam
- terazosin
- terbutaline
- thiothixene
- timolol
- timolol ophthalmic
- tirzepatide
- tizanidine
- tolcapone
- tolterodine
- torsemide
- trandolapril
- treprostinil
- triamterene
- triazolam
- trifluoperazine
- trimipramine
- valbenazine
- valsartan
- vardenafil
- venlafaxine
- verapamil
- vilanterol inhaled
- voclosporin
- voriconazole
- vosoritide
- yohimbe
- zaleplon
- ziconotide
- zolpidem
Caution Advised
- 5-HTP
- acetazolamide
- aclidinium inhaled
- allopurinol
- almotriptan
- atropine
- baclofen
- belladonna alkaloids
- botulinum toxin
- brivaracetam
- brompheniramine
- buspirone
- busulfan
- cannabidiol
- carbinoxamine
- carisoprodol
- cenobamate
- cetirizine
- chamomile, German
- chasteberry
- chlophedianol
- chlorambucil
- chlorcyclizine
- chlorpheniramine
- chlorzoxazone
- clemastine
- clidinium
- cyclobenzaprine
- cyproheptadine
- dantrolene
- darifenacin
- desvenlafaxine
- dexbrompheniramine
- dexchlorpheniramine
- dichlorphenamide
- dicyclomine
- difelikefalin
- difenoxin
- dimenhydrinate
- diphenhydramine
- diphenoxylate
- doxepin topical
- eletriptan
- elinzanetant
- eslicarbazepine acetate
- ethosuximide
- felbamate
- fenfluramine
- fesoterodine
- flavoxate
- fluvoxamine
- frovatriptan
- galantamine
- ganaxolone
- glofitamab
- glycopyrrolate
- glycopyrrolate inhaled
- glycopyrronium topical
- homatropine
- hyoscyamine
- ipratropium inhaled
- lacosamide
- lamotrigine
- levetiracetam
- levocetirizine
- levomilnacipran
- linvoseltamab
- magnesium citrate
- meclizine
- melatonin
- meprobamate
- meropenem
- methocarbamol
- methscopolamine
- methsuximide
- metyrapone
- metyrosine
- milnacipran
- mosunetuzumab
- mycophenolate mofetil
- naltrexone
- naratriptan
- nefazodone
- orphenadrine
- oxcarbazepine
- paroxetine
- passion flower
- perampanel
- pheniramine
- polyethylene glycol
- polyethylene glycol/electrolytes
- pyrilamine
- ramelteon
- repotrectinib
- revefenacin inhaled
- rivastigmine
- rizatriptan
- rufinamide
- selinexor
- sodium picosulfate
- sofpironium topical
- solriamfetol
- stiripentol
- sulfate bowel prep
- sumatriptan
- tasimelteon
- thiotepa
- tiagabine
- tiotropium inhaled
- topiramate
- treosulfan
- trihexyphenidyl
- triprolidine
- trospium
- umeclidinium inhaled
- vaborbactam
- valerian
- valproic acid
- vigabatrin
- vilazodone
- viloxazine
- zolmitriptan
- zonisamide
Adverse Reactions .
Serious Reactions
- QT prolongation
- arrhythmia
- AV block
- stroke
- TIA
- hypotension, orthostatic
- syncope
- hyperthermia
- neuroleptic malignant syndrome
- extrapyramidal symptoms, severe
- tardive dyskinesia
- dystonia
- hyperglycemia
- diabetes mellitus
- seizures
- priapism
- hypersensitivity reaction
- anaphylaxis
- angioedema
- leukopenia
- neutropenia
- agranulocytosis
- dysphagia, severe
Common Reactions
- hyperprolactinemia
- dyslipidemia
- headache
- weight gain
- injection site reaction
- URI
- agitation
- hyperglycemia
- anxiety
- somnolence
- extrapyramidal symptoms
- akathisia
- dizziness
- vomiting
- nausea
- abdominal discomfort
- abdominal pain
- diarrhea
- xerostomia
- back pain
- musculoskeletal pain
- extremity pain
- cough
- insomnia
- UTI
- asthenia
- fatigue
- HTN
- nightmares
- fever
- impaired body temperature regulation
Safety/Monitoring .
Monitoring Parameters
Cr at baseline; fasting lipid panel at baseline, then periodically; 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; no known risk of teratogenicity based on animal data at up to 10x MRHD
Pregnancy Registry
enroll patients or encourage patients to enroll in National Pregnancy Registry for Atypical Antipsychotics at 1-866-961-2388 or www.womensmentalhealth.org/research/pregnancyregistry/atypicalantipsychotic
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: for paliperidone: liver minimally; CYP450: minimal; 3A4 substrate
Excretion: for paliperidone: urine 80% (51-67% unchanged), feces 11%; Half-life: 25-49 days (1-mo IM form), 84-139 days (3-mo IM form), 148-159 days (6-mo IM form)
Subclass: Antipsychotics, 2nd generation
Mechanism of Action
for paliperidone: exact mechanism of action unknown; antagonizes dopamine D2 receptors, serotonin 5-HT2A receptors, others
Formulary .
No Formulary Selected
Manufacturer/Pricing .
Manufacturer: Janssen Pharmaceuticals, Inc.
DEA/FDA: Rx
Retail Price
Estimated prices only. For current pricing, visit GoodRx.
intramuscular suspension, extended release:
- 819 mg (1 syringe, 2.625 mL): $8,810.00
intramuscular suspension, extended release:
- 273 mg (1 syringe, 0.875 mL): $2,943.00
intramuscular suspension, extended release:
- 410 mg (1 syringe, 1.315 mL): $4,410.00
intramuscular suspension, extended release:
- 546 mg (1 syringe, 1.75 mL): $5,877.00
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