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Spravato
esketamine nasal
Black Box Warnings .
Appropriate Use
restricted distribution program (Spravato REMS) due to risk of serious adverse outcomes resulting from sedation, dissociation, respiratory depression, abuse and misuse; healthcare settings and pharmacies must be certified, and patients treated in outpatient healthcare settings must be enrolled in the program; 1-855-382-6022 or www.spravatorems.com for more information
Sedation, Dissociation, Respiratory Depression
risk of sedation, dissociative or perceptual changes after esketamine administration; respiratory depression observed post-marketing; monitor patients for at least 2h at each tx session, then assess when patient is clinically stable and ready to leave healthcare setting
Abuse and Misuse
esketamine has potential to be abused and misused; weigh risk/benefit in patients at higher risk of abuse; monitor for signs/symptoms of abuse and misuse
Suicidality
antidepressants incr. suicidality risk in peds and young adult patients in short-term studies; monitor closely for clinical worsening and suicidality; advise families and caregivers of need for close observation and communication with prescriber; not approved for peds patients
Adult Dosing .
Dosage forms: SPRAY (56 mg dose pack): 28 mg x2; SPRAY (84 mg dose pack): 28 mg x3
Restricted Distribution in US
- [1-855-382-6022 or www.spravatorems.com for more info]
Special Note
- [dosing clarification]
- Info: each device delivers 2 sprays
major depressive disorder, tx-resistant
- [induction phase]
- Dose: 56-84 mg intranasally 2x/wk x4wk; Info: evaluate benefit after 4wk before continuing tx; alternate nostrils with each spray; give 5min rest between each device use; avoid food >2h and drink >30min before administration
- [maintenance phase]
- Dose: 56-84 mg intranasally qwk x4wk, then 56-84 mg intranasally q1-2wk; Info: alternate nostrils with each spray; give 5min rest between each device use; avoid food >2h and drink >30min before administration
major depressive disorder, depressive symptoms - acutely suicidal patients
- [84 mg intranasally 2x/wk x4wk]
- Info: use with oral antidepressant; may decr. dose to 56 mg intranasally 2x/wk based on tolerability; evaluate benefit after 4wk before continuing tx; alternate nostrils with each spray; give 5min rest between each device use; avoid food >2h and drink >30min before administration
renal dosing
- [not defined]
- renal impairment: not defined
- HD/PD: not defined
hepatic dosing
- [see below]
- mild impairment: not defined; moderate impairment: not defined, caution advised; severe impairment: avoid use
Peds Dosing .
Peds dosing is currently unavailable or not applicable for this drug.
Contraindications / Cautions .
- hypersensitivity to drug or ingredient
- hypersensitivity to ketamine
- aneurysmal vascular disease
- arteriovenous malformation
- intracerebral hemorrhage history
- hepatic impairment, severe
- pregnancy
- avoid: breastfeeding
- caution: hepatic impairment, moderate
- caution: CNS depressant use, concurrent
- caution: alcohol use, concurrent
- caution: patients of childbearing potential
- caution: cardiovascular disease
- caution: cerebrovascular disease
- caution: BP >140/90
- caution: hypertensive encephalopathy history
- caution: psychosis
- caution: substance abuse history
Drug Interactions .
Overview
esketamine
NMDA antagonist
- CNS depression
- hypertensive effects
Contraindicated
- tranylcypromine
Avoid/Use Alternative
- albuterol
- buprenorphine
- butalbital
- butorphanol
- clonidine
- codeine
- dihydrocodeine
- doxylamine
- epinephrine inhaled
- ethanol (alcoholic beverage)
- ethanol injection
- fentanyl
- furosemide
- haloperidol
- hydrocodone
- hydromorphone
- isocarboxazid
- kava
- ketamine
- kratom
- landiolol
- levorphanol
- lorazepam
- meperidine
- metaxalone
- methadone
- metoclopramide
- midazolam
- midodrine
- morphine
- nalbuphine
- oliceridine
- opium
- oxybate
- oxycodone
- oxymorphone
- pentazocine
- phenelzine
- procarbazine
- promethazine
- ropeginterferon alfa-2b
- scopolamine
- tapentadol
- thalidomide
- tradipitant
- tramadol
- trimethobenzamide
- zuranolone
Monitor/Modify Tx
- 5-HTP
- abiraterone acetate
- acebutolol
- albuterol inhaled
- aldesleukin
- alfentanil
- aliskiren
- allopurinol
- almotriptan
- alprazolam
- amantadine
- amiloride
- amitriptyline
- amlodipine
- amoxapine
- amphetamine
- angiotensin II
- apomorphine
- apraclonidine ophthalmic
- aprocitentan
- arformoterol inhaled
- aripiprazole bimonthly injection
- aripiprazole lauroxil
- aripiprazole monthly injection
- aripiprazole oral
- armodafinil
- asciminib
- asenapine
- atenolol
- atogepant
- atomoxetine
- atropine ophthalmic
- axitinib
- azilsartan medoxomil
- baclofen
- baclofen intrathecal
- benazepril
- benzphetamine
- betamethasone
- betaxolol
- bevacizumab
- bismuth subsalicylate
- bisoprolol
- brexpiprazole
- brigatinib
- brimonidine ophthalmic
- brimonidine topical
- brivaracetam
- bromocriptine
- brompheniramine
- budesonide
- bumetanide
- bupropion
- buspirone
- cabozantinib
- caffeine
- caffeine citrate
- candesartan cilexetil
- cannabidiol
- cannabis
- captopril
- carbamazepine
- carbinoxamine
- carfilzomib
- cariprazine
- carisoprodol
- carvedilol
- celecoxib
- cenobamate
- cetirizine
- chamomile, German
- chlophedianol
- chlorcyclizine
- chlordiazepoxide
- chlorothiazide
- chlorpheniramine
- chlorpromazine
- chlorthalidone
- chlorzoxazone
- citalopram
- clemastine
- clevidipine
- clobazam
- clomipramine
- clonazepam
- clorazepate
- clozapine
- cocaine
- copanlisib
- corticotropin
- cortisone
- cyclobenzaprine
- cyclosporine
- cyproheptadine
- danazol
- dantrolene
- darbepoetin alfa
- daridorexant
- darifenacin
- deflazacort
- desflurane
- desipramine
- desmopressin
- desvenlafaxine
- deutetrabenazine
- dexamethasone
- dexbrompheniramine
- dexchlorpheniramine
- dexmedetomidine
- dexmedetomidine injection
- dexmethylphenidate
- dextroamphetamine
- diazepam
- dichlorphenamide
- diclofenac
- diclofenac topical
- diethylpropion
- difelikefalin
- difenoxin
- diflunisal
- dihydroergotamine
- diltiazem
- dimenhydrinate
- diphenhydramine
- diphenoxylate
- dobutamine
- domperidone
- dopamine
- doxapram
- doxazosin
- doxepin
- doxepin topical
- dronabinol
- droperidol
- droxidopa
- duloxetine
- efavirenz
- eletriptan
- elinzanetant
- enalapril
- enalaprilat
- entacapone
- entrectinib
- ephedra
- ephedrine injection
- ephedrine oral
- epinephrine
- eplerenone
- epoetin alfa
- eptinezumab
- erenumab
- ergotamine
- escitalopram
- eslicarbazepine acetate
- esmolol
- estazolam
- estetrol (contraceptive)
- estradiol (contraceptive)
- eszopiclone
- ethacrynic acid
- ethanol (in some formulations)
- ethinyl estradiol (contraceptive)
- ethosuximide
- etodolac
- etomidate
- etrasimod
- felbamate
- felodipine
- fenfluramine
- fenoldopam
- fenoprofen
- fesoterodine
- fingolimod
- flibanserin
- fludrocortisone
- fluoxetine
- fluphenazine
- flurazepam
- flurbiprofen
- fluvoxamine
- formoterol inhaled
- fosinopril
- foslevodopa
- fosphenytoin
- fostamatinib
- fremanezumab
- frovatriptan
- fruquintinib
- gabapentin
- gabapentin enacarbil
- galcanezumab
- ganaxolone
- glofitamab
- glycopyrrolate
- guanfacine
- hoodia
- hydralazine
- hydrochlorothiazide
- hydrocortisone
- hydroxocobalamin IV
- hydroxyzine
- hyoscyamine
- ibrutinib
- ibuprofen
- ifosfamide
- iloperidone
- imipramine
- indapamide
- indomethacin
- irbesartan
- isoflurane
- isradipine
- ketoprofen
- ketorolac
- labetalol
- lacosamide
- lamotrigine
- lanreotide
- leflunomide
- lemborexant
- lenvatinib
- levalbuterol inhaled
- levetiracetam
- levocetirizine
- levodopa
- levomilnacipran
- levothyroxine
- licorice
- linezolid
- linvoseltamab
- liothyronine
- lisdexamfetamine
- lisinopril
- lofexidine
- lorlatinib
- losartan
- loxapine
- lumacaftor/ivacaftor
- lumateperone
- lurasidone
- luspatercept
- magnesium salicylate
- meclizine
- meclofenamate
- mefenamic acid
- melatonin
- meloxicam
- meprobamate
- methamphetamine
- methocarbamol
- methohexital
- methoxy polyethylene glycol-epoetin beta
- methsuximide
- methyldopa
- methylergonovine
- methylphenidate
- methylprednisolone
- methyltestosterone
- metolazone
- metoprolol
- metyrapone
- metyrosine
- milnacipran
- milsaperidone
- minoxidil
- mirabegron
- mirtazapine
- mitotane
- modafinil
- moexipril
- molindone
- mosunetuzumab
- mycophenolate mofetil
- nabumetone
- nadolol
- naltrexone
- naproxen
- naratriptan
- naxitamab
- nebivolol
- nefazodone
- nelarabine
- nicardipine
- nifedipine
- nimodipine
- niraparib
- nisoldipine
- norepinephrine
- nortriptyline
- obinutuzumab
- olanzapine
- olmesartan medoxomil
- olodaterol inhaled
- opicapone
- orphenadrine
- osilodrostat
- oxaprozin
- oxazepam
- oxcarbazepine
- oxybutynin
- oxymetazoline nasal
- oxytocin
- ozanimod
- paliperidone
- paroxetine
- passion flower
- pazopanib
- pentobarbital
- perampanel
- perindopril
- perphenazine
- pexidartinib
- phendimetrazine
- pheniramine
- phenobarbital
- phenoxybenzamine
- phentermine
- phentolamine
- phenylephrine
- phenylephrine injection
- phenylephrine nasal
- phenylephrine ophthalmic
- phenylephrine rectal
- phenytoin
- pimozide
- pindolol
- piroxicam
- ponatinib
- ponesimod
- pralsetinib
- pramipexole
- prazosin
- prednisolone
- prednisone
- pregabalin
- primidone
- prochlorperazine
- propofol
- propranolol
- propylhexedrine nasal
- protriptyline
- pseudoephedrine
- pyrilamine
- quazepam
- quetiapine
- quinapril
- ramelteon
- ramipril
- ramucirumab
- rasagiline
- regorafenib
- remifentanil
- remimazolam
- repotrectinib
- rimegepant
- ripretinib
- risperidone
- rizatriptan
- ropinirole
- rotigotine transdermal
- rufinamide
- safinamide
- salmeterol inhaled
- salsalate
- selegiline
- selegiline transdermal
- selinexor
- selpercatinib
- sertraline
- sevoflurane
- siponimod
- solifenacin
- solriamfetol
- sorafenib
- spironolactone
- stiripentol
- sufentanil
- sulindac
- sumatriptan
- sunitinib
- suvorexant
- tacrolimus
- tagraxofusp
- tasimelteon
- telmisartan
- temazepam
- terazosin
- terbutaline
- teriflunomide
- testosterone
- tetrabenazine
- thioridazine
- thiotepa
- thiothixene
- thyroid
- tiagabine
- timolol
- tivozanib
- tizanidine
- tolcapone
- tolmetin
- tolterodine
- topiramate
- torsemide
- trametinib
- trandolapril
- trazodone
- triamcinolone
- triamterene
- triazolam
- trifluoperazine
- trihexyphenidyl
- trimipramine
- triprolidine
- trospium
- ubrogepant
- vadadustat
- valbenazine
- valerian
- valproic acid
- valsartan
- vamorolone
- vandetanib
- vasopressin
- venlafaxine
- verapamil
- vigabatrin
- vilanterol inhaled
- vilazodone
- viloxazine
- voclosporin
- yohimbe
- zaleplon
- zavegepant
- ziconotide
- ziprasidone
- ziv-aflibercept
- zolmitriptan
- zolpidem
- zonisamide
Caution Advised
- memantine
Adverse Reactions .
Serious Reactions
- CNS depression
- unconsciousness
- cognitive impairment, short-term
- dissociation
- respiratory depression
- respiratory arrest
- dependency
- abuse
- suicidality
- HTN, severe
- bradycardia
Common Reactions
- dissociative effects
- sedation
- dizziness
- nausea
- vertigo
- headache
- dysgeusia
- hypoesthesia
- BP incr.
- anxiety
- lethargy
- vomiting
- insomnia
- throat irritation
- nasal discomfort
- diarrhea
- intoxicated feeling
- xerostomia
- dysarthria
- euphoria
- hyperhidrosis
- abnormal feeling
- pollakiuria
- tremor
- mental impairment
- attention disturbance
- constipation
- oropharyngeal pain
- tachycardia
- lower urinary tract symptoms
Safety/Monitoring .
Monitoring Parameters
BP at baseline, 40min after administration, then as clinically needed for at least 2h after administration, more frequently if hypertensive encephalopathy history; respiratory status including pulse oximetry, signs/symptoms of sedation and dissociation for at least 2h after administration; consider monitoring for longer if moderate hepatic impairment
Look/Sound-Alike Drug Names
Spravato confused with: Steglatro
Pregnancy/Lactation .
Pregnancy
Clinical Summary
avoid use during pregnancy; inadequate human data available; possible risk of skeletal malformations based on animal data at >0.3x MRHD; possible dose-dependent risk of neonatal adverse effects based on limited human data with ketamine IV
Pregnancy Registry
encourage patients to enroll in National Pregnancy Registry for Antidepressants at 1-844-405-6185; additional info at www.womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/antidepressants
Individuals of Reproductive Potential
avoid pregnancy by using contraception during tx in patients of childbearing potential
Lactation
Clinical Summary
avoid breastfeeding; inadequate 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 esketamine: liver; CYP450: 2B6 (primary), 2C9, 2C19, 3A4; Info: active metabolite
Excretion: for esketamine: urine primarily (<1% unchanged); Half-life: 7-12h
Subclass: N-Methyl-D-Aspartate (NMDA) Receptor Antagonists, Psychiatric
Mechanism of Action
for esketamine: exact mechanism of action unknown; antagonizes N-methyl-D-aspartate (NMDA) receptor
Formulary .
No Formulary Selected
Manufacturer/Pricing .
Manufacturer: Janssen Pharmaceuticals, Inc.
DEA/FDA: Schedule III
Retail Price
Estimated prices only. For current pricing, visit GoodRx.
nasal spray:
- 28 mg (2 nasal spray): $671.00
- 84 mg (3 nasal spray): $1,002.00
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