esketamine intranasal (Rx)

Brand and Other Names:Spravato
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Dosing & Uses

AdultPediatricGeriatric

Dosage Forms & Strengths

solution, intranasal: Schedule III

  • 28mg/device; each nasal spray device delivers 2 sprays that total 28mg
  • Available as a 56mg kit (two 28-mg nasal spray devices) or an 84mg kit (three 28-mg nasal spray devices)

Treatment-resistant Depression

Indicated in conjunction with an oral antidepressant for treatment-resistant depression (TRD)

Adjust dose based on efficacy and tolerability

At the end of the induction phase, evaluate evidence of therapeutic benefit to determine need for continued treatment

Must be administered in healthcare facility under direct supervision

Induction phase

  • Weeks 1-4
    • Administer intranasally twice per week
    • Day 1 starting dose: 56 mg
    • Subsequent doses: 56 mg or 84 mg

Maintenance phase

  • Weeks 5-8
    • Administer intranasally once weekly
    • 56 mg or 84 mg
  • Week 9 and after
    • Administer intranasally q2Week or once weekly; individualize dosing frequency to the least frequent dosing to maintain remission/response
    • 56 mg or 84 mg

Major Depressive Disorder

Indicated for depressive symptoms in adults with major depressive disorder (MDD) with acute suicidal ideation or behavior

Administer intranasally in conjunction with an oral antidepressant

Must be administered in healthcare facility under direct supervision

84 mg twice per week x 4 weeks

May reduce dose to 56 mg twice per week based on tolerability

After 4 weeks of treatment, evaluate evidence of therapeutic benefit determine need for continued treatment

Use in conjunction with an oral antidepressant beyond 4 weeks has not been systematically evaluated for treatment of depressive symptoms in patients with MDD with acute suicidal ideation or behavior

Dosage Modifications

Hepatic impairment

  • Moderate (Child-Pugh class B): Higher AUC and half-life observed compared with normal hepatic function; may need to be monitored for longer period after dose administration
  • Severe (Child-Pugh class C): Not studied, and therefore not recommended

Renal impairment

  • Renal dialysis: No clinical experience

Dosing Considerations

Must be administered under direct supervision of a healthcare provider during entire treatment session (ie, nasal administration and postadministration direct observation)

Limitations of use

  • Not approved as an anesthetic agent; safety and effectiveness not established
  • Effectiveness in preventing suicide or in reducing suicidal ideation or behavior has not been demonstrated; use of esketamine intranasal does not preclude the need for hospitalization if clinically warranted, even if patients experience improvement after an initial dose

Blood pressure monitoring

  • Assess blood pressure before administration
  • If baseline blood pressure is elevated (eg, >140 mm Hg systolic, >90 mm Hg diastolic), consider the risks of short-term increases in blood pressure and benefit of treatment
  • Do not administer if increased blood pressure or intracranial pressure poses serious risk
  • After dosing, reassess blood pressure at ~40 minutes (corresponds with peak plasma concentration) and subsequently as clinically warranted
  • If blood pressure is decreasing and patient appears clinically stable for at least 2 hr, may discharge patient at the end of the postdose monitoring period; if not, continue to monitor

Food and liquid ingestion

  • Some patients may experience nausea and vomiting after administration
  • Because of this, advise patients to avoid food for at least 2 hr before administration and to avoid drinking liquids at least 30 minutes before

Nasal corticosteroids or decongestants

  • Administer nasal corticosteroid or decongestant at least 1 hr before esketamine

Safety and efficacy not established

In clinical trials, 14% of patients were aged 65 yr or older; no overall differences in safety profile were observed

See adult dosing

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Interactions

Interaction Checker

and esketamine intranasal

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              Serious - Use Alternative (1)

              • metoclopramide intranasal

                esketamine intranasal, metoclopramide intranasal. Either increases effects of the other by Other (see comment). Avoid or Use Alternate Drug. Comment: Avoid use of metoclopramide intranasal or interacting drug, depending on importance of drug to patient.

              Monitor Closely (195)

              • acetaminophen/pamabrom/pyrilamine

                esketamine intranasal, acetaminophen/pamabrom/pyrilamine. Either increases toxicity of the other by sedation. Modify Therapy/Monitor Closely.

              • acetazolamide

                esketamine intranasal, acetazolamide. Either increases toxicity of the other by sedation. Modify Therapy/Monitor Closely.

              • acrivastine

                esketamine intranasal, acrivastine. Either increases toxicity of the other by sedation. Modify Therapy/Monitor Closely.

              • alfentanil

                esketamine intranasal, alfentanil. Either increases toxicity of the other by sedation. Modify Therapy/Monitor Closely.

              • alprazolam

                esketamine intranasal, alprazolam. Either increases toxicity of the other by sedation. Modify Therapy/Monitor Closely.

              • amitriptyline

                esketamine intranasal, amitriptyline. Either increases toxicity of the other by sedation. Modify Therapy/Monitor Closely.

              • amobarbital

                esketamine intranasal, amobarbital. Either increases toxicity of the other by sedation. Modify Therapy/Monitor Closely.

              • amoxapine

                esketamine intranasal, amoxapine. Either increases toxicity of the other by sedation. Modify Therapy/Monitor Closely.

              • amphetamine

                esketamine intranasal, amphetamine. Either increases toxicity of the other by sympathetic (adrenergic) effects, including increased blood pressure and heart rate. Use Caution/Monitor. Closely monitor blood pressure with concomitant use of esketamine nasal with stimulants. .

              • amphetamine polistirex

                esketamine intranasal, amphetamine polistirex. Either increases toxicity of the other by sympathetic (adrenergic) effects, including increased blood pressure and heart rate. Use Caution/Monitor. Closely monitor blood pressure with concomitant use of esketamine nasal with stimulants. .

              • arbaclofen

                esketamine intranasal, arbaclofen. Either increases toxicity of the other by sedation. Modify Therapy/Monitor Closely.

              • aripiprazole

                esketamine intranasal, aripiprazole. Either increases toxicity of the other by sedation. Modify Therapy/Monitor Closely.

              • armodafinil

                esketamine intranasal, armodafinil. Either increases toxicity of the other by sympathetic (adrenergic) effects, including increased blood pressure and heart rate. Use Caution/Monitor. Closely monitor blood pressure with concomitant use of esketamine nasal with stimulants. .

              • asenapine

                esketamine intranasal, asenapine. Either increases toxicity of the other by sedation. Modify Therapy/Monitor Closely.

              • atomoxetine

                esketamine intranasal, atomoxetine. Either increases toxicity of the other by sympathetic (adrenergic) effects, including increased blood pressure and heart rate. Use Caution/Monitor. Closely monitor blood pressure with concomitant use of esketamine nasal with stimulants. .

              • baclofen

                esketamine intranasal, baclofen. Either increases toxicity of the other by sedation. Modify Therapy/Monitor Closely.

              • belladonna and opium

                esketamine intranasal, belladonna and opium. Either increases toxicity of the other by sedation. Modify Therapy/Monitor Closely.

              • benperidol

                esketamine intranasal, benperidol. Either increases toxicity of the other by sedation. Modify Therapy/Monitor Closely.

              • benzhydrocodone/acetaminophen

                esketamine intranasal, benzhydrocodone/acetaminophen. Either increases toxicity of the other by sedation. Modify Therapy/Monitor Closely.

              • brexanolone

                brexanolone, esketamine intranasal. Either increases toxicity of the other by sedation. Use Caution/Monitor.

              • brexpiprazole

                esketamine intranasal, brexpiprazole. Either increases levels of the other by sedation. Modify Therapy/Monitor Closely.

              • brimonidine

                esketamine intranasal, brimonidine. Either increases toxicity of the other by sedation. Modify Therapy/Monitor Closely.

              • brivaracetam

                esketamine intranasal, brivaracetam. Either increases toxicity of the other by sedation. Modify Therapy/Monitor Closely.

              • brompheniramine

                esketamine intranasal, brompheniramine. Either increases toxicity of the other by sedation. Modify Therapy/Monitor Closely.

              • buprenorphine

                esketamine intranasal, buprenorphine. Either increases toxicity of the other by sedation. Modify Therapy/Monitor Closely.

              • buprenorphine transdermal

                esketamine intranasal, buprenorphine transdermal. Either increases toxicity of the other by sedation. Modify Therapy/Monitor Closely.

              • buspirone

                esketamine intranasal, buspirone. Either increases toxicity of the other by sedation. Modify Therapy/Monitor Closely.

              • butabarbital

                esketamine intranasal, butabarbital. Either increases toxicity of the other by sedation. Modify Therapy/Monitor Closely.

              • butalbital

                esketamine intranasal, butalbital. Either increases toxicity of the other by sedation. Modify Therapy/Monitor Closely.

              • butorphanol

                esketamine intranasal, butorphanol. Either increases toxicity of the other by sedation. Modify Therapy/Monitor Closely.

              • caffeine

                esketamine intranasal, caffeine. Either increases toxicity of the other by sympathetic (adrenergic) effects, including increased blood pressure and heart rate. Use Caution/Monitor. Closely monitor blood pressure with concomitant use of esketamine nasal with stimulants. .

              • calcium/magnesium/potassium/sodium oxybates

                esketamine intranasal, calcium/magnesium/potassium/sodium oxybates. Either increases toxicity of the other by sedation. Modify Therapy/Monitor Closely.

              • cannabidiol

                esketamine intranasal, cannabidiol. Either increases toxicity of the other by sedation. Modify Therapy/Monitor Closely.

              • carbamazepine

                esketamine intranasal, carbamazepine. Either increases toxicity of the other by sedation. Modify Therapy/Monitor Closely.

              • carbinoxamine

                esketamine intranasal, carbinoxamine. Either increases toxicity of the other by sedation. Modify Therapy/Monitor Closely.

              • cariprazine

                esketamine intranasal, cariprazine. Either increases toxicity of the other by sedation. Modify Therapy/Monitor Closely.

              • carisoprodol

                esketamine intranasal, carisoprodol. Either increases toxicity of the other by sedation. Modify Therapy/Monitor Closely.

              • cenobamate

                cenobamate, esketamine intranasal. Either increases effects of the other by sedation. Use Caution/Monitor.

              • cetirizine

                esketamine intranasal, cetirizine. Either increases toxicity of the other by sedation. Modify Therapy/Monitor Closely.

              • chlordiazepoxide

                esketamine intranasal, chlordiazepoxide. Either increases toxicity of the other by sedation. Modify Therapy/Monitor Closely.

              • chlorpheniramine

                esketamine intranasal, chlorpheniramine. Either increases toxicity of the other by sedation. Modify Therapy/Monitor Closely.

              • chlorpromazine

                esketamine intranasal, chlorpromazine. Either increases toxicity of the other by sedation. Modify Therapy/Monitor Closely.

              • chlorzoxazone

                esketamine intranasal, chlorzoxazone. Either increases toxicity of the other by sedation. Modify Therapy/Monitor Closely.

              • clemastine

                esketamine intranasal, clemastine. Either increases toxicity of the other by sedation. Modify Therapy/Monitor Closely.

              • clomipramine

                esketamine intranasal, clomipramine. Either increases toxicity of the other by sedation. Modify Therapy/Monitor Closely.

              • clonazepam

                esketamine intranasal, clonazepam. Either increases toxicity of the other by sedation. Modify Therapy/Monitor Closely.

              • clonidine

                esketamine intranasal, clonidine. Either increases toxicity of the other by sedation. Modify Therapy/Monitor Closely.

                esketamine intranasal, clonidine. Either increases toxicity of the other by sympathetic (adrenergic) effects, including increased blood pressure and heart rate. Use Caution/Monitor. Closely monitor blood pressure with concomitant use of esketamine nasal with stimulants. .

              • clorazepate

                esketamine intranasal, clorazepate. Either increases toxicity of the other by sedation. Modify Therapy/Monitor Closely.

              • clozapine

                esketamine intranasal, clozapine. Either increases toxicity of the other by sedation. Modify Therapy/Monitor Closely.

              • codeine

                esketamine intranasal, codeine. Either increases toxicity of the other by sedation. Modify Therapy/Monitor Closely.

              • cyclobenzaprine

                esketamine intranasal, cyclobenzaprine. Either increases toxicity of the other by sedation. Modify Therapy/Monitor Closely.

              • cyproheptadine

                esketamine intranasal, cyproheptadine. Either increases toxicity of the other by sedation. Modify Therapy/Monitor Closely.

              • dantrolene

                esketamine intranasal, dantrolene. Either increases toxicity of the other by sedation. Modify Therapy/Monitor Closely.

              • desflurane

                esketamine intranasal, desflurane. Either increases toxicity of the other by sedation. Modify Therapy/Monitor Closely.

              • desipramine

                esketamine intranasal, desipramine. Either increases toxicity of the other by sedation. Modify Therapy/Monitor Closely.

              • desloratadine

                esketamine intranasal, desloratadine. Either increases toxicity of the other by sedation. Modify Therapy/Monitor Closely.

              • deutetrabenazine

                esketamine intranasal, deutetrabenazine. Either increases toxicity of the other by sedation. Modify Therapy/Monitor Closely.

              • dexbrompheniramine

                esketamine intranasal, dexbrompheniramine. Either increases toxicity of the other by sedation. Modify Therapy/Monitor Closely.

              • dexchlorpheniramine

                esketamine intranasal, dexchlorpheniramine. Either increases toxicity of the other by sedation. Modify Therapy/Monitor Closely.

              • dexmethylphenidate

                esketamine intranasal, dexmethylphenidate. Either increases toxicity of the other by sympathetic (adrenergic) effects, including increased blood pressure and heart rate. Use Caution/Monitor. Closely monitor blood pressure with concomitant use of esketamine nasal with stimulants. .

              • dextroamphetamine

                esketamine intranasal, dextroamphetamine. Either increases toxicity of the other by sympathetic (adrenergic) effects, including increased blood pressure and heart rate. Use Caution/Monitor. Closely monitor blood pressure with concomitant use of esketamine nasal with stimulants. .

              • diazepam

                esketamine intranasal, diazepam. Either increases toxicity of the other by sedation. Modify Therapy/Monitor Closely.

              • diazepam intranasal

                diazepam intranasal, esketamine intranasal. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Coadministration may potentiate the CNS-depressant effects of each drug.

              • diethylpropion

                esketamine intranasal, diethylpropion. Either increases toxicity of the other by sympathetic (adrenergic) effects, including increased blood pressure and heart rate. Use Caution/Monitor. Closely monitor blood pressure with concomitant use of esketamine nasal with stimulants. .

              • dimenhydrinate

                esketamine intranasal, dimenhydrinate. Either increases toxicity of the other by sedation. Modify Therapy/Monitor Closely.

              • diphenhydramine

                esketamine intranasal, diphenhydramine. Either increases toxicity of the other by sedation. Modify Therapy/Monitor Closely.

              • diphenoxylate hcl

                esketamine intranasal, diphenoxylate hcl. Either increases toxicity of the other by sedation. Modify Therapy/Monitor Closely.

              • dosulepin

                esketamine intranasal, dosulepin. Either increases toxicity of the other by sedation. Modify Therapy/Monitor Closely.

              • doxepin

                esketamine intranasal, doxepin. Either increases toxicity of the other by sedation. Modify Therapy/Monitor Closely.

              • doxylamine

                esketamine intranasal, doxylamine. Either increases toxicity of the other by sedation. Modify Therapy/Monitor Closely.

              • droperidol

                esketamine intranasal, droperidol. Either increases toxicity of the other by sedation. Modify Therapy/Monitor Closely.

              • efavirenz

                esketamine intranasal, efavirenz. Either increases toxicity of the other by sedation. Modify Therapy/Monitor Closely.

              • emedastine

                esketamine intranasal, emedastine. Either increases toxicity of the other by sedation. Modify Therapy/Monitor Closely.

              • estazolam

                esketamine intranasal, estazolam. Either increases toxicity of the other by sedation. Modify Therapy/Monitor Closely.

              • eszopiclone

                esketamine intranasal, eszopiclone. Either increases toxicity of the other by sedation. Use Caution/Monitor.

              • ethanol

                esketamine intranasal, ethanol. Either increases toxicity of the other by sedation. Modify Therapy/Monitor Closely.

              • ethosuximide

                esketamine intranasal, ethosuximide. Either increases toxicity of the other by sedation. Use Caution/Monitor.

              • ethotoin

                esketamine intranasal, ethotoin. Either increases toxicity of the other by sedation. Use Caution/Monitor.

              • ezogabine

                esketamine intranasal, ezogabine. Either increases levels of the other by sedation. Use Caution/Monitor.

              • felbamate

                esketamine intranasal, felbamate. Either increases toxicity of the other by sedation. Use Caution/Monitor.

              • fenfluramine

                fenfluramine, esketamine intranasal. Either increases effects of the other by serotonin levels. Use Caution/Monitor. Coadministration with drugs that increase serotoninergic effects may increase the risk of serotonin syndrome.

              • fentanyl

                esketamine intranasal, fentanyl. Either increases toxicity of the other by sedation. Modify Therapy/Monitor Closely.

              • fentanyl intranasal

                esketamine intranasal, fentanyl intranasal. Either increases toxicity of the other by sedation. Modify Therapy/Monitor Closely.

              • fentanyl transdermal

                esketamine intranasal, fentanyl transdermal. Either increases toxicity of the other by sedation. Modify Therapy/Monitor Closely.

              • fentanyl transmucosal

                esketamine intranasal, fentanyl transmucosal. Either increases toxicity of the other by sedation. Modify Therapy/Monitor Closely.

              • fexofenadine

                esketamine intranasal, fexofenadine. Either increases toxicity of the other by sedation. Modify Therapy/Monitor Closely.

              • flibanserin

                esketamine intranasal, flibanserin. Either increases toxicity of the other by sedation. Use Caution/Monitor.

              • fluphenazine

                esketamine intranasal, fluphenazine. Either increases toxicity of the other by sedation. Use Caution/Monitor.

              • flurazepam

                esketamine intranasal, flurazepam. Either increases toxicity of the other by sedation. Modify Therapy/Monitor Closely.

              • fosphenytoin

                esketamine intranasal, fosphenytoin. Either increases toxicity of the other by sedation. Use Caution/Monitor.

              • gabapentin

                esketamine intranasal, gabapentin. Either increases toxicity of the other by sedation. Use Caution/Monitor.

                gabapentin, esketamine intranasal. Either increases effects of the other by pharmacodynamic synergism. Modify Therapy/Monitor Closely. Coadministration of CNS depressants can result in serious, life-threatening, and fatal respiratory depression. Use lowest dose possible and monitor for respiratory depression and sedation.

              • gabapentin enacarbil

                esketamine intranasal, gabapentin enacarbil. Either increases toxicity of the other by sedation. Use Caution/Monitor.

                gabapentin enacarbil, esketamine intranasal. Either increases effects of the other by pharmacodynamic synergism. Modify Therapy/Monitor Closely. Coadministration of CNS depressants can result in serious, life-threatening, and fatal respiratory depression. Use lowest dose possible and monitor for respiratory depression and sedation.

              • guanfacine

                esketamine intranasal, guanfacine. Either increases toxicity of the other by sedation. Use Caution/Monitor.

                esketamine intranasal, guanfacine. Either increases toxicity of the other by sympathetic (adrenergic) effects, including increased blood pressure and heart rate. Use Caution/Monitor. Closely monitor blood pressure with concomitant use of esketamine nasal with stimulants. .

              • haloperidol

                esketamine intranasal, haloperidol. Either increases toxicity of the other by sedation. Use Caution/Monitor.

              • hydrocodone

                esketamine intranasal, hydrocodone. Either increases toxicity of the other by sedation. Modify Therapy/Monitor Closely.

              • hydromorphone

                esketamine intranasal, hydromorphone. Either increases toxicity of the other by sedation. Modify Therapy/Monitor Closely.

              • hydroxyzine

                esketamine intranasal, hydroxyzine. Either increases toxicity of the other by sedation. Modify Therapy/Monitor Closely.

              • iloperidone

                esketamine intranasal, iloperidone. Either increases toxicity of the other by sedation. Modify Therapy/Monitor Closely.

              • imipramine

                esketamine intranasal, imipramine. Either increases toxicity of the other by sedation. Modify Therapy/Monitor Closely.

              • isocarboxazid

                esketamine intranasal, isocarboxazid. Either increases toxicity of the other by sympathetic (adrenergic) effects, including increased blood pressure and heart rate. Use Caution/Monitor. Closely monitor blood pressure with concomitant use of esketamine nasal with MAO-Is. .

              • isoflurane

                esketamine intranasal, isoflurane. Either increases toxicity of the other by sedation. Use Caution/Monitor.

              • ketamine

                esketamine intranasal, ketamine. Either increases toxicity of the other by sedation. Use Caution/Monitor.

              • lamotrigine

                esketamine intranasal, lamotrigine. Either increases toxicity of the other by sedation. Use Caution/Monitor.

              • lasmiditan

                lasmiditan, esketamine intranasal. Either increases effects of the other by sedation. Use Caution/Monitor. Coadministration of lasmiditan and other CNS depressant drugs, including alcohol have not been evaluated in clinical studies. Lasmiditan may cause sedation, as well as other cognitive and/or neuropsychiatric adverse reactions.

              • levetiracetam

                esketamine intranasal, levetiracetam. Either increases toxicity of the other by sedation. Use Caution/Monitor.

              • levocetirizine

                esketamine intranasal, levocetirizine. Either increases toxicity of the other by sedation. Modify Therapy/Monitor Closely.

              • levorphanol

                esketamine intranasal, levorphanol. Either increases toxicity of the other by sedation. Modify Therapy/Monitor Closely.

              • lisdexamfetamine

                esketamine intranasal, lisdexamfetamine. Either increases toxicity of the other by sympathetic (adrenergic) effects, including increased blood pressure and heart rate. Use Caution/Monitor. Closely monitor blood pressure with concomitant use of esketamine nasal with stimulants. .

              • loratadine

                esketamine intranasal, loratadine. Either increases toxicity of the other by sedation. Modify Therapy/Monitor Closely.

              • lorazepam

                esketamine intranasal, lorazepam. Either increases toxicity of the other by sedation. Modify Therapy/Monitor Closely.

              • loxapine

                esketamine intranasal, loxapine. Either increases toxicity of the other by sedation. Use Caution/Monitor.

              • lurasidone

                esketamine intranasal, lurasidone. Either increases toxicity of the other by sedation. Modify Therapy/Monitor Closely.

              • maprotiline

                esketamine intranasal, maprotiline. Either increases toxicity of the other by sedation. Use Caution/Monitor.

              • meclizine

                esketamine intranasal, meclizine. Either increases toxicity of the other by sedation. Use Caution/Monitor.

              • meperidine

                esketamine intranasal, meperidine. Either increases toxicity of the other by sedation. Modify Therapy/Monitor Closely.

              • metaxalone

                esketamine intranasal, metaxalone. Either increases toxicity of the other by sedation. Modify Therapy/Monitor Closely.

              • methadone

                esketamine intranasal, methadone. Either increases toxicity of the other by sedation. Modify Therapy/Monitor Closely.

              • methamphetamine

                esketamine intranasal, methamphetamine. Either increases toxicity of the other by sympathetic (adrenergic) effects, including increased blood pressure and heart rate. Use Caution/Monitor. Closely monitor blood pressure with concomitant use of esketamine nasal with stimulants. .

              • methocarbamol

                esketamine intranasal, methocarbamol. Either increases toxicity of the other by sedation. Modify Therapy/Monitor Closely.

              • methylphenidate

                esketamine intranasal, methylphenidate. Either increases toxicity of the other by sympathetic (adrenergic) effects, including increased blood pressure and heart rate. Use Caution/Monitor. Closely monitor blood pressure with concomitant use of esketamine nasal with stimulants. .

              • midazolam

                esketamine intranasal, midazolam. Either increases toxicity of the other by sedation. Modify Therapy/Monitor Closely.

              • midazolam intranasal

                midazolam intranasal, esketamine intranasal. Either increases toxicity of the other by pharmacodynamic synergism. Modify Therapy/Monitor Closely. Concomitant use of barbiturates, alcohol, or other CNS depressants may increase the risk of hypoventilation, airway obstruction, desaturation, or apnea and may contribute to profound and/or prolonged drug effect.

              • modafinil

                esketamine intranasal, modafinil. Either increases toxicity of the other by sympathetic (adrenergic) effects, including increased blood pressure and heart rate. Use Caution/Monitor. Closely monitor blood pressure with concomitant use of esketamine nasal with stimulants. .

              • morphine

                esketamine intranasal, morphine. Either increases toxicity of the other by sedation. Modify Therapy/Monitor Closely.

              • nalbuphine

                esketamine intranasal, nalbuphine. Either increases toxicity of the other by sedation. Modify Therapy/Monitor Closely.

              • nicotine gum

                esketamine intranasal, nicotine gum. Either increases toxicity of the other by sympathetic (adrenergic) effects, including increased blood pressure and heart rate. Use Caution/Monitor. Closely monitor blood pressure with concomitant use of esketamine nasal with stimulants. .

              • nicotine inhaled

                esketamine intranasal, nicotine inhaled. Either increases toxicity of the other by sympathetic (adrenergic) effects, including increased blood pressure and heart rate. Use Caution/Monitor. Closely monitor blood pressure with concomitant use of esketamine nasal with stimulants. .

              • nicotine intranasal

                esketamine intranasal, nicotine intranasal. Either increases toxicity of the other by sympathetic (adrenergic) effects, including increased blood pressure and heart rate. Use Caution/Monitor. Closely monitor blood pressure with concomitant use of esketamine nasal with stimulants. .

              • nicotine lozenge

                esketamine intranasal, nicotine lozenge. Either increases toxicity of the other by sympathetic (adrenergic) effects, including increased blood pressure and heart rate. Use Caution/Monitor. Closely monitor blood pressure with concomitant use of esketamine nasal with stimulants. .

              • nicotine transdermal

                esketamine intranasal, nicotine transdermal. Either increases toxicity of the other by sympathetic (adrenergic) effects, including increased blood pressure and heart rate. Use Caution/Monitor. Closely monitor blood pressure with concomitant use of esketamine nasal with stimulants. .

              • nortriptyline

                esketamine intranasal, nortriptyline. Either increases toxicity of the other by sedation. Modify Therapy/Monitor Closely.

              • olanzapine

                esketamine intranasal, olanzapine. Either increases toxicity of the other by sedation. Modify Therapy/Monitor Closely.

              • oliceridine

                esketamine intranasal, oliceridine. Either increases toxicity of the other by sedation. Modify Therapy/Monitor Closely.

              • orphenadrine

                esketamine intranasal, orphenadrine. Either increases toxicity of the other by sedation. Modify Therapy/Monitor Closely.

              • oxazepam

                esketamine intranasal, oxazepam. Either increases toxicity of the other by sedation. Modify Therapy/Monitor Closely.

              • oxycodone

                esketamine intranasal, oxycodone. Either increases toxicity of the other by sedation. Modify Therapy/Monitor Closely.

              • oxymorphone

                esketamine intranasal, oxymorphone. Either increases toxicity of the other by sedation. Modify Therapy/Monitor Closely.

              • paliperidone

                esketamine intranasal, paliperidone. Either increases toxicity of the other by sedation. Modify Therapy/Monitor Closely.

              • pentazocine

                esketamine intranasal, pentazocine. Either increases toxicity of the other by sedation. Modify Therapy/Monitor Closely.

              • pentobarbital

                esketamine intranasal, pentobarbital. Either increases toxicity of the other by sedation. Modify Therapy/Monitor Closely.

              • phendimetrazine

                esketamine intranasal, phendimetrazine. Either increases toxicity of the other by sympathetic (adrenergic) effects, including increased blood pressure and heart rate. Use Caution/Monitor. Closely monitor blood pressure with concomitant use of esketamine nasal with stimulants. .

              • phenelzine

                esketamine intranasal, phenelzine. Either increases toxicity of the other by sympathetic (adrenergic) effects, including increased blood pressure and heart rate. Use Caution/Monitor. Closely monitor blood pressure with concomitant use of esketamine nasal with MAO-Is. .

              • phentermine

                esketamine intranasal, phentermine. Either increases toxicity of the other by sympathetic (adrenergic) effects, including increased blood pressure and heart rate. Use Caution/Monitor. Closely monitor blood pressure with concomitant use of esketamine nasal with stimulants. .

              • phenylephrine PO

                esketamine intranasal, phenylephrine PO. Either increases toxicity of the other by sympathetic (adrenergic) effects, including increased blood pressure and heart rate. Use Caution/Monitor. Closely monitor blood pressure with concomitant use of esketamine nasal with stimulants. .

              • phenytoin

                esketamine intranasal, phenytoin. Either increases toxicity of the other by sedation. Modify Therapy/Monitor Closely.

              • pimavanserin

                esketamine intranasal, pimavanserin. Either increases toxicity of the other by sedation. Modify Therapy/Monitor Closely.

              • pimozide

                esketamine intranasal, pimozide. Either increases toxicity of the other by sedation. Modify Therapy/Monitor Closely.

              • pomalidomide

                esketamine intranasal, pomalidomide. Either increases toxicity of the other by sedation. Modify Therapy/Monitor Closely.

              • pregabalin

                esketamine intranasal, pregabalin. Either increases toxicity of the other by sedation. Modify Therapy/Monitor Closely.

                pregabalin, esketamine intranasal. Either increases effects of the other by pharmacodynamic synergism. Modify Therapy/Monitor Closely. Coadministration of CNS depressants can result in serious, life-threatening, and fatal respiratory depression. Use lowest dose possible and monitor for respiratory depression and sedation.

              • primidone

                esketamine intranasal, primidone. Either increases toxicity of the other by sedation. Modify Therapy/Monitor Closely.

              • promethazine

                esketamine intranasal, promethazine. Either increases toxicity of the other by sedation. Modify Therapy/Monitor Closely.

              • propofol

                esketamine intranasal, propofol. Either increases toxicity of the other by sedation. Modify Therapy/Monitor Closely.

              • protriptyline

                esketamine intranasal, protriptyline. Either increases toxicity of the other by sedation. Modify Therapy/Monitor Closely.

              • pseudoephedrine

                esketamine intranasal, pseudoephedrine. Either increases toxicity of the other by sympathetic (adrenergic) effects, including increased blood pressure and heart rate. Use Caution/Monitor. Closely monitor blood pressure with concomitant use of esketamine nasal with stimulants. .

              • quazepam

                esketamine intranasal, quazepam. Either increases toxicity of the other by sedation. Modify Therapy/Monitor Closely.

              • quetiapine

                esketamine intranasal, quetiapine. Either increases toxicity of the other by sedation. Modify Therapy/Monitor Closely.

              • ramelteon

                esketamine intranasal, ramelteon. Either increases toxicity of the other by sedation. Modify Therapy/Monitor Closely.

              • remifentanil

                esketamine intranasal, remifentanil. Either increases toxicity of the other by sedation. Modify Therapy/Monitor Closely.

              • remimazolam

                remimazolam, esketamine intranasal. Either increases toxicity of the other by sedation. Modify Therapy/Monitor Closely. Coadministration may result in profound sedation, respiratory depression, coma, and/or death. Continuously monitor vital signs during sedation and recovery period if coadministered. Carefully titrate remimazolam dose if administered with opioid analgesics and/or sedative/hypnotics.

              • reserpine

                esketamine intranasal, reserpine. Either increases toxicity of the other by sedation. Modify Therapy/Monitor Closely.

              • risperidone

                esketamine intranasal, risperidone. Either increases toxicity of the other by sedation. Modify Therapy/Monitor Closely.

              • rufinamide

                esketamine intranasal, rufinamide. Either increases toxicity of the other by sedation. Modify Therapy/Monitor Closely.

              • scopolamine

                esketamine intranasal, scopolamine. Either increases toxicity of the other by sedation. Modify Therapy/Monitor Closely.

              • secobarbital

                esketamine intranasal, secobarbital. Either increases toxicity of the other by sedation. Modify Therapy/Monitor Closely.

              • sevoflurane

                esketamine intranasal, sevoflurane. Either increases toxicity of the other by sedation. Modify Therapy/Monitor Closely.

              • sodium oxybate

                esketamine intranasal, sodium oxybate. Either increases toxicity of the other by sedation. Modify Therapy/Monitor Closely.

              • stiripentol

                esketamine intranasal, stiripentol. Either increases toxicity of the other by sedation. Modify Therapy/Monitor Closely.

              • sufentanil

                esketamine intranasal, sufentanil. Either increases toxicity of the other by sedation. Modify Therapy/Monitor Closely.

              • sufentanil SL

                esketamine intranasal, sufentanil SL. Either increases toxicity of the other by sedation. Modify Therapy/Monitor Closely.

              • sulpiride

                esketamine intranasal, sulpiride. Either increases toxicity of the other by sedation. Modify Therapy/Monitor Closely.

              • suvorexant

                esketamine intranasal, suvorexant. Either increases toxicity of the other by sedation. Modify Therapy/Monitor Closely.

              • tapentadol

                esketamine intranasal, tapentadol. Either increases toxicity of the other by sedation. Modify Therapy/Monitor Closely.

              • tasimelteon

                esketamine intranasal, tasimelteon. Either increases toxicity of the other by sedation. Modify Therapy/Monitor Closely.

              • temazepam

                esketamine intranasal, temazepam. Either increases toxicity of the other by sedation. Modify Therapy/Monitor Closely.

              • tetrabenazine

                esketamine intranasal, tetrabenazine. Either increases toxicity of the other by sedation. Modify Therapy/Monitor Closely.

              • thalidomide

                esketamine intranasal, thalidomide. Either increases toxicity of the other by sedation. Modify Therapy/Monitor Closely.

              • thioridazine

                esketamine intranasal, thioridazine. Either increases toxicity of the other by sedation. Modify Therapy/Monitor Closely.

              • thiothixene

                esketamine intranasal, thiothixene. Either increases toxicity of the other by sedation. Modify Therapy/Monitor Closely.

              • tiagabine

                esketamine intranasal, tiagabine. Either increases toxicity of the other by sedation. Modify Therapy/Monitor Closely.

              • tizanidine

                esketamine intranasal, tizanidine. Either increases toxicity of the other by sedation. Modify Therapy/Monitor Closely.

              • topiramate

                esketamine intranasal, topiramate. Either increases toxicity of the other by sedation. Modify Therapy/Monitor Closely.

              • tramadol

                esketamine intranasal, tramadol. Either increases toxicity of the other by sedation. Modify Therapy/Monitor Closely.

              • tranylcypromine

                esketamine intranasal, tranylcypromine. Either increases toxicity of the other by sympathetic (adrenergic) effects, including increased blood pressure and heart rate. Use Caution/Monitor. Closely monitor blood pressure with concomitant use of esketamine nasal with MAO-Is. .

              • triazolam

                esketamine intranasal, triazolam. Either increases toxicity of the other by sedation. Modify Therapy/Monitor Closely.

              • trifluoperazine

                esketamine intranasal, trifluoperazine. Either increases toxicity of the other by sedation. Modify Therapy/Monitor Closely.

              • trimipramine

                esketamine intranasal, trimipramine. Either increases toxicity of the other by sedation. Modify Therapy/Monitor Closely.

              • triprolidine

                esketamine intranasal, triprolidine. Either increases toxicity of the other by sedation. Modify Therapy/Monitor Closely.

              • valerian

                esketamine intranasal, valerian. Either increases toxicity of the other by sedation. Modify Therapy/Monitor Closely.

              • valproic acid

                esketamine intranasal, valproic acid. Either increases toxicity of the other by sedation. Modify Therapy/Monitor Closely.

              • vigabatrin

                esketamine intranasal, vigabatrin. Either increases toxicity of the other by sedation. Modify Therapy/Monitor Closely.

              • zaleplon

                esketamine intranasal, zaleplon. Either increases toxicity of the other by sedation. Modify Therapy/Monitor Closely.

              • ziconotide

                esketamine intranasal, ziconotide. Either increases toxicity of the other by sedation. Modify Therapy/Monitor Closely.

              • ziprasidone

                esketamine intranasal, ziprasidone. Either increases toxicity of the other by sedation. Modify Therapy/Monitor Closely.

              • zolpidem

                esketamine intranasal, zolpidem. Either increases toxicity of the other by sedation. Modify Therapy/Monitor Closely.

              • zonisamide

                esketamine intranasal, zonisamide. Either increases toxicity of the other by sedation. Modify Therapy/Monitor Closely.

              Minor (0)

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                Adverse Effects

                >10% (TRD)

                Dissociation (41%)

                Dizziness (29%)

                Nausea (28%)

                Vertigo (23%)

                Sedation (23%)

                Headache (20%)

                Dysgeusia (19%)

                Hypoesthesia (18%)

                Anxiety (13%)

                Lethargy (11%)

                Sedation

                • Aged <65 yr, 84 mg (61%)
                • Aged <65 yr, 56 mg (50%)
                • Aged ≥65 yr, 28-84 mg (49%)

                Dissociation or perceptual changes

                • Aged ≥65 yr, 28-84 mg (75%)
                • Aged <65 yr, 84 mg (69%)
                • Aged <65 yr, 56 mg (61%)

                Blood pressure

                • Aged <65 yr
                  • Diastolic BP ≥25 mm Hg increase (13%)

                • Aged ≥65 yr
                  • ​Systolic BP ≥40 mm Hg increase (17%)
                  • Diastolic BP ≥25 mm Hg increase (14%)

                Nausea and vomiting

                • 56 mg
                  • Nausea (27%)
                • 84 mg
                  • Nausea (32%)
                  • Vomiting (12%)

                >10% (MDD)

                Dissociation (48%)

                Dizziness (45%)

                Sedation (29%)

                Nausea (27%)

                Dysgeusia (20%)

                Increased blood pressure (15%)

                Anxiety (15%)

                Hypoesthesia (13%)

                Vomiting (11%)

                1-10% (TRD)

                Increased blood pressure (10%)

                Vomiting (9%)

                Insomnia (8%)

                Diarrhea (7%)

                Nasal discomfort (7%)

                Throat irritation (7%)

                Dry mouth (5%)

                Feeling drunk (5%)

                Dysarthria (4%)

                Euphoric mood (4%)

                Hyperhidrosis (4%)

                Constipation (3%)

                Feeling abnormal (3%)

                Mental impairment (3%)

                Tremor (3%)

                Pollakiuria (3%)

                Oropharyngeal pain (3%)

                Tachycardia (2%)

                Blood pressure

                • Aged <65 yr
                  • Systolic BP ≥40 mm Hg increase (8%)
                  • Diastolic BP ≥110 mm Hg (4%)
                  • Systolic BP ≥180 mm Hg (3%)
                • Aged ≥65 yr
                  • Systolic BP ≥180 mm Hg (3%)

                Nausea and vomiting

                • 56 mg
                  • Vomiting (6%)
                • 84 mg
                  • Nausea, severe (3%)
                  • Vomiting, severe (3%)

                1-10% (MDD)

                Constipation (10%)

                Euphoric mood (7%)

                Vertigo (6%)

                Hyperhidrosis (5%)

                Tachycardia (4%)

                Dry mouth (4%)

                Lethargy (4%)

                Oropharyngeal pain (4%)

                Throat irritation (4%)

                Intentional self-injury (3%)

                Toothache (2%)

                Felling of relaxation (2%)

                Myalgia (2%)

                Confusion (2%)

                Dysphoria (2%)

                Pollakiuria (2%)

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                Warnings

                Black Box Warnings

                Sedation and dissociation

                • Risk for sedation and dissociation after administration
                • Because of these risks, monitor for at least 2 hr at each treatment session, followed by an assessment to determine when the patient is considered clinically stable and ready to leave the healthcare setting

                Abuse and misuse

                • Potential for drug abuse and misuse
                • Consider risks and benefits of prescribing esketamine in patients at higher risk of abuse
                • Monitor for signs and symptoms of abuse and misuse

                Suicidal thoughts and behaviors

                • Antidepressants increased the risk of suicidal thoughts and behavior in children and young adults in short-term studies
                • Closely monitor all antidepressant-treated patients for clinical worsening, and for emergence of suicidal thoughts and behaviors
                • Esketamine is not approved in pediatric patients

                REMS

                • Owing to serious adverse outcomes resulting from sedation, dissociation, abuse, and misuse, esketamine is only available through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS)
                • Patients treated in outpatient settings (e.g. medical offices and clinics) must be enrolled in the program
                • Pharmacies must be certified and only dispense esketamine to healthcare settings that are certified
                • More information is available at www.spravatorems.com or 1-855-382-6022
                • Healthcare setting must be certified
                  • Only dispensed and administered in healthcare settings
                  • Patients treated in outpatient settings must be enrolled in the program
                  • Administered by patients under the direct observation of a healthcare provider and monitored by a healthcare provider for at least 2 hr after administration

                Contraindications

                Aneurysmal vascular disease (including thoracic and abdominal aorta, intracranial, and peripheral arterial vessels) or arteriovenous malformation

                History of intracerebral hemorrhage

                Hypersensitivity to esketamine, ketamine, or any excipients

                Cautions

                Available only through a restricted access program (REMS)

                Sedation is likely to occur

                Dissociative or perceptual changes (including distortion of time, space and illusions), derealization and depersonalization reported

                The most common psychological effects are dissociative or perceptual changes (including distortion of time, space, and illusions), derealization, and depersonalization; carefully assess patients with psychosis before administering to determine if benefit outweighs risk

                Because of risk of sedation, dissociation, and increased blood pressure, patients must be monitored for at least 2 hr after each treatment session; carefully assess to determine if the patient is clinically stable and ready to leave the healthcare setting

                Esketamine is a schedule III controlled substance and may be subject to abuse and diversion; assess risk for each patient before prescribing

                Pooled analyses of placebo-controlled trials of antidepressant drugs have shown an increased risk for suicidality in patients aged ≤24 yr; monitor all patients receiving antidepressants, especially during the initial phase of treatment, for clinical worsening and emergence of suicidal thoughts and behaviors

                Ulcerative or interstitial cystitis reported with long-term, off-label use or misuse/abuse of ketamine; esketamine intranasal showed a higher rate of lower urinary tract symptoms compared with placebo; however, no cases of interstitial cystitis observed

                May cause fetal harm when administered to pregnant women

                Cognitive impairment

                • Short-term
                  • After single dose in healthy volunteers, esketamine caused cognitive performance decline 40 minutes postdose compared with placebo
                  • Cognitive performance, mental effort, and sleepiness were comparable at 2 hr postdose
                • Long-term
                  • Long-term cognitive and memory impairment reported with repeated ketamine misuse or abuse
                  • No adverse effects were observed esketamine intranasal on cognitive functioning in a 1-year open-label safety study
                  • Long-term cognitive effects have not been evaluated beyond 1 yr

                Drug interaction overview

                • No clinically significant interactions were observed when esketamine intranasal was coadministered with CYP inducers, CYP3A inhibitors, CYP2B6 inhibitors, or substrates of CYP3A or CYP2B6
                • Coadministration with other CNS depressants may cause additive risk for sedation
                • Coadministration with psychostimulants or MAOIs may add to risk of increased blood pressure
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                Pregnancy

                Pregnancy

                Not recommended during pregnancy

                Based on published findings from pregnant animals treated with ketamine (racemic mixture of arketamine and esketamine), may cause fetal harm when administered to pregnant women

                Antidepressant registry: Healthcare providers are encouraged to register patients exposed to antidepressants during pregnancy at 1-844-405-6185 or https://womensmentalhealth.org/clinical-and-researchprograms/pregnancyregistry/antidepressants/

                Animal data

                • N-methyl-D-aspartate (NMDA) receptors blockers administered during the period of peak brain development in pregnant primates increased neuronal apoptosis in the developing brain of the offspring
                • Embryo-fetal reproduction studies in rabbits showed skeletal malformations at maternally toxic doses when ketamine was intranasally administered with a No Observed Adverse Effect Level (NOAEL) at estimated esketamine exposures 0.3 times the exposures at the maximum recommended human dose (MRHD) of 84 mg/day
                • Additionally, intranasal administration of esketamine to pregnant rats during pregnancy and lactation at exposures that were similar to those at the MRHD resulted in a delay in sensorimotor development in pups during the preweaning period and a decrease in motor activity in the postweaning period

                Clinical considerations

                • A prospective, longitudinal study followed 201 pregnant women with a history of major depressive disorder who were euthymic and taking antidepressants at the beginning of pregnancy
                • The women who discontinued antidepressants during pregnancy were more likely to experience a relapse of major depression than women who continued antidepressants
                • Consider the risk of untreated depression when discontinuing or changing treatment with antidepressants during pregnancy and postpartum

                Contraception

                • Based on published animal reproduction studies, esketamine may cause embryo-fetal harm when administered to a pregnant woman
                • However, it is not clear how these animal findings relate to females of reproductive potential treated with the recommended clinical dose
                • Consider pregnancy planning and prevention for females of reproductive potential during treatment

                Lactation

                Esketamine is present in human milk; there are no data on the effects on the breastfed infant or on milk production

                Published studies in juvenile animals report neurotoxicity; because of the potential for neurotoxicity, advise patients that breastfeeding is not recommended during treatment

                Pregnancy Categories

                A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

                B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

                C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

                D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

                X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

                NA: Information not available.

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                Pharmacology

                Mechanism of Action

                Esketamine, the S-enantiomer of racemic ketamine, is a nonselective, noncompetitive N-methyl-D-aspartate (NMDA) receptor antagonist (NMDA is an ionotropic glutamate receptor)

                The mechanism by which esketamine exerts its antidepressant effect is unknown

                Absorption

                Bioavailability: 48%

                Peak plasma time: 20-40 minutes after last nasal spray of treatment session

                Distribution

                Vd (IV): 709 L

                Protein bound: 43-45%

                Metabolism

                Primarily metabolized to noresketamine by CYP2B and 3A4, and to a lesser extent by CYP2C9/2C19

                Noresketamine is metabolized by CYP-dependent pathways, and certain subsequent metabolites undergo glucuronidation

                Noresketamine demonstrated activity at the NMDA receptor with less affinity

                Elimination

                Half-life: 7-12 hr; 8 hr (noresketamine)

                Clearance (IV): 89 L/hr

                Excretion

                • Urine: <1% unchanged; ≥78% metabolites
                • Feces: ≤2% metabolites
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                Administration

                Intranasal Administration

                For nasal use only

                To prevent loss of medication, do not prime the device before use

                Use 2 devices (for 56-mg dose) or 3 devices (for 84-mg dose), with a 5-minute rest between use of each device

                See prescribing information for detailed pictures and diagrams

                Patient preparation

                • Measure blood pressure before dose; if elevated, a decision to delay therapy should take into account benefit and risk to patient
                • Instruct patient to blow nose before first device only
                • Have patient hold device and recline head to 45° to keep medication inside nose
                • See prescribing information for detailed pictures regarding administration technique
                • Food and liquid ingestion
                  • Food: Do not eat for at least 2 hr before administration
                  • Liquids: Do not drink liquids for at least 30 min before administration

                Postadministration observation

                • During and after administration at each treatment session, observe patient for at least 2 hr until the patient is safe to leave
                • Measure blood pressure 40 minutes postdose and subsequently as clinically warranted until values decline
                • Refer patients experiencing symptoms of a hypertensive crisis (eg, chest pain, shortness of breath) or hypertensive encephalopathy (eg, sudden severe headache, visual disturbances, seizures, diminished consciousness, or focal neurological deficits) immediately for emergency care
                • Closely monitor blood pressure with concomitant use of psychostimulants or MAOIs
                • Patients with history of hypertensive encephalopathy require more intensive and frequent blood pressure monitoring
                • Before administration, instruct patients not to engage in potentially hazardous activities (eg, driving a motor vehicle, operating machinery) until the next day after a restful sleep

                Missed treatment sessions

                Treatment session(s) missed resulting in worsening symptoms: Consider returning to previous dosing schedule

                Treatment session(s) missed with no worsening symptoms: Continue current dosing schedule

                Storage

                Store at 20-25°C (68-77°F); excursion permitted from 15-30°C (59-86°F)

                Security and disposal

                • Nasal spray devices must be handled with adequate security, accountability, and proper disposal, per facility procedure for a Schedule III drug product, and per applicable federal, state, and local regulations
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                Images

                BRAND FORM. UNIT PRICE PILL IMAGE
                Spravato nasal
                -
                28 mg liquid
                Spravato nasal
                -
                84 mg (28 mg x 3) liquid
                Spravato nasal
                -
                56 mg (28 mg x 2) liquid

                Copyright © 2010 First DataBank, Inc.

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                Patient Handout

                A Patient Handout is not currently available for this monograph.
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                Formulary

                FormularyPatient Discounts

                Adding plans allows you to compare formulary status to other drugs in the same class.

                To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.

                Adding plans allows you to:

                • View the formulary and any restrictions for each plan.
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                • Compare formulary status to other drugs in the same class.
                • Access your plan list on any device – mobile or desktop.

                The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

                Tier Description
                1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
                2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
                3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
                4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
                5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
                6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
                NC NOT COVERED – Drugs that are not covered by the plan.
                Code Definition
                PA Prior Authorization
                Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
                QL Quantity Limits
                Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
                ST Step Therapy
                Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
                OR Other Restrictions
                Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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                Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.