Names and pronunciation
(es-ket′-a-meen) Spravato nasal spray
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Drug reference
(es-ket′-a-meen) Spravato nasal spray
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Func. class.: Antidepressant
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Chem. class.: Augmentation agent Controlled Substance: Schedule III
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ACTION: Noncompetitively blocks the NMDA receptor, which is an iono- tropic glutamate receptor; mechanism of action for antidepressant effect is unknown; however, the activity on NMDA receptors may be responsible for both the therapeutic and the adverse psychiatric effects
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USES: Treatment-resistant depression in adults with an oral antidepressant
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CONTRAINDICATIONS Aneurysm, arteriovenous malformation, intracranial bleeding, ketamine hyper- sensitivity Precautions: Alcoholism, breastfeeding, cardiac dis- ease, cerebrovascular disease, coadminis- tration with other CNS depressants, driving or operating machinery, encephalopathy, geriatrics, hepatic disease, hypertension, hypertensive crisis, loss of consciousness, pregnancy, psychosis, schizophrenia
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Black Box Warning: Children, CNS de- pression, dissociation, requires a spe- cialized care setting, substance abuse, suicidal ideation Black Box Warning: Increased: CNS de- pression, other CNS depressants—do not use together Black Box Warning: Increased: sedation, B/P, MAOIs, psychostimulants—do not use together Black Box Warning: Dissociation: monitor B/P baseline and 40 min after use, then periodically for at least 2 hr after each treatment session, then pro- vide an assessment to determine when the patient is stable and ready to leave E the health care setting; special care is needed with those with schizophrenia Black Box Warning: Substance abuse: monitor for signs of abuse or dependence; physical dependence has been reported with prolonged use of ketamine; with- drawal symptoms of ketamine include craving, fatigue, poor appetite, anxiety Black Box Warning: Suicidal ideation: behaviors should be closely monitored dur- ing treatment, more frequently during first few months; consider changing the thera- peutic regimen, including the discontinua- tion of esketamine and/or the concurrent oral antidepressant, in patients with wors- ening of depression or emergent suicidality Evaluate • Therapeutic response: decreasing de- pression Black Box Warning: Suicidal ideation: teach family members or caregivers to monitor for changes in behavior and to alert the health care provider if such be- haviors occur Black Box Warning: CNS depression: tell health care provider about all the Rx, OTC, vitamins, and herbal supplements used, not to use with other CNS depressants unless discussed with health care provider • Prior to use instruct patients not to engage in potentially hazardous activi- ties (driving, operating heavy machin- ery), until the next day after a restful sleep HOW TO USE: • Step 1: Instruct patient to blow nose before the first device use only; confirm the required number of devices (56 mg = 2 devices; 84 mg = 3 devices) • Step 2: Check expiration date; peel blister and remove device; do not prime the device—this will cause loss of medication; ensure that the indica- tor on the device shows 2 green dots; give device to patient • Step 3: Instruct patient to hold device with thumb gently supporting but not pressing the plunger as shown in the product labeling; patient should recline head at about 45 degrees during admin- istration to keep medication in nose • Step 4: Instruct patient to insert tip straight into the first nostril; the nose rest should touch the skin between the nos- trils; close the opposite nostril; breathe in through nose while pushing plunger all the way up until it stops; sniff gently after spraying to keep medication inside nose; switch hands to insert tip into the second nostril; repeat steps to deliver second spray • Step 5: After administration is com- plete, take the device from the patient; check that indicator on device shows no green dots; if green dot remains, have patient spray again into the sec- ond nostril. Instruct patient to rest comfortably (preferably semi-re- clined) for 5 min after each device; if liquid drips out, dab nose with a tissue; DO NOT blow nose • If a second device is required, ensure a 5-min waiting period prior to use to allow medication from first device to be absorbed • Pregnancy/breastfeeding: Identify if pregnancy is planned or suspected or if breastfeeding; if patient is pregnant, she should register with the National Pregnancy Registry for Antidepressants online at https://womensmentalhealth. org/clinical-and-research-programs/ pregnancyregistry/antidepressants/ or by calling 844-405-6185 HIGH ALERT
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SIDE EFFECTS CNS: Anxiety, dissociation, drowsiness, dizziness, headache, vertigo, depen- dence, impaired cognition, hallucina- tions, confusion, lethargy, suicidal ideation CV: Hypertension, hypertensive crisis GI: Nausea
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INTERACTIONS
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DOSAGE AND ROUTES Adults: NASAL INDUCTION PHASE: On day 1, give 56 mg; for subsequent doses during wk 1 through 4, give 56 mg or 84 mg twice weekly; use 2 devices for the 56-mg dose and 3 devices for the 84-mg dose with a 5-min rest between use of each device; MAINTENANCE PHASE: During wk 5 through 8, give 56 mg or 84 mg weekly; during wk 9 and thereafter, give 56 mg or 84 mg q2wk or weekly
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Available forms: Nasal spray 56, 84 dose kit
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Administer: Nasal route • Must be given under the direct super- vision of a health care provider and in- cluding a supervised postadministration observation • Each device contains 28 mg; use 2 devices for a 56-mg dose and 3 devices for an 84-mg dose with a 5-min rest be- tween use of each device • To prevent loss of medication, do not prime the device before use • During and after use at each treatment session, observe the patient for at least 2 hr until the patient is safe to leave • Assess B/P prior to use; if baseline B/P >140 mm Hg systolic or >90 mm Hg dia- stolic, do not use if an increase in B/P or intracranial pressure poses a serious risk • Reassess B/P about 40 min after dos- ing and subsequently as clinically indi- cated; if B/P is decreasing and the patient appears clinically stable for at least 2 hr, the patient may be discharged at the end of the post-dose monitoring period; if not, continue to monitor • Because of the potential for drug- induced nausea and vomiting, advise patients to avoid food for at least 2 hr prior to use and avoid liquids at least 30 min prior to administration • Patients requiring a nasal corticoste- roid or nasal decongestant on dosing day should use these at least 1 hr before re- ceiving this product • If treatment sessions are missed and there is a worsening of depression symp- toms, consider returning to the previous dosing schedule
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CLINICAL CONSIDERATIONS Assess
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Patient and caregiver information:
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PHARMACOKINETICS Primarily metabolized to noresket- amine, the active metabolite, by CYP2B6 and CYP3A4 and to a lesser extent by CYP2C9 and CYP2C19; nores- ketamine is metabolized by CYP-depen- dent pathways and metabolism occurs through glucuronidation; elimination is biphasic, with a rapid decline for the initial 2-4 hr and a mean terminal half- life 7-12 hr; elimination of the metabo- lite is also biphasic, 4 hr and a termi- nal half-life of 8 hr; metabolites are excreted in urine (78%) and feces (2%); bioavailability 48%; peak 20-40 min
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