Esketamine Nasal Spray for Rapid Reduction of Depressive Symptoms in Patients With Major Depressive Disorder Who Have Active Suicide Ideation With Intent: Results of a Phase 3, Double-Blind, Randomized Study (ASPIRE II). Individuals with a history of drug abuse or dependence are at greater risk; therefore, use careful consideration prior to treatment of individuals with a history of substance use disorder and monitor for signs of abuse or dependence. SPRAVATO ® (esketamine) CIII Nasal Spray is indicated, in conjunction with an oral antidepressant, for the treatment of: . Treatment of depressive symptoms in adults with MDD with acute suicidal ideation or behavior: dissociation, dizziness, sedation, blood pressure increased, hypoesthesia, vomiting, euphoric mood, and vertigo. Esketamine nasal spray appears both effective and fast acting for treatment-resistant depression, but questions still remain about the drug’s safety. Epub 2018 Apr 16. SPRAVATO nasal spray is available as an aqueous solution of esketamine hydrochloride in a stoppered glass vial within a nasal spray device. Esketamine is … 1. Ketamine nasal spray for sale with or without prescription( brand name esketamine) . Pregnancy Exposure Registry: There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antidepressants, including SPRAVATO®, during pregnancy. This site is published by Janssen Pharmaceuticals, Inc., which is solely responsible for its contents. The safety and effectiveness of SPRAVATO® as an anesthetic agent have not been established. Prevention and treatment information (HHS). Esketamine, developed by Johnson & Johnson, will be administered as a nasal spray and be used in conjunction with an oral antidepressant. Abuse and Misuse: SPRAVATO® contains esketamine, a Schedule III controlled substance (CIII), and may be subject to abuse and diversion. If you are taking esketamine, you will likely receive a treatment one or two times per week. Am J Psychiatry. The mean esketamine Cmax and AUC values were higher in elderly patients compared with younger adult patients. Bozymski KM, Crouse EL, Titus-Lay EN, Ott CA, Nofziger JL, Kirkwood CK. Lactation: SPRAVATO® is present in human milk. SPRAVATO® is available only through a restricted program under a REMS.Â. Consider changing the therapeutic regimen, including possibly discontinuing SPRAVATO® and/or the concomitant oral antidepressant, in patients whose depression is persistently worse, or who are experiencing emergent suicidal thoughts or behaviors. Treatment-resistant depression (TRD) in adults. Esketamine, on the other hand, only contains the “S” ketamine molecule. People may notice a relief in symptoms within just a few hours, and it could last for several days, Dr. Anand says. Pronunciation: es-KET-a-meen. J Clin Psychiatry. Patients treated in outpatient settings (e.g., medical offices and clinics) must be enrolled in the program. Canuso CM, Singh JB, Fedgchin M, Alphs L, Lane R, Lim P, Pinter C, Hough D, Sanacora G, Manji H, Drevets WC. SPRAVATO® Risk Evaluation and Mitigation Strategy (REMS): SPRAVATO® is available only through a restricted program called the SPRAVATO® REMS because of the risks of serious adverse outcomes from sedation, dissociation, and abuse and misuse. Monitor for urinary tract and bladder symptoms during the course of treatment with SPRAVATO® and refer to an appropriate healthcare provider as clinically warranted. This is a summary and does NOT have all possible information about this product. Greater improvement in MADRS total score was observed with esketamine + standard-of-care versus placebo + standard-of-care at 24 hours (least-squares mean difference [SE]: -3.8 [1.39]; 95% CI, -6.56 to -1.09; 2-sided P = .006), as well as at earlier (4 hours) and later time points during 4-week double-blind treatment. In the US, it was approved for sale last year as a … Advise women of reproductive potential to consider pregnancy planning and prevention.Â. Esketamine seems to help alleviate depression by acting on the NMDA/glutamate receptor, which is different from more recently popular antidepressants. Esketamine nasal spray was approved in an innovative aerosol dispenser that measures a precise dose in each aerosol. SPRAVATO ® (esketamine) CIII Nasal Spray is indicated, in conjunction with an oral antidepressant, for the treatment of: . The most common adverse events among esketamine-treated patients were dizziness, dissociation, headache, nausea, and somnolence. https://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/antidepressants/. SPRAVATO ® nasal spray was evaluated for efficacy and safety in more than 1,700 adult patients (18 to 86 years) who met DSM–5 criteria for MDD … Because of the risks of dissociation, patients must be monitored by a healthcare provider for at least 2 hours at each treatment session, followed by an assessment to determine when the patient is considered clinically stable and ready to leave the healthcare setting. Because of the possibility of delayed or prolonged sedation, patients must be monitored by a healthcare provider for at least 2 hours at each treatment session, followed by an assessment to determine when the patient is considered clinically stable and ready to leave the healthcare setting. Please see full Prescribing Information, including Boxed WARNINGS, and Medication Guide for SPRAVATO®. Conclusions: Careers. Am J Psychiatry. Advise pregnant women of the potential risk to an infant exposed to SPRAVATO® in utero. Closely monitor for sedation with concomitant use of SPRAVATO® with CNS depressants [see Drug Interaction (7.1)]. doi: 10.4088/JCP.20l13482. Third party trademarks used herein are trademarks of their respective owners. Patients were randomized 1:1 to esketamine 84 mg or placebo nasal spray twice-weekly for 4 weeks, each with comprehensive standard-of-care treatment (initial psychiatric hospitalization and newly initiated or optimized oral antidepressant[s] therapy). Depressive symptoms in adults with major depressive disorder (MDD) with acute suicidal ideation or behavior. The difference between groups in the severity of suicidality was not statistically significant (median of treatment difference [95% CI]: 0.0 [-1.00 to 0.00]; 2-sided P = .107). 8600 Rockville Pike Int J Neuropsychopharmacol. Efficacy and safety of intranasal esketamine for the treatment of major depressive disorder. Esketamine: A Novel Option for Treatment-Resistant Depression. Only dispensed and administered in healthcare settings. For use in conjunction with an oral antidepressant in adults with1, Depressive symptoms in adults with MDD with acute suicidal ideation or behavior (MDSI), SPRAVATO® hypothesized mechanism of action, Administered in conjunction with an oral antidepressant, SPRAVATO® should be administered in conjunction with an oral antidepressant1, Your one source for Access, Affordability, and Treatment Support for your patients. SPRAVATO® [Prescribing Information]. The Antisuicidal Effect of Esketamine Should Be Further Investigated. The most common adverse reactions with SPRAVATO® plus oral antidepressant (incidence ≥5% and at least twice that of placebo nasal spray plus oral antidepressant) were: TRD: dissociation, dizziness, nausea, sedation, vertigo, hypoesthesia, anxiety, lethargy, blood pressure increased, vomiting, and feeling drunk. Read the Medication Guide provided by your pharmacist before you start using esketamine and … Before prescribing SPRAVATO®, patients with other cardiovascular and cerebrovascular conditions should be carefully assessed to determine whether the potential benefits of SPRAVATO® outweigh its risk. Methods: This phase 3, open-label, multicenter, long-term (up to 1 year) study was conducted between October 2015 and October 2017. Comparative efficacy and side-effect profile of ketamine and esketamine in the treatment of unipolar and bipolar depression: protocol for a systematic review and network meta-analysis. In patients whose BP is elevated prior to SPRAVATO® administration (as a general guide: >140/90 mmHg), a decision to delay SPRAVATO® therapy should take into account the balance of benefit and risk in individual patients. SPRAVATO® is available only through a restricted program under a REMS. We hope your visit was informative. Healthcare settings must be certified in the program and ensure that SPRAVATO. Impaired Ability to Drive and Operate Machinery: Before SPRAVATO® administration, instruct patients not to engage in potentially hazardous activities requiring complete mental alertness and motor coordination, such as driving a motor vehicle or operating machinery, until the next day following a restful sleep. Results: © Copyright 2020 Physicians Postgraduate Press, Inc. National Library of Medicine Assess each patient’s risk for abuse or misuse prior to prescribing and monitor all patients for the development of these behaviors or conditions, including drug-seeking behavior, while on therapy. Suicidal Thoughts and Behaviors in Adolescents and Young Adults: In pooled analyses of placebo-controlled trials of antidepressant drugs (SSRIs and other antidepressant classes) that included adult and pediatric patients, the incidence of suicidal thoughts and behaviors in patients age 24 years and younger was greater than in placebo-treated patients. This site is intended for use by healthcare professionals of the United States and its territories. Counsel family members or caregivers of patients to monitor for changes in behavior and to alert the healthcare provider. With the nasal spray, you give yourself three doses, spaced five minutes apart, under doctor supervision. Nasal Spray: 28 mg of esketamine per device. It's a new drug of intranasal administration that contains esketamine as the active ingredient. Misuse is the intentional use, for therapeutic purposes, of a drug by an individual in a way other than prescribed by a healthcare provider or for whom it was not prescribed. SPRAVATO® is contraindicated in patients for whom an increase in BP or intracranial pressure poses a serious risk (e.g., aneurysmal vascular disease, arteriovenous malformation, history of intracerebral hemorrhage). Each device contains 28 milligrams (mg) and delivers two sprays. Efficacy and Safety of Flexibly Dosed Esketamine Nasal Spray Combined With a Newly Initiated Oral Antidepressant in Treatment-Resistant Depression: A Randomized Double-Blind Active-Controlled Study. No adverse effects of SPRAVATO® nasal spray on cognitive functioning were observed in a one-year open-label safety study; however, the long-term cognitive effects of SPRAVATO® have not been evaluated beyond one year. Treatment for esketamine nasal spray is done on an outpatient basis. 2018 Jul 1;175(7):620-630. doi: 10.1176/appi.ajp.2018.17060720. Titusville, NJ: Janssen Pharmaceuticals, Inc. July 2020. Pediatric Use: The safety and effectiveness of SPRAVATO® in pediatric patients have not been established. Embryo-fetal Toxicity: SPRAVATO® may cause fetal harm when administered to pregnant women. Psychostimulants (e.g., amphetamines, methylphenidate, modafinil, armodafinil): Concomitant use may increase blood pressure. This phase 3, double-blind, multicenter study (ASPIRE I), conducted between June 2017 and December 2018, enrolled 226 adults having major depressive disorder based on Diagnostic and Statistical Manual of Mental Disorders fifth edition (DSM-5) criteria, active suicidal ideation with intent, and need for psychiatric hospitalization. 17 November, 2020. The U.S. Food and Drug Administration approved other nasal sprays to treat depression symptoms. Janssen Pharmaceuticals, Inc., recognizes that the Internet is a global communications medium; however, laws, regulatory requirements, and medical practices for pharmaceutical products vary from country to country. S0013 is a valid 2021 HCPCS code for Esketamine, nasal spray, 1 mg or just “Esketamine, nasal spray” for short, used in Medical care.. S0013 has been in effect since 01/01/2021 Sleepiness was comparable after 4 hours post-dose. No cases of esketamine-related interstitial cystitis were observed in any of the studies, which involved treatment for up to a year. Treatment-resistant depression (TRD) in adults. Privacy, Help Depressive symptoms in adults with major depressive disorder (MDD) with acute suicidal ideation or behavior. Because of the potential for neurotoxicity, advise patients that breastfeeding is not recommended during treatment with SPRAVATO®. Using esketamine nasal spray may cause sedation, fainting, dizziness, anxiety, a spinning sensation, or feeling disconnected from your body, thoughts, emotions, space and time. ESKETAMINE NASAL SPRAY is a NEW FDA-approved prescription nasal spray administered in a treatment center under the supervision of a healthcare provider, used in conjunction with oral antidepressants for treatment-resistant depression in adults. Abuse: Individuals with a history of drug abuse or dependence may be at greater risk for abuse and misuse of SPRAVATO®. FOIA 2021 Feb 12;11(2):e043457. Efficacy and Safety of Intranasal Esketamine for the Rapid Reduction of Symptoms of Depression and Suicidality in Patients at Imminent Risk for Suicide: Results of a Double-Blind, Randomized, Placebo-Controlled Study. Esketamine, like ketamine, has the potential to distort your perception during the first two hours after treatment, so it has to be administered in a clinic setting. © Janssen Pharmaceuticals, Inc. 2020. Increases in BP peak approximately 40 minutes after SPRAVATO® administration and last approximately 4 hours. Popova V, Daly EJ, Trivedi M, Cooper K, Lane R, Lim P, Mazzucco C, Hough D, Thase ME, Shelton RC, Molero P, Vieta E, Bajbouj M, Manji H, Drevets WC, Singh JB. Each nasal spray device delivers two sprays containing a total of 28 mg esketamine. Consider pregnancy planning and prevention for females of reproductive potential during treatment with SPRAVATO®. No overall differences in the safety profile were observed between patients 65 years of age and older and patients younger than 65 years of age. Ann Pharmacother. 2021 Jan 20;24(1):22-31. doi: 10.1093/ijnp/pyaa068. Objective: Spravato (esketamine) nasal spray is used for treatment-resistant depression and major depressive disorder (MDD) with acute suicidal ideation or behavior. On March 16th, 2019, the FDA approved the first Esketamine nasal spray for Treatment-Resistant Depression, called Spravato. The effectiveness of SPRAVATO® in preventing suicide or in reducing suicidal ideation or behavior has not been demonstrated. Esketamine, sold under the brand name Spravato among others, is a medication used as a general anesthetic and for treatment-resistant depression. However, new research by … Esketamine Nasal - Spray. Increase in Blood Pressure: SPRAVATO® causes increases in systolic and/or diastolic blood pressure (BP) at all recommended doses. In patients with history of hypertensive encephalopathy, more intensive monitoring, including more frequent blood pressure and symptom assessment, is warranted because these patients are at increased risk for developing encephalopathy with even small increases in blood pressure.Â. Important: How To Use This Information. Storage And Handling. You will remain in the office setting for a couple of hours so you can be monitored clos… Esketamine nasal spray costs £163 per 28mg device The 2009 NICE guideline on depression advocates a stepwise approach to the management of depression in adults. Short-Term Cognitive Impairment: In a study in healthy volunteers, a single dose of SPRAVATO® caused cognitive performance decline 40 minutes post-dose. Closely monitor blood pressure with concomitant use of SPRAVATO® with psychostimulants or monoamine oxidase inhibitors (MAOIs) [see Drug Interactions (7.2, 7.3)]. All rights reserved. Recently, the Food and Drug Administration (FDA) approved, Spravato, marketed by Janssen - for the treatment of resistant depression. SPRAVATO® has not been studied in patients with severe hepatic impairment (Child-Pugh class C). Closely monitor blood pressure with concomitant use of MAOIs.Â. Healthcare providers are encouraged to register patients by contacting the National Pregnancy Registry for Antidepressants at 1-844-405-6185 or online at https://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/antidepressants/. Please note that this third-party website is not controlled by Janssen Pharmaceuticals, Inc., or subject to our Privacy Policy. 2020 Sep 22;81(6):20l13482. It is not clear how effective racemic ketamine is compared to esketamine (marketed as a nasal spray called Spravato). Hypersensitivity to esketamine, ketamine, or any of the excipients. Epub 2019 Dec 4. SAN FRANCISCO -- Esketamine nasal spray (Spravato) was effective for alleviating symptoms of treatment-resistant depression when added to … Use of SPRAVATO® does not preclude the need for hospitalization if clinically warranted, even if patients experience improvement after an initial dose of SPRAVATO®. Depressive symptoms in adults with major depressive disorder (MDD) with acute suicidal ideation or behavior. Aneurysmal vascular disease (including thoracic and abdominal aorta, intracranial and peripheral arterial vessels) or arteriovenous malformation. COVID-19 is an emerging, rapidly evolving situation. Careful consideration is advised prior to use of individuals with a history of substance use disorder, including alcohol. Includes Spravato side effects, interactions and indications. As an FDA-approved treatment for persistent depression, it comes in the form of a nasal spray.