This is not a complete list of side effects and others may occur. Taken along with an oral antidepressant: SPRAVATO® is the first nasal spray medication specifically for adults with treatment-resistant depression. Un flacon contient 28 mg d'eskétamine. You will not be able to use this medicine at home. *Of adequate dose and duration in your current episode. It is prepared by Janssen Medical Information and is not intended for promotional purposes, nor for medical advice. You may contact the Medical Information Center by calling 1-800-JANSSEN (1-800-526-7736) 1-800-JANSSEN (1-800-526-7736) to speak to a clinical expert regarding your question or to report a product quality complaint. You should not eat anything for at least 2 hours before receiving your dose. You may contact the Medical Information Center by calling 1-800-JANSSEN (1-800-526-7736) 1-800-JANSSEN (1-800-526-7736) to speak to a clinical expert regarding your question or to report a possible adverse event or product quality complaint. -Subsequent doses: 56 to 84 mg intranasally 2 times a week However, new research by … Spravato (esketamine nasal spray) is to be co-administered with oral antidepressant therapy in the specified patient population. What is esketamine and what does it treat? You must be registered in the program and understand the risks and benefits of this medicine. Spravato nasal spray is used only in a healthcare setting. Fedgchin M, Trivedi M, Daly E, et al. 1 The nasal spray device delivers a total of 28 mg of SPRAVATO. Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use Spravato only for the indication prescribed. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. Since this medicine is given by a healthcare professional in a medical setting, an overdose is unlikely to occur. Comments: 2019;22(10):616-630. Per evitare perdite del prodotto medicinale, il dispositivo non deve essere azionato prima dell'uso. This list is not complete. Call your doctor for medical advice about side effects. Weeks 5 to 8: 56 to 84 mg intranasally once a week Tell your healthcare provider right away if you have any new or sudden changes in mood, behavior, thoughts, or feelings. Scientific Knowledge Experts are available Monday-Friday 9am-8pm ET. Available for Android and iOS devices. -Day 1: 56 mg intranasally ONCE Your healthcare provider should check you for signs of abuse and dependence before and during treatment with this medicine. Esketamine is an intranasal medication that works in the brain. A treatment session consists of nasal administration of Spravato and post-administration observation under supervision. Tell your healthcare provider if you have ever abused or been dependent on alcohol, prescription medicines, or street drugs. 3 Wir haben eine Anfrage gestellt, ob es möglich ist Spravato zu importieren, allerdings haben viele Länder momentan ihren Arzneimittelexport gestoppt oder beliefern nur Krankenhäuser. -The dosage may be decreased to 56 mg intranasally 2 times a week if intolerable symptoms occur. Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. This information is intended for healthcare providers in the United States only.This page was last modified on March 07, 2021. Ketamin Nasenspray Spravato: Neue Option? You may report side effects to FDA at 1-800-FDA-1088. If you are struggling with depression and have tried two or more antidepressants* in your current episode without adequate relief, talk to the professionals at Certus to see if you have treatment-resistant depression. See full prescribing information for SPRAVATO®. MAINTENANCE PHASE: ©Janssen Scientific Affairs, LLC 2012. Spravato (esketamine) is a nasal spray that is used together with medication taken by mouth to treat adults with depression that is resistant to to other treatments. Generic Name: esketamine (nasal) (es KET a meen) You will need to plan for a caregiver or family member to drive you home after taking SPRAVATO ® . It is not clear how effective racemic ketamine is compared to esketamine (marketed as a nasal spray called Spravato). Dosing and Administration Indication SPRAVATO® (esketamine) CIII Nasal Spray is indicated, in conjunction with an oral antidepressant (AD), for the treatment of treatment-resistant depression (TRD) in adults. Esketamine may harm an unborn baby. This site is for US healthcare professionals to provide online access to current, accurate, scientific information about our products. Avoid drinking liquids within 30 minutes before using the medicine. -Patients who require nasal corticosteroids/decongestants should use the agent(s) at least 1 hour before using this drug. Read and carefully follow any Instructions for Use that are given to you. -IMPORTANT CONSIDERATION: Treatment sessions should be directly supervised by a healthcare provider; treatment sessions should include nasal administration of the dose and post-administration observation. Report a Adverse Event to Janssen at 1-800-565-4008 (toll free) or 1-908-455-8822 (toll). Spravato is used only in a healthcare setting where you can be watched closely for at least 2 hours after each dose. Please review before taking this medication. The nasal spray device delivers a total of 28 mg of esketamine (two sprays of 14 mg each). SPRAVATO® (esketamine) nasal spray, CIII HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use SPRAVATO® safely and effectively. Spravato is a nasal spray that is used in a healthcare setting. Report any new or worsening symptoms to your doctor. Un traitement administré par voie nasale SPRAVATO se présente sous forme de solution pour pulvérisation nasale. Spray once in each nostril per device. -After 4 weeks, evidence of therapeutic benefit should be evaluated to determine the need for continued treatment. Esketamine can increase your blood pressure for several hours after each dose. Foto: APOTHEKE ADHOC . Janssen hat die US-Zulassung für das Esketamin Nasenspray Spravato erhalten. Not all possible drug interactions are listed here. You will be watched closely for at least 2 hours after you use Spravato. Spravato is usually given 2 times per week at first, and then once every 1 to 2 weeks. Spravato is for use only in adults under a special program. Each nasal spray device delivers two sprays containing a total of 28 mg of esketamine (supplied as 32.3 mg of esketamine hydrochloride). The benefit of esketamine nasal spray plus comprehensive SOC on symptoms of MDD was apparent as early as 4 hours after the first dose. * Dosing frequency should be individualized to the least frequent dosing to maintain remission/response. Das Esketamin Nasenspray ist in Deutschland nicht im Handel, sondern kann nur aus anderen EU-Länder, Schweiz sowie Kanada und USA bezogen werden. -After Week 8, the dosing frequency should be individualized to the least frequent dosing to maintain remission. Stay alert to changes in your mood or symptoms. Medically reviewed by Judith Stewart, BPharm. Spravato is a brand-name prescription drug that's prescribed for treatment-resistant depression in adults. To prevent loss of medication, do not prime the device before use. SPRAVATO® is not approved as an anesthetic agent. The efficacy and safety of Spravato nasal spray was investigated in five Phase 3 clinical studies in adult patients (18 to 86 years) with treatment-resistant depression (TRD) who met DSM-5 criteria for major depressive disorder and were non-responders to at least two oral antidepressants (ADs) treatments, of adequate dosage and duration, in the current major depressive episode. Brand Name: Spravato. Spravato should not be administered if an increase in blood pressure or intracranial pressure poses a serious risk (see section4.3). The Janssen Pharmaceutical Companies of Johnson & Johnson have announced European Commission authorization of expanded use of its esketamine nasal spray Spravato among adults with a … esketamine 28mg nasal spray, solution (Spravato®) Janssen-Cilag Ltd 7 August 2020 The Scottish Medicines Consortium (SMC) has completed its assessment of the above product and advises NHS Boards and Area Drug and Therapeutic Committees (ADTCs) on its use in NHSScotland. Tell your doctor if you have chest pain, trouble breathing, severe headache, blurred vision, pounding in your neck or ears, or a seizure. No cases of esketamine-related interstitial cystitis were observed in any of the studies, which involved treatment for up to a year. Spravato is for use only in adults under a special program. Ask your doctor or caregivers if you do not understand these instructions. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances. Comments: Use: In combination with an oral antidepressant for the treatment of depressive symptoms in adults with major depressive disorder (MDD) with acute suicidal ideation or behavior. You will give yourself the nasal spray while being supervised by a healthcare professional. All third party trademarks used herein are trademarks of their respective owners. Report a Product Quality Complaint to Janssen at 1-800-565-4008 (toll free) or 1-908-455-9922 (toll). 2.3 Administration Instructions SPRAVATO is for nasal use only. Also call your doctor at once if you have: extreme drowsiness or feeling like you might pass out; severe dizziness or feelings of floating; unusual or unpleasant memories (flashbacks); urination problems (painful urination, increased urination, urgent need to urinate). Use 2 devices Spravato nasal spray is used only in a healthcare setting. 4,5 The effectiveness of esketamine nasal … Your blood pressure will need to be checked before and after you use Spravato. Do not prime the device before use. Copyright 1996-2021 Cerner Multum, Inc. You will need someone to drive you home. Your doctor will tell you how often you need to use the medicine. Full Prescribing Information including BOXED WARNING, Risk Evaluation and Mitigation Strategy (REMS). -After the induction phase, evidence of therapeutic benefit should be evaluated to determine the need for continued treatment. SPRAVATO™ nasal spray is a different kind of medication taken with an oral antidepressant for adults with treatment-resistant depression – a first in decades approved by the FDA. Pharmacists or Nurses who are specifically trained on all aspects of the Janssen products and the therapeutic areas they treat. This site is published by Janssen Scientific Affairs, LLC, which is solely responsible for its content. -Patients who require nasal corticosteroids/decongestants should use the agent(s) at least 1 hour before using this drug. Spravato may cause worsening of depression and suicidal thoughts and behaviors, especially during the first few months of treatment and when the dose is changed. Do not drive yourself or do anything that requires you to be awake and alert until the day after your Spravato dose. Get emergency medical help if you have signs of an allergic reaction to Spravato: hives; difficult breathing; swelling of your face, lips, tongue, or throat. Es gibt auch schon wissenschaftliche Studien, die eine Gabe als Ketamin Nasenspray untersucht haben. Usual Adult Dose for Major Depressive Disorder: Call your doctor for instructions if you miss an appointment for your Spravato dose. Report a Janssen COVID-19 Vaccine Product Quality Complaint. Spravato may cause nausea or vomiting. Report a Janssen Product Adverse Event or Product Quality Complaint. To make sure Spravato is safe for you, tell your doctor if you have: heart problems (such as chest pain, heart failure, or a heart valve disorder); slow heartbeats that have caused you to faint; a brain injury or increased pressure in your brain; Some people have thoughts about suicide when first using an antidepressant. Common Spravato side effects may include: decreased sensations (touch or other senses). Some people have thoughts about suicide while taking Spravato. Your doctor should check your progress at regular visits. Spravato is available as a nasal spray to be used by the patient in a clinic or doctor’s office, under the direct supervision of a healthcare professional. You will need someone to drive you home after using Spravato. Is Spravato (esketamine) a controlled substance? -IMPORTANT CONSIDERATION: Treatment sessions should be directly supervised by a healthcare provider; treatment sessions should include nasal administration of the dose and post-administration observation. -Patients should be advised to avoid eating foods for at least 2 hours before, and to avoid drinking liquids for at least 30 minutes before administration. Tell your doctor about all your other medicines, especially: medicine for anxiety, such as diazepam, Valium, Xanax, and others; stimulant medicine, including diet pills, or ADHD medication such as Adderall or Ritalin; an MAO inhibitor, such as isocarboxazid, linezolid, methylene blue injection, phenelzine, rasagiline, selegiline, tranylcypromine, and others. SUMMARY SPRAVATO is intended for administration by the patient under the direct supervision of a healthcare professional, using 2 devices (for a 56 mg dose) or 3 devices (for an 84 mg dose), with a 5-minute rest between use of each device to allow medication to be absorbed. Int J Neuropsychopharmacol. Use effective birth control to prevent pregnancy, and tell your doctor if you become pregnant. Infra - Description du dispositif d'administration). During and after each use of the SPRAVATO ® nasal spray device, you will be checked by a healthcare provider who will decide when you are ready to leave the healthcare setting. Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. You will not be able to use this medicine at home. Report a Janssen COVID-19 Vaccine Adverse Event. Spravato can cause severe drowsiness, or feelings of being disconnected from your body or thoughts or surroundings. -Patients should be advised to avoid eating foods for at least 2 hours before, and to avoid drinking liquids for at least 30 minutes before administration. This medicine can cause side effects such as severe drowsiness, or dissociation (a sense of being detached from your body or emotions, distortions in how you perceive things or people around you). The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. Dass Ketamin als Nasenspray verabreicht werden kann, ist bereits sei langem bekannt und beispielsweise in der Schweiz auch schon praktiziert worden. Lo spray nasale è un dispositivo monouso che rilascia un totale di 28 mg di esketamina in due erogazioni (una per ciascuna narice). You may contact the Medical Information Center by calling 1-800-JANSSEN (1-800-526-7736) 1-800-JANSSEN (1-800-526-7736) to speak to a clinical expert regarding your question or to report a possible adverse event. SPRAVATO® (esketamine) nasal spray, CIII Initial U.S. Approval: 1970 (ketamine) If baseline blood pressure is elevatedthe risks of short-term increases in blood pressure and benefit of Spravato treatment should be considered(see section4.4). INDUCTION PHASE: You should not use Spravato if you are allergic to esketamine or ketamine, or if you have: a blood vessel disorder affecting your brain, chest, stomach, heart, or arms and legs; an abnormal connection between your veins and arteries (a condition called arteriovenous malformation). Week 9 and after: 56 to 84 mg intranasally every 2 weeks OR once a week If you are pregnant, your name may be listed on a pregnancy registry to track the effects of esketamine on the baby. This is followed by 1, 2 or 3 sprays in each nostril twice a week for 4 weeks. FDA approves Spravato, a fast-acting antidepressant nasal spray 3 Minute Read The first new class of antidepressant drugs in more than three decades was approved in March when the U.S. Food and Drug Administration (FDA) fast-tracked esketamine, the chemical cousin of illegal street drug ketamine, to prescribe to patients with treatment-resistant depression. The recommended starting dose is one or two sprays in each nostril (depending on the patient’s age) on the first day. Your family or other caregivers should also be alert to changes in your mood or symptoms. Weeks 1 to 4: Efficacy and safety of fixed-dose esketamine nasal spray combined with a new oral antidepressant in treatment-resistant depression: results of a randomized, double-blind, active-controlled study (TRANSFORM-1). Usual Adult Dose for Depressive Disorder, Other: 84 mg intranasally 2 times a week for 4 weeks We comply with the HONcode standard for trustworthy health information -. Cette dose est administrée en 2 pulvérisations, 1 dans chaque narine (cf. SPRAVATO is available in the following presentations: 56 mg Dose Kit: Unit-dose carton containing two 28 mg nasal spray devices (56 mg total dose) (NDC 50458-028-02). Spravato is also used to treat depressive symptoms in adults with major depressive disorder (MDD) with suicidal thoughts or actions. You should not plan to drive yourself anywhere until the next day, after a full night's sleep. dosing to maintain remission/response (either every 2 weeks or once weekly) at a dose of 56 mg or 84 mg. Spravato must be administered under the direct supervision of a healthcare provider. Prior to dosing with Spravato blood pressure should be assessed. Spravato è solo per uso nasale. In clinical studies with SPRAVATO ® nasal spray, there was a higher rate of lower urinary tract symptoms (pollakiuria, dysuria, micturition urgency, nocturia, and cystitis) in SPRAVATO ®-treated patients than in placebo-treated patients. Do not use Spravato if you are pregnant. -LIMITATION OF USE: Efficacy in suicide prevention or in reducing suicidal behavior or ideation has not been demonstrated beyond 4 weeks; this drug does not preclude hospitalization if clinically warranted, even if patients improve after an initial dose of treatment. The benefit of esketamine nasal spray plus comprehensive SOC on symptoms of MDD was apparent as early as 4 hours after the first dose.^1,2 The effectiveness of esketamine nasal … During and after each use of the SPRAVATO ® nasal spray device, you will be checked by a healthcare provider who will decide when you are ready to leave the healthcare setting. Avoid using any other nasal medicines within 1 hour before you use Spravato nasal spray. Spravato is also used to treat depressive symptoms in adults with major depressive disorder (MDD) with suicidal thoughts or actions. It comes as a nasal spray that's taken … Version: 2.01. trazodone, sertraline, Lexapro, citalopram, Xanax, Zoloft, Cymbalta, Prozac. All rights reserved. Select one or more newsletters to continue. The advice is summarised as follows: ADVICE: following a full submission esketamine (Spravato®) is accepted for … Spravato must be administered under the direct supervision of a healthcare provider. You may need to use more than one spray device based on your dose. Last updated on Sep 8, 2020. Brand name: Spravato® Nasal spray: 56 mg, 84 mg dose kit; Generic name: esketamine (es KET ah meen) All FDA black box warnings are at the end of this fact sheet. Drug class: miscellaneous antidepressants. You will need to plan for a caregiver or family member to drive you home after taking SPRAVATO ® . There is a risk for abuse and dependence with esketamine treatment. Data sources include IBM Watson Micromedex (updated 3 Mar 2021), Cerner Multum™ (updated 1 Mar 2021), ASHP (updated 3 Mar 2021) and others. Other drugs may interact with esketamine, including prescription and over-the-counter medicines, vitamins, and herbal products. Blow your nose before you start treatment. If you’ve tried two or more antidepressants* and are still struggling with depressive symptoms, talk to your doctor to see if you may have treatment-resistant depression. Use: In combination with an oral antidepressant for the treatment of treatment-resistant depression (TRD). Report a Adverse Event to FDA VAERS at www.vaers.hhs.gov/reportevent.html or call the FDA at 1-800-822-7967. The nasal spray device delivers a total of 28 mg of esketamine. Your caregivers will decide when you are ready to leave after using this medicine.