2.3 Administration Instructions SPRAVATO is for nasal use only. Use: In combination with an oral antidepressant for the treatment of treatment-resistant depression (TRD). All rights reserved. Avoid drinking liquids within 30 minutes before using the medicine. 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. What is esketamine and what does it treat? -After Week 8, the dosing frequency should be individualized to the least frequent dosing to maintain remission. -After the induction phase, evidence of therapeutic benefit should be evaluated to determine the need for continued treatment. Available for Android and iOS devices. *Of adequate dose and duration in your current episode. It comes as a nasal spray that's taken … It is not clear how effective racemic ketamine is compared to esketamine (marketed as a nasal spray called Spravato). Esketamine may harm an unborn baby. Weeks 5 to 8: 56 to 84 mg intranasally once a week Brand Name: Spravato. Please review before taking this medication. -After 4 weeks, evidence of therapeutic benefit should be evaluated to determine the need for continued treatment. You should not plan to drive yourself anywhere until the next day, after a full night's sleep. 1 The nasal spray device delivers a total of 28 mg of SPRAVATO. -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. Do not use Spravato if you are pregnant. Das Esketamin Nasenspray ist in Deutschland nicht im Handel, sondern kann nur aus anderen EU-Länder, Schweiz sowie Kanada und USA bezogen werden. Spravato (esketamine nasal spray) is to be co-administered with oral antidepressant therapy in the specified patient population. 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 … -Subsequent doses: 56 to 84 mg intranasally 2 times a week You will need to plan for a caregiver or family member to drive you home after taking SPRAVATO ® . Tell your healthcare provider right away if you have any new or sudden changes in mood, behavior, thoughts, or feelings. Esketamine is an intranasal medication that works in the brain. 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. 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. Since this medicine is given by a healthcare professional in a medical setting, an overdose is unlikely to occur. Spravato can cause severe drowsiness, or feelings of being disconnected from your body or thoughts or surroundings. Ask your doctor or caregivers if you do not understand these instructions. Spravato is a brand-name prescription drug that's prescribed for treatment-resistant depression in adults. All third party trademarks used herein are trademarks of their respective owners. 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. Per evitare perdite del prodotto medicinale, il dispositivo non deve essere azionato prima dell'uso. A treatment session consists of nasal administration of Spravato and post-administration observation under supervision. Use effective birth control to prevent pregnancy, and tell your doctor if you become pregnant. This is not a complete list of side effects and others may occur. 3 Your healthcare provider should check you for signs of abuse and dependence before and during treatment with this medicine. 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. The nasal spray device delivers a total of 28 mg of esketamine. Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. 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. -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). Spravato should not be administered if an increase in blood pressure or intracranial pressure poses a serious risk (see section4.3). Cette dose est administrée en 2 pulvérisations, 1 dans chaque narine (cf. Call your doctor for medical advice about side effects. Comments: Spravato is used only in a healthcare setting where you can be watched closely for at least 2 hours after each dose. Comments: Select one or more newsletters to continue. Report a Janssen COVID-19 Vaccine Adverse Event. 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. ©Janssen Scientific Affairs, LLC 2012. Other drugs may interact with esketamine, including prescription and over-the-counter medicines, vitamins, and herbal products. SPRAVATO® (esketamine) nasal spray, CIII Initial U.S. Approval: 1970 (ketamine) 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. You will need someone to drive you home. Blow your nose before you start treatment. Usual Adult Dose for Major Depressive Disorder: Call your doctor for instructions if you miss an appointment for your Spravato dose. 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. 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. See full prescribing information for SPRAVATO®. It is prepared by Janssen Medical Information and is not intended for promotional purposes, nor for medical advice. 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). Report a Adverse Event to FDA VAERS at www.vaers.hhs.gov/reportevent.html or call the FDA at 1-800-822-7967. Spravato is also used to treat depressive symptoms in adults with major depressive disorder (MDD) with suicidal thoughts or actions. Tell your healthcare provider if you have ever abused or been dependent on alcohol, prescription medicines, or street drugs. Un traitement administré par voie nasale SPRAVATO se présente sous forme de solution pour pulvérisation nasale. Medically reviewed by Judith Stewart, BPharm. Spravato is for use only in adults under a special program. Spravato is for use only in adults under a special program. 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. Spravato nasal spray is used only in a healthcare setting. Week 9 and after: 56 to 84 mg intranasally every 2 weeks OR once a week You should not eat anything for at least 2 hours before receiving your dose. Spravato nasal spray is used only in a healthcare setting. You will not be able to use this medicine at home. Report a Janssen Product Adverse Event or Product Quality Complaint. * Dosing frequency should be individualized to the least frequent dosing to maintain remission/response. You will not be able to use this medicine at home. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances. If you are pregnant, your name may be listed on a pregnancy registry to track the effects of esketamine on the baby. Common Spravato side effects may include: decreased sensations (touch or other senses). You may report side effects to FDA at 1-800-FDA-1088. 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. Do not drive yourself or do anything that requires you to be awake and alert until the day after your Spravato dose. 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 … Dass Ketamin als Nasenspray verabreicht werden kann, ist bereits sei langem bekannt und beispielsweise in der Schweiz auch schon praktiziert worden. Es gibt auch schon wissenschaftliche Studien, die eine Gabe als Ketamin Nasenspray untersucht haben. You will be watched closely for at least 2 hours after you use Spravato. This information is intended for healthcare providers in the United States only.This page was last modified on March 07, 2021. Avoid using any other nasal medicines within 1 hour before you use Spravato nasal spray. Lo spray nasale è un dispositivo monouso che rilascia un totale di 28 mg di esketamina in due erogazioni (una per ciascuna narice). The benefit of esketamine nasal spray plus comprehensive SOC on symptoms of MDD was apparent as early as 4 hours after the first dose. You will give yourself the nasal spray while being supervised by a healthcare professional. Esketamine can increase your blood pressure for several hours after each dose. Each nasal spray device delivers two sprays containing a total of 28 mg of esketamine (supplied as 32.3 mg of esketamine hydrochloride). 2019;22(10):616-630. Your doctor should check your progress at regular visits. Spravato è solo per uso nasale. Foto: APOTHEKE ADHOC . Stay alert to changes in your mood or symptoms. Un flacon contient 28 mg d'eskétamine. Janssen hat die US-Zulassung für das Esketamin Nasenspray Spravato erhalten. 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. -Day 1: 56 mg intranasally ONCE 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. 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. The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. Drug class: miscellaneous antidepressants. SPRAVATO® is not approved as an anesthetic agent. Int J Neuropsychopharmacol. MAINTENANCE PHASE: Tell your doctor if you have chest pain, trouble breathing, severe headache, blurred vision, pounding in your neck or ears, or a seizure. This site is for US healthcare professionals to provide online access to current, accurate, scientific information about our products. There is a risk for abuse and dependence with esketamine treatment. You must be registered in the program and understand the risks and benefits of this medicine. -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. To prevent loss of medication, do not prime the device before use. Weeks 1 to 4: 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. The recommended starting dose is one or two sprays in each nostril (depending on the patient’s age) on the first day. Report a Janssen COVID-19 Vaccine Product Quality Complaint. Use 2 devices We comply with the HONcode standard for trustworthy health information -. Report any new or worsening symptoms to your doctor. This is followed by 1, 2 or 3 sprays in each nostril twice a week for 4 weeks. 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. SPRAVATO® (esketamine) nasal spray, CIII HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use SPRAVATO® safely and effectively. Usual Adult Dose for Depressive Disorder, Other: 84 mg intranasally 2 times a week for 4 weeks Wir haben eine Anfrage gestellt, ob es möglich ist Spravato zu importieren, allerdings haben viele Länder momentan ihren Arzneimittelexport gestoppt oder beliefern nur Krankenhäuser. Not all possible drug interactions are listed here. -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. Spravato is usually given 2 times per week at first, and then once every 1 to 2 weeks. You may need to use more than one spray device based on your dose. Fedgchin M, Trivedi M, Daly E, et al. 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. 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. Last updated on Sep 8, 2020. No cases of esketamine-related interstitial cystitis were observed in any of the studies, which involved treatment for up to a year. Spravato is a nasal spray that is used in a healthcare setting. Spray once in each nostril per device. Spravato is also used to treat depressive symptoms in adults with major depressive disorder (MDD) with suicidal thoughts or actions. Ketamin Nasenspray Spravato: Neue Option? Infra - Description du dispositif d'administration). Your doctor will tell you how often you need to use the medicine. 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). 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. 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). Your family or other caregivers should also be alert to changes in your mood or symptoms. 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). Version: 2.01. trazodone, sertraline, Lexapro, citalopram, Xanax, Zoloft, Cymbalta, Prozac. Spravato must be administered under the direct supervision of a healthcare provider. Generic Name: esketamine (nasal) (es KET a meen) Scientific Knowledge Experts are available Monday-Friday 9am-8pm ET. -The dosage may be decreased to 56 mg intranasally 2 times a week if intolerable symptoms occur. 4,5 The effectiveness of esketamine nasal … 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. Spravato may cause nausea or vomiting. Some people have thoughts about suicide while taking Spravato. Copyright 1996-2021 Cerner Multum, Inc. -Patients who require nasal corticosteroids/decongestants should use the agent(s) at least 1 hour before using this drug. The advice is summarised as follows: ADVICE: following a full submission esketamine (Spravato®) is accepted for … INDUCTION PHASE: Do not prime the device before use. Data sources include IBM Watson Micromedex (updated 3 Mar 2021), Cerner Multum™ (updated 1 Mar 2021), ASHP (updated 3 Mar 2021) and others. 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. You will need to plan for a caregiver or family member to drive you home after taking SPRAVATO ® . Read and carefully follow any Instructions for Use that are given to you. You will need someone to drive you home after using Spravato. 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. 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. Report a Adverse Event to Janssen at 1-800-565-4008 (toll free) or 1-908-455-8822 (toll). 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. However, new research by … This list is not complete. -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. -Patients who require nasal corticosteroids/decongestants should use the agent(s) at least 1 hour before using this drug. Full Prescribing Information including BOXED WARNING, Risk Evaluation and Mitigation Strategy (REMS). 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). Prior to dosing with Spravato blood pressure should be assessed. Is Spravato (esketamine) a controlled substance? Your blood pressure will need to be checked before and after you use Spravato. Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. Taken along with an oral antidepressant: SPRAVATO® is the first nasal spray medication specifically for adults with treatment-resistant depression. The nasal spray device delivers a total of 28 mg of esketamine (two sprays of 14 mg each). This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. Your caregivers will decide when you are ready to leave after using this medicine. Report a Product Quality Complaint to Janssen at 1-800-565-4008 (toll free) or 1-908-455-9922 (toll).
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