ASCO's Antiemetics Drug, Dose, and Schedule Table
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CP.PMN.158 Netupitant and Palonosetron (Akynzeo)
Clinical Policy: Netupitant and Palonosetron (Akynzeo), Fosnetupitant and Palonosetron (Akynzeo IV) Reference Number: CP.PMN.158 Effective Date: 09.01.06 Last Review Date: 02.21 Coding Implications Line of Business: HIM, Medicaid Revision Log See Important Reminder at the end of this policy for important regulatory and legal information. Description Netupitant/palonosetron (Akynzeo®) and fosnetupitant/palonosetron are fixed combination products of netupitant, a substance P/neurokinin 1 (NK1) receptor antagonist, and palonosetron hydrochloride, a serotonin (5-HT3) receptor antagonist. FDA Approved Indication(s) Akynzeo capsules are indicated in combination with dexamethasone in adults for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of cancer chemotherapy, including, but not limited to, highly emetogenic chemotherapy. Akynzeo for injection is indicated in combination with dexamethasone in adults for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy. Policy/Criteria Provider must submit documentation (such as office chart notes, lab results or other clinical information) supporting that member has met all approval criteria. It is the policy of health plans affiliated with Centene Corporation® that Akynzeo is medically necessary when the following criteria are met: I. Initial Approval Criteria A. Prevention of Nausea and Vomiting Associated with Cancer Chemotherapy (must meet all): 1. Prescribed for the prevention of chemotherapy-induced nausea/vomiting; 2. Age ≥ 18 years; 3. If request is for Akynzeo capsules, member is scheduled to receive moderately to highly emetogenic cancer chemotherapy (see Appendix D); 4. If request is for Akynzeo for injection, member is scheduled to receive highly emetogenic cancer chemotherapy (see Appendix D); 5. -
Fosaprepitant Dimeglumine (Emend® for Injection) Prior Authorization Drug Coverage Policy
1 Fosaprepitant dimeglumine (Emend® for injection) Prior Authorization Drug Coverage Policy Effective Date: 9/1/2020 Revision Date: n/a Review Date: 3/13/20 Lines of Business: Commercial Policy type: Prior Authorization This Drug Coverage Policy provides parameters for the coverage of fosaprepitant dimeglumine. Consideration of medically necessary indications are based upon U.S. Food and Drug Administration (FDA) indications, recommended uses within the Centers of Medicare & Medicaid Services (CMS) five recognized compendia, including the National Comprehensive Cancer Network (NCCN) Drugs & Biologics Compendium (Category 1 or 2A recommendations), and peer-reviewed scientific literature eligible for coverage according to the CMS, Medicare Benefit Policy Manual, Chapter 15, section 50.4.5 titled, “Off-Label Use of Anti-Cancer Drugs and Biologics.” This policy evaluates whether the drug therapy is proven to be effective based on published evidence-based medicine. Drug Description 1 Fosaprepitant is a prodrug of aprepitant and accordingly, its antiemetic effects are attributable to aprepitant. Aprepitant is a selective high-affinity antagonist of human substance P/neurokinin 1 (NK1) receptors. Aprepitant has little or no affinity for serotonin (5-HT3), dopamine, and corticosteroid receptors, the targets of existing therapies for chemotherapy-induced nausea and vomiting (CINV). Aprepitant has been shown in animal models to inhibit emesis induced by cytotoxic chemotherapeutic agents, such as cisplatin, via central actions. Animal and human Positron Emission Tomography (PET) studies with aprepitant have shown that it crosses the blood brain barrier and occupies brain NK1 receptors. Animal and human studies show that aprepitant augments the antiemetic activity of the 5-HT3-receptor antagonist ondansetron and the corticosteroid dexamethasone and inhibits both the acute and delayed phases of cisplatin- induced emesis. -
MASCC/ESMO ANTIEMETIC GUIDELINE 2016 with Updates in 2019
1 ANTIEMETIC GUIDELINES: MASCC/ESMO MASCC/ESMO ANTIEMETIC GUIDELINE 2016 With Updates in 2019 Organizing and Overall Meeting Chairs: Matti Aapro, MD Richard J. Gralla, MD Jørn Herrstedt, MD, DMSci Alex Molassiotis, RN, PhD Fausto Roila, MD © Multinational Association of Supportive Care in CancerTM All rights reserved worldwide. 2 ANTIEMETIC GUIDELINES: MASCC/ESMO These slides are provided to all by the Multinational Association of Supportive Care in Cancer and can be used freely, provided no changes are made and the MASCC and ESMO logos, as well as date of the information are retained. For questions please contact: Matti Aapro at [email protected] Chair, MASCC Antiemetic Study Group or Alex Molassiotis at [email protected] Past Chair, MASCC Antiemetic Study Group 3 ANTIEMETIC GUIDELINES: MASCC/ESMO Consensus A few comments on this guideline set: • This set of guideline slides represents the latest edition of the guideline process. • This set of slides has been endorsed by the MASCC Antiemetic Guideline Committee and ESMO Guideline Committee. • The guidelines are based on the votes of the panel at the Copenhagen Consensus Conference on Antiemetic Therapy, June 2015. • Latest version: March 2016, with updates in 2019. 4 ANTIEMETIC GUIDELINES: MASCC/ESMO Changes: The Steering Committee has clarified some points: 2016: • A footnote clarified that aprepitant 165 mg is approved by regulatory authorities in some parts of the world ( although no randomised clinical trial has investigated this dose ). Thus use of aprepitant 80 mg in the delayed phase is only for those cases where aprepitant 125 mg is used on day 1. • A probable modification in pediatric guidelines based on the recent Cochrane meta-analysis is indicated. -
Emend® (Fosaprepitant Dimeglumine)
Emend® (fosaprepitant dimeglumine) (Intravenous) Document Number: IC-0036 Last Review Date: 04/01/2020 Date of Origin: 12/01/2011 Dates Reviewed: 03/2012, 06/2012, 09/2012, 12/2012, 03/2013, 06/2013, 09/2013, 12/2013, 03/2014, 06/2014, 09/2014, 12/2014, 03/2015, 05/2015, 08/2015, 11/2015, 02/2016, 05/2016, 08/2016, 11/2016, 02/2017, 05/2017, 08/2017, 11/2017, 02/2018, 05/2018, 04/2019, 04/2020 I. Length of Authorization Coverage is provided for six months and may be renewed. II. Dosing Limits A. Quantity Limit (max daily dose) [NDC unit]: Emend 150 mg powder for injection: 1 vial per 7 days B. Max Units (per dose and over time) [HCPCS Unit]: 150 billable units per 7 days III. Initial Approval Criteria1,2,3,4,5 Coverage is provided in the following conditions: Patient aged 6 months or older; AND Universal Criteria Patient is not taking pimozide concurrently; AND Prevention of Chemotherapy induced Nausea and vomiting (CINV) † Patient is receiving highly and/or moderately emetogenic chemotherapy (see HEC/MEC list below); AND Must be used in combination with a 5-HT3 antagonist such as ondansetron, granisetron, palonosetron, etc.; AND Must be used in combination with a corticosteroid such as dexamethasone Highly Emetogenic Chemotherapy (HEC) Carboplatin Carmustine Cisplatin Cyclophosphamide Dacarbazine Doxorubicin Epirubicin Ifosfamide Mechlorethamine Streptozocin Proprietary & Confidential © 2020 Magellan Health, Inc. Moderately Emetogenic Chemotherapy (MEC) Aldesleukin Amifostine Enfortumab vedotin Azacitidine Bendamustine Busulfan Clofarabine Cytarabine Dactinomycin Daunorubicin Dinutuximab Idarubicin Interferon alfa Irinotecan Melphalan Methotrexate Oxaliplatin Temozolomide Trabectedin Daunorubicin Liposomal; Cytarabine Liposomal Fam-trastuzumab deruxtecan The following regimens can be considered HEC: FOLFOX FOLFIRI FOLFIRINOX; AC (any anthracycline + FOLFOXIRI cyclophosphamide) † FDA-approved indication(s) IV. -
Deciphering Emesis
International Journal of Pharmaceutical Chemistry and Analysis 2021;8(1):19–24 Content available at: https://www.ipinnovative.com/open-access-journals International Journal of Pharmaceutical Chemistry and Analysis Journal homepage: https://www.ijpca.org/ Review Article Deciphering emesis 1, 2 Sunil Chaudhry *, Avisek Dutta 1Bioclinitech Technologies Pvt Ltd, Mumbai & GPATTutor.com,, India 2Cognizant Aolutions, Kolkata, West Bengal, India ARTICLEINFO ABSTRACT Article history: The incidence of nausea or vomiting changes much with etiopathogenesis. Multiple neurohumoural Received 04-03-2021 pathways lead to nausea and vomiting. The various classes of antiemetics target different pro-emetic Accepted 09-03-2021 pathways to alleviate nausea and vomiting. Some drugs target more than one pathway. It is demonstrated Available online 04-05-2021 that combination therapy is more effective than single anti-emetic agent. © This is an open access article distributed under the terms of the Creative Commons Attribution Keywords: License (https://creativecommons.org/licenses/by/4.0/) which permits unrestricted use, distribution, and Vomiting reproduction in any medium, provided the original author and source are credited. Chemoreceptor trigger zone Aprepitant Cannabinoid receptor agonist 5 HT receptor antagonist Neurokinin receptor antagonists 1. Introduction 5. Refractory: Nausea and/or vomiting that occurs in subsequent chemotherapy cycles despite maximum Vomiting or emesis, is defined as the involuntary, forceful antiemetic protocol expulsion of the contents of stomach through the mouth and 6. Anticipatory: Nausea and/or vomiting that is sometimes from nose. triggered by sensory stimuli associated with chemotherapy administration. 1 2. Types of Vomiting Features of Cancer Chemotherapy induced nausea and 2.1. Vomiting centre vomiting: The chemoreceptor trigger zone in the Area postrema plays 1. -
203050Orig1s000
CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 203050Orig1s000 LABELING HIGHLIGHTS OF PRESCRIBING INFORMATION ------------------------------CONTRAINDICATIONS-------------------------------- These highlights do not include all the information needed to use Hypersensitivity to the drug or any of its components (4) PALONOSETRON HYDROCHLORIDE INJECTION safely and effectively. See full prescribing information for PALONOSETRON ------------------------WARNINGS AND PRECAUTIONS------------------------- HYDROCHLORIDE INJECTION. • Hypersensitivity reactions, including anaphylaxis, have been reported with or without known hypersensitivity to other selective 5-HT3 receptor antagonists PALONOSETRON HYDROCHLORIDE injection, for intravenous (5.1) use • Serotonin syndrome has been reported with 5-HT3 receptor antagonists alone Initial U.S. Approval: 2003 but particularly with concomitant use of serotonergic drugs (5.2, 7.1) -------------------------INDICATIONS AND USAGE------------------------ --------------------------------ADVERSE REACTIONS------------------------------- Palonosetron Hydrochloride (HCl) Injection is a serotonin-3 (5-HT3) The most common adverse reactions in chemotherapy-induced nausea and receptor antagonist indicated in adults for: vomiting (≥5%) are headache and constipation (6.1) • Moderately emetogenic cancer chemotherapy -- prevention of acute and delayed nausea and vomiting associated with initial and repeat The most common adverse reactions in postoperative nausea and vomiting (≥ courses (1.1) 2%) are QT prolongation, -
Haloperidol As Prophylactic Treatment for Postoperative
Document downloaded from http://http://www.revcolanest.com.co, day 15/02/2013. This copy is for personal use. Any transmission of this document by any media or format is strictly prohibited. r e v c o l o m b a n e s t e s i o l . 2 0 1 3;4 1(1):34–43 Revista Colombiana de Anestesiología Colombian Journal of Anesthesiology www.revcolanest.com.co Review Haloperidol as prophylactic treatment for postoperative ଝ nausea and vomiting: Systematic literature review ∗ Catalina Chaparro , Diego Moreno, Verónica Ramírez, Angélica Fajardo, David González, Alejandra Sanín, Reinaldo Grueso Anesthesiology Service, Hospital Universitario San Ignacio, Bogotá, Colombia a r t i c l e i n f o a b s t r a c t Article history: Introduction: The effectiveness of haloperidol for the prophylaxis of postoperative nausea Received 3 July 2012 and vomiting (PONV) has been proven in prior trials summarized by Buttner in 2004. New Accepted 24 July 2012 evidence has surfaced since then. Our objective is thus to update the current knowledge on the topic. A systematic review and a meta-analysis were performed, in order to determine the effectiveness and safety of the use of haloperidol as prophylaxis for PONV. Keywords: Methodology: The systematic search, the selection of relevant articles, the extraction of data, Haloperidol the critical analysis of the primary studies, the comparisons and analyses were all based on Vomiting the recommendations of the Cochrane Collaboration and using RevMan5 software. Nausea Results: Ten controlled clinical trials published between 1962 and 2010, that included 2,711 Clinical trials patients, met the selection criteria. -
NEPA, a Fixed Oral Combination of Netupitant and Palonosetron
Support Care Cancer DOI 10.1007/s00520-016-3502-x ORIGINAL ARTICLE NEPA, a fixed oral combination of netupitant and palonosetron, improves control of chemotherapy-induced nausea and vomiting (CINV) over multiple cycles of chemotherapy: results of a randomized, double-blind, phase 3 trial versus oral palonosetron Matti Aapro1 & Meinolf Karthaus2 & Lee Schwartzberg3 & Igor Bondarenko4 & Tomasz Sarosiek 5 & Cristina Oprean6 & Servando Cardona-Huerta7 & Vincent Hansen 8 & Giorgia Rossi9 & Giada Rizzi9 & Maria Elisa Borroni9 & Hope Rugo10 Received: 14 May 2016 /Accepted: 25 September 2016 # The Author(s) 2016. This article is published with open access at Springerlink.com Abstract with oral PALO in a single chemotherapy cycle; maintenance Purpose Antiemetic guidelines recommend co-administration of efficacy/safety over continuing cycles is the objective of this of targeted prophylactic medications inhibiting molecular path- study. ways involved in emesis. NEPA is a fixed oral combination of a Methods This study is a multinational, double-blind study new NK1 receptor antagonist (RA), netupitant (NETU 300 mg), comparing a single oral dose of NEPA vs oral PALO in and palonosetron (PALO 0.50 mg), a pharmacologically dis- chemotherapy-naïve patients receiving anthracycline/ tinct 5-HT3 RA. NEPA showed superior prevention of cyclophosphamide-based chemotherapy along with dexa- chemotherapy-induced nausea and vomiting (CINV) compared methasone12mg(NEPA)or20mg(PALO)onday1. The primary efficacy endpoint was delayed (25–120 h) A prior publication reported the cycle 1 findings of this study [Aapro complete response (CR: no emesis, no rescue medication) et al., Annals of Oncology 2014 NCT01339260]. This paper focuses on in cycle 1. Sustained efficacy was evaluated during the the findings in the multiple-cycle extension, data which was an oral pre- multicycle extension by calculating the proportion of pa- sentation at both the ASCO and MASCC Annual Meetings in 2014. -
Safety and Efficacy of a Continuous Infusion, Patient Controlled Anti
Bone Marrow Transplantation, (1999) 24, 561–566 1999 Stockton Press All rights reserved 0268–3369/99 $15.00 http://www.stockton-press.co.uk/bmt Safety and efficacy of a continuous infusion, patient controlled anti- emetic pump to facilitate outpatient administration of high-dose chemotherapy SP Dix, MK Cord, SJ Howard, JL Coon, RJ Belt and RB Geller Blood and Marrow Transplant Program, Oncology and Hematology Associates and Saint Luke’s Hospital of Kansas City, Kansas City, MO, USA Summary: and colleagues1 described an outpatient BMT care model utilizing intensive clinic support following inpatient admin- We evaluated the combination of diphenhydramine, lor- istration of HDC. This approach facilitated early patient azepam, and dexamethasone delivered as a continuous discharge and significantly decreased the total number of i.v. infusion via an ambulatory infusion pump with days of hospitalization associated with BMT. More patient-activated intermittent dosing (BAD pump) for recently, equipped BMT centers have extended the out- prevention of acute and delayed nausea/vomiting in patient care approach to include administration of HDC in patients receiving high-dose chemotherapy (HDC) for the clinic setting. Success of the total outpatient care peripheral blood progenitor cell (PBPC) mobilization approach is dependent upon the availability of experienced (MOB) or prior to autologous PBPC rescue. The BAD staff and necessary resources as well as implementation of pump was titrated to patient response and tolerance, supportive care strategies designed to minimize morbidity and continued until the patient could tolerate oral anti- in the outpatient setting. emetics. Forty-four patients utilized the BAD pump Despite improvements in supportive care strategies, during 66 chemotherapy courses, 34 (52%) for MOB chemotherapy-induced nausea and vomiting continues to be and 32 (48%) for HDC with autologous PBPC rescue. -
HHS Template for Reports, with Instructions
Texas Vendor Drug Program 1.1 Drug Use Criteria: Substance P/Neurokinin1 Receptor Antagonists Publication History 1. Developed December 2003. 2. Revised September 2020; September 2018; September 2016; May 2015; August 2013; June 2013; September 2011; October 2009; February 2006; January 2006. Notes: Information on indications for use or diagnosis is assumed to be unavailable. All criteria may be applied retrospectively; prospective application is indicated with an asterisk [*]. The information contained is for the convenience of the public. The Texas Health and Human Services Commission is not responsible for any errors in transmission or any errors or omissions in the document. Medications listed in the tables and non-FDA approved indications included in these retrospective criteria are not indicative of Vendor Drug Program formulary coverage. Prepared by: • Drug Information Service, UT Health San Antonio. • The College of Pharmacy, The University of Texas at Austin. 1 1 Dosage [*] Current therapies for chemotherapy-induced nausea/vomiting (CINV) and post- operative nausea and vomiting (PONV) target corticosteroid, dopamine, and serotonin (5-HT3) receptors. In the central nervous system, tachykinins and neurokinins play a role in some autonomic reflexes and behaviors. Aprepitant is a selective human substance P/neurokinin 1 (NK1) antagonist with a high affinity for NK1 receptors and little, if any, attraction for corticosteroid, dopamine, or 5-HT3 receptors. Rolapitant (Varubi®), the newest substance P/NK1 antagonist, is FDA- approved to prevent delayed CINV with initial and repeat chemotherapy courses including, but not limited to, highly emetogenic chemotherapy in adults. Combination therapy including netupitant, a substance P/NK1 antagonist and palonosetron, a selective 5-HT3 receptor antagonist (Akynzeo®), is now available to prevent acute and delayed CINV with initial and repeat chemotherapy courses including, but not limited to, highly emetogenic chemotherapy in adults. -
The Effect of Intravenous Maropitant on Blood Pressure in Healthy Awake and Anesthetized Dogs
Veterinary Clinical Sciences Publications Veterinary Clinical Sciences 2-27-2020 The effect of intravenous maropitant on blood pressure in healthy awake and anesthetized dogs Ting-Ting Chi Iowa State University, [email protected] Bonnie L. Hay Kraus Iowa State University, [email protected] Follow this and additional works at: https://lib.dr.iastate.edu/vcs_pubs Part of the Comparative and Laboratory Animal Medicine Commons, and the Small or Companion Animal Medicine Commons The complete bibliographic information for this item can be found at https://lib.dr.iastate.edu/ vcs_pubs/39. For information on how to cite this item, please visit http://lib.dr.iastate.edu/ howtocite.html. This Article is brought to you for free and open access by the Veterinary Clinical Sciences at Iowa State University Digital Repository. It has been accepted for inclusion in Veterinary Clinical Sciences Publications by an authorized administrator of Iowa State University Digital Repository. For more information, please contact [email protected]. The effect of intravenous maropitant on blood pressure in healthy awake and anesthetized dogs Abstract Objective To evaluate the effects of intravenous maropitant on arterial blood pressure in healthy dogs while awake and under general anesthesia. Design Experimental crossover study. Animals Eight healthy adult Beagle dogs. Procedure All dogs received maropitant (1 mg kg-1) intravenously under the following conditions: 1) awake with non-invasive blood pressure monitoring (AwNIBP), 2) awake with invasive blood pressure monitoring (AwIBP), 3) premedication with acepromazine (0.005 mg kg-1) and butorphanol (0.2 mg kg-1) intramuscularly followed by propofol induction and isoflurane anesthesia (GaAB), and 4) premedication with dexmedetomidine (0.005 mg kg-1) and butorphanol (0.2 mg kg-1) intramuscularly followed by propofol induction and isoflurane anesthesia (GaDB). -
5-HT3 Receptor Antagonists in Neurologic and Neuropsychiatric Disorders: the Iceberg Still Lies Beneath the Surface
1521-0081/71/3/383–412$35.00 https://doi.org/10.1124/pr.118.015487 PHARMACOLOGICAL REVIEWS Pharmacol Rev 71:383–412, July 2019 Copyright © 2019 by The Author(s) This is an open access article distributed under the CC BY-NC Attribution 4.0 International license. ASSOCIATE EDITOR: JEFFREY M. WITKIN 5-HT3 Receptor Antagonists in Neurologic and Neuropsychiatric Disorders: The Iceberg Still Lies beneath the Surface Gohar Fakhfouri,1 Reza Rahimian,1 Jonas Dyhrfjeld-Johnsen, Mohammad Reza Zirak, and Jean-Martin Beaulieu Department of Psychiatry and Neuroscience, Faculty of Medicine, CERVO Brain Research Centre, Laval University, Quebec, Quebec, Canada (G.F., R.R.); Sensorion SA, Montpellier, France (J.D.-J.); Department of Pharmacodynamics and Toxicology, School of Pharmacy, Mashhad University of Medical Sciences, Mashhad, Iran (M.R.Z.); and Department of Pharmacology and Toxicology, University of Toronto, Toronto, Ontario, Canada (J.-M.B.) Abstract. ....................................................................................384 I. Introduction. ..............................................................................384 II. 5-HT3 Receptor Structure, Distribution, and Ligands.........................................384 A. 5-HT3 Receptor Agonists .................................................................385 B. 5-HT3 Receptor Antagonists. ............................................................385 Downloaded from 1. 5-HT3 Receptor Competitive Antagonists..............................................385 2. 5-HT3 Receptor