MASCC/ESMO ANTIEMETIC GUIDELINE 2016 with Updates in 2019
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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. -
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. -
Clinical Practice Guideline for Emergency Department Ketamine Dissociative Sedation: 2011 Update
PAIN MANAGEMENT/CONCEPTS Clinical Practice Guideline for Emergency Department Ketamine Dissociative Sedation: 2011 Update Steven M. Green, MD, Mark G. Roback, MD, Robert M. Kennedy, MD, Baruch Krauss, MD, EdM From the Department of Emergency Medicine, Loma Linda University Medical Center and Children’s Hospital, Loma Linda, CA (Green); the Department of Pediatrics, University of Minnesota, Minneapolis, MN (Roback); the Division of Emergency Medicine, St. Louis Children’s Hospital, Washington University, St. Louis, MO (Kennedy); and the Division of Emergency Medicine, Children’s Hospital Boston and Department of Pediatrics, Harvard Medical School, Boston, MA (Krauss). We update an evidence-based clinical practice guideline for the administration of the dissociative agent ketamine for emergency department procedural sedation and analgesia. Substantial new research warrants revision of the widely disseminated 2004 guideline, particularly with respect to contraindications, age recommendations, potential neurotoxicity, and the role of coadministered anticholinergics and benzodiazepines. We critically discuss indications, contraindications, personnel requirements, monitoring, dosing, coadministered medications, recovery issues, and future research questions for ketamine dissociative sedation. [Ann Emerg Med. 2011;xx:xxx.] 0196-0644/$-see front matter Copyright © 2011 by the American College of Emergency Physicians. doi:10.1016/j.annemergmed.2010.11.030 INTRODUCTION thalamocortical and limbic systems, effectively dissociating the The dissociative -
Specific Effects of Trabectedin and Lurbinectedin on Human Macrophage Function and Fate—Novel Insights
cancers Article Specific Effects of Trabectedin and Lurbinectedin on Human Macrophage Function and Fate—Novel Insights 1, 1, 1 Adrián Povo-Retana y, Marina Mojena y, Adrian B. Stremtan , Victoria B. Fernández-García 1, Ana Gómez-Sáez 1, Cristina Nuevo-Tapioles 2,3 , José M. Molina-Guijarro 4 , José Avendaño-Ortiz 5, José M. Cuezva 2,3 , Eduardo López-Collazo 5, Juan F. Martínez-Leal 4 and Lisardo Boscá 1,5,6,* 1 Instituto de Investigaciones Biomédicas Alberto Sols (Centro Mixto CSIC-UAM), 28029 Madrid, Spain; [email protected] (A.P.-R.); [email protected] (M.M.); [email protected] (A.B.S.); [email protected] (V.B.F.-G.); [email protected] (A.G.-S.) 2 Centro de Biología Molecular (Centro Mixto CSIC-UAM), Nicolás Cabrera S/N, Ciudad Universitaria de Cantoblanco, 28049 Madrid, Spain; [email protected] (C.N.-T.); [email protected] (J.M.C.) 3 Centro de Investigación Biomédica en Red en Enfermedades Raras (CIBERER), 28029 Madrid, Spain 4 Pharma Mar SA, 28770 Colmenar Viejo, Spain; [email protected] (J.M.M.-G.); [email protected] (J.F.M.-L.) 5 Instituto de Investigación Sanitaria La Paz (IdiPaz), Hospital Universitario La Paz, 28046 Madrid, Spain; [email protected] (J.A.-O.); [email protected] (E.L.-C.) 6 Centro de Investigación Biomédica en Red en Enfermedades Cardiovasculares (CIBERCV), 28029 Madrid, Spain * Correspondence: [email protected]; Tel.: +34-9149-72747 These authors have equal contribution. y Received: 28 August 2020; Accepted: 16 October 2020; Published: 20 October 2020 Simple Summary: Trabectedin and lurbinectedin are two potent onco-therapeutic drugs for the treatment of advanced soft tissue sarcomas. -
Combining Paclitaxel and Lapatinib As Second-Line Treatment for Patients with Metastatic Transitional Cell Carcinoma: a Case Series
ANTICANCER RESEARCH 32: 3949-3952 (2012) Combining Paclitaxel and Lapatinib as Second-line Treatment for Patients with Metastatic Transitional Cell Carcinoma: A Case Series STÉPHANE CULINE, ZINEB SELLAM, LINDA BOUAITA, ELIAS ASSAF, CATHERINE DELBALDO, MURIEL VERLINDE-CARVALHO and DAMIEN POUESSEL Department of Medical Oncology, Henri Mondor Hospital, Créteil, France Abstract. Background: Current first-line cisplatin-based trial comparing vinflunine with best supportive care (BSC) combination chemotherapy regimens provide interesting to BSC alone, an estimated difference in overall survival response rates but limited impact on survival for patients with (OS) of 2 months was reached in the intent-to-treat metastatic transitional cell carcinoma of the urothelium. Such population. However, a significant difference in OS was only results leave a significant patient population in need of salvage seen after removing patients who had major protocol therapy. Patients and Methods: As the epidermal growth factor violations (2). Therefore therapy for patients who fail first- receptors 1 and 2 (EGFR and HER2) are frequently line cisplatin-based chemotherapy remains a highly unmet overexpressed in urothelial carcinoma, we explored the medical need. feasibility of a combination of paclitaxel (80 mg/m2/week) and In a phase II study led by the French Genito-Urinary lapatinib (1,500 mg orally daily) for six patients who were Tumor group (GETUG), the activity of weekly paclitaxel as treated after failure of first-line platinum-based chemotherapy. second-line chemotherapy was assessed in 45 patients with Results: Only one out of six patients was able to receive the MTCCU. A low objective response rate (9%) along with a full doses during the first six weeks of treatment, while grade high rate of stabilization (38%) suggested limited impact as 2 or 3 diarrhea events required lapatinib dose reduction (one a single agent (3). -
Antiemetics/Antivertigo Agents
Antiemetic Agents Therapeutic Class Review (TCR) May 1, 2019 No part of this publication may be reproduced or transmitted in any form or by any means, electronic or mechanical, including photocopying, recording, digital scanning, or via any information storage or retrieval system without the express written consent of Magellan Rx Management. All requests for permission should be mailed to: Magellan Rx Management Attention: Legal Department 6950 Columbia Gateway Drive Columbia, Maryland 21046 The materials contained herein represent the opinions of the collective authors and editors and should not be construed to be the official representation of any professional organization or group, any state Pharmacy and Therapeutics committee, any state Medicaid Agency, or any other clinical committee. This material is not intended to be relied upon as medical advice for specific medical cases and nothing contained herein should be relied upon by any patient, medical professional or layperson seeking information about a specific course of treatment for a specific medical condition. All readers of this material are responsible for independently obtaining medical advice and guidance from their own physician and/or other medical professional in regard to the best course of treatment for their specific medical condition. This publication, inclusive of all forms contained herein, is intended to be educational in nature and is intended to be used for informational purposes only. Send comments and suggestions to [email protected]. May 2019 Proprietary Information. Restricted Access – Do not disseminate or copy without approval. © 2004-2019 Magellan Rx Management. All Rights Reserved. 3 FDA-APPROVED INDICATIONS Drug Manufacturer Indication(s) NK1 receptor antagonists aprepitant capsules generic, Merck In combination with other antiemetic agents for: (Emend®)1 . -
Revised Use-Function Classification (2007)
INTERNATIONAL PROGRAMME ON CHEMICAL SAFETY IPCS INTOX Data Management System (INTOX DMS) Revised Use-Function Classification (2007) The Use-Function Classification is used in two places in the INTOX Data Management System: the Communication Record and the Agent/Product Record. The two records are linked: if there is an agent record for a Centre Agent that is the subject of a call, the appropriate Intended Use-Function can be selected automatically in the Communication Record. The Use-Function Classification is used when generating reports, both standard and customized, and for searching the case and agent databases. In particular, INTOX standard reports use the top level headings of the Intended Use-Functions that were selected for Centre Agents in the Communication Record (e.g. if an agent was classified as an Analgesic for Human Use in the Communication Record, it would be logged as a Pharmaceutical for Human Use in the report). The Use-Function classification is very important for ensuring harmonized data collection. In version 4.4 of the software, 5 new additions were made to the top levels of the classification provided with the system for the classification of organisms (items XIV to XVIII). This is a 'convenience' classification to facilitate searching of the Communications database. A taxonomic classification for organisms is provided within the INTOX DMS Agent Explorer. In May/June 2006 INTOX users were surveyed to find out whether they had made any changes to the Use-Function Classification. These changes were then discussed at the 4th and 5th Meetings of INTOX Users. Version 4.5 of the INTOX DMS includes the revised pesticides classification (shown in full below). -
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. -
Drugs to Avoid in Patients with Dementia
Detail-Document #240510 -This Detail-Document accompanies the related article published in- PHARMACIST’S LETTER / PRESCRIBER’S LETTER May 2008 ~ Volume 24 ~ Number 240510 Drugs To Avoid in Patients with Dementia Elderly people with dementia often tolerate drugs less favorably than healthy older adults. Reasons include increased sensitivity to certain side effects, difficulty with adhering to drug regimens, and decreased ability to recognize and report adverse events. Elderly adults with dementia are also more prone than healthy older persons to develop drug-induced cognitive impairment.1 Medications with strong anticholinergic (AC) side effects, such as sedating antihistamines, are well- known for causing acute cognitive impairment in people with dementia.1-3 Anticholinergic-like effects, such as urinary retention and dry mouth, have also been identified in drugs not typically associated with major AC side effects (e.g., narcotics, benzodiazepines).3 These drugs are also important causes of acute confusional states. Factors that may determine whether a patient will develop cognitive impairment when exposed to ACs include: 1) total AC load (determined by number of AC drugs and dose of agents utilized), 2) baseline cognitive function, and 3) individual patient pharmacodynamic and pharmacokinetic features (e.g., renal/hepatic function).1 Evidence suggests that impairment of cholinergic transmission plays a key role in the development of Alzheimer’s dementia. Thus, the development of the cholinesterase inhibitors (CIs). When used appropriately, the CIs (donepezil [Aricept], rivastigmine [Exelon], and galantamine [Razadyne, Reminyl in Canada]) may slow the decline of cognitive and functional impairment in people with dementia. In order to achieve maximum therapeutic effect, they ideally should not be used in combination with ACs, agents known to have an opposing mechanism of action.1,2 Roe et al studied AC use in 836 elderly patients.1 Use of ACs was found to be greater in patients with probable dementia than healthy older adults (33% vs. -
Rolapitant Improves Quality of Life of Patients Receiving Highly Or Moderately Emetogenic Chemotherapy
Support Care Cancer (2017) 25:85–92 DOI 10.1007/s00520-016-3388-7 ORIGINAL ARTICLE Rolapitant improves quality of life of patients receiving highly or moderately emetogenic chemotherapy Martin Chasen1 & Laszlo Urban2 & Ian Schnadig3 & Bernardo Rapoport4 & Dan Powers5 & Sujata Arora5 & Rudolph Navari6 & Lee Schwartzberg7 & Cesare Gridelli8 Received: 4 April 2016 /Accepted: 17 August 2016 /Published online: 24 August 2016 # The Author(s) 2016. This article is published with open access at Springerlink.com Abstract with no impact on daily life (total score >108 [range 18–126]). Purpose Addition of rolapitant to standard antiemetic therapy We performed a prespecified analysis of the MEC/ improved protection against chemotherapy-induced nausea anthracycline-cyclophosphamide (AC) study and a post hoc and vomiting (CINV) in phase 3 trials of patients receiving analysis of two pooled cisplatin-based HEC studies. highly emetogenic chemotherapy (HEC) or moderately Results In the pooled HEC studies, rolapitant significantly emetogenic chemotherapy (MEC). Here, we assessed the im- improved the FLIE total score (114.5 vs 109.3, p<0.001), pact of CINV on the daily lives of patients receiving HEC or nausea score (55.3 vs 53.5, p<0.05), and vomiting score MEC using the Functional Living Index-Emesis (FLIE). (59.2 vs 55.8, p<0.001) versus control; similar results were Methods In three double-blind phase 3 studies, patients re- observed in the MEC/AC study for FLIE total score (112.7 vs ceiving HEC or MEC were randomized 1:1 to receive oral 108.6, p < 0.001), nausea score (54.1 vs 52.3, p<0.05), and rolapitant 180 mg or placebo prior to chemotherapy plus 5- vomiting score (58.6 vs 56.3, p < 0.001). -
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.