Fourth Consensus Guidelines for the Management
Total Page:16
File Type:pdf, Size:1020Kb
Load more
Recommended publications
-
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. -
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 -
Evidence for the Involvement of Spinal Cord 1 Adrenoceptors in Nitrous
Anesthesiology 2002; 97:1458–65 © 2002 American Society of Anesthesiologists, Inc. Lippincott Williams & Wilkins, Inc. Evidence for the Involvement of Spinal Cord ␣ 1 Adrenoceptors in Nitrous Oxide–induced Antinociceptive Effects in Fischer Rats Ryo Orii, M.D., D.M.Sc.,* Yoko Ohashi, M.D.,* Tianzhi Guo, M.D.,† Laura E. Nelson, B.A.,‡ Toshikazu Hashimoto, M.D.,* Mervyn Maze, M.B., Ch.B.,§ Masahiko Fujinaga, M.D.ʈ Background: In a previous study, the authors found that ni- opioid peptide release in the brain stem, leading to the trous oxide (N O) exposure induces c-Fos (an immunohisto- 2 activation of the descending noradrenergic inhibitory chemical marker of neuronal activation) in spinal cord ␥-ami- nobutyric acid–mediated (GABAergic) neurons in Fischer rats. neurons, which results in modulation of the pain–noci- 1 In this study, the authors sought evidence for the involvement ceptive processing in the spinal cord. Available evi- Downloaded from http://pubs.asahq.org/anesthesiology/article-pdf/97/6/1458/337059/0000542-200212000-00018.pdf by guest on 01 October 2021 ␣ of 1 adrenoceptors in the antinociceptive effect of N2O and in dence suggests that at the level of the spinal cord, there activation of GABAergic neurons in the spinal cord. appear to be at least two neuronal systems that are Methods: Adult male Fischer rats were injected intraperitone- involved (fig. 1). In one of the pathways, activation of ally with ␣ adrenoceptor antagonist, ␣ adrenoceptor antago- 1 2 ␣ nist, opioid receptor antagonist, or serotonin receptor antago- the 2 adrenoceptors produces either direct presynaptic nist and, 15 min later, were exposed to either air (control) or inhibition of neurotransmitter release from primary af- 75% N2O. -
Therapeutic Class Overview Irritable Bowel Syndrome Agents
Therapeutic Class Overview Irritable Bowel Syndrome Agents Therapeutic Class Overview/Summary: This review will focus on agents used for the treatment of Irritable Bowel Syndrome (IBS).1-5 IBS is a gastrointestinal syndrome characterized primarily by non-specific chronic abdominal pain, usually described as a cramp-like sensation, and abnormal bowel habits, either constipation or diarrhea, in which there is no organic cause. Other common gastrointestinal symptoms may include gastroesophageal reflux, dysphagia, early satiety, intermittent dyspepsia and nausea. Patients may also experience a wide range of non-gastrointestinal symptoms. Some notable examples include sexual dysfunction, dysmenorrhea, dyspareunia, increased urinary frequency/urgency and fibromyalgia-like symptoms.6 IBS is defined by one of four subtypes. IBS with constipation (IBS-C) is the presence of hard or lumpy stools with ≥25% of bowel movements and loose or watery stools with <25% of bowel movements. When IBS is associated with diarrhea (IBS-D) loose or watery stools are present with ≥25% of bowel movements and hard or lumpy stools are present with <25% of bowel movements. Mixed IBS (IBS-M) is defined as the presence of hard or lumpy stools with ≥25% and loose or water stools with ≥25% of bowel movements. Final subtype, or unsubtyped, is all other cases of IBS that do not fall into the other classes. Pharmacological therapy for IBS depends on subtype.7 While several over-the-counter or off-label prescription agents are used for the treatment of IBS, there are currently only two agents approved by the Food and Drug Administration (FDA) for the treatment of IBS-C and three agents approved by the FDA for IBS-D. -
Prophylactic Antiemetic Therapy with Ondansetron, Granisetron and Metoclopramide in Patients Undergoing Laparoscopic Cholecystectomy Under GA
JK SCIENCE ORIGINAL ARTICLE Prophylactic Antiemetic Therapy with Ondansetron, Granisetron and Metoclopramide in Patients Undergoing Laparoscopic Cholecystectomy Under GA Vishal Gupta, Renu Wakhloo, Anjali Mehta, Satya Dev Gupta Abstract The aim of the present study was to compare the antiemetic effect of intravenous Granisetron, Ondansetron & Metoclopramide in a randomized blinded study for prophylaxis of post operative nausea and vomiting (PONV) in patients undergoing laparoscopic cholecystectomy under general anaesthesia. 60 patients (ASA I & II) undergoing laparoscopic cholecystectomy under general anaesthesia were randomly allocated into three equal groups (n=20). Emetic episodes in first 24 hours were recorded and compared in different study groups. Results were analyzed. Minimal emetic episodes were observed in early post-operative period (1-12hrs) in patients who had received intravenous granisetron in comparison to ondansetron and metoclopramide. However, after 12 hours emesis free periods were statistically insignificant between group A and B while patients in group C had no antiemetic effect. Keywords Post Operative Nausea and Vomiting (PONV), Granisetron, Ondensetron, Metoclopramide Introduction The most common and distressing symptoms, which vascular anastomoses and increased intracranial follow anaesthesia and surgery, are pain and emesis. The pressure(4). The anaesthetic consequences are aspiration syndrome of nausea, retching and vomiting is known as pneumonitis and discomfort in recovery. For institutions 'sickness' and each part of it can be distinguished as a there is increased financial burden because of increased separate entity (1). PONV (post operative nausea and nursing care, delayed discharge from Phase I and II vomiting) has been characterized as big 'little problem(2) recovery units and unexpected admissions. Hence, and has been a common complication for both in patients prophylactic antiemetic therapy is needed for all these and out patients undergoing virtually all types of surgical patients. -
Ondansetron Does Not Attenuate the Analgesic Efficacy of Nefopam Kai-Zhi Lu 1*, Hong Shen 2*, Yan Chen 1, Min-Guang Li 1, Guo-Pin Tian 1, Jie Chen 1
Int. J. Med. Sci. 2013, Vol. 10 1790 Ivyspring International Publisher International Journal of Medical Sciences 2013; 10(12):1790-1794. doi: 10.7150/ijms.5386 Research Paper Ondansetron Does Not Attenuate the Analgesic Efficacy of Nefopam Kai-zhi Lu 1*, Hong Shen 2*, Yan Chen 1, Min-guang Li 1, Guo-pin Tian 1, Jie Chen 1 1. Department of Anaesthesiology, Southwest Hospital, Third Military Medical University, Chongqing 400038, China; 2. Department of Radiology, Chongqing Fifth Hospital, Chongqing.400062, China. * These authors contributed equally to this work. Corresponding author: Dr. Jie Chen: Department of Anaesthesiology, Southwest Hospital, Third Military Medical University, Gaotanyan 19 Street, Shapingba, Chongqing 400038, China. Tel: 0086-23-68754197. Fax: 0086-23-65463285. E-mail: [email protected] © Ivyspring International Publisher. This is an open-access article distributed under the terms of the Creative Commons License (http://creativecommons.org/ licenses/by-nc-nd/3.0/). Reproduction is permitted for personal, noncommercial use, provided that the article is in whole, unmodified, and properly cited. Received: 2012.10.15; Accepted: 2013.10.17; Published: 2013.10.29 Abstract Objectives: The aim of this study was to investigate if there is any interaction between ondansetron and nefopam when they are continuously co-administrated during patient-controlled intravenous analgesia (PCIA). Methods: The study was a prospective, randomized, controlled, non-inferiority clinical trial com- paring nefopam-plus-ondansetron to nefopam alone. A total of 230 postoperative patients using nefopam for PCIA, were randomly assigned either to a group receiving continuous infusion of ondansetron (Group O) or to the other group receiving the same volume of normal saline con- tinuously (Group N). -
Medications and Alcohol Craving
Medications and Alcohol Craving Robert M. Swift, M.D., Ph.D. The use of medications as an adjunct to alcoholism treatment is based on the premise that craving and other manifestations of alcoholism are mediated by neurobiological mechanisms. Three of the four medications approved in the United States or Europe for treating alcoholism are reported to reduce craving; these include naltrexone (ReVia™), acamprosate, and tiapride. The remaining medication, disulfiram (Antabuse®), may also possess some anticraving activity. Additional medications that have been investigated include ritanserin, which has not been shown to decrease craving or drinking levels in humans, and ondansetron, which shows promise for treating early onset alcoholics, who generally respond poorly to psychosocial treatment alone. Use of anticraving medications in combination (e.g., naltrexone plus acamprosate) may enhance their effectiveness. Future studies should address such issues as optimal dosing regimens and the development of strategies to enhance patient compliance. KEY WORDS: AOD (alcohol and other drug) craving; anti alcohol craving agents; alcohol withdrawal agents; drug therapy; neurobiological theory; alcohol cue; disulfiram; naltrexone; calcium acetylhomotaurinate; dopamine; serotonin uptake inhibitors; buspirone; treatment outcome; reinforcement; neurotransmitters; patient assessment; literature review riteria for defining alcoholism Results of craving research are often tions (i.e., pharmacotherapy) to improve vary widely. Most definitions difficult to interpret, -
KYTRIL (Granisetron Hydrochloride) Injection Is an Antinauseant and Antiemetic Agent
KYTRIL® (granisetron hydrochloride) INJECTION Rx only DESCRIPTION KYTRIL (granisetron hydrochloride) Injection is an antinauseant and antiemetic agent. Chemically it is endo-N-(9-methyl-9-azabicyclo [3.3.1] non-3-yl)-1-methyl-1H-indazole- 3-carboxamide hydrochloride with a molecular weight of 348.9 (312.4 free base). Its empirical formula is C18H24N4O•HCl, while its chemical structure is: granisetron hydrochloride Granisetron hydrochloride is a white to off-white solid that is readily soluble in water and normal saline at 20°C. KYTRIL Injection is a clear, colorless, sterile, nonpyrogenic, aqueous solution for intravenous administration. KYTRIL 1 mg/1 mL is available in 1 mL single-use and 4 mL multi-use vials. KYTRIL 0.1 mg/1 mL is available in a 1 mL single-use vial. 1 mg/1 mL: Each 1 mL contains 1.12 mg granisetron hydrochloride equivalent to granisetron, 1 mg; sodium chloride, 9 mg; citric acid, 2 mg; and benzyl alcohol, 10 mg, as a preservative. The solution’s pH ranges from 4.0 to 6.0. 0.1 mg/1 mL: Each 1 mL contains 0.112 mg granisetron hydrochloride equivalent to granisetron, 0.1 mg; sodium chloride, 9 mg; citric acid, 2 mg. Contains no preservative. The solution’s pH ranges from 4.0 to 6.0. CLINICAL PHARMACOLOGY Granisetron is a selective 5-hydroxytryptamine3 (5-HT3) receptor antagonist with little or no affinity for other serotonin receptors, including 5-HT1; 5-HT1A; 5-HT1B/C; 5-HT2; for alpha1-, alpha2- or beta-adrenoreceptors; for dopamine-D2; or for histamine-H1; benzodiazepine; picrotoxin or opioid receptors. -
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. -
Amisulpride Tablets I.P. SOLIAN® THERAPEUTIC CATEGORY Anti-Psychotic COMPOSITION Solian® 50 /100 /200 /400 Each Uncoated Tablet Contains Amisulpride IP
For the use only of a Registered Medical Practitioner (Psychiatrist) or a Hospital or a Laboratory Abridged Prescribing Information Amisulpride tablets I.P. SOLIAN® THERAPEUTIC CATEGORY Anti-psychotic COMPOSITION Solian® 50 /100 /200 /400 Each uncoated tablet contains Amisulpride IP. 50mg / 100mg / 200mg Each film coated tablet contains Amisulpride IP 400mg. THERAPEUTIC INDICATIONS Treatment of acute and chronic schizophrenic disorders, in which positive symptoms (such as delusions, hallucinations, and thought disorders) and/or negative symptoms (such as blunted affect, emotional and social withdrawal) are prominent, including patients characterised by predominant negative symptoms. DOSAGE AND ADMINISTRATION For acute psychotic episodes, oral doses between 400 and 800 mg/d are recommended. Doses above 1200 mg/d should not be used. For patients with mixed positive and negative symptoms, doses should be adjusted to obtain optimal control of positive symptoms. Maintenance treatment should be established individually with the minimally effective dose. For patients characterised by predominant negative symptoms, oral doses between 50 mg/d and 300 mg/d are recommended. Doses should be adjusted individually. Solian® can be administered once daily at oral doses up to 300 mg, higher doses should be administered bid. The Minimum effective dose should be used. Caution in elderly. Renal & Hepatic insufficiency: Dose should be reduced. Use of amisulpride from puberty to 18 years is not recommended. SAFETY-RELATED INFORMATION Contraindications: Hypersensitivity to amisulpride or to other ingredients of the product; concomitant prolactin- dependent tumours e.g. pituitary gland prolactinomas and breast cancer; phaeochromocytoma; children up to puberty; lactation; combinations with drugs which could induce torsades de pointes and levodopa. -
Yorkshire Palliative Medicine Clinical Guidelines Group Guidelines on the Use of Antiemetics Author(S): Dr Annette Edwards (Chai
Yorkshire Palliative Medicine Clinical Guidelines Group Guidelines on the use of Antiemetics Author(s): Dr Annette Edwards (Chair) and Deborah Royle on behalf of the Yorkshire Palliative Medicine Clinical Guidelines Group Overall objective : To provide guidance on the evidence for the use of antiemetics in specialist palliative care. Search Strategy: Search strategy: Medline, Embase and Cinahl databases were searched using the words nausea, vomit$, emesis, antiemetic and drug name. Review Date: March 2008 Competing interests: None declared Disclaimer: These guidelines are the property of the Yorkshire Palliative Medicine Clinical Guidelines Group. They are intended to be used by qualified, specialist palliative care professionals as an information resource. They should be used in the clinical context of each individual patient’s needs. The clinical guidelines group takes no responsibility for any consequences of any actions taken as a result of using these guidelines. Contact Details: Dr Annette Edwards, Macmillan Consultant in Palliative Medicine, Department of Palliative Medicine, Pinderfields General Hospital, Aberford Road, Wakefield, WF1 4DG Tel: 01924 212290 E-mail: [email protected] 1 Introduction: Nausea and vomiting are common symptoms in patients with advanced cancer. A careful history, examination and appropriate investigations may help to infer the pathophysiological mechanism involved. Where possible and clinically appropriate aetiological factors should be corrected. Antiemetics are chosen based on the likely mechanism and the neurotransmitters involved in the emetic pathway. However, a recent systematic review has highlighted that evidence for the management of nausea and vomiting in advanced cancer is sparse. (Glare 2004) The following drug and non-drug treatments were reviewed to assess the strength of evidence for their use as antiemetics with particular emphasis on their use in the palliative care population.