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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. -
Table S1: Sensitivity, Specificity, PPV, NPV, and F1 Score of NLP Vs. ICD for Identification of Symptoms for (A) Biome Developm
Table S1: Sensitivity, specificity, PPV, NPV, and F1 score of NLP vs. ICD for identification of symptoms for (A) BioMe development cohort; (B) BioMe validation cohort; (C) MIMIC-III; (D) 1 year of notes from patients in BioMe calculated using manual chart review. A) Fatigue Nausea and/or vomiting Anxiety Depression NLP (95% ICD (95% CI) P NLP (95% CI) ICD (95% CI) P NLP (95% CI) ICD (95% CI) P NLP (95% CI) ICD (95% CI) P CI) 0.99 (0.93- 0.59 (0.43- <0.00 0.25 (0.12- <0.00 <0.00 0.54 (0.33- Sensitivity 0.99 (0.9 – 1) 0.98 (0.88 -1) 0.3 (0.15-0.5) 0.85 (0.65-96) 0.02 1) 0.73) 1 0.42) 1 1 0.73) 0.57 (0.29- 0.9 (0.68- Specificity 0.89 (0.4-1) 0.75 (0.19-1) 0.68 0.97 (0.77-1) 0.03 0.98 (0.83-1) 0.22 0.81 (0.53-0.9) 0.96 (0.79-1) 0.06 0.82) 0.99) 0.99 (0.92- 0.86 (0.71- 0.94 (0.79- 0.79 (0.59- PPV 0.96 (0.82-1) 0.3 0.95 (0.66-1) 0.02 0.95 (0.66-1) 0.16 0.93 (0.68-1) 0.12 1) 0.95) 0.99) 0.92) 0.13 (0.03- <0.00 0.49 (0.33- <0.00 0.66 (0.48- NPV 0.89 (0.4-1) 0.007 0.94 (0.63-1) 0.34 (0.2-0.51) 0.97 (0.81-1) 0.86 (0.6-0.95) 0.04 0.35) 1 0.65) 1 0.81) <0.00 <0.00 <0.00 F1 Score 0.99 0.83 0.88 0.57 0.95 0.63 0.82 0.79 0.002 1 1 1 Itching Cramp Pain NLP (95% ICD (95% CI) P NLP (95% CI) ICD (95% CI) P NLP (95% CI) ICD (95% CI) P CI) 0.98 (0.86- 0.24 (0.09- <0.00 0.09 (0.01- <0.00 0.52 (0.37- <0.00 Sensitivity 0.98 (0.85-1) 0.99 (0.93-1) 1) 0.45) 1 0.29) 1 0.66) 1 0.89 (0.72- 0.5 (0.37- Specificity 0.96 (0.8-1) 0.98 (0.86-1) 0.68 0.98 (0.88-1) 0.18 0.5 (0-1) 1 0.98) 0.66) 0.88 (0.69- PPV 0.96 (0.8-1) 0.8 (0.54-1) 0.32 0.8 (0.16-1) 0.22 0.99 (0.93-1) 0.98 (0.87-1) NA* 0.97) 0.98 (0.85- 0.57 (0.41- <0.00 0.58 (0.43- <0.00 NPV 0.98 (0.86-1) 0.5 (0-1) 0.02 (0-0.08) NA* 1) 0.72) 1 0.72) 1 <0.00 <0.00 <0.00 F1 Score 0.97 0.56 0.91 0.28 0.99 0.68 1 1 1 *Denotes 95% confidence intervals and P values that could not be calculated due to insufficient cells in 2x2 tables. -
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. -
U.S. Geological Survey National Water-Quality Assessment Program
U.S. Geological Survey National Water-Quality Assessment Program Stream water-quality analytes Major ions and trace elementsschedule 998 (20 constituents) Pesticides schedule 2437 (229 compounds) Alkalinity 1H1,2,4Triazole Arsenic 2,3,3Trichloro2propene1sulfonic acid (TCPSA) Boron 2,4D Calcium 2(1Hydroxyethyl)6methylaniline Chloride 2[(2Ethyl6methylphenyl)amino]1propanol Fluoride 2AminoNisopropylbenzamide Iron 2Aminobenzimidazole Lithium 2Chloro2',6'diethylacetanilide 2Chloro4,6diaminostriazine {CAAT} Magnesium (Didealkylatrazine) pH 2Chloro4isopropylamino6aminostriazine Potassium 2Chloro6ethylamino4aminostriazine {CEAT} Total dissolved solids 2ChloroN(2ethyl6methylphenyl)acetamide Selenium 2Hydroxy4isopropylamino6aminostriazine 2Hydroxy4isopropylamino6ethylaminostriazin Silica e {OIET} Sodium 2Hydroxy6ethylamino4aminostriazine Specific conductance 2Isopropyl6methyl4pyrimidinol Strontium 3,4Dichlorophenylurea Sulfate 3Hydroxycarbofuran Turbidity 3Phenoxybenzoic acid Vanadium 4(Hydroxymethyl)pendimethalin 4Chlorobenzylmethyl sulfoxide Suspended sediment 4Hydroxy molinate 4Hydroxychlorothalonil Nutrientsschedule 2430 (18 constituents) 4Hydroxyhexazinone A Inorganic carbon, suspended Acephate Dissolved inorganic carbon Acetochlor ammonia + organic nitrogen (unfilteredKjeldahl) Acetochlor oxanilic acid ammonia + organic nitrogen (filteredKjeldahl) Acetochlor sulfonic acid Ammonia as N, filtered Acetochlor sulfynilacetic acid nitrite, filtered Alachlor -
Appendix H EPA Hazardous Waste Law
Appendix H EPA Hazardous Waste Law This Appendix is intended to give you background information on hazardous waste laws and how they apply to you. For most U.S. Environmental Protection Agency (EPA) requirements that apply to the University, the Safety Department maintains compliance through internal inspections, record keeping and proper disposal. In Wisconsin, the Department of Natural Resources (DNR) has adopted the EPA regulations, consequently EPA and DNR regulations are nearly identical. EPA defines This Appendix only deals with "hazardous waste" as defined by the EPA. hazardous waste as Legally, EPA defines hazardous waste as certain hazardous chemical waste. This hazardous chemical Appendix does not address other types of regulated laboratory wastes, such as waste; radioactive, infectious, biological, radioactive or sharps. Chapter 8 descibes disposal procedures infectious and biohazardous waste for animals. Chapter 9 describes disposal procedures for sharps and other waste that are regulated by can puncture tissue. Chapter 11 discusses Radiation and the Radiation Safety for other agencies. Radiation Workers provides guidelines for the disposal of radioactive waste. Procedures for medical waste are written by the UW Hospital Safety Officer. The Office of Biological Safety can provide guidance for the disposal of infectious and biological waste. EPA regulations focus on industrial waste streams. As a result, many laboratory chemical wastes are not regulated by EPA as hazardous chemical waste. However, many unregulated chemical wastes do merit special handling and disposal If a waste can be procedures. Thus, Chapter 7 and Appendix A of this Guide recommend disposal defined as: procedures for many unregulated wastes as if they were EPA hazardous waste. -
List of Union Reference Dates A
Active substance name (INN) EU DLP BfArM / BAH DLP yearly PSUR 6-month-PSUR yearly PSUR bis DLP (List of Union PSUR Submission Reference Dates and Frequency (List of Union Frequency of Reference Dates and submission of Periodic Frequency of submission of Safety Update Reports, Periodic Safety Update 30 Nov. 2012) Reports, 30 Nov. -
Comparative Study of the Efficacy of Flunixin, Ketoprofen and Phenylbutazone in Delman Horses with Mild Colic
Sys Rev Pharm 2020; 11(5): 464 468 A multifaceted review journal in the field of pharmacy E-ISSN 0976-2779 P-ISSN 0975-8453 Comparative Study of the Efficacy of Flunixin, Ketoprofen and Phenylbutazone in Delman Horses with Mild Colic Agus Purnomo1, Arya Pradana Wicaksono2, Dodit Hendrawan2, Muhammad Thohawi Elziyad Purnama3* 1Department of Veterinary Surgery and Radiology, Faculty of Veterinary Medicine, Universitas Gadjah Mada, DI Yogyakarta, 55281, Indonesia 2Postgraduate Studies, Faculty of Veterinary Medicine, Universitas Airlangga, Surabaya, 60115, Indonesia 3Department of Veterinary Anatomy, Faculty of Veterinary Medicine, Universitas Airlangga, Surabaya, 60115, Indonesia *Corresponding author E-mail: [email protected] Article History: Submitted: 26.02.2020 Revised: 16.04.2020 Accepted: 21.05.2020 ABSTRACT This study aimed to evaluate the efficacy of flunixin, ketoprofen and multiple range test. The results showed a significant alleviation in all phenylbutazone on serum biochemistry, plasma catecholamines and observed variables on Day 13, although the use of various NSAIDs serum cortisol in Delman horses with mild colic. During the study showed no significant difference. period, 32 horses were evaluated due to mild colic. Flunixin, Keywords: serum biochemical, catecholamine, cortisol, colic, NSAIDs ketoprofen, and phenylbutazone were administered intravenously at Correspondence: the recommended dose rates of 1.0; 2.2 and 4.4 mg/kg, respectively. Muhammad Thohawi Elziyad Purnama Administration of the NSAIDs commenced on Day 1 and continued Department of Veterinary Anatomy, Faculty of Veterinary Medicine, every 12 h for 12 days. Blood samples collected between days 2, 5, 9 Universitas Airlangga, Surabaya, 60115, Indonesia and 13 to evaluate AST, ALP, GGT, creatinine, urea, epinephrine, E-mail: [email protected] norepinephrine, and cortisol level. -
For Methyl Parathion
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON D.C., 20460 OFFICE OF PREVENTION, PESTICIDES AND TOXIC SUBSTANCES MEMORANDUM DATE: July 31, 2006 SUBJECT: Finalization of Interim Reregistration Eligibility Decisions (IREDs) and Interim Tolerance Reassessment and Risk Management Decisions (TREDs) for the Organophosphate Pesticides, and Completion of the Tolerance Reassessment and Reregistration Eligibility Process for the Organophosphate Pesticides FROM: Debra Edwards, Director Special Review and Reregistration Division Office of Pesticide Programs TO: Jim Jones, Director Office of Pesticide Programs As you know, EPA has completed its assessment of the cumulative risks from the organophosphate (OP) class of pesticides as required by the Food Quality Protection Act of 1996. In addition, the individual OPs have also been subject to review through the individual- chemical review process. The Agency’s review of individual OPs has resulted in the issuance of Interim Reregistration Eligibility Decisions (IREDs) for 22 OPs, interim Tolerance Reassessment and Risk Management Decisions (TREDs) for 8 OPs, and a Reregistration Eligibility Decision (RED) for one OP, malathion.1 These 31 OPs are listed in Appendix A. EPA has concluded, after completing its assessment of the cumulative risks associated with exposures to all of the OPs, that: (1) the pesticides covered by the IREDs that were pending the results of the OP cumulative assessment (listed in Attachment A) are indeed eligible for reregistration; and 1 Malathion is included in the OP cumulative assessment. However, the Agency has issued a RED for malathion, rather than an IRED, because the decision was signed on the same day as the completion of the OP cumulative assessment. -
Specialty Direct Supply Drug List
DRAFT SPECIALTY DIRECT SUPPLY DRUG LIST (DSDL) 9/27/2005 Drug Description Effective Date 5-HT3 Receptor Antagonists ALOXI - SOLN 12/09/2004 ANZEMET - SOLN 12/09/2004 ANZEMET - TABS 12/09/2004 KYTRIL - SOLN 12/09/2004 KYTRIL - TABS 12/09/2004 Additional Solids ALPROSTADIL - POWD 12/09/2004 PROSTAGLANDIN E1 - POWD 12/09/2004 Agents for Gaucher Disease CEREZYME - SOLR 12/09/2004 Agents for Pheochromocytoma PHENTOLAMINE MESYLATE - SOLR 12/09/2004 REGITINE - SOLR 12/09/2004 Alkylating Agents CARBOPLATIN - SOLN 12/09/2004 CARBOPLATIN - SOLR 12/09/2004 CISPLATIN - SOLN 12/09/2004 CISPLATIN AQ - SOLN 12/09/2004 ELOXATIN - SOLR 12/09/2004 MYLERAN - TABS 12/09/2004 PARAPLATIN - SOLN 12/09/2004 PARAPLATIN - SOLR 12/09/2004 PLATINOL - SOLN 12/09/2004 PLATINOL AQ - SOLN 12/09/2004 THIOPLEX - SOLR 12/09/2004 THIOTEPA - SOLR 12/09/2004 Alpha-Proteinase Inhibitor (Human) ARALAST - SUSR 07/01/2005 PROLASTIN - SUSR 07/01/2005 ZEMAIRA - SOLR 07/01/2005 AMINOGLYCOSIDES APOGEN - SOLN 12/09/2004 GARAMYCIN - SOLN 12/09/2004 GENTAMICIN SULFATE - SOLN 12/09/2004 G-MYCIN - SOLN 12/09/2004 JENAMICIN - SOLN 12/09/2004 NEBCIN - SOLN 12/09/2004 NEBCIN MDV - SOLN 12/09/2004 STORZ-G - SOLN 12/09/2004 TOBI - NEBU 12/09/2004 TOBRAMYCIN SULFATE - SOLN 12/09/2004 TOBRAMYCIN SULFATE FLIPTO - SOLN 12/09/2004 Antianxiety Agents - Misc. rev A Page 1 of 13 MaineCare Direct Supply Drug List (DSDL) Drug Description Effective Date Antianxiety Agents - Misc. - Continued - DROPERIDOL - POWD 12/09/2004 DROPERIDOL - SOLN 12/09/2004 INAPSINE - SOLN 12/09/2004 Antiarrhythmics Type III