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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. -
Mri Contrast Medium and Diagnostic Method
Europa.schesP— || | MMMMI 1 1||||| 1 1 1 1 1 1||| || J European Patent Office _ o it r- a 4 © Publication number: 0 673 655 A1 Office_„. europeen des brevets © EUROPEAN PATENT APPLICATION published in accordance with Art. 158(3) EPC © Application number: 93906789.8 © Int. CI.6: A61 K 49/00 @ Date of filing: 18.03.93 © International application number: PCT/JP93/00322 © International publication number: WO 93/18795 (30.09.93 93/24) ® Priority: 19.03.92 JP 93561/92 Kanagawa 211 (JP) Inventor: IWAI, Hlroyuki, Yodogawa Works of @ Date of publication of application: Daikin Ind.Ltd.s 27.09.95 Bulletin 95/39 1-1, Nlshlhltotsuya Settsu-shl, © Designated Contracting States: Osaka 566 566 (JP) DE FR GB IT Inventor: YAMASHITA, Tsuneo, Yodogawa Works © Applicant: DAIKIN INDUSTRIES, LIMITED of Daikin Ind. Ltd., Umeda Center Building, 4-12, Nakazaki-nishi 1-1, Nishihitotsuya 2-chome Settsu-shi, Kita-ku Osaka 566 566 (JP) Osaka-shi Inventor: SHIMOKAWA, Kazuhiro, Yodogawa Osaka 530 (JP) Works of Daikin Ind. Ltd., © Inventor: YOSHIKAWA, Kohki 1-1, Nishihitotsuya 14-23, Kami-saginomiya 5-chome, Settsu-shi, Nakano-ku Osaka 566 (JP) Tokyo 165 (JP) Inventor: SHIONO, Takahiro, Kanto Rohsai Hospital © Representative: TER MEER - MULLER - 2035, Kizuki Sumiyoshi-cho, STEINMEISTER & PARTNER Nakahara-ku Mauerkircherstrasse 45 Kawasaki-shi, D-81679 Munchen (DE) ^ © MRI CONTRAST MEDIUM AND DIAGNOSTIC METHOD. in m CO © An MRI contrast medium (suspension) comprising an oily fatty acid, fatty acid ester or perfluorinated compound and a particulate paramagnetic compound contained therein. It can be used stably for long and can ^ be administered to a target region, whereby its dose can be reduced. -
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. -
Suomen Lääketilasto 2019
SUOMEN LÄÄKETILASTO S LT FINNISH STATISTICS ON MEDICINES FSM 2019 Keskeisiä lukuja lääkkeiden myynnistä ja lääkekorvauksista vuonna 2019 Milj. € Muutos vuodesta 2018, % Lääkkeiden kokonaismyynti 3 460 5,2 avohoidon reseptilääkkeiden myynti (verollisin vähittäismyyntihinnoin) 2 284 4,4 avohoidon itsehoitolääkkeiden myynti (verollisin vähittäismyyntihinnoin) 357 0,8 sairaalamyynti (tukkuohjehinnoin) 818 9,9 Lääkkeistä maksetut korvaukset 1 551 6,2 peruskorvaukset 316 3,0 erityiskorvaukset 1 029 5,2 lisäkorvaukset 205 17,7 Key figures for medicine sales and their reimburssement in 2019 € million Change from 2018, % Total sales of pharmaceuticals 3,460 5.2 prescription medicines in outpatient care (at pharmacy prices with VAT) 2,284 4.4 OTC medicines in outpatient care (at pharmacy prices with VAT) 357 0.8 sales to hospitals (at wholesale prices) 818 9.9 Reimbursement of medicine costs 1,551 6.2 Basic Refunds 316 3.0 Special Refunds 1,029 5.2 Additional Refunds 205 17.7 Lähde: Fimean lääkemyyntirekisteri, Kelan sairausvakuutuskorvausten tilastointitiedosto. Source: Finnish Medicines Agency, Drug Sales Register; Register of Statistical Information on National Health Insurance General Benefit Payments. SUOMEN LÄÄKETILASTO FINNISH STATISTICS ON MEDICINES 2019 Lääkealan turvallisuus- ja kehittämiskeskus Fimea ja Kansaneläkelaitos Finnish Medicines Agency Fimea and Social Insurance Institution Helsinki 2020 LÄÄKEALAN TURVALLISUUS- KANSANELÄKELAITOS JA KEHITTÄMISKESKUS FIMEA FINNISH MEDICINES AGENCY FIMEA SOCIAL INSURANCE INSTITUTION Lääketurvallisuus Analytiikka- ja tilastoryhmä Pharmacovigilance Section for Analytics and Statistics Mannerheimintie 166 Nordenskiöldinkatu 12 P.O. Box 55 P.O. Box 450 FI-00034 Fimea FI-00056 Kela Finland Finland [email protected] [email protected] Puh. 029 522 3341 Puh. 020 634 11 Tel. +358 29 522 3341 Tel. -
Kongressjournal Wmw Wiener Medizinische Wochenschrift
W Band 8 / Heft 10 www.springer.at/wmw-skriptum ISSN Print 1613-3803 P. b. b. Verlagspostamt 1201 Wien Plus.Zeitung 07Z037513P SpringerMedizin.at/schwerpunkt/oegari-2011 10/11 skriptum Kongressjournal wmw Wiener Medizinische Wochenschrift 15. bis 17. September 2011, Wien Jahrestagung der Österreichischen Gesellschaft für Anästhesiologie, Reanimation und Intensivmedizin Austrian International Congress 2011 – AIC Wissenschaftliche Leitung: Prim. Univ.-Prof. Dr. Sibylle Kozek-Langenecker inhalt 10/11 Inhalt brief der herausgeberin Jahrestagung der 4 Willkommen in Wien! Österreichischen S. Kozek-Langenecker Gesellschaft für beiträge Anästhesiologie, 6 Sedierung durch Nicht-AnästhesistInnen Reanimation und Robert D. Fitzgerald, Wien Intensivmedizin 7 Gerinnungsmanagement bei traumatisch bedingter (ÖGARI) Massivblutung D. Fries, P. Innerhofer, P. Perger, M. Gütl, S. Heil, N. Hofmann, W. Kneifl, L. 15. bis 17. September Neuner, T. Pernerstorfer, G. Pfanner, H. Schöchl, B. Ziegler, C. Köblinger und 2011, Wien S. Kozek-Langenecker, ARGE für perioperative Gerinnung der ÖGARI 10 Erstversorgung von SHT W. Mauritz und A. Brazinova, Wien 11 Extrakorporaler Gasaustausch W. Oczenski und C. Hörmann, Wien–St. Pölten 16 „Coagulation Day 2010“: Thrombosemanagement beim kritisch Kranken E. Schaden, Wien 19 Koma: Differenzialdiagnose im Notfall Schloss Schönbrunn E. Schmutzhard, Innsbruck 20 Präklinische Intubation A. von Goedecke, Steyr 21 Perioperative Gerinnungsoptimierung P. Innerhofer, D. Fries und M. Mittermayr, Innsbruck 24 Ist Muskelrelaxation noch zeitgemäß? K. Khünl-Brady, Innsbruck 26 Impressum wmw skriptum © Springer-Verlag 10/2011 3 brief der herausgeberin Willkommen in Wien! Sehr geehrte Kolleginnen, sehr geehrte Kollegen! Kurzfristig wurde uns die Möglichkeit eröffnet, Beiträge vom diesjährigen Kongress der Österreichi- schen Gesellschaft für Anästhesiologie, Reanimation und Intensivmedizin (ÖGARI) mit diesem PRIM. -
Caracterización Fisicoquímica Y Clínica De Los Medios De Contraste Intravasculares Iodados
Anales de Radiología México 2008;2:129-140. ARTÍCULOS DE REVISIÓN Dra. Patricia Rodríguez Nava,1 Dr. Ernesto J. Dena Espinoza,1 Caracterización fisicoquímica y Dr. Roberto Basile Lenge,2 Dra. Margarita Fuentes García,3 clínica de los medios de contraste Dr. Gustavo Fink Josephi,4 Dr. Eduardo Marbez Namnum1 intravasculares iodados RESUMEN Objetivo: El propósito de sido aceptado por algunos ra- este artículo es realizar una re- diólogos. La lopromida puede Introducción: El uso de visión bibliográfica sobre las ca- ser considerada un agente uni- medios de contraste intravascu- racterísticas, clasificación, pro- versal para todas las explora- lares no iónicos (gas, sustancia piedades físico-químicas, así ciones y procedimientos radio- hidrosoluble o liposoluble) en como los efectos secundarios lógicos. imagenología ha proliferado (quimiotoxicidad) de los medios en los últimos años debido a su de contraste intravasculares no Palabras clave: Medios de excepcional tolerancia por los iónicos. contraste intravasculares ioda- pacientes. La baja osmolalidad Conclusiones: Un factor que dos, medios de contraste ióni- de este tipo de medios de con- interviene en la incidencia de cos, medios de contraste no ió- traste aporta beneficios como reacciones idiosincráticas o aler- nicos. bajo incremento del volumen goides puede ser el estado psi- sanguíneo, baja toxicidad, bajo cológico del paciente. El trata- efecto sobre la barrera hema- miento previo con antihitamíni- toencefálica. cos, corticosteroides o ambos ha continúa en la pág. 130 1 Del Servicio de Radiología e Imagen “Dr. Carlos Coqui” del Hospital General de México osmolalidad o iso-osmolares. En los Estados Unidos 2 3 O.D. De la Universidad de Buenos Aires Cardiología. -
Nexobrid 2 G Powder and Gel for Gel
ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 1 This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 for how to report adverse reactions. 1. NAME OF THE MEDICINAL PRODUCT NexoBrid 2 g powder and gel for gel 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One vial contains 2 g of concentrate of proteolytic enzymes enriched in bromelain, corresponding to 0.09 g/g concentrate of proteolytic enzymes enriched in bromelain after mixing (or 2 g/22 g gel). The proteolytic enzymes are a mixture of enzymes from the stem of Ananas comosus (pineapple plant). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Powder and gel for gel. The powder is off-white to light tan. The gel is clear and colourless. 4. CLINICAL PARTICULARS 4.1 Therapeutic indications NexoBrid is indicated for removal of eschar in adults with deep partial- and full-thickness thermal burns. 4.2 Posology and method of administration NexoBrid should only be applied by trained healthcare professionals in specialist burn centres. Posology 2 g NexoBrid powder in 20 g gel is applied to a burn wound area of 100 cm2. NexoBrid should not be applied to more than 15% Total Body Surface Area (TBSA) (see also section 4.4, Coagulopathy). NexoBrid should be left in contact with the burn for a duration of 4 hours. There is very limited information on the use of NexoBrid on areas where eschar remained after the first application. -
COMPARISON of the WHO ATC CLASSIFICATION & Ephmra/Intellus Worldwide ANATOMICAL CLASSIFICATION
COMPARISON OF THE WHO ATC CLASSIFICATION & EphMRA/Intellus Worldwide ANATOMICAL CLASSIFICATION: VERSION June 2019 2 Comparison of the WHO ATC Classification and EphMRA / Intellus Worldwide Anatomical Classification The following booklet is designed to improve the understanding of the two classification systems. The development of the two systems had previously taken place separately. EphMRA and WHO are now working together to ensure that there is a convergence of the 2 systems rather than a divergence. In order to better understand the two classification systems, we should pay attention to the way in which substances/products are classified. WHO mainly classifies substances according to the therapeutic or pharmaceutical aspects and in one class only (particular formulations or strengths can be given separate codes, e.g. clonidine in C02A as antihypertensive agent, N02C as anti-migraine product and S01E as ophthalmic product). EphMRA classifies products, mainly according to their indications and use. Therefore, it is possible to find the same compound in several classes, depending on the product, e.g., NAPROXEN tablets can be classified in M1A (antirheumatic), N2B (analgesic) and G2C if indicated for gynaecological conditions only. The purposes of classification are also different: The main purpose of the WHO classification is for international drug utilisation research and for adverse drug reaction monitoring. This classification is recommended by the WHO for use in international drug utilisation research. The EphMRA/Intellus Worldwide classification has a primary objective to satisfy the marketing needs of the pharmaceutical companies. Therefore, a direct comparison is sometimes difficult due to the different nature and purpose of the two systems. -
Rolapitant in the Current Management of Chemotherapy-Induced Nausea and Vomiting
Review Supportive Care Rolapitant in the Current Management of Chemotherapy-induced Nausea and Vomiting Bernardo Rapoport,1,2 Pere Gascon,3 Florian Scotte,3 Karin Jordan,4 Massimo Di Maio,5 Sussanne Borjeson6 and Sam H Ahmedzai6 1. The Medical Oncology Centre of Rosebank, Johannesburg, South Africa; 2. Department of Immunology, Faculty of Health Sciences, University of Pretoria, Pretoria, South Africa; 3. Department of Medical Oncology and Supportive Care, Foch Hospital, Suresnes, France; 4. Department of Medicine V, Haematology, Oncology and Rheumatology, University of Heidelberg, Germany; 5. Department of Oncology, University of Turin, Ordine Mauriziano Hospital, Turin, Italy; 6. The University of Sheffield, NIHR National Speciality Lead for Cancer, Sheffield, UK hemotherapy-induced nausea and vomiting (CINV) has a severe detrimental effect on the quality of life of patients with cancer receiving chemotherapy, and remains one of the most feared adverse events associated with chemotherapy. However, physicians C and oncology nurses often underestimate the incidence of CINV, as well as the impact of this toxicity on patients’ daily lives. Many challenges remain in the prevention and treatment of CINV, particularly in the delayed phase. The 5‐hydroxytryptamine type 3 receptor antagonists (5‐HT3 RAs) have demonstrated efficacy in CINV control during the acute phase (≤24 hours) but have limited utility in the delayed phase (>24–120 hours). The more recently introduced neurokinin-1 (NK-1) RAs have represented a relevant improvement in the prevention of CINV associated with the administration of highly and moderately emetogenic chemotherapy, particularly in the delayed phase. One of these, rolapitant, when given as one dose on the first day of the chemotherapy cycle, has been shown to protect against CINV during the complete cycle of chemotherapy in randomised controlled trials, as well as being effective in multiple cycles of chemotherapy. -
Innovationsreport 2019 Kurzfassung
Innovationsreport 2019 Auswertungsergebnisse von Routinedaten der Techniker Krankenkasse aus den Jahren 2016 bis 2017 Herausgeber: Gerd Glaeske und Wolf‐Dieter Ludwig Erstellt mit freundlicher Unterstützung der Techniker Krankenkasse (TK) 2 Herausgeber Prof. Dr. Gerd Glaeske Prof. Dr. Wolf‐Dieter Ludwig Experten für ausgewählte Kapitel Prof. Dr. med. Manfred Anlauf, Bremerhaven Prof. Dr. med. Peter Berlit, Berlin Prof. Dr. med. Winfried V. Kern, Freiburg Prof. Dr. med. Joachim Labenz, Siegen Prof. Dr. med. Ulrich A. Müller, MSc, Jena Prof. Dr. med. Bruno Müller‐Oerlinghausen, Berlin Prof. Dr. med. Wolfgang Schramm, München Prof. Dr. med. Dieter Ukena, Bremen PD Dr. med. Tobias Weberschock, Frankfurt am Main Autoren der Wirkstoffkapitel Dr. Stanislava Dicheva‐Radev, Dörte Fuchs, Dr. Iris Hinneburg, Anja Lübs, André S. Morawetz, Lutz Muth, Saskia Ritter, Dr. Kristin Sauer unter Mitarbeit von Eleonora Durakovic, Friederike Höfel, Linda Jespersen, Linda Richter, Marle Wilhelm Anschrift: Universität Bremen, SOCIUM, Mary‐Somerville‐Str. 5, 28359 Bremen Aus Gründen der besseren Lesbarkeit wurde auf die Nennung beider geschlechtsspezifischer Formen verzichtet. Im Allgemeinen ist aber das jeweils andere Geschlecht ebenfalls gemeint. 3 4 Glossar ........................................................................................... 6 Vorwort zum Innovationsreport 2019 ........................................... 13 Zweites Vorwort zum Innovationsreport 2019 .............................. 15 1 Einleitung ............................................................................... -
( 12 ) United States Patent
US009974742B2 (12 ) United States Patent (10 ) Patent No. : US 9 , 974 , 742 B2 Ottoboni et al. (45 ) Date of Patent: * May 22, 2018 ( 54 ) EMULSION FORMULATIONS OF AN NK - 1 2013 /0236501 A1 * 9 /2013 Booth . .. .. .. A61K 9 /0019 424 / 400 RECEPTOR ANTAGONIST AND USES 2013 /0317016 AL 11 /2013 Hingorani et al. THEREOF 2016 / 0024092 Al 1 / 2016 Wan et al. 2016 / 0082013 Al 3 / 2016 Ottoboni et al . @(71 ) Applicant : Heron Therapeutics , Inc. , Redwood 2016 /0206622 A1 3 / 2016 Ottoboni et al . City , CA (US ) 2017 / 0112847 AL 4 /2017 Ottoboni et al. @(72 ) Inventors : Thomas B . Ottoboni, Belmont, CA (US ) ; Han Han , Mountain View , CA FOREIGN PATENT DOCUMENTS (US ) CN 102379 * 3 / 2012 CN 102379845 A 3 / 2012 @(73 ) Assignee : Heron Therapeutics, Inc. , San Diego , WO WO 2005 /016308 AL 2 / 2005 WO WO 2009 / 124756 AL 10 / 2009 CA (US ) WO WO 2011 / 158053 AL 12 / 2011 WO WO 2013 / 177501 A2 11 / 2013 @( * ) Notice : Subject to any disclaimer , the term of this WO WO 2014 /0209962 AL 12 /2014 patent is extended or adjusted under 35 WO WO 2014 /005606 AL 3 / 2016 U . S . C . 154 ( b ) by 0 days . days . WO WO 2016 /044784 Al 3 / 2016 This patent is subject to a terminal dis claimer . OTHER PUBLICATIONS (21 ) Appl. No. : 15 /012 , 532 Cassileth et al. in Arch . Intern Med . 1983 ; 143 ( 7 ) : 1347 - 1349 ( Abstract ) . * Dexamethasone Hydrogen Phosphate at web .archive . org/ web / ( 22 ) Filed : Feb . 1 , 2016 20141224130045 /http :/ /www . drugs . com / pro / dexamethasone -so dium -phosphate .html ( retrieved on the internet Mar.