MFT Formulary V7.9 (June 2021) MFT TRUST FORMULARY
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Medical Review(S) Clinical Review
CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 200327 MEDICAL REVIEW(S) CLINICAL REVIEW Application Type NDA Application Number(s) 200327 Priority or Standard Standard Submit Date(s) December 29, 2009 Received Date(s) December 30, 2009 PDUFA Goal Date October 30, 2010 Division / Office Division of Anti-Infective and Ophthalmology Products Office of Antimicrobial Products Reviewer Name(s) Ariel Ramirez Porcalla, MD, MPH Neil Rellosa, MD Review Completion October 29, 2010 Date Established Name Ceftaroline fosamil for injection (Proposed) Trade Name Teflaro Therapeutic Class Cephalosporin; ß-lactams Applicant Cerexa, Inc. Forest Laboratories, Inc. Formulation(s) 400 mg/vial and 600 mg/vial Intravenous Dosing Regimen 600 mg every 12 hours by IV infusion Indication(s) Acute Bacterial Skin and Skin Structure Infection (ABSSSI); Community-acquired Bacterial Pneumonia (CABP) Intended Population(s) Adults ≥ 18 years of age Template Version: March 6, 2009 Reference ID: 2857265 Clinical Review Ariel Ramirez Porcalla, MD, MPH Neil Rellosa, MD NDA 200327: Teflaro (ceftaroline fosamil) Table of Contents 1 RECOMMENDATIONS/RISK BENEFIT ASSESSMENT ......................................... 9 1.1 Recommendation on Regulatory Action ........................................................... 10 1.2 Risk Benefit Assessment.................................................................................. 10 1.3 Recommendations for Postmarketing Risk Evaluation and Mitigation Strategies ........................................................................................................................ -
The National Drugs List
^ ^ ^ ^ ^[ ^ The National Drugs List Of Syrian Arab Republic Sexth Edition 2006 ! " # "$ % &'() " # * +$, -. / & 0 /+12 3 4" 5 "$ . "$ 67"5,) 0 " /! !2 4? @ % 88 9 3: " # "$ ;+<=2 – G# H H2 I) – 6( – 65 : A B C "5 : , D )* . J!* HK"3 H"$ T ) 4 B K<) +$ LMA N O 3 4P<B &Q / RS ) H< C4VH /430 / 1988 V W* < C A GQ ") 4V / 1000 / C4VH /820 / 2001 V XX K<# C ,V /500 / 1992 V "!X V /946 / 2004 V Z < C V /914 / 2003 V ) < ] +$, [2 / ,) @# @ S%Q2 J"= [ &<\ @ +$ LMA 1 O \ . S X '( ^ & M_ `AB @ &' 3 4" + @ V= 4 )\ " : N " # "$ 6 ) G" 3Q + a C G /<"B d3: C K7 e , fM 4 Q b"$ " < $\ c"7: 5) G . HHH3Q J # Hg ' V"h 6< G* H5 !" # $%" & $' ,* ( )* + 2 ا اوا ادو +% 5 j 2 i1 6 B J' 6<X " 6"[ i2 "$ "< * i3 10 6 i4 11 6! ^ i5 13 6<X "!# * i6 15 7 G!, 6 - k 24"$d dl ?K V *4V h 63[46 ' i8 19 Adl 20 "( 2 i9 20 G Q) 6 i10 20 a 6 m[, 6 i11 21 ?K V $n i12 21 "% * i13 23 b+ 6 i14 23 oe C * i15 24 !, 2 6\ i16 25 C V pq * i17 26 ( S 6) 1, ++ &"r i19 3 +% 27 G 6 ""% i19 28 ^ Ks 2 i20 31 % Ks 2 i21 32 s * i22 35 " " * i23 37 "$ * i24 38 6" i25 39 V t h Gu* v!* 2 i26 39 ( 2 i27 40 B w< Ks 2 i28 40 d C &"r i29 42 "' 6 i30 42 " * i31 42 ":< * i32 5 ./ 0" -33 4 : ANAESTHETICS $ 1 2 -1 :GENERAL ANAESTHETICS AND OXYGEN 4 $1 2 2- ATRACURIUM BESYLATE DROPERIDOL ETHER FENTANYL HALOTHANE ISOFLURANE KETAMINE HCL NITROUS OXIDE OXYGEN PROPOFOL REMIFENTANIL SEVOFLURANE SUFENTANIL THIOPENTAL :LOCAL ANAESTHETICS !67$1 2 -5 AMYLEINE HCL=AMYLOCAINE ARTICAINE BENZOCAINE BUPIVACAINE CINCHOCAINE LIDOCAINE MEPIVACAINE OXETHAZAINE PRAMOXINE PRILOCAINE PREOPERATIVE MEDICATION & SEDATION FOR 9*: ;< " 2 -8 : : SHORT -TERM PROCEDURES ATROPINE DIAZEPAM INJ. -
New Zealand Data Sheet
NEW ZEALAND DATA SHEET 1. PRODUCT NAME INCRUSE ELLIPTA Umeclidinium (as bromide), 62.5 micrograms, powder for inhalation 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each delivered dose (the dose leaving the mouthpiece of the inhaler) contains 55 micrograms umeclidinium (equivalent to 65 micrograms of umeclidinium bromide). This corresponds to a pre-dispensed dose of 62.5 micrograms of umeclidinium (equivalent to 74.2 micrograms umeclidinium bromide). Excipient with known effect: Each delivered dose contains approximately 12.5 mg of lactose (as monohydrate). For the full list of excipients, see section 6.1 List of excipients. 3. PHARMACEUTICAL FORM Powder for Inhalation White powder in a grey inhaler (Ellipta) with a light green mouthpiece cover and a dose counter. 4. CLINICAL PARTICULARS 4.1 Therapeutic indications Incruse Ellipta is indicated as a long-term once daily maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD). 4.2 Dose and method of administration Dose Adults Incruse Ellipta (umeclidinium 62.5 micrograms) should be taken as one inhalation once daily by the orally inhaled route. Incruse Ellipta should be taken at the same time every day. Do not use Incruse Ellipta more than once every 24 hours. Special populations Elderly population No dosage adjustment is required in patients over 65 years (see 5.2 Pharmacokinetics properties– Special patient populations). 1 Renal impairment No dosage adjustment is required in patients with renal impairment (see 5.2 Pharmacokinetics properties – Special patient populations). Hepatic impairment No dosage adjustment is required in patients with mild or moderate hepatic impairment. Incruse Ellipta has not been studied in patients with severe hepatic impairment (see 5.2 Pharmacokinetics properties– Special patient populations). -
Classification of Medicinal Drugs and Driving: Co-Ordination and Synthesis Report
Project No. TREN-05-FP6TR-S07.61320-518404-DRUID DRUID Driving under the Influence of Drugs, Alcohol and Medicines Integrated Project 1.6. Sustainable Development, Global Change and Ecosystem 1.6.2: Sustainable Surface Transport 6th Framework Programme Deliverable 4.4.1 Classification of medicinal drugs and driving: Co-ordination and synthesis report. Due date of deliverable: 21.07.2011 Actual submission date: 21.07.2011 Revision date: 21.07.2011 Start date of project: 15.10.2006 Duration: 48 months Organisation name of lead contractor for this deliverable: UVA Revision 0.0 Project co-funded by the European Commission within the Sixth Framework Programme (2002-2006) Dissemination Level PU Public PP Restricted to other programme participants (including the Commission x Services) RE Restricted to a group specified by the consortium (including the Commission Services) CO Confidential, only for members of the consortium (including the Commission Services) DRUID 6th Framework Programme Deliverable D.4.4.1 Classification of medicinal drugs and driving: Co-ordination and synthesis report. Page 1 of 243 Classification of medicinal drugs and driving: Co-ordination and synthesis report. Authors Trinidad Gómez-Talegón, Inmaculada Fierro, M. Carmen Del Río, F. Javier Álvarez (UVa, University of Valladolid, Spain) Partners - Silvia Ravera, Susana Monteiro, Han de Gier (RUGPha, University of Groningen, the Netherlands) - Gertrude Van der Linden, Sara-Ann Legrand, Kristof Pil, Alain Verstraete (UGent, Ghent University, Belgium) - Michel Mallaret, Charles Mercier-Guyon, Isabelle Mercier-Guyon (UGren, University of Grenoble, Centre Regional de Pharmacovigilance, France) - Katerina Touliou (CERT-HIT, Centre for Research and Technology Hellas, Greece) - Michael Hei βing (BASt, Bundesanstalt für Straßenwesen, Germany). -
Tavalisse™ (Fostamatinib) (Oral) Document Number: IC-0361 Last Review Date: 02/02/2021 Date of Origin: 06/01/2018 Dates Reviewed: 06/2018, 02/2019, 02/2020, 02/2021
Tavalisse™ (fostamatinib) (Oral) Document Number: IC-0361 Last Review Date: 02/02/2021 Date of Origin: 06/01/2018 Dates Reviewed: 06/2018, 02/2019, 02/2020, 02/2021 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]: 100 mg tablets – 2 tablets per day 150 mg tablets – 2 tablets per day B. Max Units (per dose and over time) [HCPCS Unit]: 300 mg daily III. Initial Approval Criteria 1,2 Coverage is provided in the following conditions: Patient is at least 18 years of age; AND Universal Criteria 1 Patient is not receiving a thrombopoietin receptor agonist or mimetic (e.g., romiplostim, eltrombopag, lusutrombopag, avatrombopag, etc.); AND Laboratory values are current (i.e., drawn within the previous 28 days); AND Fostamatinib is not being used to attempt to normalize platelet count; AND Patient will avoid concomitant therapy with any of the following: o Coadministration with strong CYP3A4 inhibitors (e.g., clarithromycin, itraconazole, ketoconazole, etc.), or if therapy is unavoidable, the patient will be monitored closely for adverse reaction and/or dose modifications will be implemented; AND o Coadministration with strong CYP3A inducers (e.g., rifampin, carbamazepine, St. John’s Wort, etc.); AND Chronic Immune Thrombocytopenia (ITP) † 1-5 Patient has had persistent/chronic ITP for at least 3 months; AND Proprietary & Confidential © 2021 Magellan Health, Inc. Patient has previously failed any of the following treatments for ITP: Patient has failed previous therapy with corticosteroids (i.e., patient had no response to at least a 3-month trial or is corticosteroid-dependent); OR Patient has failed previous therapy with immunoglobulins; OR Patient has had a splenectomy; OR Patient has failed previous therapy with a thrombopoietin receptor agonist; AND The patient is at increased risk for bleeding as indicated by platelet count of less than 30 × 109/L (30,000/mm³) † FDA Approved Indication(s) IV. -
SUMMARY of the PRODUCT CHARACTERISTICS 1. NAME of the MEDICINAL PRODUCT <Invented Name> 10 Mg/10 Mg Film-Coated Tablets
SUMMARY OF THE PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT <Invented name> 10 mg/10 mg film-coated tablets <Invented name> 20 mg/10 mg film-coated tablets <Invented name> 40 mg/10 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION <Invented name> 10 mg/10 mg: Each film-coated tablet contains 10 mg of rosuvastatin (as rosuvastatin calcium) and 10 mg of ezetimibe. <Invented name> 20 mg/10 mg: Each film-coated tablet contains 20 mg of rosuvastatin (as rosuvastatin calcium) and 10 mg of ezetimibe. <Invented name> 40 mg/10 mg: Each film-coated tablet contains 40 mg of rosuvastatin (as rosuvastatin calcium) and 10 mg of ezetimibe. Excipient with known effect: <Invented name> 10 mg/10 mg: Each film-coated tablet contains 111.2 mg of lactose (as lactose monohydrate). <Invented name> 20 mg/10 mg: Each film-coated tablet contains 168.6 mg of lactose (as lactose monohydrate). <Invented name> 40 mg/10 mg: Each film-coated tablet contains 286.0 mg of lactose (as lactose monohydrate). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet (tablet) <Invented name> 10 mg/10 mg: white to off-white oblong film-coated tablets. <Invented name> 20 mg/10 mg: yellow to light yellow oblong film-coated tablets. <Invented name> 40 mg/10 mg: pink oblong film-coated tablets. 4. CLINICAL PARTICULARS 4.1 Therapeutic indications Primary Hypercholesterolaemia/Homozygous Familial Hypercholesterolaemia (HoFH) <Invented name> is indicated for substitution therapy in adult patients who are adequately controlled with rosuvastatin and ezetimibe given concurrently at the same dose level as in the fixed combination, but as separate products, as adjunct to diet for treatment of primary hypercholesterolaemia (heterozygous familial and non-familial) or homozygous familial hypercholesterolaemia. -
(12) United States Patent (10) Patent No.: US 9,149,560 B2 Askari Et Al
USOO9149560B2 (12) United States Patent (10) Patent No.: US 9,149,560 B2 Askari et al. (45) Date of Patent: Oct. 6, 2015 (54) SOLID POLYGLYCOL-BASED 6,149,931 A 11/2000 Schwartz et al. BOCOMPATIBLE PRE-FORMULATION 6,153,211 A 11/2000 Hubbell et al. 6,180,687 B1 1/2001 Hammer et al. 6,207,772 B1 3/2001 Hatsuda et al. (71) Applicant: Medicus Biosciences LLC, San Jose, 6,312,725 B1 1 1/2001 Wallace et al. CA (US) 6,458,889 B1 10/2002 Trollsas et al. 6,475,508 B1 1 1/2002 Schwartz et al. (72) Inventors: Syed H. Askari, San Jose, CA (US); 6,547,714 B1 4/2003 Dailey 6,566,406 B1 5/2003 Pathak et al. Yeon S. Choi, Emeryville, CA (US); 6,605,294 B2 8/2003 Sawhney Paul Yu Jen Wan, Norco, CA (US) 6,624,245 B2 9, 2003 Wallace et al. 6,632.457 B1 10/2003 Sawhney (73) Assignee: Medicus Biosciences LLC, San Jose, 6,703,037 B1 3/2004 Hubbell et al. CA (US) 6,703,378 B1 3/2004 Kunzler et al. 6,818,018 B1 1 1/2004 Sawhney 7,009,343 B2 3/2006 Lim et al. (*) Notice: Subject to any disclaimer, the term of this 7,255,874 B1 8, 2007 Bobo et al. patent is extended or adjusted under 35 7,332,566 B2 2/2008 Pathak et al. U.S.C. 154(b) by 0 days. 7,553,810 B2 6/2009 Gong et al. -
COPD Agents Review – October 2020 Page 2 | Proprietary Information
COPD Agents Therapeutic Class Review (TCR) October 1, 2020 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]. October 2020 -
New Zealand Data Sheet
NEW ZEALAND DATA SHEET 1. PRODUCT NAME TRELEGY ELLIPTA 100/62.5/25 fluticasone furoate (100 micrograms)/umeclidinium (as bromide) (62.5 micrograms)/vilanterol (as trifenatate) (25 micrograms), powder for inhalation 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each delivered dose (the dose leaving the mouthpiece of the inhaler) contains 92 micrograms fluticasone furoate, 55 micrograms umeclidinium (equivalent to 65 micrograms umeclidinium [as bromide]) and 22 micrograms vilanterol (as trifenatate). This corresponds to a pre-dispensed dose of 100 micrograms fluticasone furoate, 62.5 micrograms umeclidinium (equivalent to 74.2 micrograms umeclidinium bromide) and 25 micrograms vilanterol (as trifenatate). Excipient with known effect: Each delivered dose contains approximately 25 milligrams of lactose (as monohydrate). For the full list of excipients, see Section 6.1 List of excipients. 3. PHARMACEUTICAL FORM Powder for inhalation. White powder in a light grey inhaler (Ellipta) with a beige mouthpiece cover and a dose counter. 4. CLINICAL PARTICULARS 4.1. Therapeutic indications TRELEGY ELLIPTA is indicated for the maintenance treatment of adults with moderate to severe chronic obstructive pulmonary disease (COPD) who require treatment with a long- acting muscarinic receptor antagonist (LAMA) + long-acting beta2-receptor agonist (LABA) + inhaled corticosteroid (ICS). TRELEGY ELLIPTA should not be used for the initiation of COPD treatment. 4.2. Dose and method of administration Patients can be changed from their existing inhalers to TRELEGY ELLIPTA at the next dose. However it is important that patients do not take other LABA or LAMA or ICS while taking TRELEGY ELLIPTA. A stepwise approach to the management of COPD is recommended, including the cessation of smoking and a pulmonary rehabilitation program. -
Blood Modifier Agents Policy #: Rx.01.208
Pharmacy Policy Bulletin Title: Blood Modifier Agents Policy #: Rx.01.208 Application of pharmacy policy is determined by benefits and contracts. Benefits may vary based on product line, group, or contract. Some medications may be subject to precertification, age, quantity, or formulary restrictions (ie limits on non-preferred drugs). Individual member benefits must be verified. This pharmacy policy document describes the status of pharmaceutical information and/or technology at the time the document was developed. Since that time, new information relating to drug efficacy, interactions, contraindications, dosage, administration routes, safety, or FDA approval may have changed. This Pharmacy Policy will be regularly updated as scientific and medical literature becomes available. This information may include new FDA-approved indications, withdrawals, or other FDA alerts. This type of information is relevant not only when considering whether this policy should be updated, but also when applying it to current requests for coverage. Members are advised to use participating pharmacies in order to receive the highest level of benefits. Intent: The intent of this policy is to communicate the medical necessity criteria for eltrombopag olamine (Promacta®), fostamatinib disodium (Tavalisse™), avatrombopag (Doptelet®), lusutrombopag (Mulpleta®) as provided under the member's prescription drug benefit. Description: Idiopathic thrombocytopenia purpura (ITP): ITP is an immune disorder in which the blood doesn't clot normally. ITP can cause excessive bruising and bleeding and can be characterized as an unusually low level of platelets, or thrombocytes, in the blood results in ITP. Thrombocytopenia in patients with hepatitis C: Thrombocytopenia can occur in patients with chronic hepatitis C virus (HCV) infection. -
Package Leaflet: Information for the Patient Nustendi 180 Mg/10 Mg Film-Coated Tablet Bempedoic Acid/Ezetimibe This Medicine Is
Package leaflet: Information for the patient Nustendi 180 mg/10 mg film-coated tablet bempedoic acid/ezetimibe This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects. Read all of this leaflet carefully before you start taking this medicine because it contains important information for you. • Keep this leaflet. You may need to read it again. • If you have any further questions, ask your doctor or pharmacist. • This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. • If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. What is in this leaflet 1. What Nustendi is and what it is used for 2. What you need to know before you take Nustendi 3. How to take Nustendi 4. Possible side effects 5. How to store Nustendi 6. Contents of the pack and other information 1. What Nustendi is and what it is used for What Nustendi is and how it works Nustendi is a medicine that lowers levels of ‘bad’ cholesterol (also called “LDL-cholesterol”), a type of fat, in the blood. Nustendi contains two active substances, which reduce your cholesterol in two ways: • bempedoic acid decreases the production of cholesterol in the liver and increases the removal of LDL-cholesterol from the blood; • ezetimibe works in your bowel by reducing the amount of cholesterol absorbed from food. -
Multiple Technology Appraisal Avatrombopag and Lusutrombopag
Multiple Technology Appraisal Avatrombopag and lusutrombopag for treating thrombocytopenia in people with chronic liver disease needing an elective procedure [ID1520] Committee papers © National Institute for Health and Care Excellence 2019. All rights reserved. See Notice of Rights. The content in this publication is owned by multiple parties and may not be re-used without the permission of the relevant copyright owner. NATIONAL INSTITUTE FOR HEALTH AND CARE EXCELLENCE MULTIPLE TECHNOLOGY APPRAISAL Avatrombopag and lusutrombopag for treating thrombocytopenia in people with chronic liver disease needing an elective procedure [ID1520] Contents: 1 Pre-meeting briefing 2 Assessment Report prepared by Kleijnen Systematic Reviews 3 Consultee and commentator comments on the Assessment Report from: • Shionogi 4 Addendum to the Assessment Report from Kleijnen Systematic Reviews 5 Company submission(s) from: • Dova • Shionogi 6 Clarification questions from AG: • Questions to Shionogi • Clarification responses from Shionogi • Questions to Dova • Clarification responses from Dova 7 Professional group, patient group and NHS organisation submissions from: • British Association for the Study of the Liver (BASL) The Royal College of Physicians supported the BASL submission • British Society of Gastroenterology (BSG) 8 Expert personal statements from: • Vanessa Hebditch – patient expert, nominated by the British Liver Trust • Dr Vickie McDonald – clinical expert, nominated by British Society for Haematology • Dr Debbie Shawcross – clinical expert, nominated by Shionogi © National Institute for Health and Care Excellence 2019. All rights reserved. See Notice of Rights. The content in this publication is owned by multiple parties and may not be re-used without the permission of the relevant copyright owner. MTA: avatrombopag and lusutrombopag for treating thrombocytopenia in people with chronic liver disease needing an elective procedure Pre-meeting briefing © NICE 2019.