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Naloxegol (Movantik) Reference Number: ERX.NSMN.02 Effective Date: 07/16 Last Review Date: 03/16
Clinical Policy: naloxegol (Movantik) Reference Number: ERX.NSMN.02 Effective Date: 07/16 Last Review Date: 03/16 Clinical policies are intended to be reflective of current scientific research and clinical thinking. This policy is current at the time of approval, may be updated and therefore is subject to change. This Clinical Policy is not intended to dictate to providers how to practice medicine, nor does it constitute a contract or guarantee regarding payment or results. Providers are expected to exercise professional medical judgment in providing the most appropriate care, and are solely responsible for the medical advice and treatment of members. This policy is the property of Envolve Pharmacy Solutions. Unauthorized copying, use, and distribution of this Policy or any information contained herein is strictly prohibited. By accessing this policy, you agree to be bound by the foregoing terms and conditions, in addition to the Site Use Agreement for Health Plans associated with Envolve Pharmacy Solutions. Description The intent of the criteria is to ensure that patients follow selection elements established by Envolve Pharmacy Solutions for the use of naloxegol (MovantikTM). Policy/Criteria It is the policy of health plans affiliated with Envolve Pharmacy Solutions that naloxegol (Movantik) is medically necessary for members meeting the following criteria: Initial Approval Criteria: I. Opioid-Induced Constipation (OIC) (must meet all) A. Age is ≥ 18 years old; B. Diagnosis of opioid-induced constipation; C. Member has used an opioid analgesic ≥ 4 weeks; D. Member is not being treated for cancer pain; E. Member has failed ≥ 2 non-bulk forming laxatives (see Table A) from different classes while on opioid therapy, unless contraindicated; F. -
RELISTOR, INN: Methylnaltrexone Bromide
The European Medicines Agency Evaluation of Medicines for Human Use EMEA/CHMP/10906/2008 ASSESSMENT REPORT FOR RELISTOR International Nonproprietary Name: METHYLNALTREXONE BROMIDE Procedure No. EMEA/H/C/870 Assessment Report as adopted by the CHMP with all information of a commercially confidential nature deleted. 7 Westferry Circus, Canary Wharf, London, E14 4HB, UK Tel. (44-20) 74 18 84 00 Fax (44-20) 74 18 8613 E-mail: [email protected] http://www.emea.eu.int TABLE OF CONTENTS Page 1 BACKGROUND INFORMATION ON THE PROCEDURE......................................... 3 1.1 Submission of the dossier ...................................................................................................... 3 1.2 Steps taken for the assessment of the product ....................................................................... 3 2 SCIENTIFIC DISCUSSION............................................................................................... 4 2.1 Introduction............................................................................................................................ 4 2.2 Quality aspects....................................................................................................................... 5 2.3 Non-clinical aspects............................................................................................................... 7 2.4 Clinical aspects .................................................................................................................... 13 2.5 Pharmacovigilance...............................................................................................................41 -
Albany-Molecular-Research-Regulatory
PRODUCT CATALOGUE API COMMERCIAL US EU Japan US EU Japan API Name Site CEP India API Name Site CEP India DMF DMF DMF DMF DMF DMF A Abiraterone Malta • Benztropine Mesylate Cedarburg • Adenosine Rozzano - Quinto de' Stampi • • * Betaine Citrate Anhydrous Bon Encontre • Betametasone-17,21- Alcaftadine Spain Spain • • Dipropionate Sterile • Alclometasone-17, 21- Spain Betamethasone Acetate Spain Dipropionate • • Altrenogest Spain • • Betamethasone Base Spain Amphetamine Aspartate Rensselaer Betamethasone Benzoate Spain * Monohydrate Milled • Betamethasone Valerate Amphetamine Sulfate Rensselaer Spain * • Acetate Betamethasone-17,21- Argatroban Rozzano - Quinto de' Stampi Spain • • Dipropionate • • • Atenolol India • • Betamethasone-17-Valerate Spain • • Betamethasone-21- Atracurium Besylate Rozzano - Quinto de' Stampi Spain • Phosphate Disodium Salt • • Bromfenac Monosodium Atropine Sulfate Cedarburg Lodi * • Salt Sesquihydrate • • Azanidazole Lodi Bromocriptine Mesylate Rozzano - Quinto de' Stampi • • • • • Azelastine HCl Rozzano - Quinto de' Stampi • • Budesonide Spain • • Aztreonam Rozzano - Valle Ambrosia • • Budesonide Sterile Spain • • B Bamifylline HCl Bon Encontre • Butorphanol Tartrate Cedarburg • Beclomethasone-17, 21- Spain Capecitabine Lodi Dipropionate • C • 2 *Please contact our Accounts Managers in case you are interested in this API. 3 PRODUCT CATALOGUE API COMMERCIAL US EU Japan US EU Japan API Name Site CEP India API Name Site CEP India DMF DMF DMF DMF DMF DMF Dexamethasone-17,21- Carbimazole Bon Encontre Spain • Dipropionate -
204760Orig1s000
CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 204760Orig1s000 OTHER REVIEW(S) MEMORANDUM DEPARTMENT OF HEALTH AND HUMAN SERVICES PUBLIC HEALTH SERVICE FOOD AND DRUG ADMINISTRATION CENTER FOR DRUG EVALUATION AND RESEARCH DATE: September 16, 2014 FROM: Julie Beitz, MD SUBJECT: Approval Action TO: NDA 204760 Movantik (naloxegol) tablets AstraZeneca Pharmaceuticals LP Summary Naloxegol is an antagonist of opioid binding at the muͲopioid receptor. When administered at the recommended dose levels, naloxegol functions as a peripherallyͲacting opioid receptor antagonist in tissues such as the gastrointestinal tract, thereby decreasing the constipating effects of opioids. Naloxegol is a PEGylated derivative of naloxone and a new molecular entity. Pegylation confers the following properties: naloxegol has reduced passive permeability across membranes compared to naloxone; naloxegol is a PͲglycoprotein (PͲgp) efflux transporter substrate; and naloxegol is orally bioavailable. The reduced passive permeability and PͲgp efflux transporter properties limit CNS entry of naloxegol compared to naloxone. This memo documents my concurrence with the Division of Gastroenterology and Inborn Errors Product’s recommendation for approval of NDA 204760 for Movantik (naloxegol) tablets for the treatment of opioidͲinduced constipation (OIC) in adult patients with chronic nonͲcancer pain. Discussions regarding product labeling, and postmarketing study requirements and commitments have been satisfactorily completed. There are no inspectional issues that preclude approval. Dosing The recommended dose of Movantik (naloxegol) tablets is 25 mg taken once daily in the morning on an empty stomach. Patients who do not tolerate this dose, may reduce the dose to 12.5 mg once daily. Maintenance laxatives should be discontinued prior to initiation of therapy with Movantik. -
Design and Synthesis of Cyclic Analogs of the Kappa Opioid Receptor Antagonist Arodyn
Design and synthesis of cyclic analogs of the kappa opioid receptor antagonist arodyn By © 2018 Solomon Aguta Gisemba Submitted to the graduate degree program in Medicinal Chemistry and the Graduate Faculty of the University of Kansas in partial fulfillment of the requirements for the degree of Doctor of Philosophy. Chair: Dr. Blake Peterson Co-Chair: Dr. Jane Aldrich Dr. Michael Rafferty Dr. Teruna Siahaan Dr. Thomas Tolbert Date Defended: 18 April 2018 The dissertation committee for Solomon Aguta Gisemba certifies that this is the approved version of the following dissertation: Design and synthesis of cyclic analogs of the kappa opioid receptor antagonist arodyn Chair: Dr. Blake Peterson Co-Chair: Dr. Jane Aldrich Date Approved: 10 June 2018 ii Abstract Opioid receptors are important therapeutic targets for mood disorders and pain. Kappa opioid receptor (KOR) antagonists have recently shown potential for treating drug addiction and 1,2,3 4 8 depression. Arodyn (Ac[Phe ,Arg ,D-Ala ]Dyn A(1-11)-NH2), an acetylated dynorphin A (Dyn A) analog, has demonstrated potent and selective KOR antagonism, but can be rapidly metabolized by proteases. Cyclization of arodyn could enhance metabolic stability and potentially stabilize the bioactive conformation to give potent and selective analogs. Accordingly, novel cyclization strategies utilizing ring closing metathesis (RCM) were pursued. However, side reactions involving olefin isomerization of O-allyl groups limited the scope of the RCM reactions, and their use to explore structure-activity relationships of aromatic residues. Here we developed synthetic methodology in a model dipeptide study to facilitate RCM involving Tyr(All) residues. Optimized conditions that included microwave heating and the use of isomerization suppressants were applied to the synthesis of cyclic arodyn analogs. -
Moventig, INN-Naloxegol
Package leaflet: Information for the patient Moventig 12.5 mg film-coated tablets Moventig 25 mg film-coated tablets naloxegol 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, pharmacist or nurse. - 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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. What is in this leaflet 1. What Moventig is and what it is used for 2. What you need to know before you take Moventig 3. How to take Moventig 4. Possible side effects 5. How to store Moventig 6. Contents of the pack and other information 1. What Moventig is and what it is used for Moventig contains the active substance naloxegol. It is a medicine used in adults to treat constipation specifically caused by pain medicines, called opioids, (e.g. morphine, oxycodone, fentanyl, tramadol, codeine) taken on a regular basis. It is used when laxatives have not provided acceptable relief of constipation. Constipation related to opioids can result in symptoms such as: • stomach pain • rectal straining (having to push very hard to move the stool out of the rectum, which can also cause pain in the anus during pushing) • hard stools (stools which are hard “like a rock”) • incomplete emptying of the rectum (after having a bowel movement, the feeling as if a stool is still in the rectum which needs to come out) In patients taking opioids with constipation, who have tried at least one laxative and had incomplete relief of constipation, Moventig has been shown in clinical trials to increase the number of bowel movements and improve symptoms of constipation caused by opioids. -
A Review of Unique Opioids and Their Conversions
A Review of Unique Opioids and Their Conversions Jacqueline Cleary, PharmD, BCACP Assistant Professor Albany College of Pharmacy and Health Sciences Adjunct Professor SAGE College of Nursing DISCLOSURES • Kaleo • Remitigate, LLC OBJECTIVES • Compare and contrast unique pharmacotherapy options for the treatment of chronic pain including: methadone, buprenoprhine, tapentadol, and tramadol • Select methadone, buprenorphine, tapentadol, or tramadol based on patient specific factors • Apply appropriate opioid conversion strategies to unique opioids • Understand opioid overdose risk surrounding opioid conversions and the use of unique opioids UNIQUE OPIOIDS METHADONE, BUPRENORPHINE, TRAMADOL, TAPENTADOL METHADONE My favorite drug because….? METHADONE- INDICATIONS • FDA labeled indications – (1) chronic pain (2) detoxification Oral soluble tablets for suspension NOT indicated for chronic pain treatment • Initial inpatient detoxification of opioids by a licensed trained provider with methadone and supportive care is appropriate • Methadone maintenance provider must have special credentialing and training as required by state Outpatient prescription must be for pain ONLY and say “for pain” on RX • Continuation of methadone maintenance from outside provider while patient is inpatient for another condition is appropriate http://cdn.atforum.com/wp-content/uploads/SAMHSA-2015-Guidelines-for-OTPs.pdf MECHANISM OF ACTION • Potent µ-opioid agonist • NMDA receptor antagonist • Norepinephrine reuptake inhibitor • Serotonin reuptake inhibitor ADVERSE EVENTS -
Prescriber Update Vo.39 No.2. June 2018
Prescriber Update Vol. 39 No. 2 June 2018 www.medsafe.govt.nz ISSN 1172-5648 (print) ISSN 1179-075X (online) Contents Spotlight on Codeine 18 Making Medicines Safer: New e-Learning Module on Reporting Adverse Reactions Launched 19 Tenofovir Disoproxil – a Salty Tale 20 Medicines Interacting with Methadone 20 Hyoscine Butylbromide Injection and Cardiovascular Adverse Reactions 22 Using New Zealand Data to Review the Risk of Venous Thromboembolism with Combined Oral Contraceptives 23 Hypocalcaemia – a Risk with Zoledronic Acid 24 Pharmacogenomics – Helps Reduce Rash Decisions 25 MARC’s Remarks: March 2018 Meeting 27 Gathering Knowledge from Adverse Reaction Reports: June 2018 28 Medicines Monitoring: Dabigatran and gout or gout-like symptoms 29 Recent Approvals of Medicines Containing a New Active Ingredient 29 The Medsafe Files – Episode Six: Global Pharmacovigilance 29 Correction: Adverse Reaction Reporting in New Zealand – 2017 30 Medicine Classification Update – November 2017 31 Quarterly Summary of Recent Safety Communications 31 Report Adverse Drug Reactions 31 Subscribe to Prescriber Update 32 Spotlight on Codeine Key Messages phenotypes varies between populations. The relative frequencies of these phenotypes in the z The following patients should not use New Zealand population are not known. codeine as the risks of harm outweigh Poor metabolisers are unable to convert codeine any benefit: to morphine and receive little if any, analgesic – children aged under 12 years benefit. Extensive metabolisers convert 5–15% – adolescents aged under 18 years: for of codeine to morphine via the CYP2D6 enzyme. pain following surgery to remove In these patients, a 30 mg dose of codeine tonsils or adenoids, for symptomatic phosphate would yield approximately 1.5 mg to relief of cough, or in patients whose 4.5 mg of morphine. -
Oncology & Haematology
Oncology & Haematology Specialist Formulary List – NON-CHEMOTHERAPY DRUGS **Other indications for particular drugs may be included on completion of further specialist lists** For information on use of unlicensed medicines or medicines used 'off-label' - click here The following medicines are approved for prescribing by or on the recommendation of a prescribing oncology or haematology specialist (including non-medical prescribers where appropriate): In the event of a broken link please forward details to [email protected] Please include the location and full title of the link MEDICINE SUMMARY OF RESTRICTED INDICATION CATEGORY PROTOCOL Aprepitant capsules Adjunct to dexamethasone and a 5HT3-receptor antagonist NOSCAN (North of Scotland Cancer in preventing nausea and vomiting associated with cisplatin Network) Antiemetic Protocol pending. containing chemotherapy regimes. Granisetron tablets, injection Chemotherapy-induced nausea and vomiting (2nd line). Prophylaxis of Chemotherapy Induced Usually given pre-chemotherapy. Nausea and Vomiting follow MASCC guidelines Levomepromazine tablets, injection Chemotherapy-induced nausea and vomiting (3rd line). www.mascc.org 6mg tablets available. Tablets may be halved. Usual dose 3mg or 6mg twice daily. Lorazepam tablets, injection Anticipatory nausea and vomiting. 0.5mg to 1mg the night before and morning of chemotherapy. Palonosetron Injection Chemotherapy-induced nausea and vomiting. Given as a single dose IV pre-chemotherapy Granisetron transdermal patch Prevention of nausea and vomiting -
Question of the Day Archives: Monday, December 5, 2016 Question: Calcium Oxalate Is a Widespread Toxin Found in Many Species of Plants
Question Of the Day Archives: Monday, December 5, 2016 Question: Calcium oxalate is a widespread toxin found in many species of plants. What is the needle shaped crystal containing calcium oxalate called and what is the compilation of these structures known as? Answer: The needle shaped plant-based crystals containing calcium oxalate are known as raphides. A compilation of raphides forms the structure known as an idioblast. (Lim CS et al. Atlas of select poisonous plants and mushrooms. 2016 Disease-a-Month 62(3):37-66) Friday, December 2, 2016 Question: Which oral chelating agent has been reported to cause transient increases in plasma ALT activity in some patients as well as rare instances of mucocutaneous skin reactions? Answer: Orally administered dimercaptosuccinic acid (DMSA) has been reported to cause transient increases in ALT activity as well as rare instances of mucocutaneous skin reactions. (Bradberry S et al. Use of oral dimercaptosuccinic acid (succimer) in adult patients with inorganic lead poisoning. 2009 Q J Med 102:721-732) Thursday, December 1, 2016 Question: What is Clioquinol and why was it withdrawn from the market during the 1970s? Answer: According to the cited reference, “Between the 1950s and 1970s Clioquinol was used to treat and prevent intestinal parasitic disease [intestinal amebiasis].” “In the early 1970s Clioquinol was withdrawn from the market as an oral agent due to an association with sub-acute myelo-optic neuropathy (SMON) in Japanese patients. SMON is a syndrome that involves sensory and motor disturbances in the lower limbs as well as visual changes that are due to symmetrical demyelination of the lateral and posterior funiculi of the spinal cord, optic nerve, and peripheral nerves. -
208854Orig1s000
CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 208854Orig1s000 SUMMARY REVIEW OND=Office of New Drugs OPQ=Office of Pharmaceutical Quality OPDP=Office of Prescription Drug Promotion OSI=Office of Scientific Investigations CDTL=Cross-Discipline Team Leader COA=Clinical Outcome Assessment CSS=Controlled Substance Staff DAAAP= Division of Anesthesia, Analgesia, and Addiction Products OSE= Office of Surveillance and Epidemiology DEPI= Division of Epidemiology DMEPA=Division of Medication Error Prevention and Analysis DPMH = Division of Pediatric and Maternal Health MHT=Maternal Health Team Quality Review Team DISCIPLINE REVIEWER BRANCH/DIVISION Drug Substance Joseph Leginus CDER/OPQ/ONDP/ DNDAPI/NDBII Drug Product Sarah Ibrahim CDER/OPQ/ONDP/ DNDPII/NDPBV Process Zhao Wang CDER/OPQ/OPF/ DPAI/PABI Microbiology Zhao Wang CDER/OPQ/OPF/ DPAI/PABI Facility Donald Lech CDER/OPQ/OPF/DIA/IABIII Biopharmaceutics Peng Duan CDER/OPQ/ONDP/ DB/BBII Regulatory Business Cheronda Cherry-France CDER/OND/ODEIII/ DGIEP Process Manager Application Technical Lead Hitesh Shroff CDER/OPQ/ONDP/ DNDPII/NDPBV Laboratory (OTR) N/A N/A ORA Lead Paul Perdue Jr. ORA/OO/OMPTO/ DMPTPO/MDTP Environmental Analysis James Laurenson CDER/OPQ/ONDP (EA) 2 Reference ID: 4073992 1. Benefit-Risk Assessment I concur with the reviewers’ conclusions that the benefit/risk of naldemedine is favorable in the population for which this product will be approved and that the risks can be managed with labeling. The applicant proposed the following indication for naldemedine, an orally administered peripheral mu opioid receptor antagonist: Symproic is indicated for the treatment of opioid-induced constipation (OIC) in adult patients with chronic non-cancer pain. -
Pain Management & Palliative Care
Guidelines on Pain Management & Palliative Care A. Paez Borda (chair), F. Charnay-Sonnek, V. Fonteyne, E.G. Papaioannou © European Association of Urology 2013 TABLE OF CONTENTS PAGE 1. INTRODUCTION 6 1.1 The Guideline 6 1.2 Methodology 6 1.3 Publication history 6 1.4 Acknowledgements 6 1.5 Level of evidence and grade of guideline recommendations* 6 1.6 References 7 2. BACKGROUND 7 2.1 Definition of pain 7 2.2 Pain evaluation and measurement 7 2.2.1 Pain evaluation 7 2.2.2 Assessing pain intensity and quality of life (QoL) 8 2.3 References 9 3. CANCER PAIN MANAGEMENT (GENERAL) 10 3.1 Classification of cancer pain 10 3.2 General principles of cancer pain management 10 3.3 Non-pharmacological therapies 11 3.3.1 Surgery 11 3.3.2 Radionuclides 11 3.3.2.1 Clinical background 11 3.3.2.2 Radiopharmaceuticals 11 3.3.3 Radiotherapy for metastatic bone pain 13 3.3.3.1 Clinical background 13 3.3.3.2 Radiotherapy scheme 13 3.3.3.3 Spinal cord compression 13 3.3.3.4 Pathological fractures 14 3.3.3.5 Side effects 14 3.3.4 Psychological and adjunctive therapy 14 3.3.4.1 Psychological therapies 14 3.3.4.2 Adjunctive therapy 14 3.4 Pharmacotherapy 15 3.4.1 Chemotherapy 15 3.4.2 Bisphosphonates 15 3.4.2.1 Mechanisms of action 15 3.4.2.2 Effects and side effects 15 3.4.3 Denosumab 16 3.4.4 Systemic analgesic pharmacotherapy - the analgesic ladder 16 3.4.4.1 Non-opioid analgesics 17 3.4.4.2 Opioid analgesics 17 3.4.5 Treatment of neuropathic pain 21 3.4.5.1 Antidepressants 21 3.4.5.2 Anticonvulsant medication 21 3.4.5.3 Local analgesics 22 3.4.5.4 NMDA receptor antagonists 22 3.4.5.5 Other drug treatments 23 3.4.5.6 Invasive analgesic techniques 23 3.4.6 Breakthrough cancer pain 24 3.5 Quality of life (QoL) 25 3.6 Conclusions 26 3.7 References 26 4.