WHO Drug Information Vol 22, No
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Us 8530498 B1 3
USOO853 0498B1 (12) UnitedO States Patent (10) Patent No.: US 8,530,498 B1 Zeldis (45) Date of Patent: *Sep. 10, 2013 (54) METHODS FORTREATING MULTIPLE 5,639,476 A 6/1997 OShlack et al. MYELOMAWITH 5,674,533 A 10, 1997 Santus et al. 3-(4-AMINO-1-OXO-1,3-DIHYDROISOINDOL- 395 A 22 N. 2-YL)PIPERIDINE-2,6-DIONE 5,731,325 A 3/1998 Andrulis, Jr. et al. 5,733,566 A 3, 1998 Lewis (71) Applicant: Celgene Corporation, Summit, NJ (US) 5,798.368 A 8, 1998 Muller et al. 5,874.448 A 2f1999 Muller et al. (72) Inventor: Jerome B. Zeldis, Princeton, NJ (US) 5,877,200 A 3, 1999 Muller 5,929,117 A 7/1999 Muller et al. 5,955,476 A 9, 1999 Muller et al. (73) Assignee: Celgene Corporation, Summit, NJ (US) 6,020,358 A 2/2000 Muller et al. - 6,071,948 A 6/2000 D'Amato (*) Notice: Subject to any disclaimer, the term of this 6,114,355 A 9, 2000 D'Amato patent is extended or adjusted under 35 SS f 1939. All et al. U.S.C. 154(b) by 0 days. 6,235,756 B1 5/2001 D'Amatoreen et al. This patent is Subject to a terminal dis- 6,281.230 B1 8/2001 Muller et al. claimer 6,316,471 B1 1 1/2001 Muller et al. 6,326,388 B1 12/2001 Man et al. 6,335,349 B1 1/2002 Muller et al. (21) Appl. No.: 13/858,708 6,380.239 B1 4/2002 Muller et al. -
Multinational Evaluation of Mycophenolic Acid, Tacrolimus
View metadata, citation and similar papers at core.ac.uk brought to you by CORE providedORIGINAL by University of QueenslandPAPER eSpace ISSN 1425-9524 © Ann Transplant, 2016; 21: 1-11 DOI: 10.12659/AOT.895664 Received: 2015.08.15 Accepted: 2015.09.01 Multinational Evaluation of Mycophenolic Published: 2016.01.05 Acid, Tacrolimus, Cyclosporin, Sirolimus, and Everolimus Utilization Authors’ Contribution: ABCDEF Kyle M. Gardiner School of Pharmacy, University of Queensland, Brisbane, QLD, Australia Study Design A ACDEF Susan E. Tett Data Collection B Statistical Analysis C ACDEF Christine E. Staatz Data Interpretation D Manuscript Preparation E Literature Search F Funds Collection G Corresponding Author: Christine E. Staatz, e-mail: [email protected] Source of support: Departmental funding only Background: Increasing immunosuppressant utilization and expenditure is a worldwide challenge as more people success- fully live with transplanted organs. Our aims were to characterize utilization of mycophenolate, tacrolimus, cy- closporin, sirolimus, and everolimus in Australian transplant recipients from 2007 to 2013; to identify specific patterns of usage; and to compare Australian utilization with Norwegian, Danish, Swedish, and the Netherlands use. Material/Methods: Australian utilization and expenditure data were captured through national Pharmaceutical Benefits Scheme and Highly Specialized Drug administrative databases. Norwegian, Danish, Swedish, and the Netherlands uti- lization were retrieved from their healthcare databases. Utilization was compared as defined daily dose per 1000 population per day (DDD/1000 population/day). Data on kidney transplant recipients, the predominant patient group prescribed these medicines, were obtained from international transplant registries. Results: From 2007–2013 Australian utilization of mycophenolic acid, tacrolimus and everolimus increased 2.7-fold, 2.2- fold, and 2.3-fold, respectively. -
Phase I/II Study Evaluating the Safety and Clinical Efficacy of Temsirolimus and Bevacizumab in Patients with Chemotherapy Refra
Investigational New Drugs (2019) 37:331–337 https://doi.org/10.1007/s10637-018-0687-5 PHASE II STUDIES Phase I/II study evaluating the safety and clinical efficacy of temsirolimus and bevacizumab in patients with chemotherapy refractory metastatic castration-resistant prostate cancer Pedro C. Barata1 & Matthew Cooney2 & Prateek Mendiratta 2 & Ruby Gupta3 & Robert Dreicer4 & Jorge A. Garcia3 Received: 25 September 2018 /Accepted: 16 October 2018 /Published online: 7 November 2018 # Springer Science+Business Media, LLC, part of Springer Nature 2018 Summary Background Mammalian target of rapamycin (mTOR) pathway and angiogenesis through vascular endothelial growth factor (VEGF) have been shown to play important roles in prostate cancer progression. Preclinical data in prostate cancer has suggested the potential additive effect dual inhibition of VEGF and mTOR pathways. In this phase I/II trial we assessed the safety and efficacy of bevacizumab in combination with temsirolimus for the treatment of men with metastatic castration-resistant prostate cancer (mCRPC). Methods In the phase I portion, eligible patients received temsirolimus (20 mg or 25 mg IV weekly) in combination with a fixed dose of IV bevacizumab (10 mg/kg every 2 weeks). The primary endpoint for the phase II portion was objective response measured by either PSA or RECIST criteria. Exploratory endpoints included changes in circulating tumor cells (CTC) and their correlation with PSA response to treatment. Results Twenty-one patients, median age 64 (53–82), with pre- treatment PSA of 205.3 (11.1–1801.0), previously treated with a median of 2 (0–5) lines of therapy for mCRPC received the combination of temsirolimus weekly at 20 mg (n =4)or25mg(n = 17) with bevacizumab 10 mg/kg every 2 weeks (n =21). -
Pediatric Patients with Refractory Central Nervous System Tumors: Experiences of a Clinical Trial Combining Bevacizumab and Temsirolimus
ANTICANCER RESEARCH 34: 1939-1946 (2014) Pediatric Patients with Refractory Central Nervous System Tumors: Experiences of a Clinical Trial Combining Bevacizumab and Temsirolimus SARINA A. PIHA-PAUL1*, SANG JOON SHIN1*, TRIBHAWAN VATS2, NANDITA GUHA-THAKURTA3, JOANN AARON1, MICHAEL RYTTING2, EUGENIE KLEINERMAN2 and RAZELLE KURZROCK4 Departments of 1Investigational Cancer Therapeutics (Phase I Clinical Trials Program), 2Pediatric Oncology, and 3Diagnostic Radiology, The University of Texas MD Anderson Cancer Center, Houston, TX, U.S.A.; 4Moores Cancer Center, The University of California San Diego, La Jolla, CA, U.S.A. Abstract. Background: Pre-clinical findings suggest that Primary central nervous system (CNS) malignancies are the combination treatment with bevacizumab and temsirolimus second most frequent tumors in pediatric patients, with 3.4 could be effective against malignant pediatric central cases per 100,000 person-years of the estimated incidence for nervous system (CNS) tumors. Patients and Methods: Six children and adolescents at or below 19 years of age in the pediatric patients were treated as part of a phase I trial with United States (1, 2). Advances in diagnostic and therapeutic intravenous temsirolimus 25 mg on days 1, 8, 15, and modalities have improved the 5-year survival rates of children bevacizumab at 5, 10, or 15 mg/kg on day 1 of each 21-day with primary CNS tumors (3). However, due to the cycle until disease progression or patient withdrawal. emergence of drug-resistant clones, the outcome is poor in Results: The median patient age was six years (range=3-14 progressive disease. During the past decade, targeted years). The primary diagnoses were glioblastoma multiforme therapies have been increasingly identified for the most (n=2), medullobalstoma (n=2), pontine glioma (n=1) and common adult malignancies. -
Haematological Malignancies
Parikh_EU Haematology 03/03/2010 12:51 Page 43 Haematological Malignancies Clinical Management of Relapsed/Refractory Acute Myeloid Leukaemia Sameer A Parikh1 and Stefan Faderl2 1. Fellow; 2. Associate Professor of Medicine, Department of Leukemia, University of Texas MD Anderson Cancer Center DOI: 10.17925/EOH.2010.04.0.43 Abstract Conventional chemotherapy for patients with relapsed/refractory acute myeloid leukaemia (AML) remains unsatisfactory, with median survival ranging from 18 weeks following first relapse to six weeks in those with a second or higher relapse. The only potentially curative therapy is stem cell transplantation. Duration of first complete remission (CR) is the best predictor of response to salvage therapy. Novel therapies directed against a number of molecular aberrations associated with AML are being developed, including anti-CD33 monoclonal antibodies, FMS-like tyrosine kinase (FLT3) inhibitors, nucleoside analogues, hypomethylating agents and histone deacetylatase inhibitors, among others. Clinical trials combining novel agents with conventional chemotherapy are of particular interest, and definition of dose, schedule and combination partners remains an area of intense research. Keywords Acute myeloid leukaemia (AML), salvage therapy, chemotherapy, targeted therapy, nucleoside analogues, FLT3 inhibition, epigenetic therapy Disclosure: Sameer A Parikh has no conflicts of interst to declare. Stefan Faderl receives research funding from Genzyme Oncology and has been a member of advisory board meetings conducted by Genzyme Oncology. He is also a member of the speaker’s bureau of Eisai Inc. Received: 22 September 2009 Accepted: 23 February 2010 Citation: European Haematology, 2010;4:43–6 Correspondence: Stefan Faderl, Department of Leukemia, Unit 428, The University of Texas MD Anderson Cancer Center, 1515 Holcombe Blvd, Houston, TX 77030, US. -
Pharmaceuticals and Medical Devices Safety Information No
Pharmaceuticals and Medical Devices Safety Information No. 277 February 2011 Table of Contents 1. Safety Measures for Gemtuzumab Ozogamicin (Genetical Recombination) .......................................................................... 5 2. Important Safety Information .................................................................... 12 (1) Imatinib Mesilate, Nilotinib Hydrochloride Hydrate ....................................... 12 (2) Sunitinib Malate ............................................................................................ 15 (3) Pilsicainide Hydrochloride Hydrate ............................................................... 17 3. Revision of Precautions (No. 223) .......................................................... 21 Ciclosporin (oral and injectable dosage forms) (and 13 others) ........................ 21 4. List of Products Subject to Early Post-marketing Phase Vigilance .................................................. 26 This Pharmaceuticals and Medical Devices Safety Information (PMDSI) is issued based on safety information collected by the Ministry of Health, Labour and Welfare (MHLW). It is intended to facilitate safer use of pharmaceuticals and medical devices by healthcare providers. The PMDSI is available on the Pharmaceuticals and Medical Devices Agency (PMDA) website (http://www.pmda.go.jp/english/index.html) and on the MHLW website (http://www.mhlw.go.jp/, only available in Japanese language). Published by Translated by Pharmaceutical and Food Safety Bureau, Pharmaceuticals and Medical -
The Effectiveness of Correcting Abnormal Metabolic Profiles
Received: 25 April 2019 Revised: 17 June 2019 Accepted: 19 June 2019 DOI: 10.1002/jimd.12139 ORIGINAL ARTICLE The effectiveness of correcting abnormal metabolic profiles Peter Theodore Clayton UCL Great Ormond Street Institute of Child Health, London, UK Abstract Inborn errors of metabolism cause disease because of accumulation of a metabolite Correspondence before the blocked step or deficiency of an essential metabolite downstream of the Peter Clayton, UCL Great Ormond Street Institute of Child Health, London, UK. block. Treatments can be directed at reducing the levels of a toxic metabolite or Email: [email protected] correcting a metabolite deficiency. Many disorders have been treated successfully first in a single patient because we can measure the metabolites and adjust treat- Communicating Editor: Sander M. Houten ment to get them as close as possible to the normal range. Examples are drawn from Komrower's description of treatment of homocystinuria and the author's trials 5 of treatment in bile acid synthesis disorders (3β-hydroxy-Δ -C27-steroid dehydro- genase deficiency and Δ4-3-oxosteroid 5β-reductase deficiency), neurotransmitter amine disorders (aromatic L-amino acid decarboxylase [AADC] and tyrosine hydroxylase deficiencies), and vitamin B6 disorders (pyridox(am)ine phosphate oxidase deficiency and pyridoxine-dependent epilepsy [ALDH7A1 deficiency]). Sometimes follow-up shows there are milder and more severe forms of the disease and even variable clinical manifestations but by measuring the metabolites we can adjust the treatment to get the metabolites into the normal range. Biochemical mea- surements are not subject to placebo effects and will also show if the disorder is improving spontaneously. -
Patient Focused Disease State and Assistance Programs
Patient Focused Disease State and Assistance Programs Medication Medication Toll-free Brand (Generic) Website number Additional Resources Allergy/Asthma Xolair (omalizumab) xolair.com 1-866-4-XOLAIR lung.org Cardiovascular Pradaxa (dabigatran) pradaxa.com 877-481-5332 heart.org Praluent (alirocumab) praluent.com 844-PRALUENT thefhfoundation.org Repatha (evolocumab) repatha.com 844-REPATHA Tikosyn (dofetilide) tikosyn.com 800-879-3477 Crohn’s Disease Cimzia (certolizumab pegol) cimzia.com 866-4-CIMZIA crohnsandcolitis.com Humira (adalimumab) humira.com 800-4-HUMIRA crohnsforum.com Stelara (ustekinumab) stelarainfo.com 877-STELARA Dermatology Cosentyx (secukinumab) cosentyx.com 844-COSENTYX psoriasis.org Dupixent (dupilumab) dupixent.com 844-DUPIXENT nationaleczema.org Enbrel (etanercept) enbrel.com 888-4-ENBREL Humira (adalimumab) humira.com 800-4-HUMIRA Otezla (apremilast) otezla.com 844-4-OTEZLA Stelara (ustekinumab) stelarainfo.com 877-STELARA Taltz (ixekizumab) taltz.com 800-545-5979 Hematology Aranesp (darbepoetin alfa) aranesp.com 805-447-1000 chemocare.com Granix (filgrastim) granixrx.com 888-4-TEVARX hematology.org Jadenu (deferasirox) jadenu.com 888-282-7630 Neulasta (pegfilgrastim) neulasta.com 800-77-AMGEN Neupogen (filgrastim) neupogen.com 800-77-AMGEN Nivestym (filgrastim) nivestym.com 800-879-3477 Zarxio (filgrastim) zarxio.com 800-525-8747 Zytiga (abiraterone) zytiga.com 800-JANSSEN Hepatitis B Baraclude (entecavir) baraclude.com 800-321-1335 cdc.gov Viread (tenofovir disoproxil viread.com 800-GILEAD-5 hepb.org fumarate) -
Express Scripts 2020 National Preferred Formulary List
2020 Express Scripts National Preferred Formulary List The 2020 National Preferred Formulary drug list is shown below. The formulary is the list of drugs included in your prescription plan. Inclusion on the list does not guarantee coverage. The following list is not a complete list of over-the-counter [OTC] products and prescription medical supplies that are on the formulary. The only OTC products and prescription medical supplies that appear on the list are in contracted classes. PLEASE NOTE: Brand-name drugs may move to nonformulary status if a generic version becomes available during the year. Not all the drugs listed are covered by all prescription plans; check your benefit materials for the specific drugs covered and the copayments for your prescription plan. For specific questions about your coverage, please call the phone number printed on your member ID card. KEY For the member: FDA-approved generic medications meet strict standards and [INJ] – Injectable Drug contain the same active ingredients as their corresponding brand-name medications, [OTC] – Over-the-counter Product although they may have a different appearance. [SP] – Specialty Drug For the physician: Please prescribe preferred products and allow generic Brand-name drugs are listed in CAPITAL letters. Example: ABILIFY MAINTENA substitutions when medically appropriate. Generic drugs are listed in lower-case letters. Example: ibuprofen A adenosine [INJ] amabelz anthralin ADVAIR HFA amantadine APLISOL [INJ] abacavir [SP] ADVATE [INJ] [SP] AMBISOME [INJ] APOKYN [INJ] [SP] -
Hpra Drug Safety 66Th Newsletter Edition
FEBRUARY 2015 HPRA DRUG SAFETY 66TH NEWSLETTER EDITION 3 Mycophenolate mofetil (CellCept) and 4 Direct Healthcare Professional In this Edition Mycophenolic acid (Myfortic) - New warnings Communications published on about the risks of hypogammaglobulinaemia the HPRA website since the last 1 Eligard (leuprorelin acetate depot injection) and bronchiectasis Drug Safety Newsletter - Risk of lack of efficacy due to incorrect reconstitution and administration process 4 Tecfidera (dimethyl fumarate) - Progressive Multifocal Leukoencephalopathy (PML) has 2 Beta interferons – Risk of thrombotic occurred in a patient with severe microangiopathy and nephrotic syndrome and prolonged lymphopenia Eligard (leuprorelin acetate depot injection) - Risk of lack of efficacy due to incorrect reconstitution and administration process Following identification of a signal and safe treatment of patients with It is available in six-monthly (45mg), of administration errors with Eligard prostate cancer. Lack of efficacy may three-monthly (22.5mg) and one- and concerns that such errors may occur due to incorrect reconstitution monthly (7.5mg) formulations. In impact on clinical efficacy, this issue of Eligard. the majority of patients, androgen was reviewed at EU level by the deprivation therapy (ADT) with Eligard Eligard is indicated for the treatment Pharmacovigilance Risk Assessment results in testosterone levels below the of hormone dependent advanced Committee (PRAC). A cumulative standard castration threshold (<50ng/ prostate cancer and for the treatment review of reported global cases dL; <1.7 nmol/L); and in most cases, of high risk localised and locally identified errors related to storage, patients reach testosterone levels advanced hormone dependent preparation and reconstitution of below <20ng/dL. prostate cancer in combination Eligard. -
Orphan Drugs Used for Treatment in Pediatric Patients in the Slovak Republic
DOI 10.2478/v10219-012-0001-0 ACTA FACULTATIS PHARMACEUTICAE UNIVERSITATIS COMENIANAE Supplementum VI 2012 ORPHAN DRUGS USED FOR TREATMENT IN PEDIATRIC PATIENTS IN THE SLOVAK REPUBLIC 1Foltánová, T. – 2Konečný, M. – 3Hlavatá, A. –.4Štepánková, K. 5Cisárik, F. 1Comenius University in Bratislava, Faculty of Pharmacy, Department of Pharmacology and Toxicology 2Department of Clinical Genetics, St. Elizabeth Cancer Institute, Bratislava 32nd Department of Pediatrics, UniversityChildren'sHospital, Bratislava 4Slovak Cystic Fibrosis Association, Košice 5Department of Medical Genetics, Faculty Hospital, Žilina Due to the enormous success of scientific research in the field of paediatric medicine many once fatal children’s diseases can now be cured. Great progress has also been achieved in the rehabilitation of disabilities. However, there is still a big group of diseases defined as rare, treatment of which has been traditionally neglected by the drug companies mainly due to unprofitability. Since 2000 the treatment of rare diseases has been supported at the European level and in 2007 paediatric legislation was introduced. Both decisions together support treatment of rare diseases in children. In this paper, we shortly characterise the possibilities of rare diseases treatment in children in the Slovak republic and bring the list of orphan medicine products (OMPs) with defined dosing in paediatrics, which were launched in the Slovak market. We also bring a list of OMPs with defined dosing in children, which are not available in the national market. This incentive may help in further formation of the national plan for treating rare diseases as well as improvement in treatment options and availability of rare disease treatment in children in Slovakia. -
Forty-Sixth Annual MALTO Medicinal Chemistry & Pharmacognosy
Forty-Sixth Annual MALTO Medicinal Chemistry & Pharmacognosy Meeting-in-Miniature May 20th – 22nd, 2019 Hosted by The Department of Pharmaceutical Sciences College of Pharmacy University of Tennessee Health Science Center, Memphis, TN A A O O M L M L T T 1 | Page 2019 MALTO Meeting At the University of Tennessee Health Science Center College of Pharmacy Table of Contents Page 2019 MALTO Contributors and Sponsors……………..………….……....4 2019 MALTO Executive Officers……………..……………..…………..…4 MALTO Board of Directors………………………………………..………5 MALTO 2019 Organizing Committee……………………………………..5 General Program…………………………………………………….……6-7 MALTO – A Brief History………………………………………………..8-9 A. Nelson Voldeng Memorial Lecture………………………...…….....10-11 Dr. Jeff Aubé, Fred Eshelman Distinguished Professor of Chemistry, The University of North Carolina Eshelman School of Pharmacy Biographical Information………………………………………..….11 Abstract………………………………………………………………12 History of The Robert A. Magarian Outstanding Podium Presentation Award ………………………..……………………………….…………13-15 History of The Thomas L. Lemke Outstanding Poster Presentation Award…………………………………………………………..… …….16-17 History of The Ronald F. Borne Outstanding Poster Presentation Award……………………………………………………………………18-19 Meeting Schedule for Monday, May 20th, 2019…………………….….…20 2 | Page Meeting Schedule for Tuesday, May 21st, 2019………………………20-26 Meeting Schedule for Wednesday, May 22nd, 2019…………………..27-28 Podium Presentation Abstracts………..……………………...………29-52 Poster Presentation Abstracts …………………..……….……………53-70 MALTO Primary Contacts………………………………………...….71-73