DOCSLIB.ORG

Bayer AG    Stock Exchange: Frankfurt Stock Exchange • Ticker: BAYN • HQ: Leverkusen, Germany • Employees: 103,824

Total Page：16

File Type：pdf, Size：1020Kb

Download full-text PDF Read full-text
Bayer AG    Stock Exchange: Frankfurt Stock Exchange • Ticker: BAYN • HQ: Leverkusen, Germany • Employees: 103,824 Access to Medicine Index 2021 – Company report cards BAY RANK SCORE . Bayer AG Stock Exchange: Frankfurt Stock Exchange • Ticker: BAYN • HQ: Leverkusen, Germany • Employees: 103,824 PERFORMANCE IN THE 2021 INDEX How score was achieved 13th place. Bayer has an average performance. It delivers a Governance of Access 3.55 strong approach to filing its new products for registration, Research & Development 1.01 but has a small-sized R&D priority pipeline and no structured process for access planning. Its approach to governance and Product Delivery 3.03 compliance is average. 0 1 2 3 4 5 Average Leader Governance of Access: 8th place. Bayer has an average per- formance in this area. It implements an access-to-medicine strategy with a business rationale and discloses outcomes of some of its access-to-medicine activities. The company has some compliance controls in place, but lacks evidence of a continuous system to monitor compliance across its activities. Product Delivery: 11th place. Bayer has an average perfor- mance in this area. It has filed to register the majority of Research & Development: 17th place. Bayer falls to the lower its new products in the majority of high-burden countries. ranks in R&D. The company features a small-sized R&D prior- The company has access strategies for some of its products ity pipeline compared to peers and does not have a structured and for some countries in scope and is able to provide evi- process to develop access plans during R&D. A few of its late- dence of how patient reach has been increased through the stage R&D projects are covered by access plans . approaches used. OPPORTUNITIES FOR BAYER CHANGE SINCE THE 2018 INDEX Expand access to more products. Bayer offers certain contraceptives for • Created a new external sustainability council to contribute to procurement through UNFPA for eligible countries and offers the same Bayer innovation, mindset and strategy as from May 2020. terms and price to non-eligible countries for ethinylestradiol/levonorge- • Disclosed a new commitment not to enforce or file for pat- strel/ferrous fumerate (Microgynon® ED Fe/Microgynon® Fe). Bayer can ents in all LICs. apply the same strategy in non-eligible countries for norethisterone enan- • Joined Pat-INFORMED, publishing patent statuses for prod- tate (Noristerat®). Furthermore, Bayer can apply equitable pricing strat- ucts in their portfolio. egies for contraceptives that are not procured through UNFPA: drosperi- • Supports the clinical development of novel antibiotics via the none/ethinylestradiol (Yasmin®), Estradiol valerate/dienogest (Qlaira®/ AMR Action Fund. Natazia®) or estradiol valerate/norethisterone enantate (Norigynon®), • Joined the COVID-19 Therapeutics Accelerator. specifically in countries with a low contraceptive prevalence rate such as • Started a new two-year partnership in January 2020 with Angola, Gambia, Guinea and Mauritania. Outside contraceptives, Bayer can Living Goods to train Community Health Workers on family expand affordable access to on patent EML products such as rivaroxaban planning and neonatal care in rural Uganda. (Xarelto®) for the prevention of stroke. • Established a new partnership with PATH for malaria and COVID-19 in Southern Senegal. Develop an access planning process and access plans for all R&D pro- • Newly partnered with the UN Foundation for malaria eradica- jects. Bayer can develop a formal access planning process and accord- tion by donating Fludora® Fusion for vector control in Haiti. ingly develop access plans for all Phase II projects, such as levonorgestrel/ • Has a new collaboration with John Hopkins University for indomethacin (a combination intrauterine device). Bayer can also further The Challenge Initiative platform to enable governments in strengthen its recently updated post-trial access policy by committing countries in scope of the Index to scale up family planning to filing the product for registration in countries where clinical trials take approaches for poorer populations in urban areas. place, while ensuring affordability. Commit to donating until NTD elimination and control goals. In partner- ship with the WHO since 2002, Bayer has worked to eliminate African Sleeping Sickness (HAT) and to control Chagas disease in Latin America by donating suramin (Germanin®) and nifurtimox (Lampit®) until 2021. Bayer can extend its public commitment indefinitely until elimination of HAT and control of Chagas disease in Latin America. The term LMIC is used to denote all low- and mid- dle-income countries in the scope of the Index, except when analysing companies’ access strat- 140 egies where the use of LMIC refers to lower-mid- dle-income countries as per the World Bank income groups classification. Access to Medicine Foundation SALES AND OPERATIONS Business segments: Crop Science; KaNDy Therapeutics (women’s healthcare) and Net sales by segment (2019) – EUR Pharmaceuticals; Consumer Health of Asklepios BioPharmaceutical (gene thera- Therapeutic areas: Cancer; Cardiovascular and pies) in 2020. Crop Science 19.832 bn kidney diseases; Eye conditions; Haemophilia; Pharmaceuticals 17.962 bn Contraception Bayer Pharma’s products are sold in 92 out of Consumer Health 5.462 bn Product categories: Innovative medicines 106 countries in scope. Bayer Pharma has sales Reconciliation 0.289 bn M&A news: Divested Bayer Animal Health offices in 37 countries, sells via suppliers in 7 to Elanco in August 2019 for USD 7.6 billion; countries and via pooled procurement into 48 Total 43.545 bn acquired BlueRock (neurology) and Century additional countries. (oncology) in 2019; announced acquisition of Sales in countries in scope Sales by geographic region BAY BN EUR In scope, has sales oce In scope, any sales In scope, has no sales Europe/Middle East/Africa Asia-Pacic Not in scope Latin America North America SAMPLE OF PIPELINE AND PORTFOLIO ASSESSED BY THE INDEX PIPELINE for diseases and countries in scope PORTFOLIO as selected for analysis by the Index Bayer has a total of 42 R&D projects featuring a small-sized priority R&D Bayer has 21 medicines and contraceptives in scope, 11 of which are on pipeline compared to its peers: 7 projects. The other 35 R&D projects patent. 67% of these medicines and contraceptives (14) are on WHO’s EML. target other diseases in scope. Of the projects targeting priority diseases In addition, the company markets 12 vector control products. The off-pat- the focus is on Chagas disease (2 projects). Of the projects targeting other ent medicines target mainly neglected tropical diseases (NTD), such as diseases in scope the focus is on oncology (18). schistosomiasis, Chagas and Human African Trypanosomiasis. One medi- 17 R&D projects are in late-stage development that target either a prior- cine targets malaria. The on-patent medicines mainly target non-commu- ity disease (6) or address a public health need in LMICs (11).* Evidence of nicable diseases, such as oncology (5), cardiovascular disease and endo- access planning was in place for 24% of these projects: 3 targeting a prior- metriosis. Additionally, one medicine targets bacterial infections. Bayer has ity disease and 1 addressing a public health need in LMICs. eight contraceptives in scope. The vector control products target malaria, dengue, Chikungunya and Zika. Access strategies were analysed for 11 products on Bayer’s portfolio – supranationally procured (4) or nationally procured HCP-administered (2) and self-administered products (5). BAY 42 projects in the pipeline 33 products as selected for analysis by the Index† Communicable Communicable** Neglected tropical Neglected tropical Maternal and neonatal Maternal and neonatal Non-communicable Non-communicable Multiple categories Multiple categories projects in the pipeline products on the market Breakdown of projects# BreakdownBAY of products Levonorgestrel/indomethacin releasing intrauterine system for contraception. WHO EML Non-EML WHO EDL Other Total Medicines on patent Pre-clinical 1 Phase 2 Phase 3 Phase Approval Total plans access W. o patent Targets established R&D priorities Vaccines Addresses needs of LMICs* Diagnostics Other projects in scope Other*** *50 diseases and 211 product gaps in scope have ical phase of development were included for this ***Other includes vector control products. See #Projects in the discovery phases and/or other been established as a priority by global health analysis. Appendix I for definitions. drug development phases were not included in stakeholders. For other diseases/product gaps, **Neglected Tropical Diseases, while also † Product included in the analysis were selected this breakdown. the Index used a set of criteria to determine which communicable, are highlighted separately using a set of criteria determined by stakeholder 141 projects in the pipeline offer a clear public health throughout the Index. consensus. See Appendix I for a full breakdown benefit to patients in LMICs. Projects in the clin- of the criteria. Access to Medicine Index 2021 – Company report cards Bayer AG GOVERNANCE OF ACCESS RANK 8 SCORE 3.55 Has an access-to-medicine strategy with measurable transparency regarding access activities. It publicly dis- Has some compliance controls to ensure that govern- objectives and a business rationale. Bayer has an average closes its commitments, measurable goals, objectives and ance efforts are not undermined by non-compliant or performance. It has an access strategy aiming at increasing targets for improving access
Load more

Recommended publications
  • July 2019 New Drugs
    July 2019 Learn more New drugs Drug name Therapeutic category Indication(s) Launch information Manufacturer(s) AirDuo® Digihaler™ Treatment of asthma in patients aged 12 years and older. AirDuo Digihaler should be used for patients not adequately (fluticasone Corticosteroid/ long-acting beta controlled on a long term asthma control medication such as TBD propionate/salmeterol) agonist (LABA) an inhaled corticosteroid or whose disease warrants initiation Teva of treatment with both an inhaled corticosteroid and LABA Accrufer® (ferric maltol) Iron replacement Treatment of iron deficiency in adults TBD Shield Therapeutics ® Anticoagulant in patients undergoing percutaneous coronary Angiomax RTU (bivalrudin) intervention, including patients with heparin-induced Direct thrombin inhibitor TBD MAIA Pharmaceuticals thrombocytopenia and heparin-induced thrombocytopenia and thrombosis syndrome Baqsimi™ (glucagon) Treatment of severe hypoglycemia in patients with diabetes nasal powder Glucagon analog July 28, 2019 ages 4 years and above Eli Lilly Cuvitru (immune globulin subcutaneous [human], 20% Replacement therapy for primary humoral immunodeficiency solution) 10 mg/50 mL Immunoglobulin July 2, 2019 subcutaneous injection in adult and pediatric patients two years of age and older Baxalta 1 RxHighlights July 2019 Drug name Therapeutic category Indication(s) Launch information Manufacturer(s) Drizalma Sprinkle™ (duloxetine) Treatment of major depressive disorder in adults; generalized Serotonin and norepinephrine anxiety disorder in adults and pediatric
    [Show full text]
  • Darolutamide in Nonmetastatic, Castration-Resistant Prostate Cancer
    The new england journal of medicine Original Article Darolutamide in Nonmetastatic, Castration-Resistant Prostate Cancer Karim Fizazi, M.D., Neal Shore, M.D., Teuvo L. Tammela, M.D., Ph.D., Albertas Ulys, M.D., Egils Vjaters, M.D., Sergey Polyakov, M.D., Mindaugas Jievaltas, M.D., Murilo Luz, M.D., Boris Alekseev, M.D., Iris Kuss, M.D., Christian Kappeler, Ph.D., Amir Snapir, M.D., Ph.D., Toni Sarapohja, M.Sc., and Matthew R. Smith, M.D., Ph.D., for the ARAMIS Investigators*​​ ABSTRACT BACKGROUND Darolutamide is a structurally unique androgen-receptor antagonist that is under de- From Institut Gustave Roussy, Université velopment for the treatment of prostate cancer. We evaluated the efficacy of darolu- Paris-Sud, Villejuif, France (K.F.); Carolina Urologic Research Center, Myrtle Beach, tamide for delaying metastasis and death in men with nonmetastatic, castration- SC (N.S.); Tampere University Hospital resistant prostate cancer. and University of Tampere, Tampere (T.L.T.), and Orion Pharma, Orion Corporation, METHODS Espoo (A.S., T.S.) — all in Finland; Na- tional Cancer Institute, Vilnius (A.U.), We conducted a randomized, double-blind, placebo-controlled, phase 3 trial involving and Medical Academy, Lithuanian Uni- men with nonmetastatic, castration-resistant prostate cancer and a prostate-specific versity of Health Sciences, Kaunas (M.J.) antigen doubling time of 10 months or less. Patients were randomly assigned in a 2:1 — both in Lithuania; Stradins Clinical University Hospital, Riga, Latvia (E.V.); ratio to receive darolutamide (600 mg [two 300-mg tablets] twice daily) or placebo N.N. Alexandrov National Cancer Center while continuing androgen-deprivation therapy.
    [Show full text]
  • Product Monograph Crestor
    PRODUCT MONOGRAPH Pr CRESTOR® rosuvastatin calcium Tablets, 5, 10, 20 and 40 mg LIPID METABOLISM REGULATOR AstraZeneca Canada Inc. Date of Revision: May 14, 2020 1004 Middlegate Road Mississauga, Ontario L4Y 1M4 www.astrazeneca.ca Control No: 235939 CRESTOR® is a registered trademark of the AstraZeneca group of companies. Licensed from Shionogi & Co. Ltd. Osaka, Japan. COPYRIGHT 2003 – 2020 ASTRAZENECA CANADA INC. Page 1 of 46 TABLE OF CONTENTS PART I: HEALTH PROFESSIONAL INFORMATION......................................................3 SUMMARY PRODUCT INFORMATION ..............................................................3 INDICATIONS AND CLINICAL USE....................................................................3 CONTRAINDICATIONS ........................................................................................4 WARNINGS AND PRECAUTIONS .......................................................................5 ADVERSE REACTIONS ...................................................................................... 10 DRUG INTERACTIONS....................................................................................... 16 DOSAGE AND ADMINISTRATION.................................................................... 22 OVERDOSAGE..................................................................................................... 25 ACTION AND CLINICAL PHARMACOLOGY................................................... 25 STORAGE AND STABILITY............................................................................... 27 DOSAGE
    [Show full text]
  • Driving Performance and Delivering New Growth Opportunities
    Driving Performance and Delivering New Growth Opportunities /////////// Capital Markets Day London, December 5, 2018 Stefan Oelrich Head of Pharmaceuticals Joerg Moeller Head of Pharmaceuticals R&D Disclaimer Cautionary Statements Regarding Forward-Looking Information This presentation contains forward-looking statements. A forward-looking statement is any statement that does not relate to historical facts and events, but rather reflects Bayer’s current beliefs, expectations and assumptions regarding the future. This applies, in particular, to statements in this presentation on revenue growth, including product introductions and peak sales potential, synergies, especially in relation to the acquisition and integration of Monsanto Company, portfolio adjustments, cost reduction, financial targets and earnings, cash flow generation, deleveraging and other similar statements relating to future performance, including with respect to the markets in which Bayer is active. Although the forward-looking statements contained in this presentation are based upon what Bayer’s management believes are reasonable assumptions, they necessarily involve known and unknown risks and uncertainties that could cause actual results and future events to differ materially from those anticipated in such statements. Forward- looking statements are not guarantees of future performance and undue reliance should not be placed on them. Bayer undertakes no obligation to update forward-looking statements if circumstances or management’s estimates or opinions should change except as required by applicable securities laws. For more information on factors that could cause actual results and future events to differ from those anticipated in forward looking statements, please refer to the factors discussed in Bayer’s public reports which are available on the Bayer website at https://www.investor.bayer.com/en/reports/annual-reports/overview/, including in the Annual Report 2017 under the caption “Report on Future Perspectives and on Opportunities and Risks”.
    [Show full text]
  • Multi-Discipline Review
    CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 212099Orig1s000 MULTI-DISCIPLINE REVIEW Summary Review Office Director Cross Discipline Team Leader Review Clinical Review Non-Clinical Review Statistical Review Clinical Pharmacology Review NDA 212099 Multi-disciplinary Review and Evaluation Darolutamide/NUBEQA NDA/BLA Multi-Disciplinary Review and Evaluation Application Type NDA Application Number(s) 212099 Priority or Standard Priority Submit Date(s) February 26, 2019 Received Date(s) February 26. 2019 PDUFA Goal Date August 26, 2019 Division/Office Division of Oncology Products 1/Office of Hematology & Oncology Products Review Completion Date Established/Proper Name Darolutamide (Proposed) Trade Name Nubeqa Pharmacologic Class Androgen receptor inhibitor Code name 427492003 | Hormone refractory prostate cancer (disorder) Applicant Bayer Doseage form 300 mg tablets Applicant proposed Dosing NUBEQA 600 mg, (two 300 mg tablets) administered orally Regimen twice daily. Swallow tablets whole. Take NUBEQA with food. Patients should also receive a gonadotropin-releasing hormone (GnRH) analog concurrently or should have had bilateral orchiectomy. Applicant Proposed NUBEQA is an androgen receptor inhibitor indicated for the Indication(s)/Population(s) treatment of patients with non-metastatic castration-resistant prostate cancer. Applicant Proposed Non-metastatic castration resistant prostate cancer (nmCRPC) SNOMED CT Indication Disease Term for each Proposed Indication Recommendation on Regular approval Regulatory Action Recommended
    [Show full text]
  • CHMP Agenda of the 11-14 November 2019 Meeting
    11 November 2019 EMA/CHMP/606044/2019 Inspections, Human Medicines Pharmacovigilance and Committees Division Committee for medicinal products for human use (CHMP) Agenda for the meeting on 11-14 November 2019 Chair: Harald Enzmann – Vice-Chair: Bruno Sepodes 11 November 2019, 13:00 – 19:30, room 1C 12 November 2019, 08:30 – 19:30, room 1C 13 November 2019, 08:30 – 19:30, room 1C 14 November 2019, 08:30 – 16:00, room 1C Health and safety information In accordance with the Agency’s health and safety policy, delegates are to be briefed on health, safety and emergency information and procedures prior to the start of the meeting. Disclaimers Some of the information contained in this agenda is considered commercially confidential or sensitive and therefore not disclosed. With regard to intended therapeutic indications or procedure scopes listed against products, it must be noted that these may not reflect the full wording proposed by applicants and may also vary during the course of the review. Additional details on some of these procedures will be published in the CHMP meeting highlights once the procedures are finalised and start of referrals will also be available. Of note, this agenda is a working document primarily designed for CHMP members and the work the Committee undertakes. Note on access to documents Some documents mentioned in the agenda cannot be released at present following a request for access to documents within the framework of Regulation (EC) No 1049/2001 as they are subject to on-going procedures for which a final decision has not yet been adopted.
    [Show full text]
  • OUH Formulary Approved for Use in Breast Surgery
    Oxford University Hospitals NHS Foundation Trust Formulary FORMULARY (Y): the medicine can be used as per its licence. RESTRICTED FORMULARY (R): the medicine can be used as per the agreed restriction. NON-FORMULARY (NF): the medicine is not on the formulary and should not be used unless exceptional approval has been obtained from MMTC. UNLICENSED MEDICINE – RESTRICTED FORMULARY (UNR): the medicine is unlicensed and can be used as per the agreed restriction. SPECIAL MEDICINE – RESTRICTED FORMULARY (SR): the medicine is a “special” (unlicensed) and can be used as per the agreed restriction. EXTEMPORANEOUS PREPARATION – RESTRICTED FORMULARY (EXTR): the extemporaneous preparation (unlicensed) can be prepared and used as per the agreed restriction. UNLICENSED MEDICINE – NON-FORMULARY (UNNF): the medicine is unlicensed and is not on the formulary. It should not be used unless exceptional approval has been obtained from MMTC. SPECIAL MEDICINE – NON-FORMULARY (SNF): the medicine is a “special” (unlicensed) and is not on the formulary. It should not be used unless exceptional approval has been obtained from MMTC. EXTEMPORANEOUS PREPARATION – NON-FORMULARY (EXTNF): the extemporaneous preparation (unlicensed) cannot be prepared and used unless exceptional approval has been obtained from MMTC. CLINICAL TRIALS (C): the medicine is clinical trial material and is not for clinical use. NICE TECHNOLOGY APPRAISAL (NICETA): the medicine has received a positive appraisal from NICE. It will be available on the formulary from the day the Technology Appraisal is published. Prescribers who wish to treat patients who meet NICE criteria, will have access to these medicines from this date. However, these medicines will not be part of routine practice until a NICE TA Implementation Plan has been presented and approved by MMTC (when the drug will be given a Restricted formulary status).
    [Show full text]
  • Orange Book Cumulative Supplement 08 August 2019
    CUMULATIVE SUPPLEMENT 8 AUGUST 2019 APPROVED DRUG PRODUCTS WITH THERAPEUTIC EQUIVALENCE EVALUATIONS 39th EDITION Department of Health and Human Services Food and Drug Administration Office of Medical Products and Tobacco Center for Drug Evaluation and Research Office of Generic Drugs Office of Generic Drug Policy 2019 Prepared By Food and Drug Administration Office of Medical Products and Tobacco Center for Drug Evaluation and Research Office of Generic Drugs Office of Generic Drug Policy APPROVED DRUG PRODUCTS with THERAPEUTIC EQUIVALENCE EVALUATIONS 39th EDITION Cumulative Supplement 8 August 2019 CONTENTS PAGE 1.0 INTRODUCTION ......................................................................................................................................... v 1.1 How to use the Cumulative Supplement ............................................................................................ v 1.2 Cumulative Supplement Content ...................................................................................................... vi 1.3 Applicant Name Changes ................................................................................................................ vii 1.4 Levothyroxine Sodium....................................................................................................................... ix 1.5 Availability of the Edition .................................................................................................................... x 1.6 Report of Counts for the Prescription Drug Product List ..................................................................
    [Show full text]
  • Cyproterone Acetate Acts As a Disruptor of the Aryl Hydrocarbon Receptor
    www.nature.com/scientificreports OPEN Cyproterone acetate acts as a disruptor of the aryl hydrocarbon receptor Chih‑Shou Chen1, Guan‑Lun Gao2,3, Dong‑Ru Ho1, Chih‑Yi Lin2, Yu‑Ting Chou2, Shan‑Chun Chen2, Min‑Cong Huang1, Wen‑Ya Kao2 & Jyan‑Gwo Joseph Su2* Prostate cancer is a major cause of death in males. Cyproterone acetate (CPA), the steroidal anti‑ androgen for part of androgen deprivation therapy, may block the androgen‑receptor interaction and then reduce serum testosterone through its weak anti‑gonadotropic action. In addition to CPA inducing hepatitis, CPA is known to cause liver tumors in rats also. Aryl hydrocarbon receptor (AhR) is a cytoplasmic receptor and regulates multiple physiological functions. CYP1A1 is an AhR‑targeted gene. We found that CPA induced CYP1A1 expression, transcriptional activity of the aryl hydrocarbon response element (AHRE), and the nuclear localization of AhR in mouse Hepa‑1c1c7 cells. However, CPA suppressed CYP1A1 mRNA expression and the transcriptional activity of AHRE in human HepG2 and MCF7 cells, and also decreased AhR ligand‑induced CYP1A1 protein expression and transcriptional activity of AHRE in HepG2 cells. In summary, CPA is an AhR agonist in mouse cells, but an AhR antagonist in human cells. Accordingly, CPA potentially plays a role as an endocrine disruptor of the AhR. This study helps us to understand why CPA induces acute hepatitis, gene mutation, and many other side efects. In addition, it may trigger further studies investigating the relationships between CPA, glucocorticoid receptor and castration‑resistant prostate cancer in the future. Abbreviations AhR Aryl hydrocarbon receptor AHRE Aryl hydrocarbon response element CPA Cyproterone acetate CYP Cytochrome P450 Cyproterone acetate is used in hormone replacement therapy and several diferent types of cancer1,2.
    [Show full text]
  • Drug Consumption at Wholesale Prices in 2017 - 2020
    Page 1 Drug consumption at wholesale prices in 2017 - 2020 2020 2019 2018 2017 Wholesale Hospit. Wholesale Hospit. Wholesale Hospit. Wholesale Hospit. ATC code Subgroup or chemical substance price/1000 € % price/1000 € % price/1000 € % price/1000 € % A ALIMENTARY TRACT AND METABOLISM 321 590 7 309 580 7 300 278 7 295 060 8 A01 STOMATOLOGICAL PREPARATIONS 2 090 9 1 937 7 1 910 7 2 128 8 A01A STOMATOLOGICAL PREPARATIONS 2 090 9 1 937 7 1 910 7 2 128 8 A01AA Caries prophylactic agents 663 8 611 11 619 12 1 042 11 A01AA01 sodium fluoride 610 8 557 12 498 15 787 14 A01AA03 olaflur 53 1 54 1 50 1 48 1 A01AA51 sodium fluoride, combinations - - - - 71 1 206 1 A01AB Antiinfectives for local oral treatment 1 266 10 1 101 6 1 052 6 944 6 A01AB03 chlorhexidine 930 6 885 7 825 7 706 7 A01AB11 various 335 21 216 0 227 0 238 0 A01AB22 doxycycline - - 0 100 0 100 - - A01AC Corticosteroids for local oral treatment 113 1 153 1 135 1 143 1 A01AC01 triamcinolone 113 1 153 1 135 1 143 1 A01AD Other agents for local oral treatment 49 0 72 0 104 0 - - A01AD02 benzydamine 49 0 72 0 104 0 - - A02 DRUGS FOR ACID RELATED DISORDERS 30 885 4 32 677 4 35 102 5 37 644 7 A02A ANTACIDS 3 681 1 3 565 1 3 357 1 3 385 1 A02AA Magnesium compounds 141 22 151 22 172 22 155 19 A02AA04 magnesium hydroxide 141 22 151 22 172 22 155 19 A02AD Combinations and complexes of aluminium, 3 539 0 3 414 0 3 185 0 3 231 0 calcium and magnesium compounds A02AD01 ordinary salt combinations 3 539 0 3 414 0 3 185 0 3 231 0 A02B DRUGS FOR PEPTIC ULCER AND 27 205 5 29 112 4 31 746 5 34 258 8
    [Show full text]
  • Reference ID: 4672534
    HIGHLIGHTS OF PRESCRIBING INFORMATION persist despite discontinuation of statin treatment; positive anti-HMG CoA These highlights do not include all the information needed to use reductase antibody; muscle biopsy showing necrotizing myopathy; and EZALLOR SPRINKLE safely and effectively. See full prescribing improvement with immunosuppressive agents. (5.2) information for EZALLOR SPRINKLE. • Liver enzyme abnormalities: Persistent elevations in hepatic transaminases can occur. Perform liver enzyme tests before initiating EZALLOR SPRINKLETM (rosuvastatin) capsules, for oral use therapy and as clinically indicated thereafter. (5.3) Initial U.S. Approval: 2003 -----------------------------------ADVERSE REACTIONS-------------------------­ ------------------------- RECENT MAJOR CHANGES --------------------------­ Most frequent adverse reactions (rate > 2%) are headache, myalgia, abdominal Dosage and Administration, Use with Concomitant Therapy (2.3) 5/2020 pain, asthenia, and nausea. (6.1) Warning and Precautions, Skeletal Muscle Effects (5.1) 5/2020 Warnings and Precautions, Immune-Mediated Necrotizing Myopathy (5.2) To report SUSPECTED ADVERSE REACTIONS, contact Sun 9/2020 Pharmaceutical Industries, Inc. at 1 - 800-818-4555 or FDA at 1-800-FDA­ 1088 or www.fda.gov/medwatch. --------------------------- INDICATIONS AND USAGE --------------------------­ EZALLOR Sprinkle is an HMG Co-A reductase inhibitor indicated for: -------------------------------DRUG INTERACTIONS-----------------------------­ • adult patients with hypertriglyceridemia as an adjunct to diet (1.1) • Combination of sofosbuvir/velpatasvir/voxilaprevir or • adult patients with primary dysbetalipoproteinemia (Type III ledipasvir/sofosbuvir: Combination increases rosuvastatin exposure. Use hyperlipoproteinemia) as an adjunct to diet (1.2) with EZALLOR Sprinkle is not recommended. (2.3, 5.1, 7.3, 12.3) • adult patients with homozygous familial hypercholesterolemia (HoFH) to • Cyclosporine and darolutamide: Combination increases rosuvastatin reduce LDL-C, total-C, and ApoB (1.3) exposure.
    [Show full text]
  • DRUG NAME: Darolutamide
    Darolutamide DRUG NAME: Darolutamide SYNONYM(S): ODM-201, BAY-18417881 COMMON TRADE NAME(S): NUBEQA® CLASSIFICATION: hormonal agent Special pediatric considerations are noted when applicable, otherwise adult provisions apply. MECHANISM OF ACTION: Darolutamide is a nonsteroidal androgen receptor inhibitor which affects several steps in the androgen receptor signaling pathway. It inhibits nuclear translocation of activated androgen receptors, DNA binding, and androgen receptor-mediated gene transcription. In xenograft models, darolutamide reduced tumour cell proliferation, which led to decreased tumour volume. Darolutamide competitively inhibits binding of androgens to androgen receptors. Unlike conventional androgen receptor inhibitors, darolutamide lacks agonist activity in cells that overexpress androgen receptors. Darolutamide has demonstrated inhibition in both wild-type and mutant androgen receptors.2-4 PHARMACOKINETICS: Oral Absorption Cmax: 4 hours; bioavailability ~30% (fasted state); 2-2.5 fold increase in bioavailability when administered with food Distribution primarily bound to serum albumin cross blood brain barrier? low penetration based on animal studies; likelihood of clinical relevance in humans is low volume of distribution 119 L plasma protein binding 92% darolutamide; 99.8% keto-darolutamide Metabolism primarily metabolized by CYP 3A4 active metabolite(s) keto-darolutamide (2-fold higher total plasma exposure compared to darolutamide) inactive metabolite(s) no information found Excretion primarily by urinary excretion urine 63.4% (~7% unchanged) feces 32.4% (~30% unchanged) terminal half life 20 h clearance 116 mL/min Elderly no clinically significant difference Ethnicity no clinically significant difference Adapted from standard reference1-3 unless specified otherwise. USES: Primary uses: Other uses: *Prostate cancer *Health Canada approved indication BC Cancer Drug Manual©. All rights reserved.
    [Show full text]