Usage of Antivirals and the Occurrence of Antiviral Resistance in Norway 2018
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Daklinza, INN-Daclatasvir
ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 1 This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 for how to report adverse reactions. 1. NAME OF THE MEDICINAL PRODUCT Daklinza 30 mg film-coated tablets Daklinza 60 mg film-coated tablets Daklinza 90 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Daklinza 30 mg film-coated tablets Each film-coated tablet contains daclatasvir dihydrochloride equivalent to 30 mg daclatasvir. Daklinza 60 mg film-coated tablets Each film-coated tablet contains daclatasvir dihydrochloride equivalent to 60 mg daclatasvir. Daklinza 90 mg film-coated tablets Each film-coated tablet contains daclatasvir dihydrochloride equivalent to 90 mg daclatasvir. Excipient(s) with known effect Each 30-mg film-coated tablet contains 58 mg of lactose (as anhydrous). Each 60-mg film-coated tablet contains 116 mg of lactose (as anhydrous). Each 90-mg film-coated tablet contains 173 mg of lactose (as anhydrous). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet (tablet). Daklinza 30 mg film-coated tablets Green biconvex pentagonal of dimensions 7.2 mm x 7.0 mm, debossed tablet with "BMS" on one side and "213" on the other side. Daklinza 60 mg film-coated tablets Light green biconvex pentagonal of dimensions 9.1 mm x 8.9 mm, debossed tablet with "BMS" on one side and "215" on the other side. Daklinza 90 mg film-coated tablets Light green biconvex round of dimension 10.16 mm diameter, embossed tablet with "BMS" on one side and "011" on the other side. -
Injectable PLGA Adefovir Microspheres; the Way for Long Term Therapy of T Chronic Hepatitis-B ⁎ Margrit M
European Journal of Pharmaceutical Sciences 118 (2018) 24–31 Contents lists available at ScienceDirect European Journal of Pharmaceutical Sciences journal homepage: www.elsevier.com/locate/ejps Injectable PLGA Adefovir microspheres; the way for long term therapy of T chronic hepatitis-B ⁎ Margrit M. Ayouba, , Neveen G. Elantounyb, Hanan M. El-Nahasa, Fakhr El-Din S. Ghazya a Department of Pharmaceutics and Industrial Pharmacy, Faculty of Pharmacy, Zagazig University, Zagazig, Egypt b Department of Internal Medicine, Faculty of Medicine, Zagazig University, Zagazig, Egypt ARTICLE INFO ABSTRACT Keywords: For patient convenience, sustained release Adefovir Poly-d,l-lactic-co-glycolic acid (PLGA) microspheres were Adefovir formulated to relieve the daily use of the drug which is a problem for patients treated from chronic hepatitis-B. Biodegradable microspheres PLGA microspheres were prepared and characterized by entrapment efficiency, particle size distribution and Poly-lactic-co-glycolic acid scanning electron microscopy (SEM). In-vitro release and in-vivo studies were carried out. Factors such as drug: Entrapment efficiency polymer ratio, polymer viscosity and polymer lactide content were found to be important variables for the preparation of PLGA Adefovir microspheres. Fourier transform infrared (FTIR) analysis and differential scanning calorimetry (DSC) were performed to determine any drug-polymer interactions. One way analysis of variance (ANOVA) was employed to analyze the pharmacokinetic parameters after intramuscular injection of the pure drug and the selected PLGA microspheres into rats. FTIR and DSC revealed a significant interaction between the drug and the polymer. Reports of SEM before and after 1 and 24 h release showed that the microspheres had nonporous smooth surface even after 24 h release. -
Highlights of Prescribing Information
HIGHLIGHTS OF PRESCRIBING INFORMATION --------------------------WARNINGS AND PRECAUTIONS-------------------- These highlights do not include all the information needed to use • New onset or worsening renal impairment: Can include acute VIREAD safely and effectively. See full prescribing information renal failure and Fanconi syndrome. Assess creatinine clearance for VIREAD. (CrCl) before initiating treatment with VIREAD. Monitor CrCl and ® serum phosphorus in patients at risk. Avoid administering VIREAD (tenofovir disoproxil fumarate) tablets, for oral use VIREAD with concurrent or recent use of nephrotoxic drugs. (5.3) VIREAD® (tenofovir disoproxil fumarate) powder, for oral use • Coadministration with Other Products: Do not use with other Initial U.S. Approval: 2001 tenofovir-containing products (e.g., ATRIPLA, COMPLERA, and TRUVADA). Do not administer in combination with HEPSERA. WARNING: LACTIC ACIDOSIS/SEVERE HEPATOMEGALY WITH (5.4) STEATOSIS and POST TREATMENT EXACERBATION OF HEPATITIS • HIV testing: HIV antibody testing should be offered to all HBV- infected patients before initiating therapy with VIREAD. VIREAD See full prescribing information for complete boxed warning. should only be used as part of an appropriate antiretroviral • Lactic acidosis and severe hepatomegaly with steatosis, combination regimen in HIV-infected patients with or without HBV including fatal cases, have been reported with the use of coinfection. (5.5) nucleoside analogs, including VIREAD. (5.1) • Decreases in bone mineral density (BMD): Consider assessment • Severe acute exacerbations of hepatitis have been reported of BMD in patients with a history of pathologic fracture or other in HBV-infected patients who have discontinued anti- risk factors for osteoporosis or bone loss. (5.6) hepatitis B therapy, including VIREAD. Hepatic function • Redistribution/accumulation of body fat: Observed in HIV-infected should be monitored closely in these patients. -
Hepsera, INN- Defovir Dipivoxil
SCIENTIFIC DISCUSSION This module reflects the initial scientific discussion for the approval of Hepsera. For information on changes after approvalplease refer to module 8B 1. Chemical, pharmaceutical and biological aspects Composition Hepsera is presented as an immediate release tablet containing 10 mg of adefovir dipivoxil, as active substance. The other ingredients in this formulation are commonly used in tablets Hepsera is supplied in high-density polyethylene bottle (HDPE), with silica gel desiccant canisters or sachets, and polyester fiber packing material. The closure system consists of a child-resistant polypropylene screw cap lined with an induction activated aluminium foil liner. Active substance Adefovir dipivoxil is an ester prodrug of the nucleotide analogue, adefovir. A structural modification of the parent drug has been carried out in order to increase the lipophilicity and to enhance the oral bioavailability of adefovir. The active substance is a white to off-white crystalline powder. It is soluble in ethanol, sparingly soluble in 0.1N HCl and very slightly soluble in water adjusted to pH 7.2 but relatively highly soluble at physiological pH. The active substance does not contain any chiral center and does not exhibit any optical isomerism. In laboratory studies the anhydrate crystal form has been observed to convert gradually into a dihydrate crystal form when adefovir dipivoxil was exposed to high humidity conditions (75% R.H., 25ºC) over an approximately one-month period. However, the only crystal form produced during the active substance synthesis and utilised in non-clinical and clinical studies has been the anhydrous crystal form. Adefovir dipivoxil undergoes also hydrolysis in aqueous solution and to a smaller degree in the solid state after exposure to humidity and heat for extended periods. -
COVID-19) Pandemic on National Antimicrobial Consumption in Jordan
antibiotics Article An Assessment of the Impact of Coronavirus Disease (COVID-19) Pandemic on National Antimicrobial Consumption in Jordan Sayer Al-Azzam 1, Nizar Mahmoud Mhaidat 1, Hayaa A. Banat 2, Mohammad Alfaour 2, Dana Samih Ahmad 2, Arno Muller 3, Adi Al-Nuseirat 4 , Elizabeth A. Lattyak 5, Barbara R. Conway 6,7 and Mamoon A. Aldeyab 6,* 1 Clinical Pharmacy Department, Jordan University of Science and Technology, Irbid 22110, Jordan; [email protected] (S.A.-A.); [email protected] (N.M.M.) 2 Jordan Food and Drug Administration (JFDA), Amman 11181, Jordan; [email protected] (H.A.B.); [email protected] (M.A.); [email protected] (D.S.A.) 3 Antimicrobial Resistance Division, World Health Organization, Avenue Appia 20, 1211 Geneva, Switzerland; [email protected] 4 World Health Organization Regional Office for the Eastern Mediterranean, Cairo 11371, Egypt; [email protected] 5 Scientific Computing Associates Corp., River Forest, IL 60305, USA; [email protected] 6 Department of Pharmacy, School of Applied Sciences, University of Huddersfield, Huddersfield HD1 3DH, UK; [email protected] 7 Institute of Skin Integrity and Infection Prevention, University of Huddersfield, Huddersfield HD1 3DH, UK * Correspondence: [email protected] Citation: Al-Azzam, S.; Mhaidat, N.M.; Banat, H.A.; Alfaour, M.; Abstract: Coronavirus disease 2019 (COVID-19) has overlapping clinical characteristics with bacterial Ahmad, D.S.; Muller, A.; Al-Nuseirat, respiratory tract infection, leading to the prescription of potentially unnecessary antibiotics. This A.; Lattyak, E.A.; Conway, B.R.; study aimed at measuring changes and patterns of national antimicrobial use for one year preceding Aldeyab, M.A. -
Chapter 12 Antimicrobial Therapy Antibiotics
Chapter 12 Antimicrobial Therapy Topics: • Ideal drug - Antimicrobial Therapy - Selective Toxicity • Terminology - Survey of Antimicrobial Drug • Antibiotics - Microbial Drug Resistance - Drug and Host Interaction An ideal antimicrobic: Chemotherapy is the use of any chemical - soluble in body fluids, agent in the treatment of disease. - selectively toxic , - nonallergenic, A chemotherapeutic agent or drug is any - reasonable half life (maintained at a chemical agent used in medical practice. constant therapeutic concentration) An antibiotic agent is usually considered to - unlikely to elicit resistance, be a chemical substance made by a - has a long shelf life, microorganism that can inhibit the growth or - reasonably priced. kill microorganisms. There is no ideal antimicrobic An antimicrobic or antimicrobial agent is Selective Toxicity - Drugs that specifically target a chemical substance similar to an microbial processes, and not the human host’s. antibiotic, but may be synthetic. Antibiotics Spectrum of antibiotics and targets • Naturally occurring antimicrobials – Metabolic products of bacteria and fungi – Reduce competition for nutrients and space • Bacteria – Streptomyces, Bacillus, • Molds – Penicillium, Cephalosporium * * 1 The mechanism of action for different 5 General Mechanisms of Action for antimicrobial drug targets in bacterial cells Antibiotics - Inhibition of Cell Wall Synthesis - Disruption of Cell Membrane Function - Inhibition of Protein Synthesis - Inhibition of Nucleic Acid Synthesis - Anti-metabolic activity Antibiotics -
KALETRA (Lopinavir/Ritonavir)
HIGHLIGHTS OF PRESCRIBING INFORMATION CONTRAINDICATIONS These highlights do not include all the information needed to use • Hypersensitivity to KALETRA (e.g., toxic epidermal necrolysis, Stevens- KALETRA safely and effectively. See full prescribing information for Johnson syndrome, erythema multiforme, urticaria, angioedema) or any of KALETRA. its ingredients, including ritonavir. (4) • Co-administration with drugs highly dependent on CYP3A for clearance KALETRA (lopinavir and ritonavir) tablet, for oral use and for which elevated plasma levels may result in serious and/or life- KALETRA (lopinavir and ritonavir) oral solution threatening events. (4) Initial U.S. Approval: 2000 • Co-administration with potent CYP3A inducers where significantly reduced lopinavir plasma concentrations may be associated with the potential for RECENT MAJOR CHANGES loss of virologic response and possible resistance and cross resistance. (4) Contraindications (4) 12/2019 WARNINGS AND PRECAUTIONS The following have been observed in patients receiving KALETRA: INDICATIONS AND USAGE • The concomitant use of KALETRA and certain other drugs may result in KALETRA is an HIV-1 protease inhibitor indicated in combination with other known or potentially significant drug interactions. Consult the full antiretroviral agents for the treatment of HIV-1 infection in adults and prescribing information prior to and during treatment for potential drug pediatric patients (14 days and older). (1) interactions. (5.1, 7.3) • Toxicity in preterm neonates: KALETRA oral solution should not be used DOSAGE AND ADMINISTRATION in preterm neonates in the immediate postnatal period because of possible Tablets: May be taken with or without food, swallowed whole and not toxicities. A safe and effective dose of KALETRA oral solution in this chewed, broken, or crushed. -
Ombitasvir, Paritaprevir/Ritonavir (Technivie )
Ombitasvir, paritaprevir/ritonavir (Technivie®) National Abbreviated Review Drug Monograph December 2015 VA Pharmacy Benefits Management Services, Medical Advisory Panel, VISN Pharmacist Executives and Office of Public Health The purpose of VA PBM Services drug monographs is to provide a comprehensive drug review for making formulary decisions. Updates will be made when new clinical data warrant additional formulary discussion. Documents will be placed in the Archive section when the information is deemed to be no longer current. FDA Approval Information1 Description/ Technivie is a fixed-dose combination of ombitasvir, paritaprevir, and ritonavir. Mechanism of Action Ritonavir does not have activity against Hepatitis C virus (HCV); it is included in the regimen as a pharmacokinetic enhancer (i.e. increase concentration of paritaprevir). The other two agents are direct-acting antivirals with different mechanisms of action. Ombitasvir is a NS5A inhibitor and paritaprevir is a NS3/4A protease inhibitor. Indication(s) under Review in Fixed-dose combination of ombitasvir, paritaprevir and ritonavir with ribavirin this document is indicated for the treatment of chronic hepatitis C genotype 4 infections in adults without cirrhosis. NOTE: Per prescribing information, this combination may be administered without ribavirin in treatment-naïve patients who cannot tolerate ribavirin Dosage Form(s) Under Ombitasvir, paritaprevir, ritonavir 12.5/75/50mg tablet Review REMS NO REMS Pregnancy Rating Pregnancy Category B; however, when ribavirin is co-administered, then regimen is contraindicated in pregnant women and in men whose female partners are pregnant. Executive Summary1-2 Efficacy The FDA approval of ombitasvir, paritaprevir and ritonavir with ribavirin was primarily based on one phase 2b randomized, open-label, multi-center trial (called PEARL-1). -
Sofosbuvir/Ledipasvir for HIV •
Hepatitis C: Drugs and Combinations Melissa Osborn MD Associate Professor MetroHealth Medical Center Case Western Reserve University Cleveland, OH Faculty and Planning Committee Disclosures Please consult your program book. Off-Label Disclosure The following off-label/investigational uses will be discussed in this presentation: • Sofosbuvir/ledipasvir for HIV •. Investigational agents for hepatitis C will be mentioned – Asunaprevir – Daclatasvir – Beclabuvir – Grazoprevir – Elbasvir – GS-5816 Learning Objectives Upon completion of this presentation, learners should be better able to: • apply clinical trial data on new hepatitis C therapies to their patient population. • select which new hepatitis C therapies are appropriate to use with common antiretrovirals. Evolution of interferon-based therapy in HCV-monoinfected genotype 1 patients Sustained Virologic Response 100% 90% 80% 80% 75% 67% 60% 42% 46% 40% 28% 20% 7% 0% Std interferon-alfa IFN + RBV Peg-alfa-2b+RBV Peg-alfa-2a +RBV P/R/Telaprevir P/R/Boceprevir P/R/Simeprevir P/R/Sofosbuvir McHutchison, NEJM 1998; 339: 1485-92 Jacobson, NEJM 2011; 364:2405-16 Fried, NEJM 2002; 347: 975-82 Poordad, NEJM 2011; 364: 1195-206 Manns, Lancet 2001; 358:958-65 Jacobson, AASLD 2013 #1122 Lawitz, NEJM 2013 Evolution of HCV Therapy: Genotype 1 Patients Naïve to Therapy: HIV-HCV coinfection Sustained Virologic Response 80% 75% 74% 67% 61% 60% 46% 42% 40% 28% 29% 20% 17% 7% 7% 0% Std interferon-alfa IFN + RBV Peg-alfa-2b+RBV Peg-alfa-2a +RBV P/R/Telaprevir P/R/Boceprevir Torriani, NEJM, 2004 351:438-50 -
Hepatitis C Agents Therapeutic Class Review
Hepatitis C Agents Therapeutic Class Review (TCR) November 2, 2018 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]. Proprietary Information. Restricted Access – Do not disseminate or copy without approval. © 2004–2018 Magellan Rx Management. All Rights Reserved. FDA-APPROVED INDICATIONS Drug Mfr FDA-Approved Indications Interferons peginterferon alfa-2a Genentech Chronic hepatitis C (CHC) 1 (Pegasys®) . -
Antiviral Agents Active Against Influenza a Viruses
REVIEWS Antiviral agents active against influenza A viruses Erik De Clercq Abstract | The recent outbreaks of avian influenza A (H5N1) virus, its expanding geographic distribution and its ability to transfer to humans and cause severe infection have raised serious concerns about the measures available to control an avian or human pandemic of influenza A. In anticipation of such a pandemic, several preventive and therapeutic strategies have been proposed, including the stockpiling of antiviral drugs, in particular the neuraminidase inhibitors oseltamivir (Tamiflu; Roche) and zanamivir (Relenza; GlaxoSmithKline). This article reviews agents that have been shown to have activity against influenza A viruses and discusses their therapeutic potential, and also describes emerging strategies for targeting these viruses. HXNY In the face of the persistent threat of human influenza A into the interior of the virus particles (virions) within In the naming system for (H3N2, H1N1) and B infections, the outbreaks of avian endosomes, a process that is needed for the uncoating virus strains, H refers to influenza (H5N1) in Southeast Asia, and the potential of to occur. The H+ ions are imported through the M2 haemagglutinin and N a new human or avian influenza A variant to unleash a (matrix 2) channels10; the transmembrane domain of to neuraminidase. pandemic, there is much concern about the shortage in the M2 protein, with the amino-acid residues facing both the number and supply of effective anti-influenza- the ion-conducting pore, is shown in FIG. 3a (REF. 11). virus agents1–4. There are, in principle, two mechanisms Amantadine has been postulated to block the interior by which pandemic influenza could originate: first, by channel within the tetrameric M2 helix bundle12. -
Sofosbuvir-Based and Elbasvir/Grazoprevir Treatment Fai
Sofosbuvir-Based and Elbasvir/Grazoprevir Treatment Fai... From www.HCVGuidance.org on September 27, 2021 Sofosbuvir-Based and Elbasvir/Grazoprevir Treatment Failures In general, persons who have experienced treatment failure with a sofosbuvir-based regimen should be retreated with 12 weeks of sofosbuvir/velpatasvir/voxilaprevir. The main exception is persons with genotype 3 and cirrhosis, in whom addition of ribavirin to sofosbuvir/velpatasvir/voxilaprevir for 12 weeks is recommended. Sixteen weeks of glecaprevir/pibrentasvir is an alternative regimen. Elbasvir/grazoprevir treatment failure patients should also be retreated with 12 weeks of sofosbuvir/velpatasvir/voxilaprevir. However, glecaprevir/pibrentasvir for 16 weeks is not recommended as an alternative for this group of patients. Recommended and alternative regimens listed by evidence level and alphabetically for: Sofosbuvir-Based Treatment Failures, With or Without Compensated Cirrhosisa RECOMMENDED DURATION RATING Daily fixed-dose combination of sofosbuvir (400 mg)/velpatasvir (100 12 weeks I, A mg)/voxilaprevir (100 mg)b ALTERNATIVE DURATION RATING Daily fixed-dose combination of glecaprevir (300 mg)/pibrentasvir (120 mg) 16 weeks I, A except for NS3/4 protease inhibitor inclusive combination DAA regimen failuresc Not recommended for genotype 3 infection with sofosbuvir/NS5A inhibitor experience. a For decompensated cirrhosis, please refer to the appropriate section. b Genotype 3: Add weight-based ribavirin if cirrhosis is present and there are no contraindications. c This regimen is not recommended for patients with prior exposure to an NS5A inhibitor plus NS3/4 PI regimens (eg. Elbasvir/grazoprevir). Recommended Regimen Sofosbuvir/Velpatasvir/Voxilaprevir The placebo-controlled, phase 3 POLARIS-1 trial evaluated a 12-week course of the daily fixed-dose combination of sofosbuvir (400 mg)/velpatasvir (100 mg)/voxilaprevir (100mg) in 263 persons with a prior NS5A inhibitor-containing DAA regimen failure.