Oritavancin Use Flowchart

Total Page:16

File Type:pdf, Size:1020Kb

Oritavancin Use Flowchart Table 1. Oritavancin Exclusion Criteria Effective 8/16/2018. Contact [email protected] for previous versions. 1. Sepsis or Septic shock 2. ABSSSI including: UW Health Emergency Department (UH & TAC) Oritavancin Use Flowchart · Orbital cellulitis Contact for Content: Lucas Schulz, PharmD; 608-890-8617; [email protected] · Diabetic foot infections · Burn related infection · Bite wound · Osteomyelitis Oritavancin Order intravenous · Physician diagnoses Necrotizing fasciitis exclusion criteria? Yes antibiotics for patient with ABSSSI · Catheter/device related infection (Table 1) ABSSSI · Environmental/polymicrobial source 3. Severe allergy to: · Oritavancin No · Dalbavancin · Abbreviations: Vancomycin ABX: Antibiotic · Daptomycin ABSSSI: Acute Bacterial Skin and Skin Structure Infections · Telavancin MPP: Multipurpose Procedure Room ≥1 risk factor(s) for oral outpatient ABX Can patient take Discharge from ED 4. CDU or inpatient admission planned CDU: Clinical Decision Unit No Yes UH: University Hospital treatment failure? oral medication? on oral antibiotics TAC: The American Center (Table 2) 5. Age < 18 years old Table 2. Risk Factors for Oral Antibiotic Outpatient Treatment Failure Yes 1. Psychosocial concern for adherence 2. Acquired Immunodeficiency Syndrome No 3. Intravenous Drug User Physician discusses 4. Cognitively impaired Appropriate ABSSSI treatment 5. Chronic edema Yes candidate for options with patient, 6. Lymphedema oritavancin including oritavancin 7. Chronic leg ulcers 8. Cirrhosis Approval via 3333 pager is not required for oritavancin 9. Duration of infection greater than 7 days administered in the ED for ABSSSI. The 3333 pager is 10. History of ABSSSI at same site within last 3 available from 0700-2200 daily if questions arise. months 11. Oral treatment failure (>24 hours of appropriate therapy)* 12. Incarcerated 13. Diabetes mellitus Order intravenous Patient accepts 14. Immunosuppression antibiotics for No treatment with ABSSSI oritavancin? *Expanding redness does not necessarily mean treatment failure Physician orders Pharmacist Discharge with ABSSSI Administer oritavancin selecting completes progress information sheet oritavancin Yes “use is approved for note to document (includes return (Consider MPP room restricted no exclusion criteria precautions and close at UH) indication” & ≥ 1 risk factor outpatient follow-up) Copyright © 2018 University of Wisconsin Hospitals and Clinics Authority. All Rights Reserved. Printed with Permission. Contact: [email protected] Vermeulen, [email protected] Last Revised: 08/2018.
Recommended publications
  • P0469 In-Vitro Activity of Oritavancin Against Daptomycin And/Or Linezolid Resistant Enterococcus Faecium Clinical Isolates: a Single Centre Study
    P0469 In-vitro activity of oritavancin against daptomycin and/or linezolid resistant Enterococcus faecium clinical isolates: a single centre study Abhay Dhand*1, Nicholas Feola1, Leslie Lee1, Guiqing Wang1 1Westchester Medical Center Background: Oritavancin is a novel antibiotic with potent activity against a broad range of gram- positive organisms. Resistance to daptomycin, linezolid and other antibiotics among enterococcus is on the rise in many US hospitals. Oritavancin may provide an alternative antibiotic therapy for serious infections caused by such very resistant enterococci. The aim of this study was to evaluate in vitro antimicrobial susceptibility of oritavancin against enterococci with focus on Daptomycin non- susceptible (DNSE) and Linezolid resistant (LRE) clinical isolates. Materials/methods: DNSE and LRE clinical isolates were recovered from patients in a tertiary medical center in suburban New York City from May 2015 through December 2016. Daptomycin susceptibility was determined by MicroScan WalkAway™ System and confirmed by E-test. Susceptibility of oritavancin and linezolid was performed by broth microdilution using the Sensititre™ panel in accordance with the guidelines of the Clinical and Laboratory Standards Institute and package insert of the manufacturer. The isolates were confirmed by analysis of 16S rRNA gene sequence or by the MALDI Biobiotyper CA System™. Results: A total of 24 nonduplicate E. faecium clinical isolates were analyzed in this study. 19/24 isolates were DNSE (6-96 μg/ml), 4/24 were LRE (8-16 μg/ml) and 2/24 were both DNSE and LRE. The MIC50 and MIC90 of oritavancin against combined resistant enterococci isolates was 0.06 μg/ml and 0.25 μg/ml (range: 0.008 – 0.25 μg/ml) respectively.
    [Show full text]
  • Use of Ceftaroline Fosamil in Children: Review of Current Knowledge and Its Application
    Infect Dis Ther (2017) 6:57–67 DOI 10.1007/s40121-016-0144-8 REVIEW Use of Ceftaroline Fosamil in Children: Review of Current Knowledge and its Application Juwon Yim . Leah M. Molloy . Jason G. Newland Received: November 10, 2016 / Published online: December 30, 2016 Ó The Author(s) 2016. This article is published with open access at Springerlink.com ABSTRACT infections, CABP caused by penicillin- and ceftriaxone-resistant S. pneumoniae and Ceftaroline is a novel cephalosporin recently resistant Gram-positive infections that fail approved in children for treatment of acute first-line antimicrobial agents. However, bacterial skin and soft tissue infections and limited data are available on tolerability in community-acquired bacterial pneumonia neonates and infants younger than 2 months (CABP) caused by methicillin-resistant of age, and on pharmacokinetic characteristics Staphylococcus aureus, Streptococcus pneumoniae in children with chronic medical conditions and other susceptible bacteria. With a favorable and those with invasive, complicated tolerability profile and efficacy proven in infections. In this review, the microbiological pediatric patients and excellent in vitro profile of ceftaroline, its mechanism of action, activity against resistant Gram-positive and and pharmacokinetic profile will be presented. Gram-negative bacteria, ceftaroline may serve Additionally, clinical evidence for use in as a therapeutic option for polymicrobial pediatric patients and proposed place in therapy is discussed. Enhanced content To view enhanced content for this article go to http://www.medengine.com/Redeem/ 1F47F0601BB3F2DD. Keywords: Antibiotic resistance; Ceftaroline J. Yim (&) fosamil; Children; Methicillin-resistant St. John Hospital and Medical Center, Detroit, MI, Staphylococcus aureus; Streptococcus pneumoniae USA e-mail: [email protected] L.
    [Show full text]
  • Consideration of Antibacterial Medicines As Part Of
    Consideration of antibacterial medicines as part of the revisions to 2019 WHO Model List of Essential Medicines for adults (EML) and Model List of Essential Medicines for children (EMLc) Section 6.2 Antibacterials including Access, Watch and Reserve Lists of antibiotics This summary has been prepared by the Health Technologies and Pharmaceuticals (HTP) programme at the WHO Regional Office for Europe. It is intended to communicate changes to the 2019 WHO Model List of Essential Medicines for adults (EML) and Model List of Essential Medicines for children (EMLc) to national counterparts involved in the evidence-based selection of medicines for inclusion in national essential medicines lists (NEMLs), lists of medicines for inclusion in reimbursement programs, and medicine formularies for use in primary, secondary and tertiary care. This document does not replace the full report of the WHO Expert Committee on Selection and Use of Essential Medicines (see The selection and use of essential medicines: report of the WHO Expert Committee on Selection and Use of Essential Medicines, 2019 (including the 21st WHO Model List of Essential Medicines and the 7th WHO Model List of Essential Medicines for Children). Geneva: World Health Organization; 2019 (WHO Technical Report Series, No. 1021). Licence: CC BY-NC-SA 3.0 IGO: https://apps.who.int/iris/bitstream/handle/10665/330668/9789241210300-eng.pdf?ua=1) and Corrigenda (March 2020) – TRS1021 (https://www.who.int/medicines/publications/essentialmedicines/TRS1021_corrigenda_March2020. pdf?ua=1). Executive summary of the report: https://apps.who.int/iris/bitstream/handle/10665/325773/WHO- MVP-EMP-IAU-2019.05-eng.pdf?ua=1.
    [Show full text]
  • Oritavancin - Rev.0 / 14.01.2016 Oritavancin Antibiotic Disc for Susceptibility Testing of Gram-Positive Bacteria
    © Liofilchem® - Oritavancin - Rev.0 / 14.01.2016 Oritavancin Antibiotic disc for susceptibility testing of Gram-positive bacteria. DESCRIPTION Oritavancin, formerly LY333328, is a lipoglycopeptide with broad-spectrum activity against Gram-positive pathogens, such as staphylococci, including methicillin resistant Staphylococcus aureus (MRSA), streptococci and enterococci. This antimicrobial agent causes cell death by inhibiting cell wall synthesis as well as depolarizing and permeabilizing the cellular membrane of susceptible organisms. Oritavancin (ORBACTIV®), has been recently approved by the FDA and EMA for the treatment of adults with acute bacterial skin and skin structure infections (ABSSSI) caused by Staphylococcus aureus (including methicillin-susceptible and methicillin–resistant isolates), Streptococcus pyogenes, Streptococcus agalactiae, Streptococcus dysgalactiae, Streptococcus anginosus group (includes S. anginosus, S. intermedius, and S. constellatus), and Enterococcus faecalis (vancomycin- susceptible isolates only). Great benefits, compared to other drugs having similar therapeutic indications, derive from its single, once-only dosing regimen administered by intravenous infusion. As claimed by the drug’s Manufacturer as well, to reduce the development of drug-resistant bacteria and maintain the effectiveness of oritavancin and other antibacterial drugs, ORBACTIV® should be used only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria. Therefore, the confirmation of susceptibility of a given isolate to oritavancin becomes of primary importance. CONTENTS OF THE PACKAGES The 50-test box contains 1 cartridge with 50 discs packed in a desiccant envelop. The 250-test box contains 5 desiccant envelops, each containing 1 cartridge with 50 discs. Each package also contains a transparent plastic resealable pouch. GATHERING AND KEEPING SAMPLES The colonies that are to be subjected to the susceptibility test are taken up by culture media that have been previously swabbed with the sample under examination.
    [Show full text]
  • 206334Orig1s000
    CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 206334Orig1s000 SUMMARY REVIEW NDA 206-334 Deputy Division Director Summary Memo disrupts the integrity of the bacterial membrane, leading to depolarization, permeabilization, and cell death. Oritavancin is active against certain Gram-positive bacteria, including staphylococci and streptococci. The initial NDA for oritavancin was submitted in February 2008 by Targanta Therapeutics Corporation, later acquired by MDCO, for an indication of complicated skin and skin structure infections (cSSSI). However, the NDA received a complete response on December 8, 2008, for deficiencies including a lack of substantial evidence of efficacy, and concerns about a greater number of deaths and serious adverse events due to sepsis and related events, and a higher reported rate of adverse events of infections and infestations among oritavancin-treated subjects. After acquiring Targanta, MDCO initiated a new clinical development program for oritavancin for ABSSSI including a new Phase 2 dose-finding study, a thorough QT study, and two new Phase 3 trials. The original NDA (22-153) was withdrawn on September 6, 2013. Under the provisions of the Generating Antibiotic Incentives Now provision of the Food and Drug Administration Safety and Innovation Act of 2012, oritavancin diphosphate was granted Qualified Infectious Disease Product (QIDP) designation and therefore this application was granted a priority review. QIDP designation qualifies oritavancin for an additional five years of marketing exclusivity. This memo will summarize important findings and conclusions by review discipline. For further details, please refer to discipline specific reviews and the CDTL memo by Yuliya Yasinskaya, MD. 2.0 Product Quality This NDA has been reviewed by multiple product quality reviewers.
    [Show full text]
  • Orbactiv, INN-Oritavancin
    ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 1 1. NAME OF THE MEDICINAL PRODUCT Tenkasi 400 mg powder for concentrate for solution for infusion 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial contains oritavancin diphosphate equivalent to 400 mg oritavancin. After reconstitution, 1 ml of the solution contains 10 mg oritavancin. After dilution, 1 ml of the solution for infusion contains 1.2 mg oritavancin. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Powder for concentrate for solution for infusion (powder for concentrate). White to off-white powder. 4. CLINICAL PARTICULARS 4.1 Therapeutic indications Tenkasi is indicated for the treatment of acute bacterial skin and skin structure infections (ABSSSI) in adults (see sections 4.4 and 5.1). Consideration should be given to official guidance on the appropriate use of antibacterial agents. 4.2 Posology and method of administration Posology 1,200 mg administered as a single dose by intravenous infusion over 3 hours. Special populations Elderly (≥ 65 years) No dosage adjustment is required for patients ≥ 65 years of age (see section 5.2). Renal impairment No dosage adjustment is needed in patients with mild or moderate renal impairment (see section 5.2). The pharmacokinetics of oritavancin in patients with severe renal impairment has not been evaluated. Oritavancin is not removed from blood by haemodialysis procedures. Hepatic impairment No dosage adjustment is required for patients with mild to moderate hepatic impairment (Child-Pugh Class B) (see section 5.2). The pharmacokinetics of oritavancin in patients with severe hepatic impairment (Child-Pugh Class C) has not been evaluated, however based on pharmacokinetic parameters, severe hepatic impairment is not expected to have an impact on oritavancin exposure.
    [Show full text]
  • Outpatient Parenteral Antimicrobial Therapy for Infectious Diseases 3Ed
    Outpatient Parenteral Antimicrobial Therapy Handbook of For Infectious Diseases 3ed The Sponsored by Medicines Company ©2016 CRG Publishing, a Division of The Curry Rockefeller Group, LLC, and the Infectious Diseases Society of America All rights reserved. No part of the OPAT eHandbook may be reproduced in any form by any means (eg, electronically, mechanically, copied, recorded, or otherwise), or utilized by any information storage or retrieval system, without the written permission of CRG Publishing and the Infectious Diseases Society of America. For information, contact Rights and Permissions Coordinator, The Curry Rockefeller Group, Suite 410, 660 White Plains Road, Tarrytown, New York, 10591, USA. The Sponsored by Medicines Company Supported by Handbook of Outpatient Parenteral Antimicrobial Therapy For Infectious Diseases 3ed Akshay B. Shah, MD, MBA, FIDSA Anne H. Norris, MD Chair, OPAT Workgroup of IDSA Co-Chair, OPAT Guidelines Committee of IDSA Metro Infectious Disease Consultants Associate Professor of Medicine Editors Clinical Assistant Professor Perelman School of Medicine, University of Pennsylvania Wayne State University Philadelphia, PA Detroit, MI CRG PUBLISHING, A DIVISION OF THE CURRY ROCKEFELLER GROUP, LLC Geneve M. Allison, MD, MSc, FACP Ajay Mathur, MD, FACP Akshay B. Shah, MD, MBA, FIDSA Assistant Professor Regional VP Chair, OPAT Workgroup of IDSA Tufts University School of Medicine ID Care Metro Infectious Disease Consultants Clinical Assistant Professor Antonio C. Arrieta, MD David S. McKinsey, MD Wayne State University Division Chief, Infectious Diseases Physician Children’s Hospital of Orange County Infectious Disease Associates of Kansas City Nabin Shrestha, MD, MPH, FACP, FIDSA Infectious Disease Physician Kavita P. Bhavan, MD Sandra B.
    [Show full text]
  • Full Prescribing Information for Prolong Aptt for up to 120 Hours, and May Prolong PT and INR for up ORBACTIV
    HIGHLIGHTS OF PRESCRIBING INFORMATION ------------------------WARNINGS AND PRECAUTIONS----------------------- These highlights do not include all the information needed to use • Coagulation test interference: ORBACTIV has been shown to artificially ORBACTIV safely and effectively. See full prescribing information for prolong aPTT for up to 120 hours, and may prolong PT and INR for up ORBACTIV. to 12 hours and ACT for up to 24 hours. For patients who require aPTT monitoring within 120 hours of ORBACTIV dosing, consider a ORBACTIV® (oritavancin) for injection, for intravenous use non-phospholipid dependent coagulation test such as a Factor Xa Initial U.S. Approval: 2014 (chromogenic) assay or an alternative anticoagulant not requiring aPTT. (5.1, 7.2) ----------------------------INDICATIONS AND USAGE--------------------------- • Serious hypersensitivity reactions, including anaphylaxis, have been ORBACTIV is a lipoglycopeptide antibacterial drug indicated for the reported with the use of oritavancin products, including ORBACTIV. treatment of adult patients with acute bacterial skin and skin structure Discontinue infusion if signs of acute hypersensitivity occur. Carefully infections caused or suspected to be caused by susceptible isolates of monitor patients with known hypersensitivity to glycopeptides. (5.2) designated Gram-positive microorganisms. (1.1) • Infusion Related Reactions: Administer ORBACTIV over 3 hours to minimize infusion. Infusion related reactions have been reported with To reduce the development of drug-resistant bacteria and maintain the the glycopeptide class of antimicrobial agents, including oritavancin effectiveness of ORBACTIV and other antibacterial drugs, ORBACTIV products (e.g. ORBACTIV). Stopping or slowing the infusion may result should be used only to treat or prevent infections that are proven or strongly in cessation of these reactions.
    [Show full text]
  • Skin, Skin Structure, and Soft Tissue Infection Diagnosis and Treatment – Adult – Inpatient/Ambulatory Clinical Practice Guideline
    Skin, Skin Structure, and Soft Tissue Infection Diagnosis and Treatment – Adult – Inpatient/Ambulatory Clinical Practice Guideline Note: Active Table of Contents – Click to follow link Table of Contents EXECUTIVE SUMMARY ........................................................................................................... 3 SCOPE ...................................................................................................................................... 4 METHODOLOGY ...................................................................................................................... 4 DEFINITIONS ............................................................................................................................ 5 INTRODUCTION ....................................................................................................................... 6 RECOMMENDATIONS .............................................................................................................. 6 TABLE 1. ANTIMICROBIAL AGENTS DIRECTED AT STREPTOCOCCUS SPP. .................. 9 TABLE 2. ANTIMICROBIAL AGENTS DIRECTED AT STREPTOCOCCUS SPP. AND MSSA9 TABLE 3. ANTIMICROBIAL AGENTS DIRECTED AT STREPTOCOCCUS SPP., MSSA, AND MRSA .......................................................................................................................................10 TABLE 4. ANTIMICROBIAL AGENTS DIRECTED AT STREPTOCOCCUS SPP., MSSA, MRSA, AND GRAM-NEGATIVES ............................................................................................10
    [Show full text]
  • Gram Positive Cocci (GPC) Gram Neg (Rods = GNR) Anaerobes
    Gram Positive Cocci (GPC) Gram Neg (rods = GNR) Anaerobes Atypicals Classification Antibiotic Cluster Streptococcus Entero- Resp Enteric Non- Bacteroides, Mycoplasma = Staph β↓ & α-hemolytic↓ coccus (cocci) GI flora enteric Clostridium Legionella Beta-Lactams General Spectrum MSSA Group pneumo, faecalis H. flu, E. coli, Pseud- (non-dfficile) Chlamydia Penicillins of Activity → only A / B Viridans only M. cat Klebsiella omonas Peptostrep. (pneumonia) Natural Penicillin G IV/ PenVK PO +/- ++ + + 0 0 0 + 0 Anti- Oxacillin/Nafcillin IV, ++ ++ + 0 0 0 0 0 0 Staphylococcal Dicloxacillin PO Aminopenicillins Amp/Amoxicillin IV/PO 0 ++ + ++ +R +/- 0 + 0 Anti-Pseudomonal Piperacillin/Ticarcillin IV 0 + + + + + ++R + 0 Beta-Lactamase Clavulanate IV/PO, sulbactam Increase Inc by Increase Increase Inhibitor added tazobactam, vaborbactam IV by + + by + by + Cephalosporins Cefazolin IV/ ++ ++ +/- 0 +/- + 0 0 0 1st Generation Cephalexin PO 2nd Generation Cefuroxime IV/PO + ++ + 0 + + 0 +/- 0 Cephamycins Cefoxitin/Cefotetan IV 0 + 0 0 + + 0 + 0 3rd Generation Ceftriaxone/Cefotaxime IV + ++ ++ 0 ++ ++R 0 +/- 0 (PO in between 2nd Ceftazidime IV (+ Avibactam 0 + 0 0 ++ ++R ++R 0 0 and 3rd gen) for Carb-Resistant Enterics) 4th Generation Cefepime IV + ++ ++ 0 ++ ++ ++R 0 0 Novel Ceftolozane-tazo/Cefiderocol 0 + + 0 ++ ++ ++ +/- 0 Carbapenems Imipenem, Meropenem IV + + + +/- ++ ++ ++R ++ 0 (+rele/vaborbactam for CRE) Ertapenem IV + ++ ++ 0 ++ ++ 0 ++ 0 Monobactam Aztreonam IV 0 0 0 0 ++ ++R + 0 0 Non β-Lactams Includes MRSA Both sp. Aminoglycosides Gentamicin,
    [Show full text]
  • Summary of the Risk Management Plan (RMP) for Orbactiv (Oritavancin)
    EMA/81390/2015 Summary of the risk management plan (RMP) for Orbactiv (oritavancin) This is a summary of the risk management plan (RMP) for Orbactiv, which details the measures to be taken in order to ensure that Orbactiv is used as safely as possible. For more information on RMP summaries, see here. This RMP summary should be read in conjunction with the EPAR summary and the product information for Orbactiv, which can be found on Orbactiv’s EPAR page. Overview of disease epidemiology Orbactiv is an antibiotic used in adults to treat acute (short-term) bacterial infections of the skin and skin structures (tissue below the skin) such as cellulitis (inflammation of the deep skin tissue), skin abscesses and wound infections. Skin infections are typically caused by bacteria that live on the skin as part of the natural flora, such as Staphylococcus aureus and Streptococcus pyogenes. Some of these bacteria may become resistant and can no longer be killed by the more commonly used antibiotics as is the case for a bacterium called methicillin-resistant Staphylococcus aureus (MRSA). The percentage of MRSA infections ranges from 10 to 40% in European hospitals Summary of treatment benefits Orbactiv contains the active substance oritavancin, which is a type of antibiotic called a glycopeptide. A single dose of Orbactiv was compared with a 10-day treatment with vancomycin (another glycopeptide) in two main studies involving a total of around 1959 patients with acute bacterial infections of the skin and of skin structures, such as cellulitis, skin abscesses and wound infections. These also included infections caused by MRSA.
    [Show full text]
  • Distinct Effectiveness of Oritavancin Against Tolerance-Induced
    antibiotics Communication Distinct Effectiveness of Oritavancin against Tolerance-Induced Staphylococcus aureus Andrew D. Berti 1,2,* , Lauren T. Harven 1 and Victoria Bingley 1 1 Department of Pharmacy Practice, Wayne State University College of Pharmacy and Health Sciences, Detroit, MI 48201, USA; [email protected] (L.T.H.); [email protected] (V.B.) 2 Department of Biochemistry, Microbiology and Immunology, Wayne State University College of Medicine, Detroit, MI 48201, USA * Correspondence: [email protected]; Tel.: +1-313-577-3565 Received: 20 October 2020; Accepted: 6 November 2020; Published: 8 November 2020 Abstract: Within a sufficiently large bacterial population, some members will naturally adopt an alternate, metabolically-active state that favors small molecule synthesis over cell division. These isogenic “tolerant” subpopulations have variable responses during antibiotic exposure and can remain viable in the presence of typically bactericidal concentrations. In this study, we determine the ability of typical and atypical antistaphylococcal therapies to reduce the viability of mupirocin-induced tolerant Staphylococcus aureus bacteria. Overall, tolerance-induced staphylococci exhibited a markedly decreased rate and extent of killing following antibiotic exposure. However, oritavancin remained effective at maintaining a similar extent of killing. Further studies to investigate the role of oritavancin against recurrent or relapse staphylococcal infection are warranted. Keywords: MRSA; oritavancin; tolerance; persistence; lipoglycopeptide 1. Introduction Staphylococcus aureus is the most common invasive human pathogen and remains a major contributor to infection-related morbidity and mortality [1]. Clinicians have long recognized the role of antibiotic resistance in treatment failures [2]. Over the past decade, it has become clear that antibiotic tolerance can also contribute to unfavorable clinical outcomes [3].
    [Show full text]