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VABOREM®(meropenem/vaborbactam)

Prescribing Information for VABOREM®(meropenem/vaborbactam), QUOFENIX®(delafloxacin), and TENKASI®(oritavancin) can be found under Useful Links

VABOREM®(meropenem/vaborbactam) offers a directed therapy optimised for the treatment of Klebsiella pneumoniae carbapenemase (KPC)-producing carbapenem-resistant Enterobacteriaceae (CRE) infections.1

Why are CRE an urgent threat for patients and healthcare systems?

Worldwide, CRE are a major concern for patients in healthcare facilities.2 Carbapenem resistance is associated with high healthcare costs, prolonged hospital stays, treatment failure and high mortality rates.2–4

  • The World Health Organization (WHO) has identified extended spectrum beta lactamase (ESBL)-producing, carbapenem-resistant Enterobacterales as critical pathogens of concern5
  • KPC accounts for 12.5% of carbapenemase-producing Enterobacterales (CPE) reported cases in the UK6
  • CPE reporting is mandatory, and rapid access to diagnostics for the “big five” carbapenemase families is outlined in the Public Health England (PHE) Toolkit “Framework of actions to contain carbapenemase-producing Enterobacterales7


Number of confirmed CPE isolates referred to PHE’s antimicrobial resistance and healthcare associated infections (AMRHAI)


"Some [Enterobacterales] are resistant to nearly all antibiotics, leaving more toxic or less effective treatment options."2

(Centers for Disease Control and Prevention, USA)


What is VABOREM®?

VABOREM® is a first-line antibiotic for KPC-CRE infections

  • VABOREM® is optimised for the treatment of KPC-CRE infections1,8,9
  • A novel cyclic boronate beta-lactamase inhibitor (BLI), vaborbactam has high activity against class A and class C beta-lactamases1,4,10

Inhibition of beta-lactamases by vaborbactam8,10,11

Adapted from Hecker et al., 2015,8 Dhillon et al., 201810 and Toussaint et al., 2014.11
Ambler class Enzyme  Inhibited by vaborbactam 
Class A Serine carbapenemases (e.g. KPC, NMC-A, SME-2)
Vector 1.png
ESBL (e.g. SHV-2, PER-1)
Vector 1.png
Narrow spectrum (e.g. TEM-1, TEM-2)
Vector 1.png
Class B Metallo-β-lactamase (e.g. VIM-1, NDM-1)
Vector 2.png
Class CCephalopsorinases (e.g. AmpC, P99, ACT-1)
Vector 1.png
Class DOXA-48
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  • Monotherapy with VABOREM® for CRE infection is associated with increased clinical cure and marked trends towards lower mortality and nephrotoxicity compared with best available therapy (BAT)12*


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* Efficacy data of VABOREM monotherapy vs BAT (various treatment regimens) in patients with microbiologic-confirmed CRE-infections (modified ITT).

From TANGO II, a phase 3, randomised, prospective, multicentre, multinational, open-label, active-controlled trial of adults with cUTI, HAP/VAP, bacteraemia, and cIAI, due to known or suspected CRE. No formal power or sample size calculations were performed: differences in clinical cure at EOT and TOC, and Day-28 all-cause mortality were analysed using Wald test of equality. CRE, carbapenem-resistant Enterobacteriaceae; EOT, end of treatment; NS, not significant; TOC, test of cure. [Adapted from Wunderink et al. 2018].


  • VABOREM® has a low incidence of reported on-treatment resistance13,14

How is Menarini committed to the fight against antimicrobial resistance (AMR)?

Our medical educational programme “Infection in Focus” has been created by Menarini with the purpose of increasing awareness of AMR. We align our activities to best practice as set out in antimicrobial stewardship (AMS) programmes. You can find out more about AMR and AMS here.

Susceptibility tests are available

Aligned to good stewardship and to support clinical decision-making, susceptibility tests are available for VABOREM®(meropenem/vaborbactam),
QUOFENIX® (delafloxacin) and TENKASI®(oritavancin). To find out more, contact Menarini.

Quofenix® (delafloxacin)

Oral and IV option for MRSA and Pseudomonas aeruginosa1–3

Indicated for the treatment of the following infections in adults:1,2

  • acute bacterial skin and skin structure infections (ABSSSI)
  • community-acquired pneumonia (CAP)

Because of the risk of prolonged, disabling and potentially irreversible serious adverse drug reactions this product must only be prescribed when other antibiotics that are commonly recommended for these infections are inappropriate.1-2

Situations where other antibiotics are considered to be inappropriate are where:

  • there is resistance to other first-line antibiotics recommended for the infection
  • other first-line antibiotics are contraindicated in an individual patient
  • other first-line antibiotics have caused side effects requiring treatment to be stopped
  • treatment with other first-line antibiotics has failed

Consideration should be given to official guidance on the appropriate use of antibacterial agents.4

Anti-infective webinars

Access a range of informative webinars on anti-infectives, on demand

Antimicrobial resistance and the role of stewardship

Menarini is committed to the fight against AMR by providing effective and innovative solutions to treat resistant infections. Menarini also supports the responsible use of antibiotics aligned to best practice in AMS.

Product indications (refer to local SmPC for full details - details may vary between GB and NI):

QUOFENIX®(delafloxacin) is indicated for the treatment of the following infections in adults: (1) acute bacterial skin and skin structure infections (ABSSSI) (2) community-acquired pneumonia (CAP). Only prescribe when other antibiotics that are commonly recommended for these infections are inappropriate. [Refer to local SmPC for full indication details including risk of prolonged, disabling and potentially irreversible serious adverse drug reactions].1

VABOREM®(meropenem/vaborbactam) is indicated for use in adults for the treatment of: complicated urinary tract infection (cUTI) including pyelonephritis; complicated intra-abdominal infection (cIAI); hospital-acquired pneumonia (HAP) including ventilator-associated pneumonia (VAP); bacteraemia that occurs in association with, or is suspected to be associated with, any of these previously listed infections; infections due to aerobic Gram-negative organisms in adults with limited treatment options.24

TENKASI® (oritavancin) is indicated for the treatment of acute bacterial skin and skin structure infections (ABSSSI) in adults and paediatric patients aged 3 months and older.

 

References:

  1. VABOREM® Summary of Product Characteristics.
  2. Centers for Disease Control and Prevention. Antibiotic Resistance Threats in the United States, 2019. December 2019. Available from: https://www.cdc.gov/drugresistance/biggest-threats.html (accessed September 2021).
  3. Decraene V et al. Antimicrob Agents Chemother 2018;62(12):e01689–18.
  4. Petty LA et al. Infect Drug Resist 2018;11:1461–1472.
  5. World Health Organization. Global priority list of antibiotic-resistant bacteria to guide research, discovery, and development of new antibiotics. February 2017. Available from: https://www.who.int/medicines/publications/WHO-PPL-Short_Summary_25Feb-ET_NM_WHO.pdf (accessed September 2021).
  6. Public Health England. English surveillance programme for antimicrobial utilisation and resistance (ESPAUR) report 2019 to 2020. November 2020. Available from: https://www.gov.uk/government/publications/english-surveillance-programme-antimicrobial-utilisation-and-resistance-espaur-report (accessed September 2021).
  7. Public Health England. Framework of actions to contain carbapenemase-producing Enterobacterales. Available from: https://www.gov.uk/government/publications/actions-to-contain-carbapenemase-producing-enterobacterales-cpe (accessed September 2021).
  8. Hecker SJ et al. J Med Chem 2015;58(9):3682–3692.
  9. Bush K, Bradford PA. Nat Rev Microbiol 2019;17(5):295–306.
  10. Dhillon S. Drugs 2018;78(12):1259–1270.
  11. Toussaint KA et al. Ann Pharmacother 2015;49:86–98.
  12. Wunderink RG et al. Infect Dis Ther 2018;7(4): 439–455.
  13. Ackley R et al. Antimicrob Agents Chemother 2020; 64: e02313–19.
  14. Shields RK et al. Clin Infect Dis 2020; 71: 667–671.
  15. Public Health England. Antimicrobial stewardship: Start smart - then focus. March 2015. Available from: https://www.gov.uk/government/publications/antimicrobial-stewardship-start-smart-then-focus (accessed September 2021).
  16. QUOFENIX® Summary of Product Characteristics.

Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. Adverse events should also be reported to A. Menarini Farmaceutica Internazionale SRL. Phone 0800 085 8678 or email: [email protected]

These medicinal products are subject to additional monitoring.

PP-VAB-UK-0224 February 2024

Adverse events should be reported. Reporting forms and information can be found at www.yellowcard.mhra.gov.uk or search for MHRA Yellow Card in Google Play or Apple App Store.

Adverse events should also be reported to A. Menarini Farmaceutica Internazionale SRL.

Phone 0800 085 8678