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QUOFENIX®(delafloxacin)

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

QUOFENIX®(delafloxacin) offers flexible oral and IV monotherapy, simplifying the treatment for complex patients with difficult-to-treat and/or polymicrobal infections. It has broad spectrum cover for Gram-positive and Gram-negative bacteria, including methicillin-resistant Staphylococcus aureus (MRSA) and Pseudomonas aeruginosa.1,2

Why do we need another quinolone antibiotic?3

Quinolone antibiotics have been widely used for more than five decades as they are highly potent, broad-spectrum agents that offer favourable bioavailability, convenient formulations, high serum concentrations and a relatively low incidence of adverse effects.

  • Development of new anti-infectives is part of the solution to the antimicrobial resistance (AMR) crisis3
  • Quinolones are classified by the WHO as one of the highest priority critically important antimicrobials3
  • Clinicians require new antibiotics that are active against resistant strains to expand their treatment options5
  • Potential monotherapies for patients with polymicrobial infections who may be at higher risk of inadequate treatment and require broad-spectrum antibacterials6
  • Finding extended spectrum fluoroquinolones with safer profiles, capable of penetrating acidic sites of infection thus requiring lower minimum inhibitory concentrations (MICs), is one solution to the fight against AMR7

Fluoroquinolone in vitro activity comparison

Approximate guide to relative in vitro activity*2,8–14

* In vitro activity does not necessarily correlate with clinical effectiveness [green = highest activity fluoroquinolones, red = lowest, orange = mid-range activity].
  delafloxacin moxifloxacin levofloxacin ciprofloxacin
S. aureus (MRSA)

 

     
S. aureus (MSSA)        
Streptococcus pneumoniae        
Haemophilus influenzae        
Escherichia
coli
       
Pseudomonas aeruginosa        
Mycoplasma pneumoniae        
Anaerobes
   
     

QUOFENIX® (delafloxacin)?

QUOFENIX® (delafloxacin) for appropriate use in complex patients with difficult-to-treat infections1

QUOFENIX® (delafloxacin):

  • has a unique anionic character and potent activity against Gram-positive bacteria including MRSA and Gram-negative bacteria including Pseudomonas aeruginosa1,15
  • is a potential monotherapy for polymicrobial infections and/or for MRSA infection15,16
  • provides dual targeting of DNA-gyrase and topoisomerase IV which helps reduce selection of resistant mutants in MRSA1,17
  • is available in both IV and oral formulations to facilitate early hospital discharge1,18
  • is generally well tolerated and is not associated with clinically relevant QTc prolongation19 or phototoxicity20 and has a low potential for drug-drug interactions1,21 making it useful for complex patients with comorbidities

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.

VABOREM® (meropenem/vaborbactam)

VABOREM is indicated 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)
  • patients with bacteraemia that occurs in association with, or is suspected to be associated with, any of the infections listed above
  • infections due to aerobic Gram-negative organisms with limited treatment options

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

Anti-infective webinars

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

Antimicrobial resistance and the role of stewardship

Committed to the fight against AMR by providing effective and innovative solutions to treat resistant infections. Supporting responsible use 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. QUOFENIX® Summary of Product Characteristics.
  2. Jorgensen SCJ et al. Infect Dis Ther 2018;7(2):197–217.
  3. World Health Organization. Critically Important Antimicrobials for Human Medicine 6th revision. Advisory Group on Integrated Surveillance of Antimicrobial Resistance (AGISAR). March 2019. Available from: https://www.who.int/publications/i/item/9789241515528 (accessed September 2021).  
  4. Pham TDM et al. Med Chem Commun 2019;10(10):1719–1739.
  5. World Health Organization. Antimicrobial resistance. October 2020. Available from: https://www.who.int/news-room/fact-sheets/detail/antimicrobial-resistance (accessed September 2021).
  6. Scott LJ. Drugs 2020;80:1247–1258.
  7. Bassetti M et al. Future Microbiol 2018;13:1081–1094.
  8. Almer LS et al. Antimicrob Agents Chemother 2004;48(7): 2771–2777.
  9. McCurdy S et al. Antimicrob Agents Chemother 2017;61(9):e00772–17.
  10. Flamm RK et al. Antimicrob Agents Chemother 2016;60(10):6381–6385.
  11. McCurdy S et al. Int J Infect Dis 2020;97:374379.
  12. Shortridge D et al. J Glob Antimicrob Resist 2020;23:278–283.
  13. Sillerström E et al. J Chemother 2004;16(3):227–229.
  14. Mogle BT et al. J Antimicrob Chemother 2018;73(6):1439–1451.
  15. O’Riordan W et al. Clin Infect Dis 2018;67(5):657–666.
  16. McCurdy S et al. Antimicrob Agents Chemother 2020;64:e01949–19.
  17. Remy JM et al. J Antimicrob Chemother 2012;67(12):2814–2820.
  18. Dryden M et al. J Antimicrob Chemother 2012;67(9):2289–2296.
  19. Litwin JS et al. Antimicrob Agents Chemother 2015;59(6):3469–3473.
  20. Dawe RS et al. Photochem Photobiol Sci 2018;17(6):773780.
  21. Hoover R et al. J Clin Pharmacol 2017;57(3):328–335.
  22. 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).
  23. 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).
  24. VABOREM® Summary of Product Characteristics.

These medicinal products are subject to additional monitoring.

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]

PP-QUO-UK-0217 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