Hvorfor Zinforo?

Dokumentert effekt

Ved cSSTI (kompliserte hud- og bløtdelsinfeksjoner)

Effekt er vist i tre store fase III kliniske studier, understøttet av erfaring fra klinisk praksis1,2,3,4.

  • Non-inferior effekt vs. vancomycin + aztreonam i CANVAS 1 og CANVAS 25
  • Non-inferior effekt av ZINFORO vs. vancomycin + aztreonam i COVERS-studien på pasienter med SIRS eller underliggende komorbiditet*3
Ved CAP (pneumoni ervervet utenfor sykehus)

Effekt er vist i tre store fase III kliniske studier, understøttet av erfaring fra klinisk praksis4,6,7,8.

  • Non-inferior effekt vs. ceftriaxone 1 g i FOCUS 1 og FOCUS 26.
  • Superior effekt vs. ceftriaxone 2 g i Asia CAP-studie9.

 

Utvidet gramnegativ og grampositiv patogendekning5,6,10

  • Inkludert nøkkelpatogener i cSSTI og CAP*

†Effekten er demonstrert i cSSTI kliniske studier mot følgende patogener som er følsomme overfor ZINFORO in vitro: Staphylococcus aureus (inkludert methicillin-resistent stamme), Streptococcus pyogenes, Streptococcus agalactiae, Streptococcus anginosus gruppe  (omfatter S. anginosus, S. intermedius og S. constellatus), Streptococcus dysgalactiae, Escherichia coli, Klebsiella pneumoniae, Klebsiella oxytoca og Morganella morganii10.

*Effekten er demonstrert i CAP kliniske studier mot følgende patogener som er følsomme overfor ceftaroline in vitro:  Streptococcus pneumoniae, Staphylococcus aureus (kun methicillin-susceptible stamme), Escherichia coli, Haemophilus influenzae, Haemophilus parainfluenzae og Klebsiella pneumoniae10.

 

 

Sikkerhets- og tolerabilitetsprofilen konsistent med andre cefalosporiner2,4,5,6,11,12

  • Egnet for bruk hos pasienter med komorbiditeter
  • Sikkerhetsprofilen i den pediatriske populasjonen er tilsvarende som den observert hos voksne‡10

‡ Basert på to kliniske studier i 227 pediatriske pasienter i alderen 2 måneder til 17 år10.

Referanser:

1. Dryden M, Zhang Y, Wilson D et al, A Phase III, randomized, controlled, non-inferiority trial of ceftaroline fosamil 600 mg every 8 h versus vancomycin plus aztreonam in patients with complicated skin and soft tissue infection with systemic inflammatory response or underlying comorbidities, J Antimicrob Chemother 2016;71:3575–84
2. Santos PD, Davis A, Jandourek A et al, Ceftaroline fosamil and treatment of acute bacterial skin and skin structure infections: CAPTURE study experience, J Chemother 2013;25:341–6
3. Maggiore C,Pasquale T, Cole P et al, Ceftaroline fosamil for treating skin and skin structure infections or community-acquired pneumonia in patients with renal insufficiency, Expert Rev Clin Pharmacol 2015;8:141–53.
4. Ramani A, Udeani G, Evans J et al, Contemporary use of ceftaroline fosamil for the treatment of community-acquired bacterial pneumonia: CAPTURE study experience, J Chemother 2014;26:229–34.
5. Corey G, Wilcox M, Talbot G, et al, CANVAS 1: the first Phase III, randomized, double-blind study
evaluating ceftaroline fosamil for the treatment of patients with complicated skin and skin structure infections, Clin Infect Dis 2010;51:641–50
6. File TM, Low DE, Eckburg PB, et al, Integrated Analysis of FOCUS 1 and FOCUS 2: Randomized, Doubled-  Blinded, Multicenter Phase 3 Trials of the Efficacy and Safety of Ceftaroline Fosamil versus Ceftriaxone in Patients with Community-Acquired Pneumonia, Clin Infect Dis 2010; 51:1395–4056. File TM, Low DE, Eckburg PB, et al, Integrated Analysis of FOCUS 1 and FOCUS 2: Randomized, Doubled-  Blinded, Multicenter Phase 3 Trials of the Efficacy and Safety of Ceftaroline Fosamil versus Ceftriaxone in Patients with Community-Acquired Pneumonia, Clin Infect Dis 2010; 51:1395–405
7.   Udeani G, Evans J, Friedland HD, Ceftaroline Fosamil for the Treatment of Community-Acquired Bacterial Pneumonia in Elderly Patients, Hosp Prac 2014;42:109–15.
8. Friedland HD, O’Neal T, Biek D et al, CANVAS 1 and 2: Analysis of clinical response at day 3 in two phase 3 trials of Ceftaroline fosamil versus Vancomycin plus Aztreonam in treatment of acute bacterial skin and skin structure infections, Antimicrob Agents Chemother 2012;56:2231–6.
9. Zhong N, Sun C, D’Souza G et al, Ceftaroline fosamil versus ceftriaxone for the treatment of Asian patients with community-acquired pneumonia: a randomised, controlled, double-blind, phase 3, non-inferiority with nested superiority trial, Lancet Infect Dis 2015;15:161–71
10. Zinforo SPC, 21.12.2017
11. Lodise TP, Low DE, Ceftaroline Fosamil in the Treatment of Community-Acquired Bacterial Pneumonia and Acute Bacterial Skin and Skin Structure, Infections Drugs 2012;72:1473–93.
12. Mannino DM, Davis KJ, Kiri VA, Chronic obstructive pulmonary disease and hospitalizations for pneumonia in a US cohort, Respir Med 2009;103:224–9.

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