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Zinforo®: an established safety and tolerability profile consistent with other cephalosporins* 

The efficacy and tolerability of Zinforo monotherapy has been consistently demonstrated in six large, double-blind, Phase III, randomised, controlled clinical trials: three involving adult patients with cSSTI and three in patients with CAP.2-5

A safety and tolerability profile consistent with comparator therapies in clinical studies *ǁ2,4,6–9

Low potential for drug–drug interactions‡1,7

No routine monitoring of renal function required§1

Suitable for use in elderly patients and those with certain  comorbidities§1,2,4,5,6, 8,10

Very common and common adverse reactions by system organ class from clinical trials and post-marketing experience1

System organ class ​​​​​​​

Very common

Common

Immune system disorders

Rash, pruritus

Nervous system disorders

Headache, dizziness

Vascular disorders

Phlebitis

Gastrointestinal disorders

Diarrhoea, abdominal pain, nausea, vomiting

Hepatobiliary disorders

Increased transaminases

General disorders and administration site conditions

Pyrexia, infusion site reactions (erythema, phlebitis, pain)

Investigations

Coombs Direct Test Positive

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Discover further specific information on the use of Zinforo in neonates, infants and children here:


Footnotes
*Zinforo is contraindicated in patients with hypersensitivity to any active substance or excipient and should not be used in patients with a history of hypersensitivity to other cephalosporin-class antibiotics or who have had an immediate and severe hypersensitivity reaction (e.g., anaphylaxis to other β-lactam antibacterial agents). Fatal hypersensitivity reactions are possible.1 Antibacterial-associated colitis and pseudomembranous colitis (Clostridium difficile) have been reported including cases that were life-threatening.1Patients with a pre-existing seizure disorder should use Zinforo with caution as seizures occurred in toxicology studies at doses higher than typical human exposures.1 DAGT (Coombs test) became positive in 11.2% of patients from five pooled pivotal studies in patients who received Zinforo every 12 hours and in 32.3% of patients who received Zinforo every 8 hours. Although no patients developed haemolytic anaemia, there remains a potential risk.1 The most common adverse reactions occurring in ≥3% of patients treated with Zinforo were diarrhoea, headache, nausea, and pruritus and were generally mild or moderate in severity.1
ǁComparator therapies: cSSTI, ceftriaxone; CAP, vancomycin or cefazolin, plus optional aztreonam.
Antibacterial-associated colitis and pseudomembranous colitis have been reported with ceftaroline fosamil and may range in severity from mild to life threatening. Therefore, it is important to consider this diagnosis in patients who present with diarrhoea during or subsequent to the administration of ceftaroline fosamil. In such circumstance, the discontinuation of therapy with ceftaroline fosamil and the use of supportive measures together with the administration of specific treatment for Clostridium difficile should be considered.
No clinical drug–drug interaction studies have been conducted with Zinforo.1
§The dose should be adjusted when CrCL is ≤50 mL/min.1
Abbreviations
​​​​​​​
cSSTI, complicated skin and soft tissue infection; CAP, community-acquired pneumonia. 

Prescribing Information​​​​​​​

Zinforo 600 mg powder for concentrate for solution for infusion

References
  1. ZINFORO. Summary of product characteristics
  2. File TM, et al. Clin Infect Dis 2010;51:1395–405
  3. Zhong N, et al. Lancet Infect Dis 2015;15:161–71
  4. Corey G, et al. Clin Infect Dis 2010;51:641–50
  5. Dryden M, et al. J Antimicrob Chemother 2016;71:3575–84
  6. Ramani A, et al. J Chemother 2014;26:229–34
  7. Lodise TP, Low DE. Drugs 2012;72:1473–93
  8. Santos PD, et al. J Chemother 2013;25:341–6
  9. Corrado ML. J Antimicrob Chemother 2010;65(Suppl 4):iv67–iv71
  10. Evans JD, et al. Postgrad Med 2014;126:128–34
PP-ZFO-GBR-0138. June 2021

Explore the outcomes of Zinforo Phase III clinical trials in adult patients with CAP and cSSTI

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PP-PFE-GBR-2688. December 2020

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