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Zinforo® has a proven tolerability profile in children of all ages, including neonates 

Similar tolerability profile to that observed in adults and consistent with comparator therapies in clinical studies*†‡1-7 

In two paediatric studies, the AE profile of Zinforo was similar to comparator therapies‡6,7:

  • Overall rates of any AE were low in the Zinforo and comparator groups
  • Most common (≥3%) AEs for Zinforo were diarrhoea, rash and vomiting
  • Most AEs were mild or moderate in intensity
  • Low rate of discontinuation due to AEs (<4% in both CAP and cSSTI)

Overall, the AEs reported in studies in neonates were consistent with the known tolerability profile for Zinforo||1

The safety assessment in neonates is based on the safety data from two trials in which 34 patients (birth to <60 days) received Zinforo; 23 of these patients received only a single dose of Zinforo1

Low potential for drug–drug interactions§1,4 

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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
†Based on two clinical trials in 227 paediatric patients aged from 2 months to 17 years. The most common adverse reactions occurring in ≥3% of patients treated with Zinforo were diarrhoea, rash and vomiting, and were generally mild or moderate in severity.6,7
‡Comparator therapies: cSSTI, ceftriaxone; CAP, vancomycin or cefazolin, plus optional aztreonam.
​​​​​​​§No clinical drug-drug interaction studies have been conducted with Zinforo.1
|| The safety assessment in neonates is based on the safety data from 2 trials in which 34 patients (age range from birth to less than 60 days) received Zinforo; 23 of these patients received only a single dose of Zinforo. Overall, the adverse events reported in these studies were consistent with the known safety profile for Zinforo.1
Abbreviations
​​​​​​​
cSSTI, complicated skin and soft tissue infection; CAP, community-acquired pneumonia. 

Prescribing Information​​​​​​​

Zinforo® (ceftaroline fosamil)
Great Britain
Zinforo 600 mg powder for concentrate for solution for infusion
Northern Ireland
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. Corey G, et al. Clin Infect Dis 2010;51:641–50
  4. Lodise TP, Low DE. Drugs 2012;72:1473–93
  5. Corrado ML. J Antimicrob Chemother 2010;65(Suppl 4):iv67–iv71
  6. Korczowski B, et al. Pediatr Infect Dis J 2016;35:e239–47
  7. Cannavino CR, et al. Pediatr Infect Dis J 2016;35:752–9
PP-ZFO-GBR-0229. September 2021

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

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