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About Zinforo

About Zinforo

OverviewExtended spectrum coverageDosing

Dosing

Adult & adolescent dosingNeonatal & paediatric dosingEfficacy & Safety

Efficacy & Safety

EfficacyFOCUS Phase III Trial (CAP)CANVAS Phase III Trial (cSSTI)ASIA CAP Phase III TrialPaediatric EfficacyAdult safetyPaediatric SafetyClinical & Scientific Data

Clinical & Scientific Data

Patient Risk FactorsCAP patient profilescSSTI patient profilesCAPTURE studySupport & Resources

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Information on how to access prescribing information and adverse event reporting can be found at the bottom of the page.

Zinforo® can be used to treat paediatric patients with cSSTI or CAP from birth1Zinforo provides an early clinical response in paediatric patients with cSSTI2

Zinforo was as effective as comparator therapy in the treatment of paediatric patients aged 2 months to <18 years with cSSTI (N=159), including those caused by MRSA (n=18)*

Dosing:

  • ​​​​​​​Zinforo: Age- and weight-adjusted doses† infused over 60 minutes every 8 hours 
  • Comparators: Vancomycin 15 mg/kg infused over ≥60 minutes every 6 hours (or a maximum of 10 mg/min, whichever was longer), or cefazolin 75 mg/kg/day divided and infused every 8 hours (plus optional aztreonam 30 mg/kg infused every 8 hours if a Gram-negative pathogen was identified or suspected) 
  • A switch to oral therapy with either cephalexin, clindamycin or linezolid (depending on pathogen susceptibility) after Day 3 was permitted 
Clinical cure rates at test-of-cure‡ (MITT population) ​​​​​​​Clinical response (cessation of spread measured by total length and width separately, and temperature ≤37.6°C) at Day 3 (MITT population) ​​​​​​​Microbiological eradication‡ by baseline pathogen​​​​​​​Zinforo provides favourable clinical outcomes in paediatric patients with CAP3​​​​​​​

Zinforo had similar effectiveness to ceftriaxone in the treatment of paediatric patients aged 2 months to <18 years who were hospitalised with CAP (N=143)¶ ​​​​​​​

Dosing:

  • Zinforo: Age- and weight-adjusted doses† every 8 hours 
  • Ceftriaxone: 75 mg/kg (up to 4 g/day) every 12 hours 
  • A switch to oral therapy with amoxicillin/clavulanate on Day 4 was permitted
Clinical cure rates at test-of-cure (MITT population) Clinical response rates at Day 4 ​​​​​​​Explore More Zinforo has a proven tolerability profile in children of all ages, including neonates​​​​​​​2,3 Access tolerability profile Loading

*Multicentre, randomised, observer-blinded, active-controlled study where the primary objective was to evaluate the safety and tolerability of Zinforo. The study was not powered for comparative inferential efficacy analysis, and no efficacy endpoint was identified as primary.
†Doses of Zinforo were based on paediatric population pharmacokinetic modelling designed to achieve the same antibiotic exposure in children that was shown to be effective in adults. 
‡Evaluated 8–15 days after the last dose of any antibiotic (IV or oral).
¶Multicentre, randomised, prospective, comparator-controlled study where the primary objective was to evaluate the safety and tolerability of Zinforo. The study was not powered for comparative inferential efficacy analysis, and no efficacy endpoint was identified as primary.
**Zinforo is not active against Pseudomonas aeruginosa. Like other cephalosporins, Zinforo is not active against ESBL-producing strains. In vitro activity does not always correlate with clinical efficacy.1

Abbreviations

CAP, community-acquired pneumonia; cSSTI, complicated skin and soft tissue infections; CE, clinically evaluable; TOC, test-of-cure; MITT, modified intent-to-treat; IV, intravenous; MRSA, methicillin-resistant Staphylococcus aureus. 

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 

Zyvox (linezolid) 2mg/ml Solution for Infusion    
Zyvox (linezolid)  600mg Film-Coated Tablets
Zyvox (linezolid) 100mg/5ml Granules for Oral Suspension

Dalacin C (clindamycin hydrochloride) 150mg capsules
Dalacin C (clindamycin hydrochloride) 75mg capsules
Dalacin C (clindamycin phosphate)  sterile solution for injection
Dalacin T (clindamycin phosphate) 1% topical lotion
Dalacin (clindamycin phosphate) 2% cream

References

ZINFORO. Summary of Product CharacteristicsKorczowski B, et al. Pediatr Infect Dis J 2016;35:e239–47Cannavino CR, et al. Pediatr Infect Dis J 2016;35:752–59Laudano JB. J Antimicrob Chemother 2011;66(Suppl.3):iii11-iii18Garrison MW, et al. Expert Rev Anti Infect Ther 2012;10:1087-103Drusano, GL. J Antimicrob Chemother 2011;66(Suppl3):iii61–7
PP-ZFO-GBR-0227. September 2021
Discover further specific information on the dosing regimen of Zinforo in neonates, infants and children here Zinforo has an extended in vitro spectrum of coverage, including key pathogens in CAP and cSSTI**1,4-6

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 Google Play or Apple App Store

 

Adverse events should also be reported to Pfizer Medical Information on 01304 616161

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