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About Zinforo

About Zinforo

OverviewExtended spectrum coverage
Dosing

Dosing

Adult & adolescent dosingNeonatal & paediatric dosing
Efficacy & Safety

Efficacy & Safety

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

Clinical & Scientific Data

Patient Risk FactorsCAP patient profilescSSTI patient profilesCAPTURE study
Support & Resources

Support & Resources

Videos & case studiesVideos
Materials

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

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 *ǁ2,4,6–9Low potential for drug–drug interactions‡1,7No routine monitoring of renal function required§1Suitable for use in elderly patients and those with certain  comorbidities§1,2,4,5,6, 8,10Very common and common adverse reactions by system organ class from clinical trials and post-marketing experience1
Scroll left to view table

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


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

Explore More

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

Abbreviations

​​​​​​​CAP, community-acquired pneumonia; cSSTI, complicated skin and soft tissue infections; CE, clinically evaluable; CANVAS, Ceftaroline fosamil vs Vancomycin in Skin and skin structure infection; CI, confidence interval; MITT, modified intent-to-treat; PORT, Pneumonia Patient Outcomes Research Team; 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 

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® (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

ZINFORO. Summary of product characteristicsFile TM, et al. Clin Infect Dis 2010;51:1395–405Zhong N, et al. Lancet Infect Dis 2015;15:161–71Corey G, et al. Clin Infect Dis 2010;51:641–50Dryden M, et al. J Antimicrob Chemother 2016;71:3575–84Ramani A, et al. J Chemother 2014;26:229–34Lodise TP, Low DE. Drugs 2012;72:1473–93Santos PD, et al. J Chemother 2013;25:341–6Corrado ML. J Antimicrob Chemother 2010;65(Suppl 4):iv67–iv71Evans JD, et al. Postgrad Med 2014;126:128–34
PP-ZFO-GBR-0228. September 2021
Explore the outcomes of Zinforo Phase III clinical trials in patients with CAP and cSSTI

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

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