ZINFORO® Safety, tolerability and dosing

Prescribing information is available at the bottom of this page.

ZINFORO®: A reassuring safety profile

A safety and tolerability profile similar to other cephalosporins*2–7

Low potential for drug–drug interactions†1,4

No routine monitoring of renal function required‡1

ZINFORO® is suitable for use in elderly patients and those with comorbidities1–3,5,6,8,9

Safety profile in the paediatric population is similar to that observed in adults§1

 

Footnotes:*ZINFOR0® 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.1
Patients 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 ZINFORQ® 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
No clinical drug–drug interaction studies have been conducted with ZINFORO®.1
The dose should be adjusted when CrCI is ≤50 m/min.1
§Based on two clinical trials in 227 paediatric patients aged from 2 months to 17 years.1
Abbreviations: CrCL, creatine clearance; DAGT, direct antiglobulin test.
References:1. .ZINFORO®. Summary of Product Characteristics; 2. Ramani A, et al. J Chemother 2014;26:229–34; 3. File TM, et al. Clin Infect Dis 2010;51:1395–405; 4. Lodise TP, Low DE. Drugs 2012;72:1473–93; 5. Corey G, et al. Clin Infect Dis 2010;51:641–50; 6. Santos PD, et al. J Chemother 2013;25:341–6; 7. Corrado ML. J Antimicrob Chemother 2010;65(Suppl4):iv67–iv71; 8. Evans JD, et al. Postgrad Med 2014;126:128–34; 9. Dryden M, et al. J Antimicrob Chemother 2016;71:3575–84.

ZINFORO® Treat the majority of patients with simple dosing

Dose in adult and adolescents ages 12 to <18 years with a bodyweight of ≥33 kg1

 
  • Based on PK/PD analyses, the recommended dose regimen for treatment of cSSTI due to Staphylococcus aureus for which the ZINFORO® MIC is 2 or 4 mg/L is 600 mg every 8 hours using 2-hour infusions1
  • No dosage adjustment required for most elderly patients or those with concurrent comorbidities, including obese patients1
  • For paediatric dosing and dosing for patients with renal impairment please refer to the SPC1

 

ZINFORO® PK/PD 

ZINFORO® has relatively low protein binding (<20%) and would be predicted to attain rapid penetration to the primary infection site.2

ZINFORO® penetrates the bronchial ELF of healthy subjects, with a penetration relative to plasma of 23%.3

At a dose of 600 mg every 12 hours and an MIC of 1 mg/L: 

  • 98.1% of patients would be expected to achieve a target free drug concentration above the MIC in plasma; for 600 mg every 8 hours, the proportion would be 100%3
  • 81.7% would be expected to achieve a target MIC in ELF3

 

 

Abbreviations: CAP, community-acquired pneumonia; cSSTI, complicated skin and soft tissue infections; ELF, epithelial lining fluid; IV, intravenous; MIC, minimum inhibitory concentration; PD, pharmacodynamic; PK, pharmacokinetic.
References:1. .ZINFORO®. Summary of Product Characteristics; 2. Drusano GL. J Antimicrob Chemother 2011;66(Suppl3):iii61–7; 3. Riccobene TA, et al. Antimicrob Agents Chemother 2016;60:5849–57.

ZINFORO® 600 mg powder for concentrate for solution for infusion – SPC
Legal category: POM.   Basic NHS cost: 10 vial pack £375.00.

Vancomycin – SPC
Legal Category: POM       Basic NHS Cost: 500 mg 10 vial pack £8.50, 1000 mg 10 vial pack £17.25

PP-ZFO-GBR-0029

Date of Preparation: June 2018