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