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

References