Footnotes
*Efficacy has been demonstrated in CAP clinical studies against the following pathogens that were susceptible to ceftaroline in vitro: Streptococcus pneumoniae, Staphylococcus aureus (methicillin-susceptible strains only), Escherichia coli, Haemophilus influenzae, Haemophilus parainfluenzae, and Klebsiella pneumoniae.¹ Efficacy has been demonstrated in cSSTI clinical studies against the following pathogens that were susceptible to Zinforo in vitro: Staphylococcus aureus (including methicillin-resistant strains), Streptococcus pyogenes, Streptococcus agalactiae, Streptococcus anginosus group, Streptococcus dysgalactiae, Escherichia coli, Klebsiella pneumoniae, Klebsiella oxytoca and Morganella morganii.^1
†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 Comparator therapies: cSSTI, ceftriaxone; CAP, vancomycin or cefazolin, plus optional aztreonam.
**There is no experience with Zinforo in the treatment of CAP in the following patient groups: the immunocompromised, patients with severe sepsis/septic shock, severe underlying lung disease, patients with PORT Risk Class V, and/or CAP requiring ventilation, CAP due to MRSA, patients requiring intensive care; the available clinical data cannot substantiate efficacy against PNSP.¹ There is no experience with Zinforo in the treatment of cSSTI in the following patient groups: the immunocompromised; patients with severe sepsis/septic shock, necrotising fasciitis, perirectal abscess and patients with third-degree and extensive burns. There is limited experience in treating patients with diabetic foot infections. Caution is advised when treating such patients.^1
‡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

References