Zinforo Adverse Reactions

Pooled Phase III studies: Four phase 3 clinical trials (two in cSSTI and two in CAP) included 1305 adult patients treated with ceftaroline fosamil (600 mg administered over 60 minutes every 12 hours).
The incidences of treatment emergent adverse events in the pooled Phase 3 cSSTI and CAP studies were similar in ceftaroline and comparator groups (45.7% vs. 46.7%, respectively). The most common adverse reactions occurring in ≥3% of patients treated with ceftaroline fosamil were diarrhoea, headache, nausea, and pruritus, and were generally mild or moderate in severity.
Additional Phase III studies: A study (Asia CAP) in Asia of 381 adult patients with CAP treated with ceftaroline fosamil (600 mg administered over 60 minutes every 12 hours) demonstrated that the safety profile of ceftaroline fosamil in these patients was similar to that observed in the pooled Phase 3 cSSTI and CAP studies.
A study (COVERS) was conducted of 506 adult patients with cSSTI treated with ceftaroline fosamil (600 mg administered over 120 minutes every 8 hours). The most common adverse reactions occurring in ≥3% of patients treated with ceftaroline fosamil were nausea, headache, and rash. The safety profile of ceftaroline fosamil was similar to that observed in previous pooled Phase III studies with the exception of both a greater incidence of rash in Asian patients (see as follows) and a greater incidence of DAGT seroconversion (see Precautions).
The safety assessment in paediatric patients is based on the safety data from 2 trials in which 227 patients aged from 2 months to 17 years with cSSTI or CAP received ceftaroline fosamil. Overall, the safety profile in these 227 patients was similar to that observed in the adult population.
In addition, the safety assessment in neonates and infants (age range from birth to less than 2 months) is based on the safety data from 2 trials in which 11 patients with late-onset sepsis received ceftaroline fosamil at 4 or 6 mg/kg as a 60 minute infusion every 8 hours (q8h) and 23 patients with a suspected or confirmed bacterial infection received only a single dose of ceftaroline fosamil at 8 mg/kg as a 60 minute infusion. Overall, the adverse events reported in these studies were consistent with the known safety profile for ceftaroline fosamil.
The following adverse reactions have been identified during clinical trials and post marketing experience with ceftaroline fosamil. (See Table 12.)

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Description of selected adverse reactions: Rash: Rash was observed at a common frequency in the pooled Phase III studies in cSSTI with administration of ceftaroline fosamil every 12 hours (600 mg administered over 60 minutes every 12 hours) and the COVERS study in cSSTI with administration every 8 hours (600 mg administered over 120 minutes every 8 hours). However, the frequency of rash in the subgroup of Asian patients receiving ceftaroline fosamil every 8 hours (COVERS) was very common (18.5%).