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Hypersensitivity reactions: As with all beta-lactam antibacterials, serious and occasionally fatal hypersensitivity reactions are possible (see Contraindications and Adverse Reactions).
Severe cutaneous adverse reactions (SCARs), such as Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalised exanthematous pustulosis (AGEP) have been reported in patients taking beta-lactam antibiotics.
Patients who have a history of hypersensitivity to cephalosporins, penicillins or other beta-lactam antibacterials may also be hypersensitive to ceftaroline fosamil. Before initiating therapy with Zinforo, careful inquiry should be made concerning previous hypersensitivity reactions to beta-lactam antibacterials. If a patient developed an immediate and severe hypersensitivity (e.g. anaphylactic reaction) previously to any type of beta-lactam antibacterial, ceftaroline fosamil should not be administered (see Contraindications).
If a severe allergic reaction or SCAR occurs, the medicinal product should be discontinued and appropriate measures taken.
Clostridium difficile-associated diarrhoea: Antibacterial-associated colitis and pseudomembranous colitis have been reported with nearly all antibacterial agents, including Zinforo, 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 (see Adverse Reactions). In such circumstance, the discontinuation of therapy with Zinforo and the use of supportive measures together with the administration of specific treatment for Clostridium difficile should be considered.
Patients with pre-existing seizure disorder: As with other cephalosporins, seizures have occurred in ceftaroline toxicology studies at 7-25 times human Cmax levels (see Pharmacology: Toxicology: Preclinical safety data under Actions). Clinical study experience with ceftaroline in patients with pre-existing seizure disorders is limited. Therefore, Zinforo should be used with caution in this patient population.
Direct antiglobulin test (Coombs test) seroconversion: The development of a positive direct antiglobulin test (DAGT) may occur during treatment with cephalosporins. The incidence of DAGT seroconversion in patients receiving ceftaroline fosamil was 11.2% in the five pooled Phase 3 studies with administration every 12 hours (600 mg administered over 60 minutes every 12 hours) and 32.3% in a study in patients receiving ceftaroline fosamil every 8 hours (600 mg administered over 120 minutes every 8 hours), (see Adverse Reactions). There was no evidence of haemolysis in any patient receiving ceftaroline fosamil who developed a positive DAGT. However, the possibility that haemolytic anaemia may occur in association with cephalosporins including Zinforo treatment cannot be ruled out. Patients experiencing anaemia during or after treatment with Zinforo should be investigated for this possibility.
Non-susceptible organisms: Superinfections may occur as with other antibacterial agents.
cSSTI caused by S. aureus with an MIC >1 mg/L to ceftaroline: There are limited clinical data on the use of ceftaroline to treat cSSTI caused by S. aureus with an MIC of >1 mg/L. The recommended dosages of Zinforo shown in Tables 11 to 14 for the treatment of cSSTI caused by S. aureus with ceftaroline MIC of 2 mg/L or 4 mg/L are based on pharmacokinetic-pharmacodynamic modelling and simulation (see Dosage & Administration and Pharmacology: Pharmacodynamics under Actions). Zinforo should not be used to treat cSSTI due to S. aureus for which the ceftaroline MIC is >4 mg/L.
Infusion time: Infusion times of less than 60 minutes are based on pharmacokinetic and pharmacodynamic analyses only.
Effects on ability to drive and use machines: No studies on the effects on the ability to drive and use machines have been performed. Undesirable effects may occur which may have an effect on ability to drive and use machines (see Adverse Reactions).
Use in Children: Paediatric patients <2 months of age: There are limited clinical data in patients less than 2 months of age. Therefore the recommended dosage of Zinforo shown in Table 12 for paediatric patients <2 months of age is based on pharmacokinetic-pharmacodynamic modelling and simulation (see Dosage & Administration).
