Product Highlight - Zinforo

• A fifth-generation cephalosporin with coverage against key causative pathogens in children with cSSTI including MRSA.^1,2
• A fifth-generation cephalosporin with coverage against key causative pathogens in children with CAP including S. pneumoniae and S. aureus.^1,2
• Provides a rapid clinical response in paediatric patients with cSSTI and CAP. ^3,4
• Can be administered as a flexible 5-60 minutes infusion in children from 2 months of age.¹

Zinforo (ceftaroline fosamil) Abbreviated Prescribing Information¹
Product presentation: Zinforo (ceftaroline fosamil) powder 600 mg for concentrate for solution for infusion, 20 ml glass vial x 10. Indications: Treatment of community-acquired pneumonia (CAP) and complicated skin and soft tissue infections (cSSTI) from the age of 2 months. Dosage: CAP and cSSTI: Adults and adolescents aged from 12 to < 18 years with bodyweight ≥33kg: 600mg every 12 hours by intravenous infusion over 5 to 60 minutes; adolescents from 12 to < 18 years with bodyweight <33 kg and children ≥ 2 years to < 12 years: 12 mg/kg every 8 hours by intravenous infusion over 5 to 60 minutes (not exceeding 400 mg); infants ≥ 2 months to < 2 years: 8 mg/kg every 8 hours by intravenous infusion over 5 to 60 minutes. cSSTI confirmed or suspected to be caused by S. aureus with an MIC=2mg/L or 4mg/L to ceftaroline: Adults: 600mg every 8 hours by intravenous infusions over 120 minutes. adolescents and children aged ≥ 2 years to < 18 years: 12mg/kg by intravenous infusion over 120 minutes every 8 hours (not exceeding 600mg); infants ≥ 2 months to <2 years: 10 mg/kg every 8 hours by intravenous infusion over 120 minutes. The recommended treatment duration for CAP is 5 - 7 days; cSSTI from 5 – 14 days. Contraindications: Hypersensitivity to the active substance, excipients or to the cephalosporin class of anti-bacterial. Immediate and severe hypersensitivity to any other type of beta-lactam antibacterial agent. Special Precautions: 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. Serious and occasionally fatal hypersensitivity reactions (including anaphylactoid and severe cutaneous adverse reactions) have been reported in patients receiving therapy with beta-lactams. Antibacterial-associated colitis and pseudomembranous colitis have been reported and may range in severity from mild to life threatening. Superinfections may occur. To be used in caution in patients with pre-existing seizure disorder. The development of a positive direct antiglobulin test (DAGT) may occur during treatment with cephalosporins. There are limited clinical data for ceftaroline in treating cSSTI in adults caused by S. aureus with an MIC >1 mg/L to ceftaroline and there are no clinical data for treating S. aureus with an MIC = 2mg/L to MIC = 4 mg/L to ceftaroline. Therefore, the recommended dosages of ceftaroline fosamil to treat cSSTI caused by S. aureus with an MIC >1 mg/L to ceftaroline are based on PKPD modelling and simulation. Adverse Reaction: Coombs Direct Test Positive, rash, pruritus, headache, dizziness, phlebitis, diarrhea, nausea, vomiting, abdominal pain, increased transaminases, pyrexia, infusion site reactions. API-ZINFORO-1220


References:
1. Zinforo Malaysia PI, Zinforo-1220
2. Laudano JB. J Antimicrob Chemother 2011;66:iii11-8.
3. Korczowski B, et al. Pediatr Infect Dis J 2016;35:e239-47;
4. Cannavino CR, et al. Pediatr Infect Dis J 2016;35:752-9

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