Product Dossier
ZINFORO
Product Dossier for ZINFORO (ceftaroline fosamil, Pfizer). ARTG record, PBS listing, PBAC outcomes, AusPAR — compiled by arcimedes.
- Sponsor: Pfizer
- Active ingredient: ceftaroline fosamil
- Therapeutic area: Infectious Disease
- Same area: RETROVIR
- Same area: Savacol Antiseptic Mouth & Throat Rinse
What it is
Zinforo is a new cephalosporin antibiotic prodrug, active against bacteria producing classical Class A β-lactamases and also active against altered penicillin-binding proteins found in methicillin-resistant Staphylococcus aureus (MRSA) and penicillin-resistant Streptococcus pneumoniae (PRSP). Zinforo is available as ceftaroline fosamil 600 mg powder for injection vials.
Approved indications
Zinforo is indicated for the treatment of adults with: — Complicated skin and soft tissue infections — Community-acquired pneumonia
Dosing overview
No dosing information is available in the provided sources.
Key safety warnings
No specific safety warnings are detailed in the provided sources.
Contraindications
No contraindications are specified in the provided sources.
PBS listing
Zinforo is not listed on the Pharmaceutical Benefits Scheme. In November 2014, the PBAC did not recommend Zinforo for the treatment of community-acquired pneumonia or complicated skin and soft tissue infections due to uncertain clinical benefit and high and uncertain cost-effectiveness.
Regulatory history
Zinforo was first registered on the ARTG on 12 February 2013. The TGA approved Zinforo for the treatment of adults with complicated skin and soft tissue infections and community-acquired pneumonia on 7 February 2013. In November 2014, the PBAC considered applications for PBS listing for both community-acquired pneumonia and complicated skin and soft tissue infections but did not recommend the medicine for either indication.