Affiliation:
1. Department of Clinical, Social, and Administrative Sciences, Department of Pharmacy Services, University of Michigan Health System and College of Pharmacy, Ann Arbor, Ml; now, Department of Pharmacy, University of Wisconsin Hospital & Clinics, Madison, WI
2. Department of Clinical, Social, and Administrative Sciences, Department of Pharmacy Services, University of Michigan Health System and College of Pharmacy; now, Clinical Scientific Director, Medical Affairs, Cubist Pharmaceuticals, Inc., Lexington, MA
3. Department of Clinical, Social, and Administrative Sciences, Department of Pharmacy Services, University of Michigan Health System and College of Pharmacy
Abstract
Objective: To review the pharmacology, microbiology, chemistry, in vitro activity, pharmacokinetics, clinical efficacy, safety, dosage, and administration of ceftaroline fosamil (Teflaro, Forest Laboratories, Inc.), a novel parenteral broad-spectrum cephalosporin approved by the Food and Drug Administration (FDA) on October 29, 2010, for the treatment of adults with acute bacterial skin and skin structure infections (ABSSSI) and community-acquired bacterial pneumonia (CABP). Data Sources: A search of MEDLINE (1966-July 2011) using the search terms ceftaroline fosamil, ceftaroline, TAK-599, PPI-0903, PPI-0903M, and T-91825 was performed. Supplementary sources included program abstracts from the Interscience Conference on Antimicrobial Agents and Chemotherapy American Society of Microbiology, European Congress on Clinical Microbiology and Infectious Diseases, and the Infectious Diseases Society of America from 2005 to 2010, as well as information available from the manufacturer's Web site. Study Selection Ano Data Extraction: All English-language articles identified from the data sources were evaluated. In vitro, preclinical, and Phase 1,2, and 3 clinical trials were included. Data Synthesis: Clinical trials have been conducted evaluating use of ceftaroline for treatment of ABSSSI and CABP. Safety data from Phase 1,2, and 3 clinical trials suggest that it is well tolerated and has a safety and tolerability profile common to the cephalosporin class. Ceftaroline has excellent in vitro activity against gram-positive pathogens, including methicillin-resistant Staphylococcus aureus (MRSA), which makes it an attractive monotherapy (or the treatment of ABSSSI. However, it lacks activity against problem gram-negative bacteria (eg, Pseudomonas spp.), which will likely limit its use for serious health care-associated infections. While its role in treating CABP is supported by excellent in vitro activity against Streptococcus pneumoniae and clinical efficacy data, currently available comparators may offer some advantages over ceftaroline. Finally, data are lacking to assess its role in the treatment of serious infections due to MRSA (eg, pneumonia, bacteremia). Conclusions: These considerations should be part of the formulary review process; however, when considering the significant role MRSA plays in ABSSSI in both the community and hospital settings, we believe that ceftaroline will provide clinicians with a welcome option in addition to currently available anti-MRSA therapies for the treatment of ABSSSI.