“This retrospective real-world study of Fetroja in hospitalized patients highlights the complicated patient characteristics where difficult-to-treat Gram-negative infections require rapid treatment with an appropriate antibiotic. This analysis suggested earlier treatment with Fetroja in high-risk patients resulted in better outcomes and lower mortality, though further investigations are needed to confirm the mortality finding,” said Simon Portsmouth, MBChB, MD, FRCP, Senior Vice President, Head of Clinical Development, Shionogi. “Seriously ill patients are often not represented in randomized clinical trials due to the difficulty with interpreting outcomes in such confounding situations. With real-world evidence, we can identify opportunities to understand and optimize patient outcomes.”
Seriously Ill Patient Population
Earlier Treatment Initiation: Observed Effect on Outcomes
Antimicrobial Resistance
Shionogi’s commitment to fighting antimicrobial resistance
About Shionogi
About cefiderocol
Cefiderocol for injection is the first and only siderophore cephalosporin antibiotic for the treatment of serious Gram-negative infections. It has a novel mechanism for penetrating the outer cell membrane of Gram-negative pathogens by acting as a siderophore. In addition to entering cells by passive diffusion through porin channels, cefiderocol binds to ferric iron and is actively transported into bacterial cells through the outer membrane via the bacterial iron transporters, which function to incorporate this essential nutrient for bacteria. These mechanisms allow cefiderocol to achieve high concentrations in the periplasmic space where it can bind to penicillin-binding proteins and inhibit cell wall synthesis in the bacterial cells. Cefiderocol has also demonstrated in vitro activity against certain bacteria that contain problematic resistant enzymes such ESBLs, AmpC, and serine- and metallo-carbapenemases. Data from multinational surveillance studies for cefiderocol demonstrated potent in vitro activity against a wide spectrum of Gram-negative pathogens including carbapenem-resistant A. baumannii complex, P. aeruginosa, Enterobacterales, and S. maltophilia. The clinical significance of the in vitro data is unknown. Cefiderocol has no clinically relevant in vitro activity against most Gram-positive bacteria and anaerobic bacteria.
U.S. INDICATIONS
USAGE
IMPORTANT SAFETY INFORMATION
CONTRAINDICATIONS
WARNINGS AND PRECAUTIONS
Increase in All-Cause Mortality in Patients with Carbapenem-Resistant Gram-Negative Bacterial Infections
Hypersensitivity Reactions
Clostridioides difficile-associated Diarrhea (CDAD)
Seizures and Other Central Nervous System (CNS) Adverse Reactions
Development of Drug-Resistant Bacteria
ADVERSE REACTIONS
Forward-Looking Statements
For Further Information, Contact:
SHIONOGI Website Inquiry Form: https://www.shionogi.com/global/en/contact.html
U.S. Media Contact: ShionogiCommunications@shionogi.com