Cefiderocol

FETROJA is a cephalosporin antibacterial indicated in patients 18 years of age or older for the treatment of the following infections caused by susceptible Gram-negative microorganisms: Complicated Urinary Tract Infections (cUTI), including Pyelonephritis. Hospital-acquired Bacterial Pneumonia and Ventilator-associated Bacterial Pneumonia (HABP/VABP). To reduce the development of drug-resistant bacteria and maintain the effectiveness of FETROJA and other antibacterial drugs, FETROJA should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.

FETROJA is an antibacterial drug.

Administer 2 grams of FETROJA for injection every 8 hours by intravenous (IV) infusion over 3 hours in patients with creatinine clearance (CLcr) 60 to 119 mL/min. Dose adjustments are required for patients with CLcr less than 60 mL/min, (including patients receiving intermittent hemodialysis (HD) or continuous renal replacement therapy (CRRT)), and for patients with CLcr 120 mL/min or greater. See full prescribing information for instructions on preparation of FETROJA doses. See full prescribing information for drug compatibilities.

FETROJA is contraindicated in patients with a known history of severe hypersensitivity to cefiderocol or other beta-lactam antibacterial drugs, or any other component of FETROJA. FETROJA is contraindicated in patients with a known history of severe hypersensitivity to cefiderocol and other beta-lactam antibacterial drugs or other components of FETROJA.

Increase in All-Cause Mortality in Patients with Carbapenem-Resistant Gram-Negative Bacterial Infections: An increase in all-cause mortality was observed in FETROJA-treated patients compared to those treated with best available therapy (BAT). Closely monitor the clinical response to therapy in patients with cUTI and HABP/VABP. Hypersensitivity Reactions: Serious and occasionally fatal hypersensitivity (anaphylactic) reactions have been reported in patients receiving beta-lactam antibacterial drugs. Hypersensitivity was observed with FETROJA. Cross-hypersensitivity may occur in patients with a history of penicillin allergy. If an allergic reaction occurs, discontinue FETROJA. Clostridioides difficile -associated Diarrhea (CDAD): CDAD has been reported with nearly all systemic antibacterial agents, including FETROJA. Evaluate if diarrhea occurs.

The following serious adverse reactions are described in greater detail in the Warnings and Precautions section: 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 Adverse Reactions cUTI: The most frequently occurring adverse reactions in greater than or equal to 2% of cUTI patients treated with FETROJA were diarrhea, infusion site reactions, constipation, rash, candidiasis, cough, elevations in liver tests, headache, hypokalemia, nausea, and vomiting. HABP/VABP: The most frequently occurring adverse reactions in greater than or equal to 4% of HABP/VABP patients treated with FETROJA were elevations in liver tests, hypokalemia, diarrhea, hypomagnesemia, and atrial fibrillation.

Use alternate testing methods to confirm positive results of dipstick tests (urine protein, ketones, or occult blood). Drug/Laboratory Test Interactions Cefiderocol may result in false-positive results in dipstick tests (urine protein, ketones, or occult blood). Use alternate clinical laboratory methods of testing to confirm positive tests.

Store in the carton until time of use. Store reconstituted solutions of FETROJA at room temperature.