Overview
11 DESCRIPTION FETROJA is a cephalosporin antibacterial drug product consisting of cefiderocol sulfate tosylate for intravenous infusion. Cefiderocol functions as a siderophore [see Microbiology (12.4) ] . The chemical name of cefiderocol sulfate tosylate is Tris[(6 R ,7 R )-7-[(2 Z...
Mechanism of Action
12 CLINICAL PHARMACOLOGY 12.1 Mechanism of Action FETROJA is an antibacterial drug [see Microbiology (12.4) ] . 12.2 Pharmacodynamics The percent time of dosing interval that unbound plasma concentrations of cefiderocol exceed the minimum inhibitory concentration (MIC) against the infecting organism best correlates with antibacterial activity in neutropenic murine thigh and lung infection models with E. coli , K. pneumoniae , P. aeruginosa , A. baumannii , and S. maltophilia . Compared to a 1-hour infusion, a 3-hour infusion increased the percent time of dosing interval that unbound plasma concentrations of cefiderocol exceed the MIC.
Indications
- 1 INDICATIONS AND USAGE 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 ( 1.1 ) Hospital-acquired Bacterial Pneumonia and Ventilator-associated Bacterial Pneumonia (HABP/VABP) ( 1.2 ) 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...
Common Doses
- 119 mL
- 60 mL
- 120 mL
- 59 mL
Dosage
2 DOSAGE AND ADMINISTRATION 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. ( 2.1 ) 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. ( 2.2 ) See full prescribing information for instructions on preparation of FETROJA doses. ( 2.3 ) See full prescribing information for drug compatibilities. ( 2.
Contraindications
- 4 CONTRAINDICATIONS 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 [see Warnings and Precautions (5.2) and Adverse Reactions (6.1) ] . 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. ( 4 )
Side Effects
- 6 ADVERSE REACTIONS 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 [see Warnings and Precautions (5.1) ] Hypersensitivity Reactions [see Warnings and Precautions (5.2) ] Clostridioides difficile -associated Diarrhea (CDAD) [see Warnings and Precautions (5.3) ] Seizures and Other Central Nervous System Adverse Reactions [see Warnings and Precautions (5.
Interactions
- 7 DRUG INTERACTIONS Use alternate testing methods to confirm positive results of dipstick tests (urine protein, ketones, or occult blood). ( 7.1 ) 7.1 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.