Source: FDA, National Drug Code (US) Revision Year: 2020
FETROJA is indicated in patients 18 years of age or older for the treatment of complicated urinary tract infections (cUTIs), including pyelonephritis caused by the following susceptible Gram-negative microorganisms: Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, Pseudomonas aeruginosa, and Enterobacter cloacae complex [see Clinical Studies (14.1)].
FETROJA is indicated in patients 18 years of age or older for the treatment of hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia, caused by the following susceptible Gram-negative microorganisms: Acinetobacter baumannii complex, Escherichia coli, Enterobacter cloacae complex, Klebsiella pneumoniae, Pseudomonas aeruginosa, and Serratia marcescens [see Clinical Studies (14.2)].
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 strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.
The recommended dosage of FETROJA is 2 grams administered every 8 hours by intravenous (IV) infusion over 3 hours in adults with a creatinine clearance (CLcr) of 60 to 119 mL/min.
Dosage adjustment of FETROJA is recommended 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 Dosage and Administration (2.2)]. The recommended duration of treatment with FETROJA is 7 to 14 days. The duration of therapy should be guided by the patient’s clinical status.
Dosage adjustment of FETROJA is recommended in patients with CLcr less than 60 mL/min (Table 1). For patients undergoing intermittent HD, start the dosing of FETROJA immediately after the completion of HD. For patients with fluctuating renal function, monitor CLcr and adjust dosage accordingly.
Table 1. Recommended Dosage of FETROJA for Patients with CLcr Less Than 60 mL/min Including Patients Receiving Intermittent HD:
| Estimated Creatinine Clearance (CLcr)* | Dose | Frequency | Infusion Time |
|---|---|---|---|
| CLcr 30 to 59 mL/min | 1.5 grams | Every 8 hours | 3 hours |
| CLcr 15 to 29 mL/min | 1 gram | Every 8 hours | 3 hours |
| CLcr less than 15 mL/min, with or without intermittent HD† | 0.75 grams | Every 12 hours | 3 hours |
HD = hemodialysis.
† Cefiderocol is removed by HD; administer FETROJA immediately after HD for patients receiving intermittent HD.
For patients receiving CRRT, including continuous venovenous hemofiltration (CVVH), continuous venovenous hemodialysis (CVVHD), and continuous venovenous hemodiafiltration (CVVHDF), the dosage of FETROJA should be based on the effluent flow rate in CRRT (see Table 2). These recommendations are intended to provide initial dosing in patients receiving CRRT. Dosing regimens may need to be tailored based on residual renal function and patient’s clinical status [see Use in Specific Populations (8.6)].
Table 2. Recommended Dosage of FETROJA for Patients Receiving CRRT:
| Effluent Flow Rate* | Recommended Dosage of FETROJA |
|---|---|
| 2 L/hr or less | 1.5 grams every 12 hours |
| 2.1 to 3 L/hr | 2 grams every 12 hours |
| 3.1 to 4 L/hr | 1.5 grams every 8 hours |
| 4.1 L/hr or greater | 2 grams every 8 hours |
CRRT = continuous renal replacement therapy.
* Ultrafiltrate flow rate for CVVH, dialysis flow rate for CVVHD, ultrafiltrate flow rate plus dialysis flow rate for CVVHDF.
For patients with CLcr greater than or equal to 120 mL/min, FETROJA 2 grams administered every 6 hours by IV infusion over 3 hours is recommended [see Use in Specific Populations (8.6)].
FETROJA is supplied as a sterile, lyophilized powder that must be reconstituted and subsequently diluted using aseptic technique prior to intravenous infusion.
Reconstitute the powder for injection in the FETROJA vial with 10 mL of either 0.9% sodium chloride injection, USP or 5% dextrose injection, USP and gently shake to dissolve. Allow the vial(s) to stand until the foaming generated on the surface has disappeared (typically within 2 minutes). The final volume of the reconstituted solution will be approximately 11.2 mL. The reconstituted solution is for intravenous infusion only after dilution in an appropriate infusion solution.
To prepare the required doses, withdraw the appropriate volume of reconstituted solution from the vial according to Table 3 below. Add the withdrawn volume to a 100 mL infusion bag containing 0.9% sodium chloride injection, USP or 5% dextrose injection, USP [see Dosage and Administration (2.4)].
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. FETROJA infusions are clear, colorless solutions. Discard any unused FETROJA solution in the vial (see Table 3).
Table 3. Preparation of FETROJA Doses:
| FETROJA Dose | Number of 1-gram FETROJA Vials to be Reconstituted | Volume to Withdraw from Reconstituted Vial(s) | Total Volume of FETROJA Reconstituted Solution for Further Dilution into a 100 mL Infusion Bag |
|---|---|---|---|
| 2 grams | 2 vials | 11.2 mL (entire contents) of each vial | 22.4 mL |
| 1.5 grams | 2 vials | 11.2 mL (entire contents) of first vial AND 5.6 mL from second vial | 16.8 mL |
| 1 gram | 1 vial | 11.2 mL (entire contents) | 11.2 mL |
| 0.75 gram | 1 vial | 8.4 mL | 8.4 mL |
FETROJA solution for administration is compatible with:
The compatibility of FETROJA solution for administration with solutions containing other drugs or other diluents has not been established.
Upon reconstitution with the appropriate diluent, the reconstituted FETROJA solution in the vial should be immediately transferred and diluted into the infusion bag. Reconstituted FETROJA can be stored for up to 1 hour at room temperature in the vial. Discard any unused reconstituted solution.
The diluted FETROJA infusion solution in the infusion bag is stable for up to 6 hours at room temperature.
The diluted FETROJA infusion solution in the infusion bag may also be refrigerated at 2°C to 8°C (36°F to 46°F) for up to 24 hours, protected from light; and then the infusion should be completed within 6 hours at room temperature.
There is no information on clinical signs and symptoms associated with an overdose of FETROJA. Patients who receive doses greater than the recommended dose regimen and have unexpected adverse reactions possibly associated with FETROJA should be carefully observed and given supportive treatment, and discontinuation or interruption of treatment should be considered.
Approximately 60% of cefiderocol is removed by a 3- to 4-hour hemodialysis session [see Clinical Pharmacology (12.3)].
FETROJA vials should be stored refrigerated at 2°C to 8°C (36°F to 46°F). Protect from light. Store in the carton until time of use. Store reconstituted solutions of FETROJA at room temperature [see Dosage and Administration (2.5)].
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