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Fetroja Dosage

Generic name: Cefiderocol sulfate tosylate 1g in 10mL
Dosage form: injection, powder, for solution

Medically reviewed by Drugs.com. Last updated on Sep 30, 2020.

Recommended Dosage

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 Adjustments in Patients with CLcr Less Than 60 mL/min (Including Patients Undergoing Intermittent HD or CRRT), and CLcr 120 mL/min or Greater

Dosage Adjustments in Patients with CLcr Less Than 60 mL/min Including Patients Receiving Intermittent HD

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
HD = hemodialysis.
*
CLcr = creatinine clearance estimated by Cockcroft-Gault equation.
Cefiderocol is removed by HD; administer FETROJA immediately after HD for patients receiving intermittent HD.
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

Dosage Adjustments in Patients Receiving CRRT

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
CRRT = continuous renal replacement therapy.
*
Ultrafiltrate flow rate for CVVH, dialysis flow rate for CVVHD, ultrafiltrate flow rate plus dialysis flow rate for CVVHDF.
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

Dosage Adjustments in Patients with CLcr 120 mL/min or Greater

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)].

Preparation of FETROJA Solution for Administration

FETROJA is supplied as a sterile, lyophilized powder that must be reconstituted and subsequently diluted using aseptic technique prior to intravenous infusion.

Preparation of Doses

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

Drug Compatibility

FETROJA solution for administration is compatible with:

  • 0.9% sodium chloride injection, USP
  • 5% dextrose injection, USP

The compatibility of FETROJA solution for administration with solutions containing other drugs or other diluents has not been established.

Storage of Reconstituted Solutions

Reconstituted FETROJA

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.

Diluted FETROJA Infusion 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.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.