Using Fetroja

Dosing1

Fetroja dosing for most patients: q8h IV infusion

Recommended dosage and dosage adjustments of Fetroja for adult patients
ESTIMATED CREATININE CLEARANCE (CLcr)a DOSE FREQUENCY
≥120 mL/min (Patients with augmented renal clearance) 2 grams Every 6 hours
60 to 119 mL/min (Recommended dosage) 2 grams Every 8 hours
30 to 59 mL/min 1.5 grams Every 8 hours
15 to 29 mL/min 1 gram Every 8 hours
<15 mL/min
(Patients with or without intermittent HDb)		 0.75 gram Every 12 hours
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  • Fetroja is primarily excreted by the kidney1
  • Three-hour infusion time regardless of creatinine clearance1
  • The recommended duration of treatment with Fetroja is 7 to 14 days1
  • The duration of therapy should be guided by the patient's clinical status1
  • No dosage adjustments recommended in patients with hepatic impairment1
a
Creatinine clearance estimated by Cockcroft-Gault equation.
b
Fetroja is removed by HD; administer Fetroja immediately after HD for patients receiving intermittent HD.
HD=hemodialysis.
Recommended dosage of Fetroja for patients receiving continuous renal replacement therapy (CRRT)c
EFFLUENT FLOW RATEd 2 L/hr OR LESS 2.1 TO 3 L/hr 3.1 TO 4 L/hr 4.1 L/hr OR GREATER
Dosage of Fetroja 1.5 grams every 12 hours 2 grams every 12 hours 1.5 grams every 8 hours 2 grams every 8 hours

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.1

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c
For patients receiving CRRT, including CVVH, CVVHD, and CVVHDF, dosage of Fetroja should be based on the effluent flow rate in CRRT.
d
Ultrafiltrate flow rate for CVVH, dialysis flow rate for CVVHD, and ultrafiltrate flow rate plus dialysis flow rate for CVVHDF.
CVVH=continuous venovenous hemofiltration; CVVHD=continuous venovenous hemodialysis; CVVHDF=continuous venovenous hemodiafiltration.

Preparation of solution for administration1

Fetroja is a sterile, lyophilized powder that must be reconstituted and subsequently diluted using aseptic technique prior to IV infusion. Each single-dose, clear glass vial contains 1 gram of cefiderocol.

  1. 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.
  2. Allow the vial(s) to stand until the foaming generated on the surface has disappeared (typically within 2 minutes). The reconstituted solution will have a final volume of approximately 11.2 mL and concentration of 0.089 gram/mL. The reconstituted solution is for IV infusion only after dilution in an appropriate infusion solution.
  3. To prepare the required dose, withdraw the appropriate volume of reconstituted solution from the vial according to the table below.
  4. Add the withdrawn volume to a 100-mL infusion bag containing 0.9% sodium chloride injection, USP or 5% dextrose injection, USP.
  5. Visually inspect drug products visually for particulate matter and discoloration prior to use—Fetroja infusions are clear, colorless solutions.

Discard any unused Fetroja solution in the vial.

Preparation of doses for Fetroja
FETROJA DOSE NUMBER OF 1-GRAM 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
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Fetroja is compatible with the MINI-BAG container system and the VIAL-MATE® adapter2

Storage1

Reconstituted solutions of Fetroja

  • Upon reconstitution with appropriate diluent, immediately transfer and dilute Fetroja into the infusion bag
  • Reconstituted Fetroja can be stored for up to 1 hour at room temperature in the vial
  • Diluted Fetroja infusion solution in the infusion bag is stable for up to 6 hours at room temperature
  • 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. Then, the infusion should be completed within 6 hours at room temperature
  • Discard any unused reconstituted solution

Storage and handling

  • Store refrigerated at 2°C to 8°C (36°F to 46°F)
  • Protect from light
  • Store in carton until time of use

Compatibility1

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.

How to order Fetroja

Ordering1

Fetroja 1 gram for injection is supplied as a white to off-white sterile lyophilized powder for reconstitution in single-dose, clear glass vials, supplied in cartons containing 10 single-dose vials.

NDC 59630-266-10
Fetroja (cefiderocol) 1 gram/vial
10 vials/carton
NDC=National Drug Code.