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 Infusion time
60 to 119 mL/min (Recommended dosage) 2 grams Every 8 hours 3 hours
30 to 59 mL/min 1.5 grams Every 8 hours 3 hours
15 to 29 mL/min 1 gram Every 8 hours 3 hours
<15 mL/min
(ESRD patients with or without intermittent HDb)
0.75 gram Every 12 hours 3 hours
≥120 mL/min 2 grams Every 6 hours 3 hours
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  • The recommended duration of treatment with Fetroja is 7 to 14 days
  • The duration of therapy should be guided by the severity of infection and the patient's clinical status for up to 14 days
  • No dosage adjustments recommended in patients with hepatic impairment
ESRD=end-stage renal disease; HD=hemodialysis.
a CLcr=creatinine clearance estimated by Cockcroft-Gault equation.
b Cefiderocol is removed by HD; thus, complete HD at the latest possible time before the start of cefiderocol dosing.

Preparation of solution for administration1

Fetroja is a sterile, lyophilized powder that must be reconstituted and subsequently diluted using aseptic technique prior to intravenous 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 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.
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Add the withdrawn volume to an infusion bag containing 100 mL of 0.9% sodium chloride injection, USP or 5% dextrose injection, USP.
5
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 at least 100 mL
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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Reconstituted solutions of Fetroja

Storage1

  • 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
  • Diluted Fetroja infusion solution in infusion bags is stable for up to 4 hours at room temperature
  • Discard any unused reconstituted solution

Unreconstituted vials of Fetroja1

  • 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:

  • 5% dextrose injection, USP
  • 0.9% sodium chloride 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-use, clear glass vials, supplied in cartons containing 10 single-use vials.


NDC 59630-266-10 Fetroja (cefiderocol) 1 gram/vial 10 vials/carton

NDC=National Drug Code.