Medically reviewed by Drugs.com. Last updated on Nov 19, 2021.
Generic name: Cefiderocol sulfate tosylate 1g in 10mL
Dosage form: injection, powder, for solution
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.
|Estimated Creatinine Clearance (CLcr)*||Dose||Frequency||Infusion Time|
|HD = hemodialysis.|
|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)].
|Effluent Flow Rate *||Recommended Dosage of FETROJA|
|CRRT = continuous renal replacement therapy.|
|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 reconstituted solution will have a final volume of approximately 11.2 mL and concentration of 0.089 gram/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).
|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:
- 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
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.
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