Cefiderocol

Renal Impairment Patients with CLcr 60 to 89 mL/min No dosage adjustment of FETROJA is recommended in patients with CLcr 60 to 89 mL/min. Patients with CLcr Less Than 60 mL/min Including Patients Receiving Intermittent HD Dose adjustment is required in patients with CLcr less than 60 mL/min, and in patients who are receiving HD.

In patients requiring HD, complete HD at the latest possible time before the start of cefiderocol dosing [see Dosage and Administration and Clinical Pharmacology ] . Monitor renal function regularly and adjust the dosage of FETROJA accordingly as renal function may change during the course of therapy. Patients Receiving CRRT A total of 16 patients treated with FETROJA received CRRT in clinical trials.

Dosage adjustment of FETROJA is required in patients receiving CRRT including CVVH, CVVHD, and CVVHDF. Dosage of FETROJA should be based on the effluent flow rate in patients receiving CRRT [see Dosage and Administration and Clinical Pharmacology ]. While on CRRT, a patient's residual renal function may change. Improvements or reductions in residual renal function may warrant a change in FETROJA dosage.

Patients with CLcr 120 mL/min or Greater CLcr 120 mL/min or greater may be seen in seriously ill patients, who are receiving intravenous fluid resuscitation. Dosage adjustment of FETROJA is required in patients with CLcr 120 mL/min or greater [see Dosage and Administration and Clinical Pharmacology ]. Monitor renal function regularly and adjust the dosage of FETROJA accordingly as renal function may change during the course of therapy.

Hepatic Impairment The effects of hepatic impairment on the pharmacokinetics of cefiderocol have not been evaluated. Hepatic impairment is not expected to alter the elimination of cefiderocol as hepatic metabolism/excretion represents a minor pathway of elimination for cefiderocol. Dosage adjustments are not necessary in patients with impaired hepatic function.

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 ] . 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 ). [See table below.] 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.