AHFS Class:

8:12.06.28 Siderophore Cephalosporins

Generic Name

• Cefiderocol Sulfate Tosylate

Cefiderocol sulfate tosylate is available as a lyophilized powder in single-dose vials containing the equivalent of 1 g of cefiderocol.³⁵³¹ Each vial also contains sucrose 900 mg, sodium chloride 216 mg, and sodium hydroxide to adjust the pH.³⁵³¹

The contents of each 1-g vial of cefiderocol should be reconstituted with 10 mL of sodium chloride 0.9% or dextrose 5% and the vial should be shaken gently to dissolve the powder.³⁵³¹ Vials should be allowed to stand until any foam that has been generated on the surface has disappeared (usually about 2 minutes).³⁵³¹ The reconstituted solution must be diluted prior to infusion.³⁵³¹

The manufacturer’s instructions for preparing various doses of cefiderocol from the reconstituted solution are as follows:³⁵³¹

For a 2-g dose, withdraw the entire contents of 2 vials (i.e., approximately 11.2 mL per vial).

For a 1.5-g dose, withdraw the entire contents of 1 vial (i.e., approximately 11.2 mL) and 5.6 mL from a second vial.

For a 1-g dose, withdraw the entire contents of 1 vial (i.e., approximately 11.2 mL).

For a 0.75-g dose, withdraw 8.4 mL from 1 vial.

All doses should then be added to a 100-mL infusion bag containing sodium chloride 0.9% or dextrose 5%.³⁵³¹; ³⁵⁴⁴

pH

The pH of the resulting solution that forms when 1 g of cefiderocol is dissolved in 10 mL of water is within the range of 5.2 to 5.8.³⁵³¹

Equivalency

Cefiderocol sulfate tosylate 1.6 g is equivalent to 1 g of cefiderocol.³⁵³¹

Sodium Content

Each 1-g vial of cefiderocol contains approximately 176 mg of sodium.³⁵³¹

Trade Name(s)

Fetroja

Cefiderocol sulfate tosylate is administered by intravenous infusion over 3 hours following reconstitution and further dilution.³⁵³¹

Cefiderocol sulfate tosylate is a white to off-white powder that forms a clear, colorless solution upon reconstitution and dilution.³⁵³¹ Intact vials of cefiderocol sulfate tosylate should be stored at 2 to 8°C in the original carton until time of use to protect from light.³⁵³¹

After reconstitution with an appropriate diluent as instructed, the drug may be stored for up to 1 hour at room temperature.³⁵³¹ Following dilution, the drug is stable for 6 hours at room temperature.³⁵³¹ The diluted solution for infusion also may be refrigerated at 2 to 8°C for up to 24 hours when protected from light; administration should be completed within 6 hours at room temperature following refrigerated storage.³⁵³¹

Solution Compatibility

Y-Site Injection Compatibility (1:1 Mixture)

For a list of references cited in the text of this monograph, search the monograph titled References.

ASHP^® Injectable Drug Information^TM. Selected Revisions March 31, 2024. © Copyright, 2024. American Society of Health-System Pharmacists^®, 4500 East-West Highway, Suite 900, Bethesda, Maryland 20814.