Cefiderocol Application Scope

Is indicated for the treatment of adult patients with:

- Complicated urinary tract infections (cUTI), including pyelonephritis, caused by susceptible Gram-negative microorganisms.
- Hospital-acquired bacterial pneumonia (HABP) and ventilator-associated bacterial pneumonia (VABP) caused by susceptible Gram-negative microorganisms.

Cefiderocol Characteristics

Ingredients: Each vial contains cefiderocol sulfate tosylate equivalent to 1 gram of cefiderocol.
Properties: Is a siderophore cephalosporin antibacterial drug. It binds to extracellular free iron and utilizes bacterial iron transport systems to enter the periplasmic space of Gram-negative bacteria, where it binds to penicillin-binding proteins and inhibits cell wall synthesis.
Specification: For injection: 1 gram of cefiderocol as a lyophilized powder for reconstitution in single-dose vials.
Packaging Specification: Supplied in single-dose, clear glass vials containing 1 gram of cefiderocol.
Storage: Store unopened vials at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C and 30°C (59°F and 86°F). Reconstituted solutions should be used immediately or stored under refrigeration and used within 6 hours.
Expiry Date: Refer to the expiration date printed on the vial and carton.
Executive Standard: Approved by the U.S. Food and Drug Administration (FDA) under NDA 209445.
Approval Number: NDA 209445.
Date of Revision: October 2020.
Manufacturer: Shionogi Inc.

Dosage and Administration: The recommended dosage of cefiderocol for adult patients with creatinine clearance (CLcr) ≥60 mL/min is 2 grams every 8 hours, administered by intravenous infusion over 3 hours. Dosage adjustments are required for patients with renal impairment.
Adverse Reactions: The most common adverse reactions (≥2%) include diarrhea, infusion site reactions, constipation, rash, candidiasis, and cough. Serious adverse reactions include hypersensitivity reactions and Clostridioides difficile-associated diarrhea.
Contraindications: Cefiderocol is contraindicated in patients with a known history of severe hypersensitivity to cefiderocol or other beta-lactam antibacterial drugs, or any other component of cefiderocol.
Precautions: Monitor for signs of hypersensitivity reactions during treatment. Clostridioides difficile-associated diarrhea has been reported; evaluate if diarrhea occurs. Adjust dosage in patients with renal impairment.

Drug Interactions:

Cefiderocol Has moderate interactions with warfarin; monitor INR levels if co-administered. No other significant drug interactions have been identified.

Note:

If there is a new packaging for the drug, the new packaging shall prevail. The above information is sourced from DengYue Medicine.
It is only for internal discussion among medical staff and does not serve as a basis for medication. For specific medication guidelines, please consult the attending physician.