Fetroja (Cefiderocol)

Brand Name

Fetroja

Generic Name

Cefiderocol

View Brand Information

FDA approval date: January 31, 2020

Classification: Cephalosporin Antibacterial

Form: Injection

What is Fetroja (Cefiderocol)?

FETROJA is a cephalosporin antibacterial indicated in patients 18 years of age or older for the treatment of the following infections caused by susceptible Gram-negative microorganisms: Complicated Urinary Tract Infections , including Pyelonephritis.

Approved To Treat

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A Phase 1, Open-label, Single-dose Study to Determine the Safety and Pharmacokinetics of Intravenous Cefiderocol/Xeruborbactam (S-649228) in Participants With Renal Impairment

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Brand Information

Fetroja (Cefiderocol sulfate tosylate)

1DOSAGE FORMS AND STRENGTHS

FETROJA 1 gram for injection is supplied as a white to off-white, sterile, lyophilized powder for reconstitution in single-dose, clear glass vials; each vial contains 1 gram of cefiderocol.

2CONTRAINDICATIONS

FETROJA is contraindicated in patients with a known history of severe hypersensitivity to cefiderocol or other beta-lactam antibacterial drugs, or any other component of FETROJA

3ADVERSE REACTIONS

The following serious adverse reactions are described in greater detail in the Warnings and Precautions section:

Increase in All-Cause Mortality in Patients with Carbapenem-Resistant Gram-Negative Bacterial Infections
Hypersensitivity Reactions
Clostridioides difficile-associated Diarrhea (CDAD) [see
Seizures and Other Central Nervous System Adverse Reactions

3.1Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

3.2Postmarketing Experience

The following adverse reactions have been identified during postapproval use of FETROJA. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Blood and lymphatic system disorders: neutropenia

Renal and urinary disorders: chromaturia

4OVERDOSAGE

There is no information on clinical signs and symptoms associated with an overdose of FETROJA. Patients who receive doses greater than the recommended dose regimen and have unexpected adverse reactions possibly associated with FETROJA should be carefully observed and given supportive treatment, and discontinuation or interruption of treatment should be considered.

Approximately 60% of cefiderocol is removed by a 3- to 4-hour hemodialysis session

5DESCRIPTION

FETROJA is a cephalosporin antibacterial drug product consisting of cefiderocol sulfate tosylate for intravenous infusion. Cefiderocol functions as a siderophore

The chemical name of cefiderocol sulfate tosylate is Tris[(6

FETROJA for injection is a white to off-white, sterile, lyophilized powder formulated with 1 gram of cefiderocol (equivalent to 1.6 grams of cefiderocol sulfate tosylate), sucrose (900 mg), sodium chloride (216 mg), and sodium hydroxide to adjust pH. The sodium content is approximately 176 mg/vial. The pH of the reconstituted solution of 1 gram cefiderocol (1 vial) dissolved in 10 mL water is 5.2 to 5.8.

6PRINCIPAL DISPLAY PANEL - 1 Gram Vial Carton

Rx ONLY

1 gram

Fetroja

For Intravenous Infusion.

SHIONOGI

PRINCIPAL DISPLAY PANEL - 1 Gram Vial Carton