Cefiderocol

What is Cefiderocol?

Cefiderocol (FETROJA) is a cephalosporin antibacterial agent.

What are the uses of this medicine?

This medicine is 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 (cUTI), including Pyelonephritis.
• Hospital-acquired Bacterial Pneumonia and Ventilator-associated Bacterial Pneumonia (HABP/VABP).

How does this medicine work?

• FETROJA is an antibacterial drug.
• FETROJA is a cephalosporin antibacterial with activity against Gram-negative aerobic bacteria.
• Cefiderocol functions as a siderophore and binds to extracellular free (ferric) iron.
• In addition to passive diffusion via porin channels, cefiderocol is actively transported across the outer cell membrane of bacteria into the periplasmic space using the bacterial siderophore iron uptake mechanism.
• Cefiderocol exerts bactericidal action by inhibiting cell wall biosynthesis through binding to penicillin-binding proteins (PBPs).

Who Should Not Use this medicine ?

This medicine cannot be used in patients with:

• severe hypersensitivity to cefiderocol or other beta-lactam antibacterial drugs, or any other component of FETROJA.

What drug interactions can this medicine cause?

• Cefiderocol may result in false-positive results in dipstick tests (urine protein, ketones, or occult blood). Use alternate clinical laboratory methods of testing to confirm positive tests.

Is this medicine FDA approved?

• It was approved for use in the United States in 2019.

How should this medicine be used?

Recommended Dosage

• 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.
• Dose adjustments are required 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.

Dosage Adjustments in Patients with CLcr less than 60 mL/min including patients receiving intermittent HD

• CLcr 30 to 59 mL/min: 1.5 grams administered every 8 hours
• CLcr 15 to 29 mL/min: 1 gram administered every 8 hours
• CLcr less than 15 mL/min, with or without intermittent HD†: 0.75 grams administered every 12 hours

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As injection: 1 gram of cefiderocol as a lyophilized powder for reconstitution in single-dose vials

This medicine is available in fallowing brand namesː

• FETROJA

What side effects can this medication cause?

The most common side effects of this medicine include: Complicated Urinary Tract Infections (cUTI), including Pyelonephritis

• diarrhea
• infusion site reactions
• constipation
• rash
• candidiasis
• cough
• elevations in liver tests
• headache
• hypokalemia
• nausea
• vomiting

Hospital-acquired Bacterial Pneumonia and Ventilator-associated Bacterial Pneumonia (HABP/VABP)

• elevations in liver tests
• hypokalemia
• diarrhea
• hypomagnesemia
• atrial fibrillation

= What special precautions should I follow?

• An increase in all-cause mortality was observed in FETROJA-treated patients compared to those treated with best available therapy (BAT). Closely monitor the clinical response to therapy in patients with cUTI and HABP/VABP.
• Serious and occasionally fatal hypersensitivity (anaphylactic) reactions and serious skin reactions have been reported in patients receiving beta-lactam antibacterial drugs. Hypersensitivity was observed in FETROJA-treated patients.Cross-hypersensitivity may occur in patients with a history of penicillin allergy. If an allergic reaction occurs, discontinue FETROJA.
• Clostridioides difficile-associated Diarrhea (CDAD) has been reported with nearly all systemic antibacterial agents, including FETROJA. Evaluate if diarrhea occurs.
• CNS adverse reactions such as seizures have been reported with FETROJA. If focal tremors, myoclonus, or seizures occur, evaluate patients to determine whether FETROJA should be discontinued.

What to do in case of emergency/overdose?

• There is no information on clinical signs and symptoms associated with an overdose of FETROJA.

Management for overdosage:

• Patients 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.

Can this medicine be used in pregnancy?

• There are no available data on FETROJA use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes.

Can this medicine be used in children?

• Safety and effectiveness of FETROJA in pediatric patients younger than 18 years of age have not been established.

What are the active and inactive ingredients in this medicine?

Active ingredient:

• Cefiderocol sulfate tosylate

Inactive ingredients:

• Sucrose
• Sodium chloride
• Sodium hydroxide
• Nitrogen

Who manufactures and distributes this medicine?

• Manufactured by

Shionogi & Co., Ltd. Osaka 541-0045 Japan

• Manufactured for

Shionogi Inc. Florham Park, NJ USA, 07932

What should I know about storage and disposal of this medication?

• FETROJA vials should be stored refrigerated at 2°C to 8°C (36°F to 46°F).
• Protect from light.
• Store in the carton until time of use.
• Store reconstituted solutions of FETROJA at room temperature.

• Dailymed label info on Cefiderocol
• FDA Cefiderocol