Cefiderocol
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Omid AfkhamiArdakani
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Black Box Warning
|
Increased Mortality in Critically Ill Patients
See full prescribing information for complete Boxed Warning.
An increase in all-cause mortality was observed in cefiderocol-treated patients compared to those treated with best available therapy in a clinical trial of critically ill patients with multidrug-resistant Gram-negative bacterial infections.
The cause of the increase in mortality has not been established. Carefully consider the potential risks and benefits of cefiderocol in these patients. Reserve cefiderocol for use in patients who have limited or no alternative treatment options. |
Overview
Cefiderocol is a Siderophore Cephalosporin Antibiotic that is FDA approved for the treatment of Complicated Urinary Tract Infections (cUTIs), Hospital-Acquired Bacterial Pneumonia (HABP), and Ventilator-Associated Bacterial Pneumonia (VABP) in adult patients.. There is a Black Box Warning for this drug as shown here. Common adverse reactions include Diarrhea, Infusion site reactions, Constipation, Rash, Candidiasis (including oral and vulvovaginal), Cough, Elevated liver tests (increased alanine aminotransferase), Headache, Hypokalemia (low potassium levels), Nausea and vomiting..
Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
Recommended Dosage:
For patients with creatinine clearance (CLcr) 60 to 119 mL/min: 2 grams administered intravenously every 8 hours over 3 hours.
Dosage Adjustments:
For patients with CLcr ≥120 mL/min (augmented renal clearance): 2 grams every 6 hours.
For patients with CLcr 30 to 59 mL/min: 1.5 grams every 8 hours.
For patients with CLcr 15 to 29 mL/min: 1 gram every 8 hours.
For patients with CLcr <15 mL/min, including those on intermittent hemodialysis: 0.75 grams every 12 hours.
Off-Label Use and Dosage (Adult)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Cefiderocol in adult patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Cefiderocol in adult patients.
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
The safety and effectiveness of cefiderocol in pediatric patients (under 18 years of age) have not been established.
Off-Label Use and Dosage (Pediatric)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Cefiderocol in pediatric patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Cefiderocol in pediatric patients.
Contraindications
Cefiderocol is contraindicated in patients with a known history of severe hypersensitivity to cefiderocol, other beta-lactam antibacterial drugs, or any component of the formulation.
Warnings
|
Increased Mortality in Critically Ill Patients
See full prescribing information for complete Boxed Warning.
An increase in all-cause mortality was observed in cefiderocol-treated patients compared to those treated with best available therapy in a clinical trial of critically ill patients with multidrug-resistant Gram-negative bacterial infections.
The cause of the increase in mortality has not been established. Carefully consider the potential risks and benefits of cefiderocol in these patients. Reserve cefiderocol for use in patients who have limited or no alternative treatment options. |
Increase in All-Cause Mortality
Hypersensitivity Reactions
Clostridioides difficile-associated Diarrhea (CDAD)
Adverse Reactions
Clinical Trials Experience
Diarrhea, Infusion site reactions, Constipation, Rash, Candidiasis (including oral and vulvovaginal), Cough, Elevated liver tests (increased alanine aminotransferase), Headache, Hypokalemia (low potassium levels), Nausea and vomiting.
Postmarketing Experience
There is limited information regarding Cefiderocol Postmarketing Experience in the drug label.
Drug Interactions
No Clinically Significant CYP Interactions
Caution is advised when cefiderocol is co-administered with nephrotoxic agents, such as: Aminoglycosides (e.g., gentamicin) Vancomycin Nonsteroidal anti-inflammatory drugs (NSAIDs)
Use in Specific Populations
Pregnancy
Pregnancy Category (FDA):
There is no FDA guidance on usage of Cefiderocol in women who are pregnant.
Pregnancy Category (AUS):
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Cefiderocol in women who are pregnant.
Labor and Delivery
There is no FDA guidance on use of Cefiderocol during labor and delivery.
Nursing Mothers
There is no FDA guidance on the use of Cefiderocol in women who are nursing.
Pediatric Use
The safety and efficacy of cefiderocol in pediatric patients (<18 years of age) have not been established.
Geriatic Use
There is no FDA guidance on the use of Cefiderocol in geriatric settings.
Gender
There is no FDA guidance on the use of Cefiderocol with respect to specific gender populations.
Race
There is no FDA guidance on the use of Cefiderocol with respect to specific racial populations.
Renal Impairment
Cefiderocol is primarily excreted by the kidneys. Dose adjustment is required in patients with moderate to severe renal impairment, including those on hemodialysis.
Hepatic Impairment
There is no FDA guidance on the use of Cefiderocol in patients with hepatic impairment.
Females of Reproductive Potential and Males
There is no FDA guidance on the use of Cefiderocol in women of reproductive potentials and males.
Immunocompromised Patients
There is no FDA guidance one the use of Cefiderocol in patients who are immunocompromised.
Administration and Monitoring
Administration
Infuse intravenously over 3 hours. Do not mix with other medications or infuse simultaneously through the same IV line.
Monitoring
Renal Function: Assess creatinine clearance (CrCl) prior to initiating therapy and regularly thereafter, especially in patients with fluctuating renal function.
Hypersensitivity Reactions: Monitor for signs such as rash, pruritus, or anaphylaxis during and after infusion.
Clostridioides difficile Infection: Be vigilant for symptoms like persistent diarrhea, abdominal pain, or fever, indicative of C. difficile-associated diarrhea.
IV Compatibility
There is limited information regarding the compatibility of Cefiderocol and IV administrations.
Overdosage
There is limited information regarding Cefiderocol overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.
Pharmacology
There is limited information regarding Cefiderocol Pharmacology in the drug label.
Mechanism of Action
Cefiderocol is a siderophore cephalosporin antibiotic. It functions by chelating extracellular iron and utilizing bacterial iron transport systems to penetrate the outer membrane of Gram-negative bacteria. Once inside, it binds to penicillin-binding proteins, inhibiting cell wall synthesis and leading to bacterial cell death.
Structure
There is limited information regarding Cefiderocol Structure in the drug label.
Pharmacodynamics
Bactericidal Activity: Cefiderocol exhibits time-dependent killing against Gram-negative bacteria, similar to other β-lactams.
Post-Antibiotic Effect: Minimal to modest post-antibiotic effect observed.
Pharmacokinetics
Absorption: Administered intravenously; thus, bioavailability is 100%.
Distribution: Volume of distribution is approximately 18 liters. Plasma protein binding ranges from 40% to 60%, primarily to albumin.
Metabolism: Undergoes minimal hepatic metabolism.
Elimination: Primarily excreted unchanged by the kidneys. Elimination half-life is approximately 2 to 3 hours. Renal clearance is the predominant elimination pathway; dose adjustments are necessary for patients with impaired renal function.
Nonclinical Toxicology
There is limited information regarding Cefiderocol Nonclinical Toxicology in the drug label.
Clinical Studies
There is limited information regarding Cefiderocol Clinical Studies in the drug label.
How Supplied
1 gram of cefiderocol in a single-dose vial as a sterile lyophilized powder for IV infusion. Supplied in cartons containing 10 vials.
Storage
Store vials at 20°C to 25°C (68°F to 77°F). Do not freeze.
Reconstituted solution: Stable for up to 1 hour at room temperature.
Diluted solution:
Room temp: Use within 6 hours
Refrigerated (2–8°C): Use within 24 hours
Images
Drug Images
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Package and Label Display Panel
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Patient Counseling Information
Inform patients that cefiderocol is given by IV infusion, usually in a hospital or clinical setting.
Advise patients to complete the full course of therapy even if symptoms improve, to prevent resistance.
Educate patients on the possibility of side effects such as diarrhea, rash, or nausea, and to report severe or persistent symptoms.
Instruct patients to notify their healthcare provider if they experience signs of allergic reactions (rash, itching, swelling, difficulty breathing).
Warn about the potential for Clostridioides difficile-associated diarrhea, and advise patients to report any prolonged or severe diarrhea.
Advise patients to inform their doctor if they are pregnant, planning to become pregnant, or breastfeeding.
Reinforce the importance of renal monitoring if they have kidney problems or are receiving other nephrotoxic medications.
Precautions with Alcohol
Alcohol-Cefiderocol interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
Brand Names
Cefiderocol is marketed under the brand name Fetroja.
Look-Alike Drug Names
There is limited information regarding Cefiderocol Look-Alike Drug Names in the drug label.
Drug Shortage Status
Price
References
The contents of this FDA label are provided by the National Library of Medicine.