cefiderocol

REMS

Complicated urinary tract infections, including pyelonephritis, in patients who have limited or no alternative treatment options.
Hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia.

Contraind./Precautions ⬆ ⬇

Contraindicated in:

Known serious hypersensitivity to cefiderocol or other beta-lactams.

Use Cautiously in:

Carbapenem-resistant gram-negative bacterial infections, including nosocomial pneumonia, bloodstream infections, and sepsis (↑ risk of mortality);
Seizure disorders;
Renal impairment (dosage ↓ required for CCr <60 mL/min);
OB: Use during pregnancy only if potential maternal benefit justifies potential fetal risk;
Lactation: Use while breastfeeding only if potential maternal benefit justifies potential risk to infant;
Pedi: Safety and effectiveness not established in children;
Geri: Dose adjustment may be necessary in older adults for age-related ↓ in renal function.

Adv. Reactions/Side Effects ⬆ ⬇

Derm: rash

EENT: thrush

F and E: hypokalemia

GI: ↑liver enzymes, CLOSTRIDIOIDES DIFFICILE-ASSOCIATED DIARRHEA (CDAD), constipation, diarrhea, nausea, vomiting

GU: candiduria, vaginal candidiasis

Local: infusion site reactions

Neuro: headache, SEIZURES

Resp: cough

Misc: HYPERSENSITIVITY REACTIONS (INCLUDING ANAPHYLAXIS)

Interactions ⬆ ⬇

Drug-drug:

None reported.

Availability ⬆ ⬇

Lyophilized powder for injection: 1 g/vial

Route/Dosage ⬆ ⬇

IV (Adults ): CCr ≥120 mL/min: 2 g every 6 hr for 7–14 days; CCr 60–119 mL/min: 2 g every 8 hr for 7–14 days.

Renal Impairment

IV (Adults ): CCr 30–59 mL/min: 1.5 g every 8 hr for 7–14 days; CCr 15–29 mL/min: 1 g every 8 hr for 7–14 days; CCr <15 mL/min (with or without hemodialysis): 0.75 g every 12 hr for 7–14 days (in patients receiving hemodialysis, administer dose immediately following hemodialysis session); Continuous renal replacement therapy: Effluent flow rate ≥4.1 L/hr: 2 g every 8 hr for 7–14 days; effluent flow rate 3.1–4 L/hr: 1.5 g every 8 hr for 7–14 days; Effluent flow rate 2.1–3 L/hr: 2 g every 12 hr for 7–14 days; Effluent flow rate ≤2 L/hr: 1.5 g every 12 hr for 7–14 days.

US Brand Names ⬆ ⬇

Action ⬆ ⬇

Functions as a siderophore and binds to extracellular free ferric iron. Iron transport systems then deliver cefiderocol across the outer membrane of gram-negative bacilli, where it binds to the bacterial cell wall, thereby inhibiting cell wall synthesis.

Therapeutic effects:

Bactericidal action against susceptible bacteria.

Spectrum:

Active against the following gram-negative bacilli: Acinetobacter baumannii, Enterobacter cloacae, Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, Pseudomonas aeruginosa, and Serratia marcescens.

Classifications ⬆ ⬇

Therapeutic Classification: anti-infectives

Pharmacologic Classification: cephalosporin derivatives

Pharmacokinetics ⬆ ⬇

Absorption: IV administration results in complete bioavailability.

Distribution: Some distribution to tissues.

Metabolism/Excretion: Undergoes minimal metabolism by liver; primarily excreted in urine (99%; 91% as unchanged drug).

Half-Life: 2–3 hr.

Time/Action Profile ⬆ ⬇

(plasma concentrations)

ROUTE	ONSET	PEAK	DURATION
IV	rapid	end of infusion	8 hr

Patient/Family Teaching ⬆ ⬇

Explain purpose and side effects to patient.
Advise patient to report the signs of superinfection (furry overgrowth on the tongue, vaginal itching or discharge, loose or foul-smelling stools) and allergy.
Instruct patient to notify health care professional immediately if diarrhea, abdominal cramping, fever, or bloody stools or signs and symptoms of anaphylaxis occur and not to treat with antidiarrheals without consulting health care professional.
Inform patient of risk of seizures, especially in patient with a seizure disorder. Advise patient to notify health care professional immediately if seizure occurs.
Advise patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and to consult with health care professional before taking other medications.
Rep: Advise women of reproductive potential to notify health care professional if pregnancy is planned or suspected or if breastfeeding.

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Indications ⬇