Pneumonia, hospital acquired or ventilator associated; Urinary tract infection

Antibiotic, Cephalosporin

Distribution: Vd: 18 (±3.36) L. Protein binding: 40% to 60% (primarily to albumin). Metabolism: Minimal. Half-life elimination: 2 to 3 hours. Excretion: Urine: 98.6% (90.6% as unchanged drug); feces: 2.8%.

Severe hypersensitivity to cefiderocol, other beta-lactam antibacterial drugs, or any other component of the formulation.

In general, an increase in most types of birth defects or adverse maternal or fetal outcomes was not found following exposure to cephalosporins.

It is not known if cefiderocol is present in breast milk. According to the manufacturer, the decision to breastfeed during therapy should consider the risk of infant exposure, the benefits of breastfeeding to the infant, and benefits of treatment to the mother.

>10%:Endocrine & metabolic: Hypokalemia (2% to 11%)Hepatic: Increased liver enzymes (2% to 16%)1% to 10%:Cardiovascular: Acute myocardial infarction (<4%), atrial fibrillation (5%), atrial flutter (<4%), bradycardia (<2%), heart failure (<2%), peripheral edema (<2%)Dermatologic: Erythematous rash (<4%), pruritus (<2%), skin rash (3%)Endocrine & metabolic: Hyperkalemia (<4%), hypervolemia (<2%), hypocalcemia (<4%), hypomagnesemia (5%)Gastrointestinal: Abdominal pain (<4%), biliary colic (<2%), cholecystitis (<4%), cholelithiasis (<4%), Clostridioides difficile-associated diarrhea (<4%), constipation (3%), decreased appetite (<2%), diarrhea (4% to 9%), dysgeusia (<2%), nausea (2%), oral candidiasis (<4%), stomatitis (<2%), vomiting (2%), xerostomia (<2%)Genitourinary: Hematuria (<2%)Hematologic & oncologic: Increased INR (<4%), prolonged partial thromboplastin time (<4%), prolonged prothrombin time (<4%), thrombocytopenia (<4%), thrombocytosis (<4%)Hypersensitivity: Hypersensitivity reaction (<2%)Infection: Candidiasis (2%)Local: Infusion-site reaction (4%)Nervous system: Headache (2%), insomnia (<2%), restlessness (<2%), seizure (<4%)Neuromuscular & skeletal: Increased creatine phosphokinase in blood specimen (<2%)Renal: Acute interstitial nephritis (<4%)Respiratory: Cough (2%), dyspnea (<2%), pleural effusion (<2%)Miscellaneous: Fever (<2%)

Pneumonia, hospital acquired or ventilator associated (alternative agent): IV: 2 g every 8 hours. Duration of therapy varies based on disease severity and response to therapy; treatment is typically given for 7 days. Note: For patients with CrCl ?120 mL/minute, increase dose to 2 g every 6 hours. Urinary tract infection: Cystitis, acute uncomplicated or acute simple cystitis (infection limited to the bladder without signs/symptoms of upper tract, prostate, or systemic infection) (off-label use): IV: 2 g every 8 hours for 5 to 7 days. Urinary tract infection, complicated (pyelonephritis or urinary tract infection with systemic signs/symptoms): IV: 2 g every 8 hours. For patients with symptomatic improvement within the first ~48 hours of therapy, total duration is 5 to 7 days (7 days if therapy is completed with cefiderocol). Note: For patients with CrCl ?120 mL/minute, increase dose to 2 g every 6 hours.

Systemic infections, due to multidrug-resistant gram-negative bacilli: Limited data available:Note: Not recommended for routine empiric use; reserve for patients with or at risk for antibiotic-resistant infections.Infants <2 months: IV: 40 mg/kg/dose every 8 hours.Infants ?2 months, Children, and Adolescents: IV: 60 mg/kg/dose every 8 hours; maximum dose: 2,000 mg/dose.

Altered kidney function: IV: Note: Kidney function may be estimated using the Cockcroft-Gault formula. CrCl ?120 mL/minute: 2 g every 6 hours. CrCl 60 to <120 mL/minute: 2 g every 8 hours. CrCl 30 to <60 mL/minute: 1.5 g every 8 hours. CrCl 15 to <30 mL/minute: 1 g every 8 hours. CrCl <15 mL/minute: 750 mg every 12 hours.

No dosage adjustment necessary.

FETROJA vials should be stored refrigerated at 2°C to 8°C. Protect from light. Store in thecarton until time of use. Store reconstituted solutions of FETROJA at room temperature 【文字內容由仿單翻譯而來】