Fetroja (Cefiderocol) is indicated in patients of or over the age of 18 years suffering from Complicated Urinary Tract Infections including pyelonephritis, Hospital Acquired Bacterial Pneumonia and Ventilator-associated Bacterial Pneumonia infections caused by susceptible Gram-negative microorganisms.
To reduce the development of drug-resistant bacteria and maintain the effectiveness of Fetroja and other antibacterial drugs, Fetroja should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria.
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. Dosage adjustment of cefiderocol is recommended 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. The recommended duration of Fetroja therapy is 7-14 days. The duration of therapy should be guided by the patient’s clinical status.
Precaution & Warnings:
• Closely monitor the clinical response to therapy in patients with cUTI and HABP/VABP, taking treatment with Cefiderocol.
• Counsel patients on the implication of cephalosporins, including cefiderocol, in triggering seizures, mainly in patients with renal impairment and history of epilepsy.
• Therapy with fetroja injection may result in false-positive results in dipstick tests ( ketones, urine protein, or occult blood). Use alternate clinical laboratory methods of testing to confirm positive tests.
• Diarrhea is a common problem caused by antibacterial drugs, including cefiderocol. If severe watery or bloody diarrhea develops, contact your health specialists immediately.
Proper doctor prescription is needed.
*Note: The prescription should not be older than 6 month.
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 [see Warnings and Precautions (5.2) and Adverse Reactions (6.1)].