Is Cefiderocol approved by the FDA?
Yes, Cefiderocol, marketed under the brand name Fetroja, is FDA approved. The U.S. Food and Drug Administration (FDA) approved Cefiderocol on November 14, 2019, for the treatment of complicated urinary tract infections (cUTIs) and hospital-acquired bacterial pneumonia (HABP), including ventilator-associated bacterial pneumonia (VABP).
What is Cefiderocol?
Cefiderocol is a cephalosporin antibiotic used to treat serious bladder or kidney infections in adults, as well as pneumonia developed in hospital settings or during the use of a ventilator. This antibiotic works by inhibiting cell wall synthesis, which is vital for bacterial survival.
Indications and Usage
Cefiderocol is specifically indicated for:
- Complicated Urinary Tract Infections (cUTIs): Including pyelonephritis caused by susceptible Gram-negative microorganisms such as Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, Pseudomonas aeruginosa, and Enterobacter cloacae complex.
- Hospital-Acquired Bacterial Pneumonia (HABP) and Ventilator-Associated Bacterial Pneumonia (VABP): Caused by susceptible strains of Acinetobacter baumannii complex, Escherichia coli, Enterobacter cloacae complex, Klebsiella pneumoniae, Pseudomonas aeruginosa, and Serratia marcescens.
Dosage and Administration
Cefiderocol is administered intravenously and must be given slowly over a period of three hours. The typical dosage for adults is 2 grams every 8 hours for 7 to 14 days, depending on the severity and type of infection.
Side Effects
Common Side Effects
- Nausea, vomiting, diarrhea, constipation
- Mouth sores
- Cough
- Abnormal liver function tests
- Headache
- Rash
- Pain, redness, itching, bruising, or swelling around the IV needle site
Serious Side Effects
- Severe stomach pain, watery or bloody diarrhea
- Tremors, rigid muscles, seizures
- White patches or sores inside the mouth or on the lips
- Low potassium levels, leading to symptoms like leg cramps, constipation, irregular heartbeats, increased thirst or urination, numbness or tingling, muscle weakness
Warnings and Precautions
Cefiderocol can cause serious or life-threatening allergic reactions. Patients with a history of severe allergic reactions to antibiotics, particularly beta-lactams (penicillins, cephalosporins), should inform their healthcare provider before starting this medication.
How is Cefiderocol Given?
Cefiderocol must be mixed with a diluent and further diluted with another liquid in an IV bag before administration. It is important to follow the exact preparation and administration instructions provided by healthcare professionals. Each IV bag is for single use only and should be disposed of after one use.
Storage
Store cefiderocol vials in the original carton in a refrigerator to protect them from light. Once mixed, the solution should be stored at room temperature and used within 1 hour or stored in a refrigerator and used within 24 hours after reaching room temperature.
Conclusion
Cefiderocol (Fetroja) has been FDA-approved since November 14, 2019, for treating serious infections such as complicated urinary tract infections and hospital-acquired bacterial pneumonia. Its efficacy in treating multi-drug resistant Gram-negative infections makes it a valuable option in the antibiotic arsenal. Patients should be aware of potential side effects and follow their healthcare provider's instructions carefully to ensure safe and effective use.
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