Cefiderocol is a cephalosporin (SEF-a-lo-SPOR-in) antibiotic that is used to treat serious bladder or kidney infections in adults.

Cefiderocol is also used to treat adults who have developed pneumonia while being in a hospital or using a ventilator.

Cefiderocol may also be used for purposes not listed in this medication guide.

Cefiderocol can cause serious or life-threatening allergic reactions. Tell your doctor if you have an allergy to an antibiotic, especially penicillin.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Cefiderocol is injected into a vein.

This medicine must be given slowly over 3 hours.

Ask your doctor or pharmacist if you don't understand how to use an injection.

Cefiderocol must be mixed with a liquid (diluent) and then further diluted with another liquid in an IV bag. Prepare an injection only when you are ready to give it. Call your pharmacist if the medicine has changed colors or has particles in it.

Do not reuse a needle or syringe. Place them in a puncture-proof "sharps" container and dispose of it following state or local laws. Keep out of the reach of children and pets.

Cefiderocol is usually given for 7 to 14 days.

Keep using this medicine even if your symptoms quickly improve. Skipping doses could make your infection resistant to medication. Cefiderocol will not treat a viral infection (flu or a common cold).

This medicine can affect the results of certain medical tests. Tell any doctor who treats you that you are using cefiderocol.

Store vials in the original carton in a refrigerator. Protect from light.

After mixing a diluent into the vial: Store at room temperature and further dilute into an IV bag within 1 hour.

After diluting the mixture in an IV bag: Store the bag at room temperature for up to 6 hours, or in a refrigerator for up to 24 hours. Protect from light.

After removing the IV bag from a refrigerator, you must use the medicine within 6 hours once it reaches room temperature.

Each IV bag is for one use only. Throw it away after one use, even if there is still medicine left inside.

Usual Adult Dose for Pyelonephritis:

2 g IV every 8 hours for 7 to 14 days

Comments:
-Recommended for patients with CrCl 60 to 119 mL/min

Use: Treatment of complicated urinary tract infections (including pyelonephritis) due to susceptible Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, Pseudomonas aeruginosa, and Enterobacter cloacae complex

Usual Adult Dose for Urinary Tract Infection:

2 g IV every 8 hours for 7 to 14 days

Comments:
-Recommended for patients with CrCl 60 to 119 mL/min

Use: Treatment of complicated urinary tract infections (including pyelonephritis) due to susceptible Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, Pseudomonas aeruginosa, and Enterobacter cloacae complex

Usual Adult Dose for Nosocomial Pneumonia:

2 g IV every 8 hours for 7 to 14 days

Comments:
-Recommended for patients with CrCl 60 to 119 mL/min

Uses: For the treatment of hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia due to susceptible Acinetobacter baumannii complex, E coli, E cloacae complex, K pneumoniae, P aeruginosa, and Serratia marcescens

Cefiderocol can cause serious or life-threatening allergic reactions. You should not use cefiderocol if you have ever had a severe allergic reaction to an antibiotic, such as:

• cefadroxil, cefdinir, cefoxitin, cefprozil, ceftriaxone, cefuroxime, cephalexin, Keflex, Omnicef, and others;

• avibactam, relebactam, sulbactam, tazobactam, vaborbactam, and others; or

• amoxicillin (Amoxil, Augmentin, Moxatag), ampicillin, dicloxacillin, oxacillin, penicillin, and others.

Tell your doctor if you have ever had:

• an allergy to any drug (especially penicillin);

• kidney disease (or if you are on dialysis);

• a seizure;

• liver disease; or

• intestinal problems, such as colitis.

Tell your doctor if you are pregnant or breastfeeding.

Call your doctor for instructions if you miss a dose.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Antibiotic medicines can cause diarrhea. Tell your doctor if you have diarrhea that is watery or bloody.

Get emergency medical help if you have signs of an allergic reaction (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning in your eyes, skin pain, red or purple skin rash that spreads and causes blistering and peeling).

Cefiderocol may cause serious side effects. Call your doctor at once if you have:

• severe stomach pain, diarrhea that is watery or bloody (even if it occurs months after your last dose);

• tremor, rigid muscles, or a seizure;

• white patches or sores inside your mouth or on your lips; or

• low potassium level--leg cramps, constipation, irregular heartbeats, fluttering in your chest, increased thirst or urination, numbness or tingling, muscle weakness or limp feeling.

Common side effects of cefiderocol may include:

• nausea, vomiting, diarrhea, constipation;

• mouth sores;

• cough;

• abnormal liver function tests;

• headache;

• rash; or

• pain, redness, itching, bruising, or swelling around the IV needle.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Other drugs may affect cefiderocol, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all other medicines you use.