cefiderocol

What is the most important information I should know about cefiderocol?

What is cefiderocol?

Cefiderocol is a cephalosporin (SEF-a-lo-SPOR-in) antibiotic.

Cefiderocol 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 can cause serious or life-threatening allergic reactions. This medicine should be used only for infections that cannot be treated with a safer antibiotic.

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

What should I discuss with my healthcare provider before using cefiderocol?

• 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.

How is cefiderocol given?

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed. Cefiderocol is sometimes given for up to 14 days.

Cefiderocol is given as an infusion into a vein. A healthcare provider will give your first dose and may teach you how to properly use the medication by yourself.

This medicine must be given slowly, and the infusion can take at least 3 hours to complete.

Read and carefully follow any Instructions for Use provided with your medicine. Ask your doctor or pharmacist if you don't understand all instructions.

Prepare an injection only when you are ready to give it. Do not use if the medicine has changed colors or has particles in it. Call your pharmacist for new medicine.

Cefiderocol must be mixed with a liquid (diluent) and then further diluted with another liquid in an IV bag. When using injections by yourself, be sure you understand how to properly mix and store the medicine.

Use this medicine for the full prescribed length of time, even if your symptoms quickly improve. Skipping doses can increase your risk of infection that is resistant to medication. Cefiderocol will not treat a viral infection such as the 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.

After mixing cefiderocol with a diluent, keep the vial at room temperature and further dilute it within 1 hour. After diluting the mixture into an IV bag, keep the bag at room temperature and use it within 6 hours.

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

Use a needle and syringe only once and then place them in a puncture-proof "sharps" container. Follow state or local laws about how to dispose of this container. Keep it out of the reach of children and pets.

What happens if I miss a dose?

What happens if I overdose?

What should I avoid while using cefiderocol?

Antibiotic medicines can cause diarrhea, which may be a sign of a new infection. If you have diarrhea that is watery or bloody, call your doctor before using anti-diarrhea medicine.

What are the possible side effects of cefiderocol?

• 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 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.

What other drugs will affect cefiderocol?

Other drugs may affect cefiderocol, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.

Where can I get more information?

Your pharmacist can provide more information about cefiderocol.