Cefiderocol Injection

WHY is this medicine prescribed?

Cefiderocol injection is used to treat certain types of urinary tract infections in adults unable to take or receive other treatment options. It is also used to treat pneumonia in adults who are on ventilators or who were already in a hospital. Cefiderocol injection is in a class of medications called cephalosporin antibiotics. It works by killing bacteria.

Antibiotics such as cefiderocol injection will not work for colds, flu, or other viral infections. Taking or using antibiotics when they are not needed increases your risk of getting an infection later that resists antibiotic treatment.

Are there OTHER USES for this medicine?

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

HOW should this medicine be used?

Cefiderocol injection comes as a powder to be added to fluid and injected intravenously (into a vein). It is usually given over a period of 3 hours every 8 hours for 7 to 14 days. The length of your treatment depends on your general health and how well you respond to the medication. You may receive cefiderocol injection in a hospital or you may administer the medication at home. If you will be receiving cefiderocol injection at home, your healthcare provider will show you how to use the medication. Be sure that you understand these directions, and ask your healthcare provider if you have any questions.

You should begin to feel better during the first few days of treatment with cefiderocol injection. If your symptoms do not improve or get worse, tell your doctor. If you still have symptoms of infection after you finish cefiderocol injection, tell your doctor.

Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.

What SPECIAL PRECAUTIONS should I follow?

Before receiving cefiderocol injection,

• tell your doctor and pharmacist if you are allergic to cefiderocol; carbapenem antibiotics such as imipenem and cilastatin (Primaxin) or meropenem (Merrem); other cephalosporin antibiotics such as cefaclor, cefadroxil, cefdinir, cefepime (Maxipime), cefixime (Suprax), cefotaxime, cefotetan, cefoxitin (Mefoxin), cefpodoxime, cefprozil, ceftaroline (Teflaro), ceftazidime (Fortaz, Tazicef, in Avycaz), ceftriaxone, cefuroxime (Zinacef), and cephalexin (Keflex); penicillin antibiotics; or any other medications. Ask your pharmacist for a list of the ingredients.

• tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.

• tell your doctor if you have or have ever had epilepsy or seizures or kidney disease.

• tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while receiving cefiderocol injection, call your doctor.

What SPECIAL DIETARY instructions should I follow?

Unless your doctor tells you otherwise, continue your normal diet.

What SIDE EFFECTS can this medicine cause?

Cefiderocol injection may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• nausea
• vomiting
• diarrhea
• constipation
• swelling, pain, or redness near the spot where the medication was injected
• genital itching
• white patches in mouth

Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately or get emergency medical treatment:

• seizures
• rash, itching, hives, difficulty breathing or swallowing ,wheezing, or swelling of the face, throat, tongue, lips, or eyes
• severe diarrhea (watery or bloody stools) that may occur with or without fever and stomach cramps (may occur up to 2 months or more after your treatment)

Cefiderocol injection may cause other side effects. Call your doctor if you have any unusual problems while receiving this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

What should I do in case of OVERDOSE?

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

What OTHER INFORMATION should I know?

Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests to check your body's response to cefiderocol injection.

Before having any laboratory tests, tell your doctor and the laboratory personnel that you are receiving cefiderocol. Talk to your doctor about which glucose tests you can use during your treatment with while using this medication.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.