Drug information of Cefiderocol

Cefiderocol is a siderophore cephalosporin. A catechol side chain promotes formation of chelated complexes with ferric iron, allowing use of iron transport systems to deliver cefiderocol across the outer membrane of gram-negative bacilli. The cephalosporin moiety binds to penicillin-binding proteins which in turn inhibits the final transpeptidation step of peptidoglycan synthesis in bacterial cell walls, thus inhibiting cell wall biosynthesis.

Vd: 18 (±3.36) L.

Minimal.

Urine: 98.6% (90.6% as unchanged drug); feces: 2.8%.

2 to 3 hours.

40% to 60% (primarily to albumin).

Urinary tract infection, complicated (including pyelonephritis): Treatment of complicated urinary tract infections, including pyelonephritis, caused by the following susceptible gram-negative microorganisms: Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, Pseudomonas aeruginosa, and Enterobacter cloacae complex, in patients ≥18 years of age who have limited or no alternative treatment options.

Usual Adult Dose for Pyelonephritis

2 g IV every 8 hours
Duration of therapy: 7 to 14 days

Comments:
-Recommended for patients with CrCl 60 to 119 mL/min
-Approval based on limited clinical safety and efficacy data.
-Therapy duration should be guided by severity of infection and patient's clinical status for up to 14 days.
Usual Adult Dose for Urinary Tract Infection

2 g IV every 8 hours
Duration of therapy: 7 to 14 days

Comments:
-Recommended for patients with CrCl 60 to 119 mL/min
-Approval based on limited clinical safety and efficacy data.
-Therapy duration should be guided by severity of infection and patient's clinical status for up to 14 days.

Severe hypersensitivity to cefiderocol, other beta-lactam antibacterial drugs, or any other component of the formulation.

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skinwith or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Signs of low potassiumlevels like muscle pain or weakness, muscle cramps, or a heartbeat that does not feel normal.
• Feeling confused.
• Seizures.
• Trouble controlling body movements.
• Extra muscle action.
• Redness or white patches in mouth or throat.
• Diarrheais common with antibiotics. Rarely, a severe form called C diff–associated diarrhea (CDAD) may happen. Sometimes, this has led to a deadly bowel problem (colitis). CDAD may happen during or a few months after taking antibiotics. Call your doctor right away if you have stomach pain, cramps, or very loose, watery, or bloody stools. Check with your doctor before treating diarrhea.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Irritation where the shot is given.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

Before taking this medicine

You should not take cefiderocol if you are allergic to cefiderocol or other cephalosporin antibiotics, such as:

• cefaclor;
• cefadroxil;
• cefazolin;
• cefditoren;
• cefpodoxime;
• cefprozil;
• ceftibuten;
• cefuroxime;
• cephalexin; or
• cephradine, and others.

Tell your doctor if you have ever had:

• an allergy to any drug (especially penicillin);
• kidney disease;
• a seizure
• liver disease; or
• intestinal problems, such as colitis.

Tell your doctor if you are pregnant or breastfeeding.

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.

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.

Store unmixed cefiderocol in the original carton in a refrigerator. Protect from light and do not freeze.

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 4 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.

Storage

Store intact vials at 2°C to 8°C (36°F to 46°F). Protect from light. Reconstituted vials may be stored at room temperature for ≤1 hour. As of July 2020, the manufacturer's labeling states diluted solutions for infusion may be stored at room temperature for ≤6 hours or at 2°C to 8°C (36°F to 46°F) for ≤24 hours (and protected from light); prior to July 2020, the manufacturer's labeling only stated storage at room temperature for ≤4 hours was acceptable. Infusion should be completed within 6 hours after removal from refrigeration.