Cefiderocol

Cefiderocol is a prescription medication used to treat the symptoms of Urinary Tract Infection and Bacterial Pneumonia. 

• Cefiderocol is available under the following different brand names: Fetroja

Common side effects of Cefiderocol include:

• Nausea,
• Vomiting,
• Diarrhea,
• Constipation,
• Mouth sores,
• Cough,
• Abnormal liver function tests,
• Headache,
• Rash, and
• Pain, redness, itching bruising, or swelling around the iv needle

Serious side effects of Cefiderocol include:

• Hives,
• Difficulty breathing,
• Swelling of the face, lips, tongue, or throat,
• Fever,
• Sore throat,
• Burning in your eyes,
• Skin pain,
• Red or purple skin rash that spreads and causes blistering and peeling,
• Severe stomach pain,
• Diarrhea that is watery or bloody (even if it occurs months after your last dose),
• Tremor,
• Rigid muscles,
• Seizure,
• White patches or sores inside your mouth or on your lips,
• Leg cramps,
• Constipation,
• Irregular heartbeats,
• Fluttering in your chest,
• Increased thirst or urination,
• Numbness or tingling,
• Muscle weakness, and
• Limp feeling

Rare side effects of Cefiderocol include:

• none 

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors;
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheadedness, or passing out.

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult dosage

• Injection, lyophilized powder of reconstitution
  • 1 gram

Urinary Tract Infection

Adult dosage

• 2 grams Intravenous every 8 hours for 7-14 days
• Duration of therapy should be dependent on infection severity and patient’s clinical status for up to 14 days

Hospital-acquired and Ventilator-associated Bacterial Pneumonia

Adult dosage

• 2 grams Intravenous every 8 hours for 7-14 days

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Cefiderocol has severe interactions with no other drugs.
• Cefiderocol has serious interactions with no other drugs.
• Cefiderocol has moderate interactions with the following drug:
  • Warfarin
• Cefiderocol has minor interactions with no other drugs.

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all your products. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your healthcare professional or doctor for additional medical advice, or if you have health questions or concerns.

Contraindications

• Severe hypersensitivity to cefiderocol or other beta-lactam antibacterial drugs, or any other component of cefiderocol 

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Cefiderocol?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Cefiderocol?”

Cautions

• An increase in all-cause mortality was observed; reserve use for patients who have limited or no alternative treatment options for the treatment of cUTI
• Closely monitor clinical response to therapy in patients with chronic urinary tract infection and hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP); increase in all-cause mortality in patients with carbapenem-resistant gram-negative bacterial infection reported; significance unknown
• Serious and occasionally fatal hypersensitivity (anaphylactic) reactions and serious skin reactions were reported; reactions are more likely to occur in individuals with a history of beta-lactam hypersensitivity and/or a history of sensitivity to multiple allergens; discontinue therapy if an allergic reaction occurs
• Cephalosporins may trigger seizures; nonconvulsive status epilepticus, encephalopathy, coma, asterixis, neuromuscular excitability, and myoclonia reported with cephalosporins, particularly in patients with a history of epilepsy and/or when recommended dosages of cephalosporins were exceeded due to renal impairment; if CNS adverse reactions including seizures occur, patients should undergo a neurological evaluation to determine whether to discontinue treatment
• Dosage adjustment is required in patients receiving continuous renal replacement therapy (CRRT) including CVVH, CVVHD, and CVVHDF; dosage should be based on effluent flow rate in patients receiving; while on CRRT, a patient’s residual renal function may change; improvements or reductions in residual renal function may warrant a change in dosage
• Prescribing in absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit and may increase the risk for the development of drug-resistant bacteria
• C difficile-associated diarrhea
  • C difficile-associated diarrhea (CDAD) reported
  • CDAD may range in severity from mild diarrhea to fatal colitis
  • Treatment with antibacterial agents alters the normal flora of the colon and may permit overgrowth of C difficile
  • If CDAD is suspected or confirmed, consider discontinuing antibacterial drugs not directed against C difficile; manage fluid and electrolyte levels as appropriate, supplement protein intake, monitor antibacterial treatment of C difficile, and institute surgical evaluation as clinically indicated
• Drug interaction overview
  • Use may result in false-positive results in dipstick tests (urine protein, ketones, or occult blood); use alternate clinical laboratory methods of testing to confirm positive tests

Pregnancy and Lactation

• There are no available data on use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes
• Available data from published prospective cohort studies, case series, and case reports over several decades with cephalosporin use in pregnant women have not established drug-associated risks of major birth defects, miscarriage, or adverse maternal or fetal outcomes
• Lactation
  • Unknown whether cefiderocol is excreted into human milk; however, cefiderocol-derived radioactivity was detected in the milk of lactating rats that received IV cefiderocol
  • When a drug is present in animal milk, the drug will likely be present in human milk
  • No information is available on the effects of cefiderocol on the breastfed infant or milk production