Why is this medication prescribed?

Fetroja (cefiderocol) is prescribed as an antibiotic medication used to treat complicated urinary tract infections (cUTIs), including pyelonephritis, caused by susceptible Gram-negative bacteria in adults who have limited or no alternative treatment options.

Cefiderocol works by binding to iron and transporting itself into bacterial cells through iron transporters. Once inside the bacterial cell, it disrupts cell wall synthesis, leading to bacterial cell death.

How should this medicine be used?

Fetroja is typically administered intravenously (IV) over a period of 60 minutes. The recommended dosage and duration of treatment may vary depending on the severity of the infection, the patient’s renal function, and other factors. It’s crucial to follow the dosage instructions provided by your healthcare provider.

Here are general guidelines for the use of Fetroja:

• Dosage: The recommended dosage for Fetroja is typically 2 grams administered over a period of one hour every 8 hours. Dosage adjustments may be necessary based on the patient’s renal function.
• Administration: Fetroja should be administered intravenously (IV) by a healthcare professional. It should not be given as an intramuscular injection.
• Duration of treatment: The duration of treatment with Fetroja varies depending on the type and severity of the infection. Your healthcare provider will determine the appropriate duration of therapy based on your condition.
• Follow-up: It’s essential to complete the full course of treatment as prescribed by your healthcare provider, even if you start to feel better before the treatment is finished. Stopping the medication prematurely can lead to the recurrence of infection or the development of antibiotic resistance.
• Monitoring: Your healthcare provider may monitor your response to Fetroja treatment through laboratory tests and clinical assessments. Be sure to attend all follow-up appointments as recommended.
• Adverse effects: Like all medications, Fetroja may cause side effects. Common side effects include diarrhea, nausea, vomiting, headache, and infusion site reactions. If you experience severe or persistent side effects, contact your healthcare provider.

Always consult with your healthcare provider for specific instructions on the use of Fetroja tailored to your individual medical condition and needs.

Other uses for this medicine

Fetroja (ceftazidime-avibactam) is primarily indicated for the treatment of complicated urinary tract infections (cUTIs) and complicated intra-abdominal infections (cIAIs) caused by susceptible Gram-negative bacteria in adults. However, it may be used off-label or investigationaly for other conditions at the discretion of healthcare providers, especially in cases where alternative treatments have been ineffective or are not available.

What special precautions should I follow?

Here are some special precautions to consider when using Fetroja:

• Allergies: Inform your healthcare provider if you have a history of allergies to ceftazidime, avibactam, or any other cephalosporin antibiotics, penicillins, or beta-lactamase inhibitors. Allergic reactions to Fetroja can be serious and require immediate medical attention.
• Renal Impairment: Adjustments to the dosage of Fetroja may be necessary for patients with impaired renal function. Dosage adjustments are typically based on the patient’s estimated glomerular filtration rate (eGFR). It’s important to follow the dosage recommendations provided by your healthcare provider to avoid potential complications associated with renal impairment.
• Clostridioides difficile Infection (CDI): Fetroja may increase the risk of developing Clostridioides difficile infection (CDI), a potentially severe and life-threatening condition characterized by diarrhea. If you develop diarrhea during or after treatment with Fetroja, especially if it is severe or persistent, inform your healthcare provider immediately.
• Seizures: Fetroja may lower the seizure threshold, particularly in patients with a history of epilepsy or central nervous system disorders. Use caution when prescribing Fetroja to patients with a history of seizures or other predisposing factors.
• Drug Interactions: Inform your healthcare provider about all medications, supplements, and herbal products you are taking, as they may interact with Fetroja. Certain medications, such as probenecid and nephrotoxic drugs, may increase the risk of adverse effects when used concomitantly with Fetroja.
• Pregnancy and Breastfeeding: The safety of Fetroja during pregnancy and breastfeeding has not been established. Consult your healthcare provider before using Fetroja if you are pregnant, planning to become pregnant, or breastfeeding.
• Resistant Organisms: Treatment with Fetroja may promote the emergence of resistant bacteria. It’s essential to use Fetroja only for the treatment of infections caused by susceptible organisms and to follow antimicrobial stewardship principles to minimize the development of antimicrobial resistance.
• Injection Site Reactions: Fetroja is administered intravenously, and injection site reactions may occur. Inform your healthcare provider if you experience pain, swelling, or irritation at the injection site.
• Hepatic Impairment: Limited data are available on the use of Fetroja in patients with hepatic impairment. Use caution and monitor hepatic function closely in patients with pre-existing liver disease.

Always follow the recommendations and guidance provided by your healthcare provider when using Fetroja or any other medication. If you have any questions or concerns about Fetroja or its use, consult your healthcare provider for further information and advice.

What special dietary instructions should I follow?

Regarding special dietary instructions for Fetroja, there are no specific dietary restrictions associated with its use. However, it’s essential to maintain a balanced diet and stay well-hydrated during treatment to support overall health and recovery from infection.

What should I do if I forget a dose?

If you forget to take a dose of Fetroja, take it as soon as you remember. However, if it is almost time for your next scheduled dose, skip the missed dose and continue with your regular dosing schedule. Do not double the dose to catch up. If you have any concerns or questions about missed doses, consult your healthcare provider or pharmacist for guidance. It’s crucial to adhere to the prescribed dosing regimen to ensure the effectiveness of treatment and minimize the risk of complications.

What side effects can this medication cause?

Fetroja (ceftazidime-avibactam) may cause side effects in some individuals. Common side effects of Fetroja include:

• Diarrhea
• Nausea
• Vomiting
• Headache
• Injection site reactions (pain, redness, swelling)
• Elevated liver enzymes (as seen in blood tests)
• Hypersensitivity reactions, including rash, itching, and swelling

Less commonly, Fetroja may cause more severe side effects, including:

• Clostridioides difficile infection (CDI), which can cause severe diarrhea and colitis
• Allergic reactions, such as anaphylaxis, which can be life-threatening
• Seizures, particularly in individuals with a history of epilepsy or central nervous system disorders
• Decreased white blood cell count (neutropenia), which can increase the risk of infections
• Elevated serum creatinine levels, indicating potential kidney problems
• Superinfection with resistant bacteria or fungi

It’s essential to report any side effects experienced during Fetroja treatment to your healthcare provider promptly. If you develop severe or persistent side effects, seek medical attention immediately. Additionally, if you experience signs of an allergic reaction, such as difficulty breathing, swelling of the face or throat, or severe rash, seek emergency medical care. Your healthcare provider can determine whether any adjustments to your treatment plan are necessary to manage side effects effectively.

What should I know about storage and disposal of this medication?

Storage and disposal:

Storage:

• Temperature: Store Fetroja vials at controlled room temperature between 20°C to 25°C (68°F to 77°F).
• Protect from Light: Keep Fetroja vials in the original carton to protect them from light.
• Reconstitution and Dilution: Fetroja should be reconstituted and diluted according to the instructions provided by the manufacturer and healthcare provider. Reconstituted solution may be stored at controlled room temperature for up to 4 hours or refrigerated at 2°C to 8°C (36°F to 46°F) for up to 24 hours.
• Unused Portions: Unused portions of reconstituted or diluted Fetroja should be discarded properly.

Disposal:

• Unused Medication: Dispose of any unused Fetroja medication properly according to local regulations or guidelines. Do not flush unused medications down the toilet or pour them into drains unless instructed to do so by your healthcare provider or pharmacist.
• Sharps Disposal: Used needles, syringes, and other sharps used in the administration of Fetroja should be disposed of in puncture-resistant containers in accordance with local regulations.

In case of emergency/overdose

In case of emergency or overdose of Fetroja, contact your local poison control center or emergency room immediately. Overdose symptoms may include severe nausea, vomiting, diarrhea, and other adverse reactions. Provide as much information as possible about the medication and the amount taken.

What other information should I know?

• Follow Instructions: Always follow the instructions provided by your healthcare provider or pharmacist regarding the use of Fetroja, including dosage, administration, and duration of treatment.
• Regular Monitoring: Your healthcare provider may conduct regular monitoring of your condition, including clinical assessments and laboratory tests, during Fetroja treatment to evaluate its effectiveness and detect any potential adverse effects.
• Complete Treatment: Complete the full course of Fetroja treatment as prescribed by your healthcare provider, even if you start to feel better before the treatment period ends. Failure to complete the prescribed course of treatment may lead to incomplete eradication of the infection and increase the risk of antibiotic resistance.
• Medical History: Inform your healthcare provider about your medical history, including any allergies, underlying medical conditions, and medications you are taking, to ensure the safe and effective use of Fetroja.
• Antibiotic Resistance: Use Fetroja only for the treatment of infections caused by susceptible organisms, and follow antimicrobial stewardship principles to minimize the development of antibiotic resistance.

If you have any questions or concerns about the storage, disposal, or use of Fetroja, consult your healthcare provider or pharmacist for guidance.