Fetcroja

It is recommended that Fetcroja should be used to treat patients that have limited treatment options only after consultation with a physician with appropriate experience in the management of infectious diseases. Posology Table 1 Recommended dose of Fetcroja1 for patients with a creatinine clearance (CrCL) ≥ 90 mL/min2 Renal function Dose Frequency Duration of treatment Normal renal function 2 g Every 8 hours Duration in accordance with the site of infection3 (CrCL ≥90 to < 120 mL/min) Augmented renal clearance 2 g Every 6 hours Duration in accordance with the site of infection3 (CrCL ≥ 120 mL/min) 1To be used in combination with antibacterial agents active against anaerobic pathogens and/or Gram-positive pathogens when these are known or suspected to be contributing to the infectious process.

2As calculated using the Cockcroft-Gault formula. g. for complicated urinary tract infections including pyelonephritis and complicated intra-abdominal infections the recommended treatment duration is 5 to 10 days. For hospital-acquired pneumonia including ventilator- 3 associated pneumonia the recommended treatment duration is 7 to 14 days.

Treatment up to 21 days may be required. 75 g Every 12 hours 1As calculated using the Cockcroft-Gault formula. 2As cefiderocol is removed by haemodialysis, administer cefiderocol at the earliest possible time after completion of haemodialysis on haemodialysis days.

2). 2). Paediatric population The safety and efficacy of Fetcroja in children below 18 years of age has not yet been established. No data are available. Method of administration Intravenous use. Fetcroja is administered by intravenous infusion over 3 hours.

6. If treatment with a combination of another medicinal product and Fetcroja is unavoidable, administration should not occur in the same syringe or in the same infusion solution. It is recommended to adequately flush intravenous lines between administration of different medicinal products.

3%) and cough (2%). Tabulated list of adverse reactions The following adverse reactions have been reported with cefiderocol during clinical studies (Table 3). Adverse reactions are classified according to frequency and System Organ Class (SOC).

Frequency categories are defined as: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1000); very rare (<1/10,000); not known (cannot be estimated from the available data). Within each System Organ Class, undesirable effects are presented in order of decreasing seriousness.

Table 3 Tabulated list of adverse reactions System organ class Common Uncommon Not known (≥1/100 to <1/10) (≥1/1,000 to <1/100) Infections and infestations Candidiasis including oral candidiasis, vulvovaginal candidiasis, candiduria and candida infection, Clostridioides difficile coli tis including pseudomembranous colitis and Clostridioides difficile infection Blood and lymphatic system disorders Neutropenia Immune System Disorders Hypersensitivity including skin reactions and Pruritus Respiratory, thoracic and Cough 7 mediastinal disorders Gastrointestinal disorders Diarrhoea, Nausea, Vomiting Skin and subcutaneous tissue disorders Rash including rash macular, rash maculo- papular, rash erythematous and drug eruption Renal and urinary disorders: Chromaturia General disorders and administration site conditions Infusion site reaction including infusion site pain, injection site pain, infusion site erythema and injection site phlebitis Investigations Alanine aminotransferase increased, Gamma- glutamyltransferase increased, Aspartate aminotransferase increased, Hepatic function abnormal including liver function test increased, hepatic enzyme increased, transaminases increased and liver function test abnormal, Blood creatinine increased Blood urea increased Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.

8). Patients who have a history of hypersensitivity to carbapenems, penicillins or other beta-lactam antibacterial medicinal products may also be hypersensitive to cefiderocol. 3). If a severe allergic reaction occurs, treatment with Fetcroja must be discontinued immediately and adequate emergency measures must be initiated.

8). The condition can range in severity from mild diarrhoea to fatal colitis and should be considered in patients who present with diarrhoea during or subsequent to the administration of cefiderocol. Discontinuation of therapy with cefiderocol and the use of supportive measures together with the administration of specific treatment for Clostridioides difficile should be considered.

Medicinal products that inhibit peristalsis should not be given. Seizure Cephalosporins have been implicated in triggering seizures. Patients with known seizure disorders should continue anticonvulsant therapy. Patients who develop focal tremors, myoclonus, or seizures should be evaluated neurologically and placed on anticonvulsant therapy if not already instituted.

2). Alternatively, cefiderocol should be discontinued. Limitations of the clinical data In clinical trials, cefiderocol has only been used to treat patients with the following types of infection: complicated urinary tract infections (cUTI); hospital-acquired pneumonia (HAP), ventilator-associated pneumonia (VAP), healthcare-associated pneumonia (HCAP); sepsis and patients with bacteraemia (some with no identified primary focus of infection).

The use of cefiderocol to treat patients with infections due to Gram-negative aerobic pathogens who have limited treatment options is based on pharmacokinetic-pharmacodynamic analyses for cefiderocol and on limited clinical data from a randomized clinical trial in which 80 patients were treated with cefiderocol and 38 patients were treated with best available therapy for infections caused by carbapenem-resistant organisms.

1. Hypersensitivity to any cephalosporin antibacterial medicinal product. g. g. penicillins, monobactams or carbapenems).