What is Fetcroja used for?

Fetcroja is indicated for the treatment of infections due to aerobic Gram-negative organisms in adults with limited treatment options (see sections 4.2, 4.4 and 5.1). Consideration should be given to official guidance on the appropriate use of antibacterial agents.

What pharmaceutical form is Fetcroja available in?

Fetcroja: Proszek do sporządzania koncentratu roztworu do infuzji 1 g (dożylna)

What are the side effects of Fetcroja?

Summary of the safety profile The most common adverse reactions were diarrhoea (8.2%), vomiting (3.6%), nausea (3.3%) 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

Who should NOT take Fetcroja?

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Hypersensitivity to any cephalosporin antibacterial medicinal product. Severe hypersensitivity (e.g. anaphylactic reaction, severe skin reaction) to any other type of beta-lactam antibacterial agent (e.g. penicillins, monobactams or carbapenems).

Does Fetcroja interact with other medications?

Based on in vitro studies and two phase 1 clinical studies no significant drug-drug interactions are anticipated between cefiderocol and substrates, inhibitors or inducers of cytochrome P450 enzymes (CYPs) or transporters (see section 5.2).

Can Fetcroja be used during pregnancy?

Pregnancy There are no or limited amount of data (less than 300 pregnancy outcomes) from the use of cefiderocol sodium in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see section 5.3). As a precautionary measure, it is preferable to avoid the use of Fetcroja during pregnancy. Breast-feeding It is unknown whether Fetcroja/metabolites are excreted in human milk. A decision must be made whether to discontinue breast-feeding

What precautions should be taken with Fetcroja?

Each vial is for single use only. The powder should be reconstituted with 10 mL of either sodium chloride 9 mg/ml (0.9%) solution for injection or 5% dextrose injection taken from the 100 mL bags that will be used to prepare the final infusion solution and should be gently shaken to dissolve. The vial(s) should be allowed to stand until the foaming generated on the surface has disappeared (typically within 2 minutes). The final volume of the reconstituted solution in the vial will be approximate

What ATC class does Fetcroja belong to?

Fetcroja: ATC J01DI04. ATC is the WHO Anatomical Therapeutic Chemical classification — it groups drugs by organ system and pharmacological mechanism.

Fetcroja

This information is for educational purposes only. It is not intended as medical advice. Always consult a qualified healthcare professional.

Pharmacotherapeutic group: Antibacterials for systemic use. ATC code: J01DI04 Mechanism of action Cefiderocol is a siderophore cephalosporin. In addition to passive diffusion through outer membrane porin channels, cefiderocol is able to bind to extracellular free iron via its siderophore side chain, allowing active transport into the periplasmic space of Gram-negative bacteria through siderophore uptake systems. Cefiderocol subsequently binds to penicillin binding proteins (PBPs), inhibiting bacterial peptidoglycan cell wall synthesis which leads to cell lysis and death. Resistance Mechanisms of bacterial resistance that may lead to resistance to cefiderocol include mutant or acquired PBPs; beta-lactamase enzymes with ability to hydrolyse cefiderocol; mutations affecting regulation of bacterial iron uptake; mutations in siderophore transport proteins; overexpression of native bacterial siderophores The in vitro antibacterial activity effect of cefiderocol against normally susceptible species is not affected by the majority of beta-lactamases, including metallo-enzymes. Due to the siderophore-mediated mode of cell entry, the in vitro activity of cefiderocol activity is generally less affected by porin loss or efflux-mediated resistance compared to many other beta-lactam agents. Cefiderocol has little or no activity against Gram-positive or anaerobic bacteria due to intrinsic resistance. Antibacterial activity in combination with other antibacterial agents In vitro studies demonstrated no antagonism between cefiderocol and amikacin, ceftazidime/avibactam, ceftolozane/tazobactam, ciprofloxacin, clindamycin, colistin, daptomycin, linezolid, meropenem, metronidazole, tigecycline, or vancomycin. Susceptibility testing breakpoints Minimum Inhibitory Concentration (MIC) breakpoints established by the European Committee on Antimicrobial Susceptibility Testing (EUCAST) for cefiderocol are as follows: Minimum inhibitory concentrations (mg/L) Organisms Susceptible Resistant Enterobacterales ≤2 >2 Pseudomonas aeruginosa ≤2 >2 Pharmacokinetic/pharmacodynamic relationship The time that unbound plasma concentrations of cefiderocol exceeds the minimum inhibitory concentration (% f T >MIC ) against the infecting organism has been shown to best correlate with efficacy. Antibacterial activity against specific pathogens In-vitro studies suggest that the following pathogens would be susceptible to cefiderocol in the absence of acquired mechanisms of resistance: Aerobic Gram-negative organisms Achromobacter spp. Acinetobacter baumannii complex Burkholderia cepacia complex Citrobacter freundii complex Citrobacter koseri Escherichia coli Enterobacter cloacae complex Klebsiella (Enterobacter) aerogenes Klebsiella pneumoniae Klebsiella oxytoca Morganella morganii Proteus mirabilis Proteus vulgaris Providencia rettgeri Serratia spp. Pseudomonas aeruginosa Serratia marcescens Stenotrophomonas maltophilia In vitro studies indicate that the following species are not susceptible to cefiderocol: Aerobic Gram-positive organisms Anaerobic organisms Paediatric population The European Medicines Agency has deferred the obligation to submit the results of studies with Fetcroja in one or more subsets of the paediatric population in the treatment of infections due to aerobic Gram-negative bacteria (see section 4.2 for information on paediatric use).

Fetcroja

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