Chemical formula: C₃₀H₃₄ClN₇O₁₀S₂ Molecular mass: 752.21 g/mol
Cefiderocol interacts in the following cases:
Recommended dose of cefiderocol for patients with a CrCl <90 ml/min1:
| Renal function | Dose | Frequency |
|---|---|---|
| Mild renal impairment (CrCL ≥60 to <90 mL/min) | 2 g | Every 8 hours |
| Moderate renal impairment (CrCL ≥30 to <60 mL/min) | 1.5 g | Every 8 hours |
| Severe renal impairment (CrCL ≥15 to <30 mL/min) | 1 g | Every 8 hours |
| End stage renal disease (CrCL <15 mL/min) | 0.75 g | Every 12 hours |
| Patient with intermittent haemodialysis2 | 0.75 g | Every 12 hours |
1 As calculated using the Cockcroft-Gault formula.
2 As cefiderocol is removed by haemodialysis, administer cefiderocol at the earliest possible time after completion of haemodialysis on haemodialysis days.
Cephalosporins have been implicated in triggering seizures. Patients with known seizure disorders should continue anticonvulsant therapy.
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. As a precautionary measure, it is preferable to avoid the use of cefiderocol during pregnancy.
It is unknown whether cefiderocol/metabolites are excreted in human milk. A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from cefiderocol therapy taking into account the benefit of breast feeding for the child and the benefit of therapy for the woman.
The effect of cefiderocol on fertility in humans has not been studied. Based on preclinical data, from a study with sub-clinical exposure, there is no evidence that cefiderocol has an effect on male or female fertility.
Cefiderocol has no or negligible influence on the ability to drive and use machines.
The most common adverse reactions were diarrhoea (8.2%), vomiting (3.6%), nausea (3.3%) and cough (2%).
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.
Tabulated list of adverse reactions:
| System organ class | Common (≥1/100 to <1/10) | Uncommon (≥1/1,000 to <1/100) | Not known |
|---|---|---|---|
| Infections and infestations | Candidiasis including oral candidiasis, vulvovaginal candidiasis, candiduria and candida infection, Clostridioides difficile colitis including pseudomembranous colitis and Clostridioides difficile/em> infection | ||
| Blood and lymphatic system disorders | Neutropenia | ||
| Immune System Disorders | Hypersensitivity including skin reactions and Pruritus | ||
| Respiratory, thoracic and mediastinal disorders | Cough | ||
| Gastrointestinal disorders | Diarrhoea, Nausea, Vomiting | ||
| Skin and subcutaneous tissue disorders | Rash including rash macular, rash maculo- papular, rash erythematous and drug eruption | ||
| 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 |
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