- Drugs List
- Therapeutic Indications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
Infusion of cefiderocol.
Infections caused by Gram-negative bacteria
For the treatment of infections due to aerobic Gram-negative organisms in adults with limited treatment options.
It is recommended the cefiderocol 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.
2g every 8 hours.
Duration to be in accordance with the site of infection.
Patients with Renal Impairment
Creatinine clearance equal to or over 120mL/min (augmented renal clearance)
2g every 6 hours.
Creatinine clearance 60 to 120mL/min
2g every 8 hours.
Creatinine clearance 30 to 60mL/min
1.5g every 8 hours.
Creatinine clearance 15 to 30mL/min
1g every 8 hours.
Creatinine clearance less than 15mL/min or with intermittent haemodialysis
0.75g every 12 hours.
Children under 18 years
Restricted sodium intake
Precautions and Warnings
Creatinine clearance equal to or above 120ml/minute
History of seizures
Moderate renal impairment
Reduce dose in patients with creatinine clearance below 60ml/min
Sodium content of formulation may be significant
Consult national/regional policy on the use of anti-infectives
Monitor renal function regularly
Consider pseudomembranous colitis if patient presents with diarrhoea
If tremors, myoclonus or convulsion occur, consider anticonvulsant therapy
May affect results of some laboratory tests
Discontinue at once if pseudomembranous colitis occurs
Discontinue if overgrowth of resistant organisms occurs
Discontinue if severe hypersensitivity reactions occur
Cephalosporins have been implicated in triggering seizures. Patients that have seizure disorders should continue with anticonvulsant therapy. If patients develop focal tremors, myoclonus, or seizures, a neurological evaluation should be performed and placed on anticonvulsant therapy if not already instituted.
Pregnancy and Lactation
Cefiderocol is contraindicated during pregnancy.
The manufacturer does not recommend using cefiderocol during pregnancy. At the time of writing, there is limited data on the use of cefiderocol during pregnancy (less than 300 pregnancy outcomes). Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity.
Use cefiderocol with caution during breastfeeding.
The manufacturer advises that the patient either discontinues cefiderocol or discontinues breastfeeding. It is unknown whether cefiderocol is excreted in human breast milk.
Abnormal liver function
Alanine aminotransferase increased
Altered liver function tests
Aspartate aminotransferase increased
Clostridium difficile diarrhoea
Erythema at injection site
Gamma glutamyl transferase (GGT) increased
Increase of liver transaminases
Increased susceptibility to infection
Increases in hepatic enzymes
Injection site reactions
Local pain (injection site)
Overgrowth by non-susceptible organisms
Phlebitis (injection site)
Effects on Laboratory Tests
Cefiderocol may result in false-positive results in urine dipstick tests (urine protein, ketones, or occult blood). Alternative methods of testing should be used by the clinical laboratories to confirm positive tests.
A positive direct or indirect Coombs test may develop during treatment with cefiderocol.
It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.
The following number will direct the caller to the relevant local centre (0844) 892 0111
Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).
Last Full Review Date: October 2020
Summary of Product Characteristics: Fetcroja 1g powder. Shionogi. Revised April 2020.
NICE Evidence Services Available at: www.nice.org.uk Last accessed: 06 May 2021
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Medscape UK | Univadis prescription drug monographs & interactions are based on FDB Multilex Content
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