Fetcroja 1 g powder

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or nurse.
• If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

1. What Fetcroja is and what it is used for
2. What you need to know before you are given Fetcroja
3. How Fetcroja is used
4. Possible side effects
5. How to store Fetcroja
6. Contents of the pack and other information

• if you are allergic to cefiderocol or any of the other ingredients of this medicine (listed in section 6);
• if you are allergic to other antibiotics known as cephalosporins;
• if you have had a severe allergic reaction to certain antibiotics, such as penicillins or carbapenems. This can include severe skin peeling, swelling of the hands, face, feet, lips, tongue or throat; or difficulty swallowing or breathing.

Tell your doctor if any of these apply to you.

Talk to your doctor or nurse before you are given Fetcroja:

• if you have ever had any allergic reaction to other antibiotics. See also section above, “Do not use Fetcroja”;
• if you have kidney problems. Your doctor will adjust your dose to ensure you don’t get too much or too little medicine;
• if you suffer from diarrhoea during your treatment;
• if you are on a low sodium diet;
• if you have ever had seizures.

Talk to your doctor or nurse before you are given Fetcroja.

New Infection

Although Fetcroja can fight certain bacteria, there is a possibility that you may get a different infection caused by another organism during or after your treatment. Your doctor will monitor you closely for any new infections and give you another treatment if necessary.

Blood/laboratory Tests

Tell your doctor that you are taking Fetcroja if you are going to have any blood/laboratory tests. This is because you may get an abnormal result. With something called a “Coombs test” this looks for the presence of antibodies that can destroy red blood cells or may be affected by the response of your immune system to Fetcroja. Fetcroja may also result in false-positive results in urine dipstick tests (urine protein or diabetes markers).

Fetcroja should not be given to children and adolescents under the age of 18. This is because it is not known if the medicine is safe to use in these age groups.

Tell your doctor or nurse if you are taking, have recently taken or might take any other medicines.

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.

Fetcroja does not affect your ability to drive or operate machinery.

This medicine contains 7.64 mmol (176 mg) of sodium per vial. The total daily dose is 2.1 g, just greater than the WHO recommend daily maximum of 2 g sodium for an adult. Talk to your doctor before you are given Fetcroja if you are on a low sodium diet.

If you have kidney problems, talk to your doctor before you are given Fetcroja. The doctor will adjust your dose of Fetcroja.

Fetcroja will be given to you by a doctor or nurse, so it is unlikely you will be given the wrong dose. Tell your doctor or nurse straight away if you think you have been given more Fetcroja than you should have.

If you think you have not been given a dose of Fetcroja, tell your doctor or nurse straight away.

Tell your doctor straight away if you notice any of the following serious side effects – you may need urgent medical treatment:

• Severe allergic reaction – signs include sudden swelling of your lips, face, throat or tongue; a severe rash or other severe skin reactions; difficulty swallowing or breathing. This reaction may be life-threatening.
• Diarrhoea that gets worse or does not go away, or stools that contain blood or mucus. This may happen during treatment, or after it has been stopped. If this happens, do not take medicines that stop or slow bowel movement.

Tell your doctor straight away if you notice any of the serious side effects above.

Tell your doctor or nurse if you notice any of the following side effects.

Common

(may affect up to 1 in 10 people)

• Feeling sick (nausea) or being sick (vomiting)
• Swelling, redness and/or pain around the needle where the medicine is given into a vein
• Yeast infections e.g. thrush
• Increase in levels of liver enzymes, shown in blood tests
• Cough
• Rash, with small raised bumps
• Severe gut infection known as Clostridioides difficile colitis. Symptoms include watery diarrhoea, abdominal pain, fever, etc.
• Increased blood creatinine values

Uncommon

(may affect up to 1 in 100 people)

• Increased blood urea values
• Allergy to Fetcroja

Not known

(frequency cannot be estimated from the available data)

• Reduced count of specific white blood cells (neutrophil granulocytes)

If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via

or search for MHRA Yellow Card in the Google Play or Apple App Store.

By reporting side effects, you can help provide more information on the safety of this medicine.

• The active substance is cefiderocol sulfate tosylate, equivalent to 1 g cefiderocol.
• The other excipients are sucrose, sodium chloride and sodium hydroxide.

Fetcroja is a white to off-white powder for concentrate for solution for infusion in a vial. It is available in packs containing 10 vials.

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder: