FETCROJA 1 g POWDER FOR CONCENTRATE FOR PERFUSION SOLUTION

Introduction

Package Leaflet: Information for the User

Fetcroja 1 g powder for concentrate for solution for infusion

cefiderocol

Read all of this leaflet carefully before you are given this medicine because it contains important information for you.

• 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.

Contents of the pack

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

1. What is Fetcroja and what is it used for

Fetcroja contains the active substance cefiderocol. It is an antibiotic that belongs to a group of antibiotics called cephalosporins. Antibiotics help fight bacteria that cause infections.

Fetcroja is used in adults to treat infections caused by certain types of bacteria when other antibiotics cannot be used.

2. What you need to know before you are given Fetcroja

Do not use Fetcroja

• if you are allergic to cefiderocolor to any of the other ingredients of this medicine (listed in section 6);
• if you are allergic to other antibioticsknown 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 doctorif any of these points apply to you.

Warnings and precautions

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

• if you have ever had an allergic reaction to other antibiotics.See also the previous section «Do not use Fetcroja»;
• if you have kidney problems.Your doctor will adjust your dose to make sure you do not receive too much or too little medicine;
• if you get diarrheaduring your treatment;
• if you have ever had seizures.

• Talk to your doctor or nursebefore you are given Fetcroja.

New infection

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

Blood/laboratory tests

If you need to have any blood/laboratory tests, tell your doctor that you are taking Fetcroja, as you may get an abnormal result. With a test called «Coombs test», the presence of antibodies that can destroy red blood cells or that can be affected by your immune system's response to Fetcroja is sought. Fetcroja can also produce false positive results in urine tests with test strips (proteins in urine or diabetes markers).

Children and adolescents

Fetcroja must not be given to children and adolescents under 18 years of age, as it is not known if it is safe to use the medicine in these age groups.

Other medicines and Fetcroja

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

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before you are given this medicine.

Driving and using machines

Fetcroja does not affect your ability to drive or use machines.

Fetcroja contains sodium

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

3. How to use Fetcroja

Your doctor or nurse will give you this medicine by infusion (drip) into a vein over 3 hours, 3 times a day. The recommended dose is 2 g.

The number of days you will receive treatment with Fetcroja depends on the type of infection you have and how the infection is going.

If you feel pain at the site where Fetcroja is being administered to your vein, tell your doctor or nurse.

People with kidney problems

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

If you are given too much Fetcroja

A doctor or nurse will give you Fetcroja, so it is unlikely that you will be given the wrong dose. If you think you have been given too much Fetcroja, tell your doctor or nurse immediately.

If you miss a dose of Fetcroja

If you think you have missed a dose of Fetcroja, tell your doctor or nurse immediately.

If you have any other questions about the use of this medicine, ask your doctor or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Serious side effects

Tell your doctor immediately if you notice any of the following serious side effects, as you may need urgent medical treatment:

• Severe allergic reaction: signs include sudden swelling of the lips, face, throat or tongue; a severe skin rash or other severe skin reactions; difficulty swallowing or breathing. This reaction can be life-threatening.
• Diarrhea that gets worse or does not go away, or stools that contain blood or mucus. This can happen during treatment or after stopping treatment. If this happens, do not take medicines that slow down or stop bowel movements.

• Tell your doctorimmediately if you notice any of the above serious side effects.

Other side effects

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

Common

(may affect up to 1 in 10 people)

• Nausea or vomiting.
• Swelling, redness and/or pain around the needle where the medicine is administered into a vein.

• Fungal infections, e.g. candidiasis.

• Increased levels of liver enzymes; seen in blood tests.
• Cough.

• Rash with small bumps.

• Severe intestinal infection called Clostridioides difficilecolitis. Symptoms include watery diarrhea, abdominal pain, fever, etc.
• Increased creatinine in blood.

Uncommon

(may affect up to 1 in 100 people)

• Increased urea in blood.
• Allergy to Fetcroja.

Frequency not known

(frequency cannot be estimated from the available data)

• Decreased number of certain white blood cells (neutrophil granulocytes).
• Discoloration of urine (chromaturia).

Reporting of side effects

If you experience any side effects, talk to your doctor or nurse, even if it is possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Medicines Agency website: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Fetcroja

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the label. The expiry date is the last day of the month stated.

Store the vials in a refrigerator (between 2°C and 8°C).

Store in the original packaging to protect from light.

6. Contents of the pack and other information

What Fetcroja contains

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

Appearance and packaging

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

Marketing authorisation holder and manufacturer

Shionogi B.V.

Herengracht 464

1017CA Amsterdam

Netherlands

For further information about this medicine, contact the local representative of the marketing authorisation holder:

Date of last revision of this leaflet: 01/2025

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu

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This information is intended only for healthcare professionals:

Each vial is for single use only.

The powder should be reconstituted with 10 ml of sodium chloride 9 mg/ml (0.9%) injection solution or 5% glucose injection solution, which is drawn from 100 ml bags that will be used to prepare the final infusion solution, and the vials should be gently shaken to dissolve the powder. The vials should be left to stand until the foam generated on the surface disappears (usually within 2 minutes). The final volume of the reconstituted solution in the vial will be approximately 11.2 ml (warning: the reconstituted solution must not be injected directly).

To prepare the required doses, the appropriate volume of reconstituted solution should be withdrawn from the vial according to the table below. Add the withdrawn volume to the infusion bag containing the remaining 100 ml of sodium chloride 9 mg/ml (0.9%) injection solution or 5% glucose injection solution, visually inspect the resulting solution with the diluted medicine in the infusion bag for particles or color change before use. Do not use solutions that have changed color or have visible particles.

Preparation of cefiderocol doses

Standard aseptic techniques should be followed to prepare and administer the solution.

This medicine should not be mixed with other medicines except for those mentioned above in this section. If it is not possible to avoid combined treatment with another medicine and Fetcroja, administration should not be in the same syringe or infusion solution. It is recommended to properly clean the intravenous lines between the administration of different medicines.

Disposal of unused medicine and all materials that have come into contact with it should be in accordance with local regulations.