FETCROJA 1 G POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION

Package leaflet: Information for the user

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 this medicine is administered to you, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or nurse.
• If you experience any adverse reactions, talk to your doctor or nurse, even if they are not listed in this leaflet. See section 4.

Contents of this leaflet

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

1. What Fetcroja is and what it is 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 cefiderocol or to 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 may 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.

Warnings and precautions

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

• if you have or have ever had an allergic reaction to other antibiotics. See also the section above “Do not use Fetcroja”;

• if you have kidney problems. Your doctor will adjust your dose to ensure you do not receive too little or too much medicine;

• if you develop diarrhoea during your treatment;

• 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, you may develop a different infection caused by another microorganism during or after treatment. Your doctor will monitor you closely for any new infection and will give you additional treatment if needed.

Blood/laboratory tests

If you are having any blood or laboratory tests, tell your doctor that you are taking Fetcroja, as it may cause abnormal results. The “Coombs test” looks for antibodies that may destroy red blood cells or that may be affected by your immune system’s response to Fetcroja. Fetcroja may also cause false positive results in urine dipstick tests (urine proteins or diabetes markers).

Children and adolescents

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

Other medicines and Fetcroja

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

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant or are planning to become pregnant, talk to your doctor 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 total daily dose is 2.1 g, just above the maximum daily intake of 2 g of sodium recommended by the WHO for an adult. Consult 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 administer this medicine to you as an intravenous infusion (drip) over 3 hours, 3 times a day. The usual recommended dose is 2 g.

The number of days you will receive Fetcroja treatment depends on the type of infection you have and how your infection responds.

If you feel pain at the site where Fetcroja is being infused into your vein, inform your doctor or nurse.

Patients with kidney problems

If you have kidney problems, consult your doctor before being given Fetcroja. Your doctor will adjust your Fetcroja dose.

If you are given more Fetcroja than you should

A doctor or nurse will administer Fetcroja to you, so it is unlikely that you will be given an incorrect dose. However, if you think you have been given more Fetcroja than you should have, inform your doctor or nurse immediately.

If a dose of Fetcroja is missed

If you think a dose of Fetcroja has not been administered to you, inform your doctor or nurse immediately.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

Serious adverse effects

Inform your doctor immediately if you notice any of the following serious adverse effects, as you may require urgent medical treatment:

• Severe allergic reaction: signs include sudden swelling of the lips, face, throat, or tongue; severe rash or other serious skin reactions; difficulty swallowing or breathing. This reaction may be life-threatening.

• Diarrhea that worsens or does not go away, or stools containing blood or mucus. This may occur during treatment or after stopping it. If this happens, do not take medicines that slow down or reduce the number of bowel movements.

• Inform your doctor immediately if you notice any of the serious adverse effects listed above.

Other adverse effects

Inform your doctor or nurse if you notice any of the following adverse effects.

Common

(may affect up to 1 in 10 people)

• Nausea or vomiting.

• Swelling, redness and/or pain around the needle used to administer the medicine into a vein.

• Fungal infections, e.g., candidiasis.

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

• Cough.

• Skin rash with small bumps.

• Severe intestinal infection called Clostridioides difficile colitis. Symptoms include watery diarrhea, abdominal pain, fever, etc.

• Increased blood creatinine levels.

Uncommon

(may affect up to 1 in 100 people)

• Increased blood urea levels.
• Allergy to Fetcroja.

Frequency not known

(frequency cannot be estimated from the available data)

• Decrease in the number of certain white blood cells (neutrophil granulocytes).
• Discoloration of urine (chromaturia).

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or nurse, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines website: www.notificaRAM.es. By reporting adverse 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 stated on the label. The expiry date is the last day of the month indicated.

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

Keep in the original packaging to protect from light.

6. Contents of the pack and other information

Composition of Fetcroja

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

Appearance of the product and contents of the container

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 Authorization Holder and Manufacturer

Shionogi B.V.

Herengracht 464

1017CA Amsterdam

The Netherlands

Further information on this medicinal product is available upon request by contacting the local representative of the Marketing Authorization Holder:

Date of the most recent review of this summary: 01/2025

Other sources of information

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

This information is intended for healthcare professionals only:

Each vial is for single use only.

The powder must be reconstituted with 10 ml of 9 mg/ml (0.9 %) sodium chloride injection solution or 5 % dextrose injection solution taken from the 100 ml bags to be used for preparing the final infusion solution, and the vials should be gently shaken until the powder dissolves. The vials should then be allowed to stand until foam 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, withdraw the appropriate volume of reconstituted solution from the vial according to the table below. Add the withdrawn volume to the infusion bag containing the remaining 100 ml of 9 mg/ml (0.9 %) sodium chloride injection solution or 5 % dextrose injection solution. Visually inspect the resulting solution in the infusion bag for particles or discoloration prior to use. Do not use solutions that show discoloration or contain visible particles.

Preparation of cefiderocol doses

Standard aseptic techniques must be followed when preparing and administering the solution.

This medicinal product must not be mixed with others, except those mentioned above in this section. If combined treatment with another medicinal product and Fetcroja cannot be avoided, administration must not be performed using the same syringe or the same infusion solution. It is recommended to adequately flush the intravenous lines between administration of the different medicinal products.

Disposal of unused medicinal product and all materials that have been in contact with it must be carried out in accordance with local regulations.