Package Insert: Information for the User

Fetcroja 1 g Powder for Concentrate for Solution for Infusion

Cefiderocol

Read this package insert carefully before you receive this medication, as it contains important information for you.

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

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

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

Do not use Fetcroja

• if you areallergic to cefiderocolor to any of the other ingredients of this medicine (listed in section 6);
• if you areallergic to other antibioticsknown as cephalosporins;
• if you have had asevere 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.

• Inform your doctorif any of these points apply to you.

Warnings and precautions

Consult your doctor or nurse before Fetcroja is administered to you:

• if you have or have had areaction to other antibiotics.See also the previous section «Do not use Fetcroja»;
• if you havekidney problems.Your doctor will adjust your dose to ensure you receive neither too little nor too much medicine;
• if you experiencediarrheaduring your treatment;
• if you have ever hadanyseizures.

• Consult your doctor or nursebefore Fetcroja is administered to you.

New infection

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

Blood/laboratory tests

If you are required to undergo any blood/laboratory tests, inform your doctor that you are taking Fetcroja, as this may result in an abnormal reading. With a test called the «Coombs test» the presence of antibodies that may destroy red blood cells or be affected by your immune system's response to Fetcroja is sought. Fetcroja may also produce false positive results in urine tests using a dipstick (protein in urine or diabetes markers).

Children and adolescents

Fetcroja should not be administered to children or adolescents under 18 years of age, as its safety in these age groups is unknown.

Other medicines and Fetcroja

Inform your doctor or nurse if you are taking, have taken recently, or may need to take any other medicine.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor before this medicine is administered to you.

Driving and operating machinery

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

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 Fetcroja is administered to you if you follow a low-sodium diet.

Your doctor or nurse will administer this medication through an intravenous infusion (drip) in a vein for 3 hours, 3 times a day. The usual recommended dose is 2 g.

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

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

People with kidney problems

If you have kidney problems, consult your doctor before receiving Fetcroja. The doctor will adjust your dose of Fetcroja.

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 receive an incorrect dose. If you believe you have been given more Fetcroja than you should, inform your doctor or nurse immediately.

If you forget a dose of Fetcroja

If you believe you have not received a dose of Fetcroja, inform your doctor or nurse immediately.

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

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

Severe side effects

Inform your doctor immediately if you observe any of the following severe side effects, as you may require urgent medical treatment:

• Severe allergic reaction: signs include sudden swelling of the lips, face, throat, or tongue; severe skin rash or other severe skin reactions; difficulty swallowing or breathing. This reaction can be fatal.
• Diarrhea that worsens or does not resolve, or stools that contain blood or mucus. This can occur during treatment or after stopping it. If this happens, do not take medications that slow or reduce the number of bowel movements.

• Inform your doctorimmediately if you observe any of the previous severe side effects.

Other side effects

Inform your doctor or nurse if you observe any of the following side effects.

Frequent

(may affect up to 1 in 10 people)

• Nausea or vomiting.
• Swelling, redness, and/or pain around the needle through which the medicine is administered 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 creatinine in blood.

Rare

(may affect up to 1 in 100 people)

• Increased urea in blood.
• Allergy to Fetcroja.

Unknown frequency

(frequency cannot be estimated from available data)

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

Reporting side effects

If you experience any type of side effect, consult your doctor or nurse, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through theSpanish System for Pharmacovigilance of Medicines for Human Use website:www.notificaRAM.es.By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not use this medication after the expiration date shown on the label. The expiration date is the last day of the month indicated.

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

Store in the original packaging to protect it from light.

Composition of Fetcroja

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

Appearance of the product and contents of the package

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

Holder of the marketing authorization and responsible for manufacturing

Shionogi B.V.

Herengracht 464

1017CA Amsterdam

Netherlands

For more information about this medication, please contact the local representative of the marketing authorization holder:

Last review date of this leaflet: 01/2025

Other sources of information

The detailed information about this medication is available on the website of the European Medicines Agency:http://www.ema.europa.eu

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This information is intended solely for healthcare professionals:

Each vial is for single use only.

The powder must be reconstituted with 10 ml of sodium chloride 9 mg/ml (0.9%) or dextrose 5% solution, which is extracted from 100 ml bags that will be used to prepare the final infusion solution, and the vials must be gently agitated to dissolve the powder. The vials must 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 is not injected directly).

To prepare the necessary doses, the appropriate volume of reconstituted solution must be extracted from the vial according to the table below. Add the extracted volume to the infusion bag containing the remaining 100 ml of sodium chloride 9 mg/ml (0.9%) or dextrose 5% solution, visually inspect the resulting solution with the medication diluted in the infusion bag for particles or color change before use. Do not use solutions with color change or visible particles.

Preparation of cefiderocol doses

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

This medication must not be mixed with other medications, except as mentioned in this section. If co-administration with another medication cannot be avoided, administration must not be performed in the same syringe or in the same infusion solution. It is recommended to properly clean the intravenous lines between administration of different medications.

The elimination of unused medication and all materials that have come into contact with it will be carried out in accordance with local regulations.