FETCROJA 1G POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION - patient leaflet, side effects, dosage

Fetcroja 1 g powder for concentrate for solution for infusion

ThS This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects, you may get. See the end of section 4 for how to report side effects.

Read all of this leaflet carefully before you start using 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 or nurse.
• If you get any side effects, talk to your doctor or or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

What is in 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 is an antibiotic medicine that belongs to a group of antibiotics called cephalosporins and contains the active substance cefiderocol. Antibiotics work by killing bacteria that cause infections.

Fetcroja can be used in adults to treat a range of serious infections caused by bacteria that other antibiotics cannot kill.

2. what you need to know before you are given fetcroja

Do not use Fetcroja:

• 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 types of antibiotics, known as cephalosporins
• if you have had a severe allergic reaction to other antibiotics, such as penicillins or carbapenems. Symptoms of a severe reaction 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 applies to you, before you are given Fetcroja.

Warnings and precautions

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

• if you have ever had any allergic reaction (even if only a skin rash) to other antibiotics such as penicillins or carbapenems
• 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 a history of seizures.

Talk to your doctor before being given Fetcroja if any of these apply to you.

Children and adolescents

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

Other medicines and Fetcroja

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

Pregnancy, breast-feeding and fertility Ask your doctor for advice before you are given Fetcroja if you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby.

Driving and using machines

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.

3. how to use fetcroja

Your doctor or nurse will give you this medicine as an infusion (a drip) into your vein over 3 hours, three times a day. The typical dose of Fetcroja is 2 g.

The number of days you will be given Fetcroja treatment depends on the type of infection you have and how you respond to treatment.

People with kidney problems

If you have kidney problems, your doctor will adjust your dose of Fetcroja. This is because it is removed from your body by the kidneys.

If you are given more Fetcroja than you should

Fetcroja will be given to you by a doctor or nurse, so it is unlikely you will be given the wrong dose. However, if you have side effects, tell your doctor or nurse straight away.

If you miss a dose of Fetcroja

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

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

4. possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. The following side effects may happen with this medicine:

Serious side effects

• Tell your doctor straight away if you notice any of the following serious side effects -you may need urgent medical treatment: Severe allergic reactions – 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 lifethreatening.
• Diarrhoea (frequent, loose watery stools) that keeps getting 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.

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)

• diarrhoea (frequent, loose watery stools)
• feeling sick (nausea) or being sick (vomiting)
• pain where Fetcroja was given into a vein
• yeast infections
• increase in levels of liver enzymes, shown in blood tests
• cough
• rash, with small raised bumps.

Uncommon

(may affect up to 1 in 100 people)

• allergy to Fetcroja
• severe gut infection known as Clostridium difficile colitis.

Reporting of side effects

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 the national reporting system listed in Appendix V.* By reporting side effects, you can help provide more information on the safety of this medicine.

5. how to store 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 refers to the last day of that month.

Unopened vials: Store in a refrigerator (2°C – 8°C).

Store in the original package in order to protect from light.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicnes you no longer require. These measures will help to protect the environment,

6. contents of the pack and other information

What Fetcroja contains

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