Xydalba 500 mg powder for concentrate for solution for infusion – patient leaflet, side effects, dosage

1. What Xydalba is and what it is used for

Xydalba contains the active substance dalbavancin, which is an antibiotic of the glycopeptide group.

Xydalba is used to treat adults and children from birth with infections of the skin or in the layers of flesh below the skin.

Xydalba works by killing certain bacteria, which can cause serious infections. It kills these bacteria by interfering with the formation of bacterial cell walls.

If you also have other bacteria that cause your infection, your doctor may decide to treat you with other antibiotics in addition to Xydalba.

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

Do not use Xydalba if you are allergic to dalbavancin or any of the other ingredients of this medicine (listed

in section 6).

Warnings and precautions

Talk to your doctor, pharmacist or nurse before being given Xydalba:

• If you have or have had kidney problems.

  Depending on your age and the condition of your kidney, your doctor may have to reduce your dose.

• If you are suffering from diarrhoea, or you have

  previously suffered from diarrhoea when being treated with antibiotics.

  • If you are allergic to other antibiotics such as

    vancomycin or teicoplanin.

Diarrhoea during or after treatment

If you develop diarrhoea during or after your treatment, tell your doctor at once. Do not take any medicine to treat your diarrhoea without first checking with your doctor.

Infusion-related reactions

Intravenous infusions with these types of antibiotics can

cause flushing of the upper body, hives, itching and/or rashes. If you experience these types of reactions your doctor may decide to stop or slow the infusion.

Other infections

Using antibiotics may sometimes allow a new and different infection to develop. If this happens tell your doctor and they will decide what to do.

Other medicines and Xydalba

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

Pregnancy and breast-feeding

Xydalba is not recommended during pregnancy unless clearly necessary. This is because it is not known what effect it might have on an unborn baby. Before you are given this medicine, tell your doctor if you are pregnant, think you may be pregnant or are planning to have a baby. You and your doctor will decide if you will be given Xydalba.

It is not known if Xydalba passes into breast milk in humans. Ask your doctor for advice before breast-feeding your

baby. You and your doctor will decide if you will be given Xydalba. You should not breastfeed when given Xydalba.

Driving and using machines

Xydalba may cause dizziness. Take care with driving and using machines after you have been given this medicine.

Xydalba contains sodium

This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodium-free’.

3. How you will be given Xydalba

Xydalba will be given to you by a doctor or nurse.

• Adults: Xydalba is given in a single dose of

  1500 mg or in two doses a week apart: 1000 mg on Day 1 and 500 mg on Day 8.

• Children and adolescents aged from 6 years to

  less than 18 years: Xydalba is given in a single dose of 18 mg/kg (maximum 1500 mg).

• Infants and children aged from birth to less

  than 6 years: Xydalba is given in a single dose of 22.5 mg/kg (maximum 1500 mg).

The dose for children aged from birth to less than 18 years will be calculated by the doctor based on the age and weight of the child.

You will be given Xydalba through a drip directly into your bloodstream through a vein (intravenously) over 30 minutes.

Patients with chronic kidney problems

If you suffer from chronic kidney problems, your doctor may decide to reduce your dose. There is not enough information to recommend the use of Xydalba for children with chronic kidney problems.

If you are given more Xydalba than you should

Tell your doctor or nurse immediately if you are concerned that you may have been given too much

Xydalba.

If you miss a dose of Xydalba

Tell your doctor or nurse immediately if you are concerned that you are missing the 2^nd dose.

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.

Serious side effects

Tell your doctor straight away if you get any of these symptoms - you may need urgent medical attention:

• Sudden swelling of your lips, face, throat or tongue; severe rash; itchiness; throat

  tightening; drop in blood pressure; difficulty in swallowing and /or difficulty in breathing. These may all be signs of a hypersensitivity reaction and may be life-threatening. This severe reaction has been reported as a rare side effect. It may affect up to 1 in 1000 people.

• Abdominal pain (stomach ache) and/or

  watery diarrhoea. The symptoms may become severe or may not go away and the stools may contain blood or mucus. These may be signs of an infection of the bowel. In this situation, you

  should not take medicines that stop or slow bowel movement. Infection of the bowel has been reported as an uncommon side effect. It may affect up to 1 in 100 people.

• Changes in hearing. This has been reported

  as a side effect with a similar medicine. The frequency is not known. The frequency cannot be estimated from the available data.

Other side effects reported with Xydalba are listed below.

Talk to your doctor, pharmacist or nurse if you get any of the following side effects:

Common - may affect up to 1 in 10 people:

• Headache
• Feeling sick (nausea)
• Diarrhoea

Uncommon - may affect up to 1 in 100 people:

• Vaginal infections, fungal infections, oral thrush

• Urinary tract infections

  • Anaemia (low levels of red blood cells), high

    blood platelet counts (thrombocytosis), increased blood counts of a type of white blood cell called eosinophils (eosinophilia), low levels of other types of white blood cell (leucopenia, neutropenia)

  • Changes in other blood tests
  • Decreased appetite
  • Difficulty sleeping
  • Dizziness
  • Change in sense of taste
  • Inflammation and swelling of surface veins, flushing
  • Cough

  • Abdominal pain and discomfort, indigestion,

    constipation

  • Abnormal liver function test

  • An increase in alkaline phosphatase (an enzyme

    found in the body)

  • Itching, hives
  • Genital itching (females)

  • Pain, redness or swelling at the place where the

    infusion was given

  • Feeling hot

  • Increase in blood levels of gamma-glutamyl

    transferase (an enzyme produced by the liver and other body tissues)

  • Rash
  • Being sick (vomiting)

Rare - may affect up to 1 in 1000 people:

• Difficulty breathing (bronchospasm)

Reporting of side effects

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

United Kingdom

Yellow Card Scheme, Website:

www.mhra.gov.uk/yellowcard 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.

5. How to store Xydalba

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 vial after EXP. The expiry date refers to the last day of that month.

This medicine does not require any special storage conditions if kept unopened in the original container.

The prepared Xydalba solution for infusion must not be used if there are any particles or the solution is cloudy.

Xydalba is for single use only.

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

Brief ID: PROD-2025-000301

6. Contents of the pack and other information

What Xydalba contains

• The active substance is dalbavancin. Each vial of powder contains dalbavancin hydrochloride equivalent to 500 mg of dalbavancin.
• The other ingredients are mannitol (E421), lactose monohydrate, hydrochloric acid and/or sodium hydroxide (for pH adjustment only).

What Xydalba looks like and contents of the pack

Xydalba powder for concentrate for solution for infusion is provided in a 48 ml glass vial with a green flip off seal. The vial contains white to off-white to pale yellow powder.

It is available in packs containing 1 vial.

Marketing Authorisation Holder

AbbVie Ltd.

Maidenhead

SL6 4UB

UK

Manufacturer

Almac Pharma Services (Ireland) Limited

Finnabair Industrial Estate,

Dundalk,

Co. Louth, A91 P9KD, Ireland

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

Holder:

United Kingdom

Mercury Pharmaceuticals Limited Tel: +44 (0)208 588 9131

medicalinformation@advanzpharma.com This leaflet was last revised in 04/2025