Xydalba

Package leaflet: Information for the patient

Xydalba 500 mg powder for concentrate for solution for infusion

dalbavancin
Please read 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 questions, ask your doctor, pharmacist or nurse.
• If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of this leaflet

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

1. What Xydalba is and what it is used for

Xydalba contains the active substance dalbavancin, which is a glycopeptide antibiotic.
Xydalba is used in adults and children from birth for the treatment of skin infections or
infections of the underlying skin layers.
Xydalba works by killing certain bacteria that can cause serious infections. It kills these bacteria
by interfering with the formation of the bacterial cell wall.
If other bacteria causing the infection are also present, the doctor may decide to treat them with additional
antibiotics alongside Xydalba.

2. What you should know before being given Xydalba

Do not use Xydalba if you are allergic to dalbavancin or to any of the other ingredients of this
medicine (listed in section 6).
Warnings and precautions
Talk to your doctor, pharmacist, or nurse before you are given Xydalba:

• If you have or have had kidney problems. Depending on your age and kidney function, your doctor may consider it appropriate to reduce the dose.
• If you suffer from diarrhoea, or if you have previously experienced diarrhoea during treatment 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 treatment, inform your doctor immediately. Do not take
any medicine for diarrhoea without first consulting your doctor.
Infusion-related reactions
Intravenous infusions of this type of antibiotics may cause flushing of the upper body, hives, itching, and/or skin rashes. If you experience these types of reactions, your doctor may decide to stop or slow down the infusion.
Other infections
The use of antibiotics may sometimes promote the development of a new and different infection. If this occurs, contact your doctor, who will decide on the appropriate action.
Other medicines and Xydalba
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Pregnancy and breastfeeding
Xydalba is not recommended during pregnancy unless strictly necessary. This is because it is unknown what effect it may have on the fetus. If you are pregnant, suspect you may be pregnant, or are planning a pregnancy, consult your doctor before being given this medicine. Together with your doctor, you can decide whether to receive Xydalba.
It is not known whether Xydalba passes into human breast milk. Ask your doctor for advice before breastfeeding. Together with your doctor, you can decide whether to receive Xydalba. You must not breastfeed while receiving Xydalba.
Driving and using machines
Xydalba may cause dizziness. Exercise caution when driving or using machinery after this medicine has been administered.
Xydalba contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e. essentially ‘sodium-free’.

3. How Xydalba is administered

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

• Adults: Xydalba is given as a single dose of 1,500 mg or as two doses given one week apart: 1,000 mg on day 1 and 500 mg on day 8.
• Children and adolescents aged 6 years and under 18 years: Xydalba is given as a single dose of 18 mg/kg (maximum 1,500 mg).
• Infants and children from birth to under 6 years: Xydalba is given as a single dose of 22.5 mg/kg (maximum 1,500 mg).

The dose for children from birth to under 18 years will be calculated by the doctor based on the child's age and weight.
Xydalba will be administered to you via an intravenous infusion directly into the bloodstream through a vein (intravenously). The infusion will last 30 minutes.
Patients with chronic kidney problems
If you have chronic kidney problems, your doctor may decide to reduce your dose. There is insufficient information to recommend the use of Xydalba in children with chronic kidney problems.
If you are given more Xydalba than you should
Tell your doctor or nurse immediately if you think you have been given too high a dose of Xydalba.
If you miss a dose of Xydalba
Tell your doctor or nurse immediately if you are concerned about not having received the second dose.
If you have any doubts about how to use this medicine, consult 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 immediately if you experience any of the following symptoms, as they may require urgent medical attention:

• Sudden swelling of the lips, face, throat or tongue; severe rash; itching; sensation of suffocation; drop in blood pressure; difficulty swallowing and/or breathing. These may all be symptoms of a hypersensitivity reaction and may be life-threatening. This serious reaction has been reported as a rare side effect. It may affect up to 1 in 1,000 people.
• Abdominal pain (stomach ache) and/or watery diarrhoea. Symptoms may become severe or may not go away, and stools may contain blood or mucus. These may be signs of a bowel infection. In this case, do not take medicines that stop or slow down bowel movement. Bowel infections have been reported as an uncommon side effect. They 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 unknown. The frequency cannot be estimated from the available data.

Other side effects reported with Xydalba are listed below.
Contact your doctor, pharmacist or nurse if you experience any of the following side effects:

Common – may affect up to 1 in 10 people.

• Headache
• Feeling unwell (nausea)
• Diarrhoea

Uncommon – may affect up to 1 in 100 people.

• Vaginal infections, fungal infections, oral thrush
• Urinary tract infections
• Anaemia (low red blood cell levels), increased number of platelets in the blood (thrombocytosis), increased levels of a type of white blood cells called eosinophils in the blood (eosinophilia), low levels of other types of white blood cells (leucopenia, neutropenia)
• Changes in other blood tests
• Reduced appetite
• Sleep disturbances
• Dizziness
• Change in taste sensation
• Inflammation and swelling of superficial veins, hot flushes
• Cough
• Abdominal pain and discomfort, indigestion, constipation
• Abnormal liver function tests
• Increased alkaline phosphatase (an enzyme present in the body)
• Itching, hives
• Genital itching (in females)
• Pain, redness or swelling at the infusion site
• Feeling of warmth
• Increased levels of gamma-glutamyl transferase in the blood (an enzyme produced by liver tissue and other body tissues)
• Rash
• Feeling unwell (vomiting)

Rare – may affect up to 1 in 1,000 people.

• Breathing difficulties (bronchospasm)

Reporting of side effects

If you get any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse. You can also report side effects directly via the national reporting system referred to in Annex V. 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 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 when kept closed in the
original container.
The Xydalba solution prepared for infusion must not be used if particulate matter is present or if the solution is cloudy.
Xydalba is a single-use medicine.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents 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 components are mannitol (E421), lactose monohydrate, hydrochloric acid and/or sodium hydroxide (only for pH adjustment).

Description of the appearance of Xydalba and contents of the pack
Xydalba powder for concentrate for solution for infusion is supplied in a 48 mL glass vial with a green tear-off seal. The vial contains a powder ranging in colour from white to off-white or pale yellow.
It is available in packs containing 1 vial.

Marketing Authorisation Holder and Manufacturer
AbbVie Deutschland GmbH & Co. KG
Knollstrasse
67061 Ludwigshafen
Germany

Manufacturer
Almac Pharma Services (Ireland) Limited
Finnabair Industrial Estate,
Dundalk,
Co. Louth, A91 P9KD, Ireland
Almac Pharma Services Ltd
Seagoe Industrial Estate, Craigavon, Country Armagh BT63 5UA
United Kingdom
Aziende Chimiche Riunite Angelini Francesco A.C.R.A.F. S.p.A.
Via Vecchia del Pinocchio, 22
60131 Ancona
Italy

For further information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien Lietuva
Advanz Pharma Belgium Angelini Pharma S.p.A
Tél/Tel: +32 (0)800 78 941 Tel: + 39 06 78 0531
[email protected]

България Luxembourg/Luxemburg
Анджелини Фарма България ЕООД Amdipharm Ltd
Teл.: +359 2 975 1395 Tél/Tel: +352 27861461
[email protected] [email protected]

Česká republika Magyarország
Angelini Pharma Česká republika s.r.o. Angelini Pharma Magyarország Kft
Tel: +420 546 123 111 Tel: + 36 1 336 1614
[email protected] [email protected]

Danmark Malta
Abcur AB Correvio
Sverige Tel: +44 (0)208 588 9131
Tlf: +45 8082 6022 [email protected]
[email protected]

Deutschland Nederland
Advanz Pharma Germany GmbH Amdipharm Ltd
Tel: +49 (0)800 1802 091 Tel: +31 (0)20 808 32 06
[email protected] [email protected]

Eesti Norge
Angelini Pharma S.p.A Abcur AB
Tel: + 39 06 78 0531 Sverige
Tlf: +47 800 16 689
[email protected]

Ελλάδα Österreich
ANGELINI PHARMA HELLAS A.B.E.E. Angelini Pharma Österreich GmbH
Τηλ: + 30 210 626 9200 Tel: + 43 5 9606 0
[email protected] [email protected]

España Polska
ANGELINI PHARMA ESPAÑA, S.L. Angelini Pharma Polska Sp. z o.o.
Tel: + 34 93 253 45 00 Tel.: +48 22 70 28 200
[email protected]

France Portugal
Correvio SAS AbbVie, Lda.
Tél: +33 (0)1 77 68 89 17 Tel: +351 (0)21 1908400
[email protected]

Hrvatska România
Angelini Pharma S.p.A Angelini Pharmaceuticals România SRL
Tel: + 39 06 78 0531 Tel: + 40 21 331 6767
[email protected]

Ireland Slovenija
Correvio Angelini Pharma S.p.A
Tel: +352 1800 851 119 Tel: + 39 06 78 0531
[email protected]

Ísland Slovenská republika
Abcur AB Angelini Pharma Slovenská republika s.r.o.
Svíþjóð Tel: + 421 2 59 207 320
Sími: +46 20 088 02 36 [email protected]
[email protected]

Italia Suomi/Finland
Angelini Pharma S.p.A Abcur AB
Tel: +39 06 78 0531 Ruotsi/Sverige
Puh/Tel: +358 800 416231
[email protected]

Κύπρος Sverige
ANGELINI PHARMA HELLAS A.B.E.E. Abcur AB
Τηλ: + 30 210 626 9200 Sverige
[email protected] Tel: +46 (0)20 088 02 36
[email protected]

Latvija
Angelini Pharma S.p.A
Tel: + 39 06 78 0531

More detailed information on this medicine is available on the European Medicines Agency website: https://www.ema.europa.eu.

The following information is intended for healthcare professionals only:

Important: Before prescribing, consult the Summary of Product Characteristics (SmPC).
Xydalba must be reconstituted with sterile water for injections and subsequently diluted with a 50 mg/mL (5%) glucose infusion solution.
Xydalba vials are for single use only.

Instructions for reconstitution and dilution
Aseptic technique must be used for the reconstitution and dilution of Xydalba.

1. The contents of each vial must be reconstituted by slowly adding 25 mL of water for injections.
2. Do not shake. To avoid foaming, gently swirl and invert the vial alternately until the contents are completely dissolved. Reconstitution may take up to 5 minutes.
3. The reconstituted concentrate in the vial contains 20 mg/mL of dalbavancin.
4. The reconstituted concentrate should be clear, colourless to yellow, and free of visible particles.
5. The reconstituted concentrate must be further diluted with a 50 mg/mL (5%) glucose infusion solution.
6. To dilute the reconstituted concentrate, the appropriate volume of the 20 mg/mL concentrate should be transferred from the vial into an intravenous infusion bag or a vial containing a 50 mg/mL (5%) glucose infusion solution. For example: 25 mL of concentrate contains 500 mg of dalbavancin.
7. After dilution, the infusion solution must have a final concentration between 1 and 5 mg/mL of dalbavancin.
8. The infusion solution should be clear, colourless to yellow, and free of visible particles.
9. If particulate matter is observed or a colour change occurs, the solution must be discarded.

Xydalba must not be mixed with other medicinal products or intravenous solutions. Solutions containing sodium chloride may cause precipitation and must not be used for reconstitution or dilution. Compatibility of the reconstituted Xydalba concentrate has been established only with a 50 mg/mL (5%) glucose infusion solution.
If a common intravenous line is used to administer other drugs in addition to Xydalba, the line must be flushed before and after each Xydalba infusion with a 5% glucose infusion solution.

Use in the paediatric population
In paediatric patients, the dose of Xydalba will vary according to the child's age and weight, up to a maximum of 1,500 mg. Transfer the required dose of reconstituted dalbavancin solution, as calculated according to the child's weight and based on the instructions above, from the vial into an intravenous infusion bag or vial containing a 50 mg/mL (5%) glucose infusion solution. The diluted solution must have a final concentration between 1 and 5 mg/mL of dalbavancin.
Table 1 below provides guidance for preparing an infusion solution with a final concentration of 2 mg/mL or 5 mg/mL (sufficient for most scenarios), to be administered via syringe pump, to achieve a dose of 22.5 mg/kg in paediatric patients from birth to 12 months of age and weighing between 1 and 12 kg. Alternative concentrations may be prepared, but must fall within a final concentration range of 1 to 5 mg/mL of dalbavancin. Refer to Table 1 to verify calculations. The values provided are approximate. Please note that the table does not include all possible doses for every age group, but may be used to estimate the approximate volume to verify calculations.

Table 1. Preparation of Xydalba (final infusion concentration of 2 mg/mL or 5 mg/mL to be administered via syringe pump) in paediatric patients from birth to 12 months of age (dose of 22.5 mg/kg)
[Note: The actual table content was not provided in the source text and therefore cannot be translated.]

Disposal
Discard any unused portion of the reconstituted solution.
Any unused medicinal product and waste materials derived from such medicinal product should be disposed of in accordance with local regulations.