XYDALBA Powder for concentrate for solution for infusion Ref.[8445] Active ingredients: Dalbavancin

Posology

Adults

The recommended dose of dalbavancin is 1,500 mg administered as either a single infusion of 1,500 mg or as 1,000 mg followed one week later by 500 mg (see sections 5.1 and 5.2).

Children and adolescents aged from 6 years to less than 18 years

The recommended dose of dalbavancin is a single dose of 18 mg/kg (maximum 1,500 mg).

Infants and children aged from 3 months to less than 6 years

The recommended dose of dalbavancin is a single dose of 22.5 mg/kg (maximum 1,500 mg).

Special populations

Elderly

No dose adjustment is necessary (see section 5.2).

Renal impairment

Dose adjustments are not required for adult and paediatric patients with mild or moderate renal impairment (creatinine clearance ≥30 to 79 ml/min). Dose adjustments are not required for adult patients receiving regularly scheduled haemodialysis (3 times/week), and dalbavancin may be administered without regard to the timing of haemodialysis.

In adult patients with chronic renal impairment whose creatinine clearance is <30 ml/min and who are not receiving regularly scheduled haemodialysis, the recommended dose is reduced to either 1,000 mg administered as a single infusion or 750 mg followed one week later by 375 mg (see section 5.2).

There is insufficient information to recommend dosage adjustment for patients younger than 18 years with creatinine clearance less than 30 ml/min/1.73 m². Currently available information is described in section 5.2, but no recommendation on a posology can be made.

Hepatic impairment

No dose adjustment of dalbavancin is recommended for patients with mild hepatic impairment (Child-Pugh A). Caution should be exercised when prescribing dalbavancin to patients with moderate or severe hepatic impairment (Child-Pugh B & C) as no data are available to determine appropriate dosing (see sections 5.2).

Paediatric population

The safety and efficacy of dalbavancin in children aged <3 months old has not yet been established. Currently available data are described in section 5.2, but no recommendation on a posology can be made.

Method of administration

Intravenous use.

Xydalba must be reconstituted and then further diluted prior to administration by intravenous infusion over a 30-minute period. For instructions on reconstitution and dilution of the medicinal product before administration, see section 6.6.

No specific information is available on the treatment of overdose with dalbavancin, as dose-limiting toxicity has not been observed in clinical studies. In Phase 1 studies, healthy volunteers have been administered single doses of up to 1,500 mg, and cumulative doses up to 4,500 mg over a period of up to 8 weeks, with no signs of toxicity or laboratory results of clinical concern. In Phase 3 studies, patients have been administered single doses of up to 1,500 mg.

Treatment of overdose with dalbavancin should consist of observation and general supportive measures. Although no information is available specifically regarding the use of haemodialysis to treat overdose, it should be noted that in a Phase 1 study in patients with renal impairment, less than 6% of the recommended dalbavancin dose was removed after 3 hours of haemodialysis.

Dry powder: 4 years.

Chemical and physical in-use stability of Xydalba has been demonstrated for both the reconstituted concentrate and for the diluted solution for 48 hours at or below 25°C. The total in-use stability from reconstitution to administration should not exceed 48 hours.

From a microbiological point of view, the product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 to 8°C, unless reconstitution/dilution has taken place in controlled and validated aseptic conditions. Do not freeze.

This medicinal product does not require any special storage conditions.

For storage conditions after reconstitution and dilution of the medicinal product, see section 6.3.

Single-use 48 ml type I glass vial with an elastomeric stopper and a green flip off seal.

Each pack contains 1 vial.

Xydalba must be reconstituted with sterile water for injections and subsequently diluted with 50 mg/ml (5%) glucose solution for infusion.

Xydalba vials are for single-use only.

Instructions for reconstitution and dilution

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

1. The content of each vial must be reconstituted by slowly adding 25 ml of water for injections.
2. Do not shake. To avoid foaming, alternate between gentle swirling and inversion of the vial, until its contents are completely dissolved. The reconstitution time may be up to 5 minutes.
3. The reconstituted concentrate in the vial contains 20 mg/ml dalbavancin.
4. The reconstituted concentrate must be a clear, colourless to yellow solution with no visible particles.
5. The reconstituted concentrate must be further diluted with 50 mg/ml (5%) glucose solution for infusion.
6. To dilute the reconstituted concentrate, the appropriate volume of the 20 mg/ml concentrate must be transferred from the vial to an intravenous bag or bottle containing 50 mg/ml (5%) glucose solution for infusion. For example: 25 ml of the concentrate contains 500 mg dalbavancin.
7. After dilution the solution for infusion must have a final concentration of 1 to 5 mg/ml dalbavancin
8. The solution for infusion must be clear, colourless to yellow solution with no visible particles.
9. If particulate matter or discoloration is identified, the solution must be discarded.

Xydalba must not be mixed with other medicinal products or intravenous solutions. Sodium chloride containing solutions can cause precipitation and should NOT be used for reconstitution or dilution. The compatibility of reconstituted Xydalba concentrate has only been established with 50 mg/ml (5%) glucose solution for infusion.

If a common intravenous line is being used to administer other medicinal products in addition to Xydalba, the line should be flushed before and after each Xydalba infusion with 5% glucose solution for infusion.

Use in the paediatric population

For paediatric patients, the dose of Xydalba will vary according to the age and weight of the child up to a maximum of 1,500 mg. Transfer the required dose of reconstituted dalbavancin solution, according to the instructions above, based on the child’s weight, from the vial to an intravenous bag or bottle containing 50 mg/ml (5%) glucose solution for infusion. The diluted solution must have a final dalbavancin concentration of 1 to 5 mg/ml.

Table 4 below provides information to prepare an infusion solution with a final concentration of 2 mg/ml or 5 mg/ml (sufficient for most scenarios), to be administered by syringe pump, to achieve a dose of 22.5 mg/kg in paediatric patients from 3 to 12 months of age weighing from 3 to 12 kg. Alternative concentrations may be prepared, but must have a final concentration range of 1 to 5 mg/ml of dalbavancin. Refer to Table 4 to confirm the calculations. Values shown are approximate. Note that the table is NOT inclusive of all possible calculated doses for every age group but may be utilised to estimate the approximate volume to verify the calculation.

Table 4. Preparation of Xydalba (final infusion concentration 2 mg/ml or 5 mg/ml to be administered by syringe pump) in paediatric patients aged 3 to 12 months (22.5 mg/kg dose):

Disposal

Discard any portion of the reconstituted solution that remains unused.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.