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GLASS VIAL (Concentrate for solution for infusion))
Recommended dose and duration of treatment for adults:
The recommended dose of dalbavancin in adult patients with ABSSSI 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.
No dose adjustment is necessary.
Dose adjustments are not required for patients with mild or moderate renal impairment (CrCl 30 – 79 ml/min). Dose adjustment. are not required for patients receiving regularly scheduled haemodialysis (3 times/week), and dalbavancin may be administered without regard to the timing of haemodialysis.
In 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
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.
The safety and efficacy of dalbavancin in children aged from birth to < 18 years 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
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 prescribing information for full details.
Treatment of acute bacterial skin and skin structure infections (ABSSSI) in adults.
Hypersensitivity to the active substance or to any of the excipients.
Dalbavancin should be administered with caution in patients known to be hypersensitive to other glycopeptides since cross-hypersensitivity may occur. If an allergic reaction to dalbavancin occurs, administration should be discontinued and appropriate therapy for the allergic reaction should be instituted.
Clostridioides (formerly Clostridium) difficile-associated diarrhoea
Antibacterial-associated colitis and pseudomembranous colitis have been reported with the use of nearly all antibiotics and may range in severity from mild to life threatening. Therefore, it is important to consider this diagnosis in patients who present with diarrhoea during or subsequent to the treatment with dalbavancin. In such circumstance, the discontinuation of dalbavancin and the use of supportive measures together with the administration of specific treatment for Clostridioides (formerly Clostridium) difficile should be considered. These patients must never be treated with medicinal products that suppress the peristalsis.
Xydalba is to be administered via intravenous infusion, using a total infusion time of 30 minutes to minimise the risk of infusion-related reactions. Rapid intravenous infusions of glycopeptide antibacterial agents can cause reactions that resemble “Red-Man Syndrome”, including flushing of the upper body, urticaria, pruritus, and/or rash. Stopping or slowing the infusion may result in cessation of these reactions.
Information on the efficacy and safety of dalbavancin in patients with creatinine clearance < 30 ml/min is limited. Based on simulations, dose adjustment is needed for patients with chronic renal impairment whose creatinine clearance is < 30 ml/min and who are not receiving regular haemodialysis.
In mixed infections in which Gram-negative bacteria are suspected patients should also be treated with an appropriate antibacterial agent(s) against Gram-negative bacteria.
The use of antibiotics may promote the overgrowth of non-susceptible micro-organisms. If superinfection occurs during therapy, appropriate measures should be taken.
Limitations of the clinical data
There is limited data on safety and efficacy of dalbavancin when administered for more than two doses (one week apart). In the major trials in ABSSSI the types of infections treated were confined to cellulitis/erysipelas, abscesses and wound infections only. There is no experience with dalbavancin in the treatment of severely immunocompromised patients.
See prescribing information for full details.
Headache, nausea, diarrhea. See prescribing information for full details.
Results from an in vitro receptor screening study do not indicate a likely interaction with other therapeutic targets or a potential for clinically relevant pharmacodynamic interactions.
Clinical drug-drug interaction studies with dalbavancin have not been conducted. Potential for other medicinal products to affect the pharmacokinetics of dalbavancin. Dalbavancin is not metabolised by CYP enzymes in vitro, therefore co-administered CYP inducers or inhibitors are unlikely to influence the pharmacokinetics of dalbavancin.
It is not known if dalbavancin is a substrate for hepatic uptake and efflux transporters.
Co-administration with inhibitors of these transporters may increase the exposure to dalbavancin.
Examples of such transporter inhibitors are boosted protease inhibitors, verapamil, quinidine, itraconazole, clarithromycin and cyclosporine.
Potential for dalbavancin to affect the pharmacokinetics of other medicinal products. The interaction potential of dalbavancin on medicinal products metabolised by CYP enzymes is expected to be low since it is neither an inhibitor nor an inducer of CYP enzymes in vitro. There are no data on dalbavancin as an inhibitor of CYP2C8.
It is not known if dalbavancin is an inhibitor of transporters. Increased exposure to transporter substrates sensitive for inhibited transporter activity, such as statins and digoxin, cannot be excluded if combined with dalbavancin.
Pregnancy and Lactation
Xydalba is not recommended during pregnancy unless clearly necessary. See prescribing information for full details.
It is not known if Xydalba passes into breast milk in humans. See prescribing information for full details.
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
Storage: This medicine does not require any special storage conditions if kept unopened in the original container.
Compatibility: 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.