What is Xydalba - dalbavancina used for?
Xydalba is an antibiotic used in adults for the treatment of acute (short-term) bacterial infections of the skin and skin structure (tissue under the skin), such as cellulite (inflammation of deep skin tissue), cutaneous abscesses and infected wounds. It contains the active substance dalbavancin . Before using Xydalba, doctors must consider the official guidelines on the correct use of antibiotics.
How is Xydalba used - dalbavancin?
Xydalba is available as a powder to be made into a solution for infusion (drip) into a vein and can only be obtained with a prescription. Xydalba is given once a week with a 30-minute infusion. The recommended dose is 1, 000 mg in the first week, followed by 500 mg a week later. In patients with severely impaired renal function it may be necessary to reduce the dose.
How does Xydalba - dalbavancin work?
The active ingredient in Xydalba, dalbavancin, is a type of antibiotic called glycopeptide. It works by preventing certain bacteria from forming their own cell walls, thus killing these organisms. Dalbavancin has been shown to act against bacteria (such as methicillin-resistant Staphylococcus aureus (MRSA)) for which standard antibiotics are not effective. In the summary of product characteristics (included with the EPAR) the list of bacteria against which Xydalba is active is shown.
What benefit has Xydalba - dalbavancin shown during the studies?
Xydalba was compared with vancomycin (another glycopeptide) or with linezolid (an antibiotic that can be taken by mouth) in three main studies involving a total of about 2, 000 patients with serious skin and soft tissue infections under the skin, such as cellulite, cutaneous abscesses and infected wounds. These also included infections caused by MRSA. Patients who had received vancomycin and had responded to treatment had a chance to switch to linezolid after 3 days. In all studies, the main indicator of effectiveness was the number of patients whose infection was cured after treatment. Xydalba was at least as effective as vancomycin or linezolid in treating the infection. In the 3 studies, between 87% and 94% of patients treated with Xydalba were recovered, compared with 91% -93% of patients treated with one of the two comparators.
What is the risk associated with Xydalba - dalbavancin?
The most common side effects with Xydalba (which may affect between 1 and 3 people in 100) are nausea, diarrhea, headache, increased levels of some liver enzymes (gamma-glutamyl transferase) in the blood, rash and vomiting. These side effects were generally mild or moderate in severity. For the full list of all side effects reported with Xydalba and restrictions, see the package leaflet.
Why has Xydalba - dalbavancin been approved?
The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Xydalba's benefits are greater than its risks and recommended that it be approved for use in the EU. In light of the need for new antibiotics targeted at multi-resistant bacteria, the CHMP concluded that Xydalba, which has shown activity against some bacteria resistant to other antibiotics, could be a valuable alternative therapeutic option. The safety profile of Xydalba is comparable to that of other antibiotics of the glycopeptide class; the undesirable effects on hearing and renal function, typical of glycopeptides, have not been shown with the proposed Xydalba regimen in clinical trials.
What measures are being taken to ensure the safe and effective use of Xydalba - dalbavancin?
A risk management plan has been developed to ensure that Xydalba is used as safely as possible. Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Xydalba, including the appropriate precautions to be followed by healthcare professionals and patients. Further information is available in the summary of the risk management plan.
More information on Xydalba - dalbavancina
On 19 February 2015, the European Commission issued a marketing authorization for Xydalba, valid throughout the European Union. For more information on Xydalba therapy, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. Last update of this summary: 02-2015
