What is Xydalba and what is it used for?
Xydalba is an antibiotic used in adults to treat acute (short-term) bacterial infections of the skin and skin structure (tissue under the skin), such as cellulitis (inflammation of the deep skin tissue), skin abscesses and infected wounds. Contains the active substance dalbavancin. Before using Xydalba, doctors should consider official guidelines on the proper use of antibiotics.
How is Xydalba used - dalbavancin?
Xydalba is available as a powder to be made up into a solution for infusion (drip) into a vein and can only be obtained with a prescription. Xydalba is given once a week as 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 the dose may need to be reduced.
How does Xydalba work - dalbavancin?
The active substance in Xydalba, dalbavancin, is a type of antibiotic called a glycopeptide. It works by preventing certain bacteria from forming their own cell walls, thereby killing those organisms. Dalbavancin has been shown to work against bacteria (such as methicillin-resistant Staphylococcus aureus (MRSA)) for which standard antibiotics are not effective. The list of bacteria against which Xydalba is active is given in the summary of product characteristics (included in the EPAR).
What benefit has Xydalba - dalbavancin shown during the studies?
Xydalba has been compared with vancomycin (another glycopeptide) or linezolid (an antibiotic that can be taken by mouth) in three main studies involving a total of approximately 2,000 patients with severe skin and soft tissue infections under the skin, such as cellulitis, skin abscesses and infected wounds. These also included infections caused by MRSA. Patients who received vancomycin and responded to treatment had the option to switch to linezolid after 3 days. In all studies, the main measure 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, they were found to be effective. between 87% and 94% of patients treated with Xydalba healed, compared with 91% -93% of patients treated with one of the two comparator drugs.
What is the risk associated with Xydalba - dalbavancin?
The most common side effects with Xydalba (which may affect between 1 and 3 in 100 people) are nausea, diarrhea, headache, increased levels of some liver enzymes (gamma-glutamyl transferase) in the blood, rash and vomiting. These side effects were usually mild or moderate in severity. For the full list of all side effects reported with Xydalba and their limitations, 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 targeting the bacteria multi-resistant, the CHMP concluded that Xydalba, which has shown activity against some bacteria resistant to other antibiotics, could represent a valuable alternative treatment option. The safety profile of Xydalba is comparable to that of other antibiotics of the glycopeptide class; the undesirable effects affecting hearing and renal function, typical of glycopeptides, have not been shown with the proposed regimen of Xydalba 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 added to the summary of product characteristics and package leaflet for Xydalba, including the appropriate precautions to be followed by healthcare professionals and patients. Further information can be found in the summary of the risk management plan.
Other information about Xydalba - dalbavancin
On 19 February 2015, the European Commission granted a "Marketing Authorization" for Xydalba, valid throughout the European Union. For more information on Xydalba therapy, read the package leaflet (included with the EPAR) or consult your doctor. or the pharmacist. Last update of this summary: 02-2015
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