What is Orbactiv - oritavancin used for?
Orbactiv is an antibiotic used in adults for the treatment of acute (short-term) bacterial infections of the skin and skin structure (the tissue present under the skin) including infectious cellulite (inflammation of deep skin tissue), cutaneous abscesses and infected wounds . It contains the active substance oritavancin. Before using Orbactiv, doctors must consider official guidelines on the correct use of antibiotics.
How is Orbactiv - oritavancin used?
Orbactiv 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. The recommended dose is 1 200 mg administered as a single intravenous infusion lasting 3 hours.
How does Orbactiv - oritavancin work?
The active ingredient in Orbactiv, oritavancin, is a type of antibiotic called glycopeptide. It works by preventing certain bacteria from forming their cell walls, thereby killing them. Orbactiv has been shown to act against bacteria (such as methicillin-resistant Staphylococcus aureus (MRSA)) for which standard antibiotics are not effective. The summary of product characteristics (also included with the EPAR) contains the list of bacteria to which Orbactiv is active.
What benefit has Orbactiv - oritavancin shown during the studies?
Orbactiv administered as a single infusion was compared with a 7-10 day treatment based on vancomycin (another glycopeptide) in two main studies involving a total of 1 959 patients with acute bacterial skin infections and skin structures including infectious cellulite, cutaneous abscesses and infected wounds. Conditions caused by MRSA were also among the investigated infections. In both studies the main measure of effectiveness was the number of patients who responded to initial therapy within 3 days showing an improvement in the skin in the infected area and the disappearance of the fever, such that the need to administer a new antibiotic was lacking . The studies also considered the number of patients recovered from infection at the end of treatment. Orbactiv had an efficacy at least equal to vancomycin in the treatment of infection: 80.1% of patients treated with Orbactiv in the first study and 82.3% of those in the second study compared to 82 responded to treatment., 9% and 78.9%, respectively, of subjects treated with vancomycin. Furthermore, 82.7% of patients treated with Orbactiv in the first study and 79.6% of those in the second study were found to be healed from infection compared with 80.5% and 80.0%, respectively, of subjects treated with the comparator medicine.
What is the risk associated with Orbactiv - oritavancin?
The most common side effects with Orbactiv (seen in 5 patients or more than 100) are nausea, hypersensitivity reactions or reactions at the site of injection and headache. The most common side effects related to discontinuation of therapy were cellulitis and osteomyelitis (bone infection). Patients treated with Orbactiv should not receive an infusion of unfractionated heparin (a medicine used to prevent the formation of blood clots) for at least 48 hours after the dose of Orbactiv. For the full list of all side effects and limitations with Orbactiv, see the package leaflet.
Why has Orbactiv - oritavancin been approved?
The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Orbactiv's benefits are greater than its risks and recommended that it be approved for use in the EU. The CHMP is of the opinion that Orbactiv, which can be given in a single dose, could be a valid alternative therapeutic option for acute bacterial infections of the skin and skin structures. Although overall the safety profile of Orbactiv is similar to that of other glycopeptides, the CHMP noted that some undesirable effects, including abscesses and bone infections, occurred more frequently. The CHMP considers that these side effects are manageable and adequately addressed in the product information.
What measures are being taken to ensure the safe and effective use of Orbactiv - oritavancin?
A risk management plan has been developed to ensure that Orbactiv 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 Orbactiv, 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 Orbactiv - oritavancin
On 19 March 2015, the European Commission issued a marketing authorization for Orbactiv, valid throughout the European Union. For more information about treatment with Orbactiv, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. Last update of this summary: 03-2015
