What is Orbactiv and what is it used for?
Orbactiv is an antibiotic used in adults to treat acute (short-term) bacterial infections of the skin and skin structure (the tissue under the skin) including infectious cellulitis (inflammation of the deep skin tissue), skin abscesses and infected wounds . Contains the active ingredient oritavancin. Before using Orbactiv, doctors should consider official guidelines on the proper use of antibiotics.
How is Orbactiv used - oritavancin?
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 work - oritavancin?
The active ingredient in Orbactiv, oritavancin, is a type of antibiotic called a glycopeptide. It works by preventing certain bacteria from forming their own cell walls, thereby killing those organisms. Orbactiv has been shown to work against bacteria (such as methicillin-resistant Staphylococcus aureus (MRSA)) for which standard antibiotics are not effective. In the summary of the product characteristics (also included in the EPAR) the list of bacteria against which Orbactiv is active is shown.
What benefit has Orbactiv - oritavancin shown during the studies?
Orbactiv given as a single infusion was compared with a 7-10 day treatment of vancomycin (another glycopeptide) in two main studies involving a total of 1,959 patients with acute bacterial infections of the skin and skin structures including infectious cellulitis, skin abscesses and infected wounds. The infections studied also included conditions caused by MRSA. In both studies, the main measure of effectiveness was the number of patients who responded to initial therapy within 3 days showing a improvement of the skin in the infected area and the disappearance of the fever, so that the need for a new antibiotic was eliminated. The studies also took into account the number of patients who recovered from the infection at the end of the treatment. Orbactiv had a ' at least as effective as vancomycin in treating the infection: 80.1% of patients responded to treatment treated with Orbactiv in the first study and 82.3% of those in the second study compared to 82.9% and 78.9%, respectively, of the subjects treated with vancomycin. In addition, 82.7% of patients treated with Orbactiv in the first study and 79.6% of those in the second study were cured of the infection compared to 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 in 100) are nausea, hypersensitivity reactions or reactions at the injection site 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 blood clots). for at least 48 hours after the Orbactiv dose. For the full list of all side effects and limitations reported 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 represent a valid alternative treatment option for acute bacterial infections of the skin and skin structures. Although overall the safety profile of Orbactiv is similar to that than other glycopeptides, the CHMP noted that some side effects, including bone abscesses and infections, occurred more frequently.The CHMP considered these side effects to be 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 added to the summary of product characteristics and package leaflet for Orbactiv, 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
More information about Orbactiv - oritavancin
On 19 March 2015, the European Commission granted a "Marketing Authorization" for Orbactiv, valid throughout the European Union. For more information on Orbactiv therapy, read the package leaflet (included with the EPAR) or consult your doctor or the pharmacist. Last update of this summary: 03-2015
The information on Orbactiv - oritavancin published on this page may be out of date or incomplete. For a correct use of this information, see the Disclaimer and useful information page.
