drugs

Sivextro - tedizolid

What is Sivextro - tedizolid used for and what is it used for?

Sivextro is an antibiotic used in adults for the treatment of acute (short-term) bacterial infections of the skin and skin structure (the tissues under the skin) including infectious cellulite (inflammation of deep skin tissue), cutaneous abscesses and infected wounds . It contains the active substance tedizolid. Before using Sivextro, doctors should consider official guidelines on the correct use of antibiotics.

How is Sivextro - tedizolid used?

Sivextro is available as a powder to be made up into a solution for infusion (drip) into a vein and as tablets (200 mg). The recommended dosage is 200 mg once a day for 6 days. If clinically indicated, patients starting treatment with the infusion can switch to tablets. Sivextro can only be obtained with a prescription

How does Sivextro - tedizolid work?

The active substance in Sivextro, tedizolid, is a type of antibiotic called oxazolidinone. It works by preventing certain bacteria from producing proteins, thus preventing their growth. Sivextro 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 EPAR) includes the list of bacteria against which Sivextro is active.

What benefit has Sivextro - tedizolid shown during the studies?

Sivextro was compared with linezolid (another oxazolidinone) in two main studies involving a total of 1 333 patients with acute bacterial infections of the skin and skin structure including infectious cellulitis, cutaneous abscesses and infected wounds. Conditions caused by MRSA were also among the investigated infections. In both studies, patients were treated with Sivextro for 6 days; this treatment was compared with a 10-day linezolid therapy. In all the studies, the main indicator of effectiveness was the number of patients recovered from the infection at the end of the treatment. Sivextro has been shown to be at least as effective as linezolid in the treatment of infection. 85.5% (first study) and 88.0% (second study) of patients treated with Sivextro compared to 86.0% and 87.7%, respectively subjects treated with linezolid.

What is the risk associated with Sivextro - tedizolid?

The most common side effects with Sivextro (which may affect between 2 and 7 people in 100) are nausea, headache, diarrhea and vomiting. These side effects were generally mild to moderate in intensity. For the full list of all side effects and restrictions with Sivextro, see the package leaflet.

Why has Sivextro - tedizolid been approved?

The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Sivextro's benefits are greater than its risks and recommended that it be approved for use in the EU. Although the investigated infections were not serious, the CHMP considered that the results also apply to this type of infection. Given the need for new effective antibiotics against multi-resistant bacteria, especially if available in oral (oral) formulation, the CHMP concluded that Sivextro could be a valid alternative therapeutic option for the treatment of bacterial infections of the skin and skin structure. The security profile of Sivextro is similar to that of linezolid and was considered acceptable.

What measures are being taken to ensure the safe and effective use of Sivextro - tedizolid?

A risk management plan has been developed to ensure that Sivextro 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 Sivextro, 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 Sivextro - tedizolid

On March 23, 2015, the European Commission issued a marketing authorization for Sivextro, valid throughout the European Union. For the full version of the EPAR and the summary of the Sivextro risk management plan, consult the website of the Agency: ema.Europa.eu/Find medicine / Human medicines / European public assessment reports. For more information on Sivextro therapy, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. Last update of this summary: 03-2015