Sivextro - tedizolid

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

Sivextro is an antibiotic used in adults to treat acute (short-term) bacterial infections of the skin and skin structure (the tissues under the skin) including infectious cellulitis (inflammation of the deep skin tissue), skin abscesses and infected wounds . Contains the active ingredient tedizolid. Before using Sivextro, doctors should consider the official guidelines on the correct use of antibiotics.

How is Sivextro used - tedizolid?

Sivextro is available as a powder to be made up into a solution for infusion (drip) into a vein and in tablet form (200 mg). The recommended dosage is 200 mg once a day for 6 days. If clinically indicated, patients starting infusion treatment can be switched 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 stopping certain bacteria from making proteins, thus preventing their growth. Sivextro 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 attached to the EPAR) the list of bacteria against which Sivextro is active is given.

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 skin and skin structure infections including infectious cellulitis, skin abscesses and infected wounds. The study also included conditions caused by MRSA. In both studies, patients were treated for 6 days with Sivextro; this treatment was compared to 10-day linezolid therapy. In all 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 treating the infection. 85.5% (first study) and 88.0% (second study) of the patients treated with Sivextro were cured of the infection compared to 86.0% and 87.7%, respectively, of the 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 in 100 people) are nausea, headache, diarrhea and vomiting. These side effects were generally mild to moderate in intensity. For the full list of side effects and limitations reported 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 infections under study were not serious, the The CHMP considered that the findings also apply to these types of infections. Given the need for new antibiotics effective against multidrug-resistant bacteria, especially if available in oral (by mouth) formulations, the CHMP concluded that Sivextro could be a viable therapeutic option. alternative for the treatment of bacterial infections of the skin and skin structure The safety 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 added to the summary of product characteristics and package leaflet for Sivextro, 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 Sivextro - tedizolid

On 23 March 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 Sivextro's risk management plan, please visit the website Agency: ema.Europa.eu/Find medicine / Human medicines / European public assessment reports. For more information on Sivextro therapy, read the package leaflet (included with the EPAR) or contact your doctor or pharmacist. Last update of this summary: 03-2015

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