Vibativ - telavancin

PLEASE NOTE: THE USE OF THIS MEDICINAL PRODUCT IS CURRENTLY SUSPENDED IN THE EUROPEAN UNION

What is Vibativ - telavancin?

Vibativ is a medicine containing the active substance telavancin. It is available as a powder for concentrate for solution for infusion (drip into a vein).

What is Vibativ - telavancin used for?

Vibativ is indicated in the treatment of adult patients with nosocomial pneumonia (an infection of the lungs). "Nosocomial" means that the infection was contracted in the hospital. This definition also includes pneumonia associated with mechanical ventilation (a machine used in hospitals to help patients breathe). Vibativ should only be used when it is known or suspected that the infection was caused by a bacterium called "Methicillin-resistant Staphylococcus aureus" (MRSA) and that there are no alternative therapies (for example, antibiotics) that are valid.

The medicine can only be obtained with a prescription.

How is Vibativ used - telavancin?

Vibativ is given by infusion into a vein within an hour. The recommended dose is 10 mg / kg body weight once every 24 hours; a course of treatment lasts 7 to 21 days. Renal function must be monitored; it may be necessary to reduce the initial and subsequent doses in patients with mild kidney problems. In the event that renal function deteriorates markedly, treatment may need to be stopped.

How does Vibativ - telavancin work?

The active substance in Vibativ, telavancin, is an antibiotic belonging to the group of "glycopeptides"; it acts both by preventing S. aureus bacteria from creating the cell wall and by interfering with the relative membranes, so as to eliminate the bacteria responsible for the infection.

MRSA is a S. aureus bacterium resistant to antibiotics commonly used in clinical practice known as penicillins (including methicillin and oxacillin) and cephalosporins. Telavancin is used in the treatment of MRSA infections because it is able to act against bacteria resistant to these medicines.

What studies have been carried out on Vibativ - telavancin?

The effects of Vibativ were first tested in experimental models before being studied in humans.

Vibativ was compared with vancomycin (another antibiotic) in two main studies involving a total of 1, 503 adults with nosocomial pneumonia caused by Gram-positive bacteria (types of bacteria that include MRSA). Antibiotics were administered for up to 21 days. Vibativ was also compared to vancomycin in two main studies involving a total of 1, 897 adults with complicated skin and soft tissue infections caused by Gram-positive bacteria; in this case the medicines were administered for a period not exceeding 14 days. In all the studies the main measure of effectiveness was the number of patients recovered from the infection at the end of treatment.

What benefit has Vibativ - telavancin shown during the studies?

Compared to the comparator medicine, Vibativ was equally effective in the treatment of nosocomial pneumonia and complicated skin and soft tissue infections. In the first study conducted on subjects with nosocomial pneumonia, 58% of patients treated with Vibativ (214 of 372) had recovered at the end of therapy, compared with 59% of patients treated with vancomycin (221 of 374). In the second study, healing was recorded at the end of therapy in 60% of patients treated with Vibativ (227 out of 377), compared to 60% of patients treated with vancomycin (228 out of 380).

In the first study conducted on subjects suffering from skin and soft tissue infections, treatment led to recovery in 76% of patients treated with Vibativ (323 of 426), compared with 75% of patients treated with vancomycin (321 out of 429). In the second study, this result was achieved in 77% of patients treated with Vibativ (387 out of 502), compared to 74% of patients treated with vancomycin (376 of 510).

What is the risk associated with Vibativ - telavancin?

The most common side effects with Vibativ (seen in more than 1 patient in 10) are dysgeusia (disturbance of sense of taste) and nausea. Studies have shown that the number of patients who developed kidney problems was higher after Vibativ treatment compared to vancomycin therapy (3.8% and 2.2% respectively). For the full list of all side effects reported with Vibativ, see the Package Leaflet.

Vibativ should not be used in people who may be hypersensitive (allergic) to telavancin or any of the other substances. It must not be used in patients with severe kidney problems or acute (sudden) kidney failure. The use of the medicine is contraindicated in pregnant women.

Why has Vibativ - telavancin been approved?

The CHMP concluded that, although the efficacy of Vibativ in the treatment of nosocomial pneumonia and in complicated skin and soft tissue infections has been demonstrated, its toxic effect on the kidneys is an important safety issue. However, the committee considered that Vibativ could be useful in the treatment of patients with nosocomial pneumonia when the cause of MRSA is known or suspected, for which other therapies are not valid. Therefore, the CHMP decided that the benefits of Vibativ outweigh its risks only in patients seriously ill with nosocomial pneumonia and closely observed in hospital, and recommended that it be given marketing authorization.

What measures are being taken to ensure the safe use of Vibativ - telavancin

The pharmaceutical company that markets Vibativ will ensure that all doctors who can prescribe or use Vibativ receive an information package containing a letter and a guide containing important information on safety and the correct use of Vibativ.