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FDA Expands Use of Televancin (Vibativ) for Hospitalized Patients With Bacterial Pneumonia
The FDA has expanded the approved use of the antibiotic drug telavancin (Vibativ, Theravance, Inc.) to treat patients with hospital-acquired and ventilator-associated bacterial pneumonia (HABP/VABP) caused by Staphylococcus aureus. Telavancin should be used for the treatment of HABP/VABP only when alternative treatments are not suitable.
Bacterial pneumonia can be caused by many different types of bacteria. Telavancin is approved only to treat S. aureus, not other bacteria that cause pneumonia. HABP/VABP, also known as nosocomial pneumonia, is a particularly serious lung infection because patients in the hospital — especially those on ventilators — are often already very sick and usually cannot fight the infection.
The safety and efficacy of telavancin in the treatment of HABP/VABP were evaluated in 1,532 patients enrolled in two clinical trials. The patients were randomly assigned to receive either telavancin or vancomycin, another antibiotic approved by the FDA.
The trials evaluated all-cause mortality at 28 days after the initiation of treatment. Among patients presumed to test positive for S. aureus taken at baseline, mortality rates were comparable between the telavancin and vancomycin treatment arms, except for patients who had pre-existing kidney problems.
During clinical trials, more patients with kidney problems treated with telavancin died compared with those treated with vancomycin. Telavancin may also cause new or worsening kidney problems in patients. This information has been added to the boxed warning in the drug’s package insert.
Diarrhea was the most common side effect in the clinical trials.
Source: FDA; June 21, 2013.