Vibativ (telavancin)

The following drug information is obtained from various newswires, published medical journal articles, and medical conference presentations.

Company:

Approval Status:

Approved June 2013

Specific Treatments:

hospital-acquired and ventilator-associated bacterial pneumonia caused by staph aureus

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General Information

Vibativ (telavancin) is a semisynthetic, lipoglycopeptide antibiotic. It inhibits cell wall biosynthesis and disrupts membrane barrier function.

Vibativ is specifically indicated for the treatment of adult patients with hospital-acquired and ventilator-associated bacterial pneumonia (HABP/VABP), caused by susceptible isolates of Staphylococcus aureus (including methicillin-susceptible and -resistant isolates). Vibativ should be reserved for use when alternative treatments are not suitable.

Vibativ is supplied as a solution for intravenous infusion. The recommended dose is 10 mg/kg administered over a 60-minute period in patients >18 years of age by intravenous infusion once every 24 hours for 7 to 21 days. The duration of therapy should be guided by the severity of the infection and the patient’s clinical progress.

Clinical Results

FDA Approval
The FDA approval of Vibativ for hospital-acquired and ventilator-associated pneumonia was based on two randomized, parallel-group, multinational, multicenter, double-blinded trials of identical design comparing Vibativ (10 mg/kg IV every 24 hours) with vancomycin (1 g IV every 12 hours) for 7 to 21 days. The subjects were premitted concomitant medication for gram-negative infections. All subjects had known or suspected infections due to methicillin-resistant Staphylococcus aureus. A total of 1,532 subjects were enrolled. The trials measured the percentage of subjects who died from any cause (all-cause mortality) 28 days after the initiation of treatment. Mortality rates were comparable between the Vibativ and vancomycin treatment arms, except for subjects who had pre-existing kidney problems. During clinical trials, more subjects with pre-existing kidney problems treated with Vibativ died compared to those treated with vancomycin.

Side Effects

Adverse events associated with the use of Vibativ may include, but are not limited to, the following:

  • diarrhea
  • infusion-related reactions

Mechanism of Action

Vibativ (telavancin) s a semisynthetic, lipoglycopeptide antibiotic. It inhibits cell wall biosynthesis by binding to late-stage peptidoglycan precursors, including lipid II. Telavancin also binds to the bacterial membrane and disrupts membrane barrier function.

Literature References

Rubinstein E, Lalani T, Corey GR, Kanafani ZA, Nannini EC, Rocha MG, Rahav G, Niederman MS, Kollef MH, Shorr AF, Lee PC, Lentnek AL, Luna CM, Fagon JY, Torres A, Kitt MM, Genter FC, Barriere SL, Friedland HD, Stryjewski ME; ATTAIN Study Group Telavancin versus vancomycin for hospital-acquired pneumonia due to gram-positive pathogens. Clinical Infectious Disease 2011 Jan 1;52(1):31-40

Additional Information

For additional information regarding Vibativ or hospital acquired pnuemonia, please visit the Vibativ web page.