FDA Approves Telavancin for Treating MRSA Skin Infections

Yael Waknine

September 14, 2009

September 14, 2009 — The US Food and Drug Administration (FDA) has approved telavancin injection (Vibativ, Theravance, Inc, and Astellas Pharma US, Inc) for the once-daily treatment of adults with complicated skin and skin structure infections (cSSSI) caused by susceptible Gram-positive bacteria, including methicillin-resistant and methicillin-susceptible strains of Staphylococcus aureus.

The injectable lipoglycopeptide antibiotic is a synthetic derivative of vancomycin, the current standard of care for cSSSI. Telavancin and vancomycin both inhibit bacterial cell wall synthesis by interfering with the polymerization and cross-linking of peptidoglycan; telavancin also binds to the bacterial membrane, disrupting its barrier function.

Approval of telavancin was based on data from 2 double-blind, randomized phase 3 studies (ATLAS I and II) of 1867 patients, showing that its use was statistically noninferior to vancomycin (1 g intravenously every 12 hours) for curing cSSSI caused by Gram-positive bacteria, including methicillin-resistant S aureus.

"Vibativ has demonstrated its efficacy and safety in clinical trials for the treatment of Gram-positive complicated skin and skin structure infections which included the largest cohort of patients with methicillin-resistant Staphylococcus aureus studied to date," said Ralph Corey, MD, professor of medicine at the Duke University Medical Center, Durham, North Carolina, and the principal investigator in the ATLAS program in a company news release. "I believe Vibativ will be a welcome addition for physicians treating this serious infection."

The recommended dose of telavancin is 10 mg/kg administered by intravenous infusion once every 24 hours for 7 to 14 days. An infusion period of at least 60 minutes is recommended to reduce the risk for infusion reactions ("red man syndrome").

Women of childbearing potential should have a serum pregnancy test before treatment with telavancin; use during pregnancy should be avoided unless the potential benefit to the mother outweighs fetal risk.

Because of the potential for new-onset or worsening renal impairment, renal function should be monitored during treatment; dose adjustments are recommended for those with creatinine clearance of 50 mL/min or less, and caution is advised when treating elderly patients.

Although telavancin does not interfere with coagulation, it does affect laboratory tests such as prothrombin time, international normalized ratio, and activated partial thromboplastin time. Blood samples for these tests should be collected as closely as possible before the patient's next dose of telavancin.

Because of the potential for QTc prolongation, caution is advised when treating patients taking other drugs known to have this effect.

Adverse reactions most commonly reported with use of telavancin in clinical studies included taste disturbance, nausea, vomiting, and foamy urine.


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