Telavancin

VIBATIV is a lipoglycopeptide antibacterial drug indicated for the treatment of the following infections in adult patients caused by designated susceptible bacteria: Complicated skin and skin structure infections (cSSSI). Hospital-acquired and ventilator-associated bacterial pneumonia (HABP/VABP) caused by susceptible isolates of Staphylococcus aureus. VIBATIV should be reserved for use when alternative treatments are not suitable. To reduce the development of drug-resistant bacteria and maintain the effectiveness of VIBATIV and other antibacterial drugs VIBATIV should only be used to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.

Telavancin is an antibacterial drug.

Complicated skin and skin structure infections (cSSSI): 10 mg/kg by IV infusion over 60 minutes every 24 hours for 7 to 14 days. Dosage adjustment in patients with renal impairment. Hospital-acquired and ventilator-associated bacterial pneumonia (HABP/VABP): 10 mg/kg by IV infusion over 60 minutes every 24 hours for 7 to 21 days. Dosage adjustment in patients with renal impairment. a Calculate using the Cockcroft-Gault formula and ideal body weight (IBW). Use actual body weight if < IBW. Creatinine Clearance a (CrCl) (mL/min) VIBATIV Dosage Regimen >50 10 mg/kg every 24 hours 30-50 7.5 mg/kg every 24 hours 10-<30 10 mg/kg every 48 hours Insufficient data are available to make a dosing recommendation for patients with CrCl <10 mL/min, including patients on hemodialysis.

Intravenous Unfractionated Heparin Sodium. Known hypersensitivity to VIBATIV Intravenous Unfractionated Heparin Sodium Use of intravenous unfractionated heparin sodium is contraindicated with VIBATIV administration because the activated partial thromboplastin time (aPTT) test results are expected to be artificially prolonged for 0 to 18 hours after VIBATIV administration.

Boxed warning: Patients with pre-existing moderate/severe renal impairment (CrCl ≤ 50 mL/min) who were treated with VIBATIV for hospital-acquired bacterial pneumonia/ventilator-associated bacterial pneumonia (HABP/VABP) had increased mortality observed versus vancomycin. Decreased efficacy among patients treated for skin and skin structure infections with moderate/severe pre-existing renal impairment: Consider these data when selecting antibacterial therapy for patients with baseline CrCl ≤50 mL/min. Coagulation test interference: Telavancin interferes with some laboratory coagulation tests, including prothrombin time, international normalized ratio, and activated partial thromboplastin time. Hypersensitivity reactions: Serious and potentially fatal hypersensitivity reactions, including anaphylactic reactions, may occur after first or subsequent doses.

The following serious adverse reactions are also discussed elsewhere in the labeling: Nephrotoxicity Infusion-related reactions Clostridium difficile -associated diarrhea Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Most common adverse reaction (≥10% of patients treated with VIBATIV) in the HABP/VABP trials is diarrhea, in the cSSSI trials, the most common adverse reactions (≥10% of patients treated with VIBATIV) include: taste disturbance, nausea, vomiting, and foamy urine.

Drug-Laboratory Test Interactions Effects of Telavancin on Coagulation Test Parameters Telavancin binds to the artificial phospholipid surfaces added to common anticoagulation tests, thereby interfering with the ability of the coagulation complexes to assemble on the surface of the phospholipids and promote clotting in vitro. These effects appear to depend on the type of reagents used in commercially available assays. Thus, when measured shortly after completion of an infusion of VIBATIV, increases in the PT, INR, aPTT, and ACT have been observed. These effects dissipate over time, as plasma concentrations of telavancin decrease. Urine Protein Tests Telavancin interferes with urine qualitative dipstick protein assays, as well as quantitative dye methods (e.g., pyrogallol red-molybdate).

Store original packages at refrigerated temperatures of 2°C to 8°C (35°F to 46°F). Excursions to ambient temperatures (up to 25°C (77°F) are acceptable.