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Vibativ (telavancin) Injection

INDICATION: Vibativ is indicated in adults for the treatment of:

• complicated skin and skin structure infections (cSSSI) caused by susceptible isolates of the following Gram-positive microorganisms: Staphylococcus aureus (including methicillin-susceptible and -resistant isolates), Streptococcus pyogenes, Streptococcus agalactiae, Streptococcus anginosus group (includes S. anginosus, S. intermedius, and S. constellatus), or Enterococcus faecalis (vancomycin-susceptible isolates only).
• hospital-acquired and ventilator-associated bacterial pneumonia (HABP/VABP), caused by susceptible isolates of Staphylococcus aureus (both methicillin-susceptible and -resistant isolates). Vibativ should be reserved for use when alternative treatments are not suitable.

IMPORTANT DOSAGE AND ADMINISTRATION INSTRUCTIONS
Because telavancin is eliminated primarily by the kidney, a dosage adjustment is required for patients whose creatinine clearance is ≤50 mL/min. There is insufficient information to make specific dosage adjustment recommendations for patients with end-stage renal disease (CrCl <10 mL/min), including patients undergoing hemodialysis.

IMPORTANT SAFETY INFORMATION

• Decreased efficacy among patients treated for cSSSI with moderate/severe pre-existing renal impairment. Consider when selecting antibacterial therapy for patients with baseline CrCl ≤50 mL/min.
• Laboratory tests: interferes with some laboratory coagulation tests, including prothrombin time, international normalized ratio, and activated partial thromboplastin time.
• Serious and potentially fatal hypersensitivity reactions, including anaphylactic reactions, may occur after first or subsequent doses. Use with caution in patients with known hypersensitivity to vancomycin.
• Administer Vibativ over at least 60 minutes to minimize infusion-related reactions.
• Clostridium difficile-Associated Diarrhea; may range from mild diarrhea to fatal colitis. Evaluate if diarrhea occurs.
• Avoid use in patients at risk for QTc prolongation and who are taking drugs known to prolong the QT interval.

ADVERSE REACTIONS
The 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.

USE IN SPECIAL POPULATIONS
Pediatric Use: Safety and efficacy have not been established. There is a concern for poor clinical outcomes in pediatric patients less than one year of age due to immature renal function.

This product includes the following Boxed Warning:

WARNING: INCREASED MORTALITY IN HABP/VABP PATIENTS WITH PRE-EXISTING MODERATE OR SEVERE RENAL IMPAIRMENT, NEPHROTOXICITY, and EMBRYO-FETAL TOXICITY
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 had increased mortality observed versus vancomycin. Use of VIBATIV in patients with pre-existing moderate/severe renal impairment (CrCl ≤50 mL/min) should be considered only when the anticipated benefit to the patient outweighs the potential risk.

• Nephrotoxicity: New onset or worsening renal impairment has occurred. Monitor renal function in all patients.
• Embryo-Fetal Toxicity: VIBATIV may cause fetal harm. In animal reproduction studies, adverse developmental outcomes were observed in 3 animal species at clinically relevant doses. Verify pregnancy status prior to initiating treatment and advise females of reproductive potential to use effective contraception.