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PLEASE SEE FULL PRESCRIBING INFORMATION INCLUDING BOXED WARNING

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.


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 susceptible bacteria.

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 CONTRAINDICATIONS

VIBATIV should not be used with intravenous unfractionated heparin sodium because the activated partial thromboplastin time (aPTT) test results are expected to be artificially prolonged for 0 to 18 hours after VIBATIV administration. VIBATIV should not be used in patients with known hypersensitivity to VIBATIV (telavancin).

WARNINGS AND PRECAUTIONS

There is 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. Telavancin 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. VIBATIV should be used 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 has been reported and may range from mild diarrhea to fatal colitis. Evaluate if diarrhea occurs. Avoid use in patients at risk for QTc prolongation. Use with caution in patients 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.

WARNING: INCREASED MORTALITY IN HABP/VABP PATIENTS WITH PRE-EXISTING
MODERATE OR SEVERE RENAL IMPAIRMENT, NEPHROTOXICITY, POTENTIAL
ADVERSE DEVELOPMENTAL OUTCOMES

See full prescribing information for the complete 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 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.
• Women of childbearing potential should have a serum pregnancy test prior to administration of VIBATIV.
• Avoid use of VIBATIV during pregnancy unless potential benefit to the patient outweighs potential risk to the fetus.
• Adverse developmental outcomes observed in 3 animal species at clinically relevant doses raise concerns about potential adverse developmental outcomes in humans.