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Treating HABP/VABP

Choose VIBATIV for a proven clinical advantage and consistently high cure rates against S. aureus

Primary endpoint results from studies of VIBATIV in HABP/VABP1

In the Phase 3 ATTAIN studies, VIBATIV demonstrated similar cure rates to vancomycin in patients with HABP/VABP due to MRSA and MSSA.

Clinically evaluable population:
  • VIBATIV: 84.2%
  • Vancomycin: 80.7%
All-treated population:
  • VIBATIV: 58.9%
  • Vancomycin: 59.5%

In patients with HABP, more than 41% did not receive appropriate therapy and had higher mortality rates compared with patients receiving adequate therapy2

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With a P value of 0.056, this comparison did not reach statistical significance.

In patients with VABP, more than 25% did not receive appropriate therapy until after 24 hours of diagnosis and had higher mortality rates compared with patients receiving adequate therapy3

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Cure Rates

In the ATTAIN trials, VIBATIV provided higher cure rates vs vancomycin in HABP/VABP populations1,2

Phase-3-HABP_VABP

VIBATIV delivered significantly higher cure rates vs vancomycin in HABP/VABP due to any single Gram-positive pathogen or S. aureus with MIC ≥1 μg/mL.1,2

Phase-3-MRSA_MSSA

VIBATIV provided high cure rates vs vancomycin in HABP/VABP patients with infections due to MRSA or MSSA.2

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LUNG PENETRATION

VIBATIV demonstrated high levels in ELF and AM throughout 24 hours that exceeded the MIC90 for MRSA and MSSA (0.06 μg/mL)3

High levels of lung penetration

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HABP/VABP and concurrent bacteremia

VIBATIV is the only anti-MRSA agent with data in the product label for HABP/VABP and concurrent S. aureus bacteremia1

Clinical cure rates for S. aureus bacteremia

Of the 797 patients in the Modified All-Treated (MAT) population with at least 1 Gram-positive respiratory pathogen at baseline4:

  • 73 patients had concurrent S. aureus bacteremia at baseline
    • 35 (8.5%) were treated with VIBATIV (21 for MRSA)
    • 38 (9.8%) were treated with vancomycin (24 for MRSA)
  • Clinical cure rates in these patients were 54.3% with VIBATIV and 47.4% with vancomycin
  • Given the limited sample size in this subgroup, the interpretation of these results is limited
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Efficacy in challenging patients

Consistently favorable cure rates with VIBATIV vs vancomycin in important subgroups with HABP/VABP1

Baseline CPIS score >6

APACHE II ≥20

Clinically evaluable population

References: 1. Data on file. Theravance Biopharma Antibiotics, Inc. 2. Rubinstein E, Lalani T, Corey GR, et al, for the ATTAIN Study Group. Telavancin versus vancomycin for hospital-acquired pneumonia due to Gram-positive pathogens. Clin Infect Dis. 2011;52:31-40. 3. Gotfried MH, Shaw JP, Benton BM, et al. Intrapulmonary distribution of intravenous telavancin in healthy subjects and effect of pulmonary surfactant on in vitro activities of telavancin and other antibiotics. Antimicrob Agents Chemother. 2008;52:92-97. 4. VIBATIV [prescribing information]. South San Francisco, CA: Theravance Biopharma Antibiotics, Inc; May 2016.



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.