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TREATING cSSSI

Choose VIBATIV for clinically meaningful efficacy in surgery-associated cSSSI

Primary endpoint results from studies of VIBATIV in cSSSI1

In the Phase 3 ATLAS studies, VIBATIV demonstrated similar cure rates to vancomycin in patients with cSSSI due to MRSA and MSSA.

Clinically evaluable population:
  • VIBATIV: 88.3%
  • Vancomycin: 87.1%
All-treated population:
  • VIBATIV: 76.5%
  • Vancomycin: 74.2%
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Cure Rates

VIBATIV demonstrated a consistent trend of both clinical cure and microbiologic eradication rates vs vancomycin2

  • The trend of favorable clinical cure rates vs vancomycin was seen even in patients with hard-to-treat infections due to MRSA2
  • Patients in the telavancin group appeared to have more severe conditions, including2:
    • Elevated WBC prior to therapy
    • >1 surgical procedure; secondary surgical procedures unrelated to therapy were more often performed after the first dose of telavancin than vancomycin
  • Clinical-cure and microbiologic-eradication rates demonstrated consistent trends favoring telavancin over vancomycin2
    • Differences were not significant due to the small numbers of patients

IMPORTANT CLARIFICATION: This data includes results from a retrospective analysis from the ATLAS clinical trials that are not referenced in the VIBATIV Prescribing Information. Please consult the full Prescribing Information for VIBATIV, including Boxed Warning.

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tissue penetration

VIBATIV achieved penetration into skin blister fluid that was 40% of the plasma concentration over 24 hours3

High levels of skin penetration

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cSSSI and concurrent bacteremia

As part of the phase 3 cSSSI clinical trials, VIBATIV was studied in patients with cSSSI and S. aureus bacteremia at the start of treatment4

Clinical cure rates for S. aureus bacteremia

Of the 1784 patients in the All Treated efficacy (ATe) population in the 2 cSSSI trials4:

  • 32 patients had concurrent S. aureus bacteremia at baseline
  • Clinical cure rates in these patients were 57.1% with VIBATIV and 54.6% with vancomycin
  • Given the limited sample size in this subgroup, the interpretation of these results is limited
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Subgroups

VIBATIV has proven efficacy in clinically meaningful subgroups of patients with cSSSI due to S. aureus.4

Cure rates in subpopulations

References: 1. Data on file. Theravance Biopharma Antibiotics, Inc. 2. Wilson SE, O'Riordan W, Hopkins A, et al, on behalf of the ATLAS Investigators. Telavancin versus vancomycin for the treatment of complicated skin and skin-structure infections associated with surgical procedures. Am J Surg. 2009;197(6):791-796. 3. Sun HK, Duchin K, Nightingale CH, Shaw JP, Seroogy J, Nicolau DP. Tissue penetration of telavancin after intravenous administration in healthy subjects. Antimicrob Agents Chemother. 2006;50(2):788-790. 4. VIBATIV [prescribing information]. South San Francisco, CA: Theravance Biopharma Antibiotics, Inc; May 2016.

Indication

HABP/VABP

VIBATIV is indicated for the treatment of adult patients with hospital-acquired and ventilator-associated bacterial pneumonia (HABP/VABP), caused by susceptible isolates of Staphylococcus aureus (including methicillin-susceptible and -resistant isolates). VIBATIV should be reserved for use when alternative treatments are not suitable.

cSSSI

VIBATIV is indicated for the treatment of adult patients with 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)

Combination therapy may be clinically indicated if the documented or presumed pathogens include Gram-negative organisms.

Appropriate specimens for bacteriological examination should be obtained in order to isolate and identify the causative pathogens and to determine their susceptibility to telavancin. VIBATIV may be initiated as empiric therapy before results of these tests are known. To reduce the development of drug-resistant bacteria and maintain the effectiveness of VIBATIV and other antibacterial drugs, VIBATIV should be used only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.

Important Safety Information

Mortality

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 occurred in patients who received VIBATIV. Renal adverse events were more likely to occur in patients with baseline comorbidities known to predispose patients to kidney dysfunction and in patients who received concomitant medications known to affect kidney function. Monitor renal function in all patients receiving VIBATIV prior to initiation of treatment, during treatment, and at the end of therapy. If renal function decreases, the benefit of continuing VIBATIV versus discontinuing and initiating therapy with an alternative agent should be assessed.

Fetal Risk

Women of childbearing potential should have a serum pregnancy test prior to administration of VIBATIV. Avoid use of VIBATIV during pregnancy unless the potential benefit to the patient outweighs the potential risk to the fetus. Adverse developmental outcomes observed in three animal species at clinically relevant doses raise concerns about potential adverse developmental outcomes in humans. If not already pregnant, women of childbearing potential should use effective contraception during VIBATIV treatment.

Contraindication

Intravenous unfractionated heparin sodium is contraindicated with VIBATIV administration due to artificially prolonged activated partial thromboplastin time (aPTT) test results for up to 18 hours after VIBATIV administration.

VIBATIV is contraindicated in patients with a known hypersensitivity to the drug.

Hypersensitivity Reactions

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.

Geriatric Use

Telavancin is substantially excreted by the kidney, and the risk of adverse reactions may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection in this age group.

Infusion Related Reactions

VIBATIV is a lipoglycopeptide antibacterial agent and should be administered over a period of 60 minutes to reduce the risk of infusion-related reactions. Rapid intravenous infusions of the glycopeptide class of antimicrobial agents can cause “Red-man Syndrome” like reactions including: flushing of the upper body, urticaria, pruritus, or rash.

QTc Prolongation

Caution is warranted when prescribing VIBATIV to patients taking drugs known to prolong the QT interval. In a study involving healthy volunteers, VIBATIV prolonged the QTc interval. Use of VIBATIV should be avoided in patients with congenital long QT syndrome, known prolongation of the QTc interval, uncompensated heart failure, or severe left ventricular hypertrophy.

Most Common Adverse Reactions

The most common adverse reactions (greater than or equal to 10% of patients treated with VIBATIV) were diarrhea, taste disturbance, nausea, vomiting, and foamy urine.

Please see full Prescribing Information including Boxed Warning and Medication Guide.