Why Vibativ

VIBATIV for victory in the 49th hour

The CDC recommends an antibiotic time-out after 48 hours on an initial therapy.1 When that empiric therapy is ineffective in patients with HABP/VABP or cSSSI due to S. aureus (MRSA or MSSA), consider VIBATIV in the 49th hour for:

  • Reliably low MICs2
  • 6-hour bactericidal activity maintained up to 24 hours3
  • High levels of lung and skin penetration4,5
  • Once-daily dosing with no loading dose or therapeutic drug-level monitoring required6

VIBATIV for reliably low MICs

VIBATIV offered consistently potent in vitro bactericidal activity against S. aureus, even when other classes of agents showed diminished potency.2

VIBATIV for in vitro bactericidal activity vs other anti-MRSA agents

Only VIBATIV reduced the MRSA CFU/mL to the limit of detection and maintained it for up to 24 hours compared with other agents used to treat MRSA infections.3

VIBATIV for high levels of lung penetration

VIBATIV demonstrated high levels of ELF and AM throughout 24 hours that exceeded the MIC90 for MRSA and MSSA (0.06 μg/mL).4

VIBATIV for high levels of skin penetration

VIBATIV achieved penetration into skin blister fluid that was 40% of the plasma concentration over 24 hours.5

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Dual Moa

VIBATIV is the only once-daily in vitro bactericidal antibiotic with a dual mechanism of action indicated for infections due to S. aureus, including MRSA and MSSA6

  • Like vancomycin, VIBATIV inhibits cell wall synthesis6,7
  • Unlike vancomycin, VIBATIV disrupts cell membrane integrity6,7

Watch the MOA video

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Once-daily dosing with user-friendly administration

Once-daily dosing with no therapeutic drug-level monitoring required6

  • No loading dose required
  • Administered over a 60-minute period
  • Dosed once every 24 hours
    • For 7 to 14 days in cSSSI
    • For 7 to 21 days in HABP/VABP
  • Duration of therapy should be guided by the severity and site of the infection, and by the patient’s clinical progress

Dosing adjustments for patients with renal impairment

Monitoring renal function6

  • Monitor renal function in all patients as new onset or worsening renal impairment has occurred
    • Prior to initiation of treatment
    • During treatment (at 48- to 72-hour intervals or more frequently, if clinically indicated)
    • At end of treatment

Other considerations6

  • No drug-drug interactions were observed
  • VIBATIV shares the same potential as vancomycin for infusion reactions if not infused over at least 60 minutes
  • Physicians are encouraged to register pregnant patients, or pregnant women may enroll themselves in the VIBATIV pregnancy registry by calling 1-855-633-8479
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Safety profile characterized in large clinical trials

VIBATIV has been studied extensively in some of the largest clinical registration trials of any anti-MRSA agent for cSSSI or HABP/VABP6,8,9

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Safety Information Regarding
Use in Pregnancy

An informational program for healthcare providers has been established to help minimize the risks associated with the use of VIBATIV during pregnancy. The most important relates to the use of the product during pregnancy. Animal data indicate that use of VIBATIV during pregnancy is associated with reduced fetal weight and increased rates of digit and limb malformations in offspring, although these malformations were infrequent.6

Women of childbearing potential should have a serum pregnancy test prior to administration of VIBATIV.6 Patients should be counseled on the risks and benefits of VIBATIV. Consideration should be given to using an alternative course of therapy if a positive test result is obtained.

The use of VIBATIV should be avoided during pregnancy unless the potential benefit to the patient outweighs the risk to the fetus.6 Women of childbearing potential (those who have not had complete absence of menses for at least 24 months or medically confirmed menopause, medically confirmed primary ovarian failure, a history of hysterectomy, bilateral oophorectomy, or tubal ligation) should use effective contraception during VIBATIV therapy. Patients should be instructed to notify their prescribing physician or healthcare provider if they become pregnant while taking VIBATIV.

A pregnancy registry has been established to collect information about the effects of VIBATIV use during pregnancy. Physicians are encouraged to register pregnant patients, or pregnant women may enroll themselves in the pregnancy registry by calling 1-855-633-8479.

The VIBATIV Medication Guide should be provided to all patients who receive a course of VIBATIV. Please refer to the full Prescribing Information and Medication Guide.

For additional information, please contact Medical Information by calling 1-855-633-8479 or emailing medinfo@theravance.com.

Download a PDF of the letter to healthcare professionals, which also includes important safety information regarding use in pregnancy.

PREGNANCY REGISTRY

To register women exposed to VIBATIV during pregnancy, call 1-855-633-8479.

References: 1. Centers for Disease Control and Prevention. Antibiotic Resistance Threats in the United States. 2013. 2. Mendes RE, Sader HS, Flamm RK, Farrell DJ, Jones RN. Telavancin in vitro activity against a collection of methicillin-resistant Staphylococcus aureus isolates, including resistant subsets, from the United States. Antimicrob Agents Chemother. 2015;59(3):1811-1814. 3. Data on file. Theravance Biopharma Antibiotics, Inc. 4. 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. 5. 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. 6. VIBATIV [prescribing information]. South San Francisco, CA: Theravance Biopharma Antibiotics, Inc; May 2016. 7. Lunde CS, Hartouni SR, Janc JW, Mammen M, Humphrey PP, Benton BM. Telavancin disrupts the functional integrity of the bacterial membrane through targeted interaction with the cell wall precursor lipid II. Antimicrob Agents Chemother. 2009;53(8):3375-3383. 8. 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(1):31-40. 9. 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.

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.