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 615-255-0068
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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 877-484-2700.

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 877-683-6110 or emailing vibativinfo@cumberlandpharma.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 877-484-2700.

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.



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.