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Vibativ (Telavancin Hydrochloride) - Summary

 
 



WARNINGS

  • 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 [see Warnings and Precautions (5.1) ].
  • Nephrotoxicity: New onset or worsening renal impairment has occurred. Monitor renal function in all patients [see Warnings and Precautions (5.3) ].
  • Women of childbearing potential should have a serum pregnancy test prior to administration of VIBATIV [see Warnings and Precautions (5.4), Use in Specific Populations (8.1) ].
  • Avoid use of VIBATIV during pregnancy unless the potential benefit to the patient outweighs the potential risk to the fetus [see Warnings and Precautions (5.4), Use in Specific Populations (8.1) ].
  • Adverse developmental outcomes observed in 3 animal species at clinically relevant doses raise concerns about potential adverse developmental outcomes in humans [see Warnings and Precautions (5.4), Use in Specific Populations ( 8.1 ) ]
 

VIBATIV SUMMARY

VIBATIV contains telavancin hydrochloride (Figure 1), a lipoglycopeptide antibacterial that is a synthetic derivative of vancomycin.

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.

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.

Complicated Skin and Skin Structure Infections

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).

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.


See all Vibativ indications & dosage >>

NEWS HIGHLIGHTS

Published Studies Related to Vibativ (Telavancin)

Telavancin versus vancomycin for hospital-acquired pneumonia due to gram-positive pathogens. [2011.01.01]
BACKGROUND: Telavancin is a lipoglycopeptide bactericidal against gram-positive pathogens... CONCLUSIONS: The primary end point of the studies was met, indicating that telavancin is noninferior to vancomycin on the basis of clinical response in the treatment of HAP due to gram-positive pathogens.

Telavancin versus vancomycin for hospital-acquired pneumonia due to gram-positive pathogens. [2011]
pathogens... CONCLUSIONS: The primary end point of the studies was met, indicating that

ATLAS trials: efficacy and safety of telavancin compared with vancomycin for the treatment of skin infections. [2010.12]
Telavancin is an injectable lipoglycopeptide that is bactericidal in vitro against staphylococci, streptococci and vancomycin-susceptible enterococci. Telavancin inhibits bacterial cell wall synthesis by interfering with the synthesis of peptidoglycan, and binds to the bacterial membrane and disrupts membrane barrier function...

Effect of Telavancin on the pharmacokinetics of the cytochrome P450 3A probe substrate midazolam: a randomized, double-blind, crossover study in healthy subjects. [2010.02]
CONCLUSION: These pharmacokinetic data show that intravenous telavancin administered at the intended therapeutic dose does not affect the pharmacokinetics of intravenous midazolam. The results indicate that telavancin is unlikely to inhibit hepatic CYP3A activity to a clinically meaningful extent.

Lack of pharmacokinetic drug interactions following concomitant administration of telavancin with aztreonam or piperacillin/tazobactam in healthy participants. [2009.07]
This randomized crossover study in healthy participants assessed pharmacokinetic interactions between telavancin, aztreonam, and piperacillin/tazobactam... Administration of aztreonam or piperacillin/tazobactam with telavancin had no clinically significant effect on the pharmacokinetic disposition of any of these drugs.

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Clinical Trials Related to Vibativ (Telavancin)

Safety and Efficacy of Telavancin [Recruiting]
The goal of this clinical research study is to learn if Vibativ (telavancin) can help to control blood stream infections (BSIs). The safety of this treatment will also be studied.

Objectives:

Evaluate the clinical efficacy and safety of Telavancin given for treatment of gram positive bacteremia in cancer patients (including neutropenics).

VIBATIV Pregnancy Registry [Recruiting]
The purpose of this registry is to evaluate the outcome of pregnancy in women exposed to VIBATIV at any time during pregnancy. There are no mandated physician visits for the registry.

An Open-Label Study of the Pharmacokinetics of a Single Dose of Telavancin in Pediatric Subjects Aged 1 to 17 Years [Not yet recruiting]
This is a multicenter, open-label, single-dose pharmacokinetic (PK) study. Infants, children, and adolescents will receive a single 10 mg/kg dose of telavancin infused intravenously (IV) over 60 minutes

A Phase 3 Telavancin Staph Aureus Bacteremia Trial [Recruiting]
This is a multicenter, randomized, open-label, noninferiority trial of telavancin versus standard IV therapy (e. g., vancomycin, daptomycin, anti-staphylococcal penicillin (PCN), or cefazolin) control in the treatment of subjects with complicated Staphylococcus. aureus (SA) bacteremia and SA right-sided infective endocarditis (RIE).

Telavancin Observational Use Registry (TOUR) [Not yet recruiting]
This is a prospective, multicenter, observational study to examine telavancin efficacy and safety an a real-word setting and to characterize the pattern of use of telavancin in hospital-based inpatients and in outpatient infusion centers in the U. S. All treatment decisions and clinical assessment will be made at the discretion of the treating physician per usual care and are not mandated by study design or protocol.

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Reports of Suspected Vibativ (Telavancin) Side Effects

Chills (3)Blood Glucose Increased (3)Vomiting (3)Nausea (3)Tremor (3)Muscle Spasms (2)Extravasation (2)Electrocardiogram QT Prolonged (1)Disease Progression (1)Death (1)more >>


Page last updated: 2013-02-10

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