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Vibativ (Telavancin Hydrochloride) - Summary

 
 



WARNING: 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 3 animal species at clinically relevant doses raise concerns about potential adverse developmental outcomes in humans [see Warnings and Precautions Use in Specific Populations]
 

VIBATIV SUMMARY

VIBATIV contains telavancin hydrochloride, a lipoglycopeptide antibacterial that is a synthetic derivative of vancomycin.

VIBATIV is a lipoglycopeptide antibacterial indicated for the treatment of adult patients with complicated skin and skin structure infections (cSSSI) caused by susceptible Gram-positive bacteria.
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.

more studies >>

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 [Not yet 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.

more trials >>

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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