TYGACIL SUMMARY
TYGACIL (tigecycline) is a glycylcycline antibacterial for intravenous infusion. The chemical name of tigecycline is (4 S,4a S,5a R,12a S)-9-[2-(tert -butylamino)acetamido]-4,7-bis(dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,10,12,12a-tetrahydroxy-1,11-dioxo-2-naphthacenecarboxamide.
TYGACIL is indicated for the treatment of infections caused by susceptible strains of the designated microorganisms in the conditions listed below for patients 18 years of age and older:
Complicated skin and skin structure infections caused by Escherichia coli, Enterococcus faecalis (vancomycin-susceptible isolates only), Staphylococcus aureus (methicillin-susceptible and ‑resistant isolates), Streptococcus agalactiae, Streptococcus anginosus grp. (includes S. anginosus, S. intermedius, and S. constellatus), Streptococcus pyogenes and Bacteroides fragilis.
Complicated intra-abdominal infections caused by Citrobacter freundii, Enterobacter cloacae, Escherichia coli, Klebsiella oxytoca, Klebsiella pneumoniae, Enterococcus faecalis (vancomycin-susceptible isolates only), Staphylococcus aureus (methicillin-susceptible isolates only), Streptococcus anginosus grp. (includes S. anginosus, S. intermedius, and S. constellatus) , Bacteroides fragilis, Bacteroides thetaiotaomicron, Bacteroides uniformis, Bacteroides vulgatus, Clostridium perfringens, and Peptostreptococcus micros.
Appropriate specimens for bacteriological examination should be obtained in order to isolate and identify the causative organisms and to determine their susceptibility to tigecycline. TYGACIL may be initiated as empiric monotherapy before results of these tests are known.
To reduce the development of drug-resistant bacteria and maintain the effectiveness of TYGACIL and other antibacterial drugs, TYGACIL 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.
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NEWS HIGHLIGHTS
Published Studies Related to Tygacil (Tigecycline)
Safety and efficacy of intravenous tigecycline in treatment of community-acquired pneumonia: results from a double-blind randomized phase 3 comparison study with levofloxacin. [2009.01]
Tigecycline exhibits potent in vitro activity against many community-acquired pneumonia (CAP) pathogens, including antibiotic-resistant ones... Tigecycline was safe, effective, and noninferior to levofloxacin in hospitalized patients with CAP.
Tigecycline versus levofloxacin for the treatment of community-acquired pneumonia: European experience. [2008.10]
Tigecycline (TGC), a first-in-class glycylcycline that has been approved for treating complicated skin and skin structure infections and complicated intra-abdominal infections, has an expanded spectrum of activity against Gram-positive, Gram-negative, anaerobic, and atypical bacteria, including resistant strains.
Overview of tigecycline efficacy and safety in the treatment of complicated skin and skin structure infections - a European perspective. [2008.10]
In a randomized, double-blind, multicenter, multinational, controlled trial, 546 patients with complicated skin and skin structure infections received tigecycline 100 mg/day (a 100-mg initial dose and then 50 mg intravenously twice daily) or the combination of vancomycin 2 g/day (1 g intravenously twice daily) and aztreonam 4 g/day (2 g intravenously twice daily) for up to 14 days...
The efficacy and safety of tigecycline for the treatment of complicated intra-abdominal infections - the European experience. [2008.10]
The polymicrobial nature of complicated intra-abdominal infections makes these infections particularly challenging to treat...
Efficacy and safety of tigecycline compared with vancomycin or linezolid for treatment of serious infections with methicillin-resistant Staphylococcus aureus or vancomycin-resistant enterococci: a Phase 3, multicentre, double-blind, randomized study. [2008.09]
INTRODUCTION: Methicillin-resistant Staphylococcus aureus (MRSA) and vancomycin-resistant enterococci (VRE) are causing serious nosocomial infections. Tigecycline was evaluated in hospitalized patients with MRSA or VRE infection... CONCLUSIONS: Tigecycline is safe and effective in hospitalized patients with serious infection caused by MRSA. There were too few cases of VRE to draw any conclusions.
Clinical Trials Related to Tygacil (Tigecycline)
Post-Marketing Study of the Safety of Tygacil (Tigecycline) [Recruiting]
Open Label Non-Comparative Clinical Trial of Tigecycline in Patients With Catheter Infection [Completed]
Tigecycline is being developed as an agent that overcomes tetracycline-resistance mechanisms
and provides activity against emerging multi-drug resistant pathogens. The purpose of this
protocol is to determine the linkage between time related clinical measures of infection
response and time to bacterial eradication in patients with intravascular catheter infections
caused by Staphylococcus epidermidis and other coagulase negative staphylococci.
A Pharmacovigilance Evaluation and Assessment of the Prescribing Practice for Tygacil in Usual Health Care Setting [Recruiting]
To assess the efficacy and safety of Tygacil in the usual German hospital setting. The main
goals are: • to assess the efficacy of Tygacil under usual care conditions (cure rate) • to
assess the main side effects observed in daily medical practice (Safety of Tygacil) • to
determine whether patients are optimally dosed with Tygacil (according to the label) and the
proportion of patients receiving a monotherapy versus combination therapy. • to observe the
potential resistance development against Tygacil in Germany • to determine which antibiotic
agents are chosen for a combination therapy with Tygacil • to determine to which antibiotic
substance non-responders to Tygacil are switched • to assess the duration of the intravenous
therapy with Tygacil and to determine whether and which patients receive an oral antibiotic
substance after the therapy with Tygacil • to collect information on profile, comorbidities
and characteristics of patients treated with Tygacil
Study Evaluating the Safety and Efficacy of Tigecycline in Hospitalized Patients With cIAI [Recruiting]
In light of tigecycline's activity against these resistant bacteria, tigecycline may represent a viable new therapy for complicated intra-abdominal infections.
Health Economic Assessment of Tygacil® in the Treatment of Secondary Peritonitis in Intensive Care Units (ICUs) [Recruiting]
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