Invanz (Ertapenem Sodium) - Summary

INVANZ SUMMARY

INVANZ (Ertapenem for Injection) is a sterile, synthetic, parenteral, 1-(beta) methyl-carbapenem that is structurally related to beta-lactam antibiotics.

INVANZ is indicated for the treatment of adult patients with the following moderate to severe infections caused by susceptible strains of the designated microorganisms. (See DOSAGE AND ADMINISTRATION):

Complicated Intra-abdominal Infections due to Escherichia coli, Clostridium clostridioforme, Eubacterium lentum, Peptostreptococcus species, Bacteroides fragilis, Bacteroides distasonis, Bacteroides ovatus, Bacteroides thetaiotaomicron, or Bacteroides uniformis.

Complicated Skin and Skin Structure Infections due to Staphylococcus aureus (methicillin susceptible strains only), Streptococcus pyogenes, Escherichia coli, or Peptostreptococcus species.

Community Acquired Pneumonia due to Streptococcus pneumoniae (penicillin susceptible strains only) including cases with concurrent bacteremia, Haemophilus influenzae (beta-lactamase negative strains only), or Moraxella catarrhalis.

Complicated Urinary Tract Infections including pyelonephritis due to Escherichia coli, including cases with concurrent bacteremia, or Klebsiella pneumoniae.

Acute Pelvic Infections including postpartum endomyometritis, septic abortion and post surgical gynecologic infections due to Streptococcus agalactiae, Escherichia coli, Bacteroides fragilis, Porphyromonas asaccharolytica, Peptostreptococcus species, or Prevotella bivia.

Appropriate specimens for bacteriological examination should be obtained in order to isolate and identify the causative organisms and to determine their susceptibility to ertapenem. Therapy with INVANZ (ertapenem) may be initiated empirically before results of these tests are known; once results become available, antimicrobial therapy should be adjusted accordingly.

To reduce the development of drug-resistant bacteria and maintain the effectiveness of INVANZ and other antibacterial drugs, INVANZ should be used only to treat or prevent 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 Invanz (Ertapenem)

Phase 2, randomized, double-blind study of the efficacy and safety of two dose regimens of eravacycline versus ertapenem for adult community-acquired complicated intra-abdominal infections. [2014]
Eravacycline is a novel fluorocycline, highly active against Gram-positive and Gram-negative pathogens in vitro, including those with tetracycline and multidrug resistance. This phase 2, randomized, double-blind study was conducted to evaluate the efficacy and safety of two dose regimens of eravacycline compared with ertapenem in adult hospitalized patients with complicated intra-abdominal infections (cIAIs)...

Randomised clinical trial of moxifloxacin versus ertapenem in complicated intra-abdominal infections: results of the PROMISE study. [2013]
Antibiotic therapy for complicated intra-abdominal infections (cIAIs) should provide broad-spectrum coverage both Gram-positive and Gram-negative microorganisms... The results show that moxifloxacin is a valuable treatment option for a range of community-acquired cIAIs with mild-to-moderate severity.

A prospective, multi centre, randomized clinical study to compare the efficacy and safety of Ertapenem 3 days versus Ampicillin-Sulbactam 3 days in the treatment of localized community acquired intra-abdominal infection. (T.E.A. Study: Three days Ertapenem vs three days Ampicillin-sulbactam). [2011.04.18]
BACKGROUND: The recommendations outlined in the latest guidelines published by the Surgical Infection Society (SIS) and the Infectious Disease Society of America (IDSA) regarding the proper duration of antibiotic therapy in patients with intra-abdominal infections are limited and non-specific.

Infection after elective colorectal surgery: bacteriological analysis of failures in a randomized trial of cefotetan vs. ertapenem prophylaxis. [2009.04]
BACKGROUND: A randomized study comparing single-dose cefotetan and ertapenem prophylaxis for elective colorectal surgery in 1,002 patients found ertapenem to be significantly more effective (p < 0.001). Failures of prophylaxis were thought to involve organisms resistant to both antimicrobial agents, isolated most often from deep or superficial incision sites... CONCLUSIONS: The in vitro activity of ertapenem was superior to that of cefotetan against all anaerobic and many aerobic bacteria isolated from postoperative cultures of patients who failed prophylaxis with these agents. Our findings help to elucidate the results of the clinical trial.

Ertapenem or ticarcillin/clavulanate for the treatment of intra-abdominal infections or acute pelvic infections in pediatric patients. [2007.09]
BACKGROUND: Ertapenem, a group I carbapenem antibiotic, has been shown to be safe and effective in treating adults with complicated intra-abdominal (cIAI) or acute pelvic infection (API). This study evaluated ertapenem for treating these infections in children... CONCLUSIONS: This study suggests that ertapenem is generally safe and efficacious for treating cIAI or API in pediatric patients.

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Clinical Trials Related to Invanz (Ertapenem)

Pharmacokinetics of Ertapenem in Continuous Venovenous Hemodialysis [Completed]
Critically ill patients in the intensive care unit often receive continuous hemodialysis to treat their kidney failure. Ertapenem is an antibiotic often used in these patients. Continuous dialysis may remove ertapenem, putting patients at risk for inappropriate treatment of their infection. This study will determine how much ertapenem is removed by continuous hemodialysis.

Pharmacokinetics and Optimal Dose of Ertapenem in Hemodialysis Patients [Not yet recruiting]
The purpose of this study is to determine the amount of ertapenem in the blood over time between hemodialysis session.

Study to Compare TP-434 and Ertapenem in CA Complicated Intra-abdominal Infections [Completed]
This is a Phase 2, randomized, double-blind, double-dummy, multicenter, prospective study to assess the efficacy, safety, and pharmacokinetics of two dose regimens of TP-434 compared with ertapenem in the treatment of adult community-acquired complicated intra-abdominal infections.

Efficacy and Safety Study of Eravacycline Compared With Ertapenem in Complicated Intra-abdominal Infections [Active, not recruiting]
This is a Phase 3, randomized, double-blind, double-dummy, multicenter, prospective study to assess the efficacy, safety, and pharmacokinetics of eravacycline compared with ertapenem in the treatment of adult complicated intra-abdominal infections (cIAI).

Safety and Tolerability of Ertapenem Sodium in the Treatment of Complicated Urinary Tract Infections (0826-055) [Completed]
The purpose of this study is to determine the efficacy of ertapenem sodium (Invanz) in treatment of complicated urinary tract infections with respect to the proportion of patients with a favorable microbiological response at 5-9 days post therapy.

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Reports of Suspected Invanz (Ertapenem) Side Effects

Convulsion (20),  Clostridial Infection (10),  Confusional State (9),  Hallucination, Visual (8),  Drug Ineffective (6),  Posterior Reversible Encephalopathy Syndrome (6),  Agitation (5),  Enterococcal Infection (5),  Tachycardia (5),  Drug Interaction (5), more >>