Doribax (Doripenem) - Summary

DORIBAX SUMMARY

Doripenem is a carbapenem with in vitro antibacterial activity against aerobic and anaerobic Gram-positive and Gram-negative bacteria. DORIBAX™, doripenem monohydrate for injection vials contain 500 mg of doripenem on an anhydrous basis.

To reduce the development of drug-resistant bacteria and maintain the effectiveness of DORIBAX™ and other antibacterial drugs, DORIBAX™ 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 and modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.

Complicated Intra-Abdominal Infections

DORIBAX™ (doripenem for injection) is indicated as a single agent for the treatment of complicated intra-abdominal infections caused by Escherichia coli, Klebsiella pneumoniae, Pseudomonas aeruginosa, Bacteroides caccae, Bacteroides fragilis, Bacteroides thetaiotaomicron, Bacteroides uniformis, Bacteroides vulgatus, Streptococcus intermedius, Streptococcus constellatus and Peptostreptococcus micros.

Complicated Urinary Tract Infections, Including Pyelonephritis

DORIBAX™ (doripenem for injection) is indicated as a single agent for the treatment of complicated urinary tract infections, including pyelonephritis caused by Escherichia coli including cases with concurrent bacteremia, Klebsiella pneumoniae, Proteus mirabilis, Pseudomonas aeruginosa,  and Acinetobacter baumannii.

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NEWS HIGHLIGHTS

Published Studies Related to Doribax (Doripenem)

Influence of continuous venovenous hemofiltration and continuous venovenous hemodiafiltration on the disposition of doripenem. [2011.03]
The pharmacokinetics, safety, and tolerability of a single 1-hour, 500-mg intravenous infusion of doripenem were assessed in dialysis-dependent subjects with stage 5 chronic kidney disease undergoing continuous renal replacement therapy (CRRT) via 12-hour continuous venovenous hemofiltration (CVVH) (n = 6) or continuous venovenous hemodiafiltration (CVVHDF) (n = 5)...

Safety and efficacy of intravenous doripenem for the treatment of complicated urinary tract infections and pyelonephritis. [2010.12]
Doripenem was evaluated in adults with complicated urinary tract infections and pyelonephritis in two phase 3 studies. DORI-05, a randomized, double-blind study compared doripenem 500 mg every 8 hours with levofloxacin 250 mg every 24 hours.coli infections were often due to infection with new strains.

Pharmacokinetics, safety, and tolerability of doripenem after 0.5-, 1-, and 4-hour infusions in healthy volunteers. [2009.07]
The pharmacokinetics, safety, and tolerability of doripenem in healthy subjects were evaluated in 2 studies. Study 1 was a double-blind, randomized, placebo-controlled dose-escalation study in which doripenem was administered for 7 days by infusion over 30 minutes (500 mg) or 1 hour (1000 mg)... All regimens of doripenem were safe and well tolerated.

Urinary bactericidal activity of Doripenem versus that of levofloxacin in patients with complicated urinary tract infections or pyelonephritis. [2009.04]
The aim of this study was to investigate the urinary bactericidal titers (UBTs) and 24-h area under the UBT-versus-time curve (AUBT) of intravenous doripenem (500 mg every 8 h [q8h]), a new carbapenem, versus those of intravenous levofloxacin (250 mg q24h) in patients with complicated urinary tract infections (cUTIs) or pyelonephritis...

Efficacy and safety of intravenous infusion of doripenem versus imipenem in ventilator-associated pneumonia: a multicenter, randomized study. [2008.04]
OBJECTIVE: Doripenem is an investigational carbapenem with broad-spectrum activity against gram-negative and gram-positive pathogens, including multidrug-resistant strains, commonly responsible for ventilator-associated pneumonia (VAP). This large, phase III study compared doripenem with imipenem for the treatment of ventilator-associated pneumonia... CONCLUSIONS: In this large, phase III study of patients with ventilator-associated pneumonia, a 4-hr intravenous infusion of doripenem was clinically efficacious and therapeutically noninferior to imipenem.

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Clinical Trials Related to Doribax (Doripenem)

A Safety and Tolerability Study of Doripenem Compared With Meropenem in Children Hospitalized With Complicated Intra-abdominal Infections [Recruiting]
The purpose of the study is to evaluate the safety and tolerability of doripenem compared with meropenem in children hospitalized with complicated intra abdominal infections.

A Study of Doripenem in CerebrospinalFluid After Doripenem Administration in Pediatric Patients Less Than 1 Year of Age [Not yet recruiting]
The purpose of this study is to characterize the penetration of doripenem in the cerebral spinal fluid in pediatric patients less than 1 year of age who are hospitalized and have a documented or suspected infection in the central nervous system (CNS) and are planning to, or undergoing treatment with intravenous (IV) antibiotics.

A Safety and Tolerability Study of Doripenem Compared With Cefepime in Hospitalized Children With Bacterial Pneumonia [Recruiting]
The purpose of this study is to evaluate the safety and tolerability of doripenem compared to cefepime in children hospitalized with pneumonia.

A Safety and Tolerability Study of Doripenem Compared With Cefepime in Children Hospitalized With Complicated Urinary Tract Infections [Recruiting]
The purpose of this study is to evaluate the safety and tolerability of doripenem compared to cefepime in children hospitalized with complicated urinary tract infections.

A Study of Doripenem in Infants Less Than 12 Weeks of Age [Recruiting]
The purpose of this study is to measure drug levels of doripenem in blood samples collected before and after administration of doripenem to infants less than 12 weeks of age who are hospitalized and documented, presumed to have, or are at risk for bacterial infection (s) and are undergoing treatment with intravenous (i. v.) antibiotics. Safety and tolerability will also be assessed.

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