Xerava (eravacycline)

The following drug information is obtained from various newswires, published medical journal articles, and medical conference presentations.

Approval Status:

Approved August 2018

Specific Treatments:

complicated intra-abdominal infections

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General Information

Xerava (eravacycline) is a tetracycline class antibacterial.

Xerava is specifically indicated for the treatment of complicated intra-abdominal infections (cIAI) caused by susceptible microorganisms: Escherichia coli, Klebsiella pneumoniae, Citrobacter freundii, Enterobacter cloacae, Klebsiella oxytoca, Enterococcus faecalis, Enterococcus faecium, Staphylococcus aureus, Streptococcus anginosus group, Clostridium perfringens, Bacteroides species, and Parabacteroides distasonis in patients 18 years or older.

Xerava is supplied as a solution for intravenous administration. To reduce the development of drug-resistant bacteria and maintain the effectiveness of Xerava and other antibacterial drugs, Xerava should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. The recommended dose regimen of Xerava is 1 mg/kg every 12 hours. Administer intravenous infusions over approximately 60 minutes every 12 hours. The recommended duration of treatment with Xerava for cIAI is 4 to 14 days. The duration of therapy should be guided by the severity and location of infection and the patient’s clinical response.

Clinical Results

FDA Approval

The FDA approval of Xerava was based on two phase III trials. A total of 1,041 adults hospitalized with cIAI were enrolled in the two randomized, double blind, active-controlled, multinational, multicenter trials. These trials compared Xerava (1 mg/kg intravenous every 12 hours) with either ertapenem (1 g every 24 hours) or meropenem (1 g every 8 hours) as the active comparator for 4 to 14 days of therapy. In the first trial twice-daily intravenous (IV) eravacycline met the primary endpoint by demonstrating statistical non-inferiority of clinical response compared to ertapenem and was well-tolerated. In the second clinical trial in patients with cIAI, twice-daily IV eravacycline met the primary endpoint by demonstrating statistical non-inferiority of clinical response compared to meropenem and was well-tolerated. In both trials, Xerava achieved high cure rates in patients with Gram-negative pathogens, including resistant isolates.

Side Effects

Adverse effects associated with the use of Xerava may include, but are not limited to, the following:

injection site reactions

nausea

vomiting

Mechanism of Action

Xerava (eravacycline) is a fluorocycline antibacterial within the tetracycline class of antibacterial drugs. Eravacycline disrupts bacterial protein synthesis by binding to the 30S ribosomal subunit thus preventing the incorporation of amino acid residues into elongating peptide chains. In general, eravacycline is bacteriostatic against gram-positive bacteria (e.g., Staphylococcus aureus and Enterococcus faecalis); however, in vitro bactericidal activity has been demonstrated against certain strains of Escherichia coli and Klebsiella pneumoniae.

Additional Information

For additional information regarding Xerava or complicated intra-abdominal infections, please visit https://www.xerava.com/