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The increasing prevalence of Gram-negative resistance poses an empiric treatment challenge in cIAI

ESBL-producing Gram-negative bacteria are on the rise

Microorganisms such as ESBL-producing E coli and K pneumoniae have led to extensive carbapenem use, increasing the prevalence of carbapenem-resistant pathogens1

Preventing the increased use of carbapenems and the selection of carbapenem-resistant pathogens requires antibiotic alternatives that

MAINTAIN

activity against ESBLs

PROVIDE

appropriate coverage needed for cIAI

DEMONSTRATE

comparable clinical efficacy to carbapenems

Carbapenem-resistant Enterobacteriaceae are classified as an urgent threat by the CDC and critical priority pathogens by the World Health Organization2,3

Surveillance data reveal the prevalence of Gram-negative resistance in the United States

Susceptibility rates among ESBL-producing Enterobacteriaceae isolated from intra-abdominal infections4

STUDY DESIGN: The SMART surveillance program collected 1,285 Gram-negative bacilli from patients with hospital-associated intra-abdominal infections between 2012 and 2013. The isolates were obtained from 21 geographically diverse US medical centers. The most common isolates were from peritoneal fluid (24.3%), intra-abdominal abscess (22.1%), stomach (10.8%), and gallbladder (8.3%).4

Timely, effective empiric antibiotic therapy is critical to outcomes

LEARN ABOUT EMPIRIC TREATMENT CHALLENGES

XERAVA is the FIRST fully synthetic fluorocycline antibacterial to help fight resistant pathogens in cIAI5,6

Discover the difference

CDC, Centers for Disease Control and Prevention; cIAI, complicated intra-abdominal infection; E coli, Escherichia coli; ESBL, extended-spectrum beta-lactamase; K pneumoniae, Klebsiella pneumoniae; SMART, Study for Monitoring Antimicrobial Resistance Trends.

References: 1. Viale P, Giannella M, Bartoletti M, Tedeschi S, Lewis R. Considerations about antimicrobial stewardship in settings with epidemic extended-spectrum beta-lactamase-producing or carbapenem-resistant Enterobacteriaceae. Infect Dis Ther. 2015;4(suppl 1):S65-S83. 2. Antibiotic resistance threats in the United States, 2013. Centers for Disease Control and Prevention website. https://www.cdc.gov/drugresistance/pdf/ar-threats-2013-508.pdf. Accessed October 29, 2019. 3. Tacconelli E, Magrini N. Global priority list of antibiotic-resistant bacteria to guide research, discovery, and development of new antibiotics. World Health Organization website. http://www.who.int/medicines/publications/WHO-PPL-Short_Summary_25Feb-ET_NM_WHO.pdf. Accessed October 29, 2019. 4. Zalacain M, Biedenbach DJ, Badal RE, Young K, Motyl M, Sahm DF. Pathogen prevalence and antimicrobial susceptibility among Enterobacteriaceae causing hospital-associated intra-abdominal infections in adults in the United States (2012-2013). Clin Ther. 2016;38(6):1510-1521. 5. XERAVA [prescribing information]. Watertown, MA: Tetraphase Pharmaceuticals, Inc.; Rev. 2019. 6. Zhanel GG, Cheung D, Adam H, et al. Review of eravacycline, a novel fluorocycline antibacterial agent. Drugs. 2016;76(5):567-588.

Indications and Usage; Important Safety Information

EXPAND COLLAPSE

Indications and Usage

XERAVA is 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.

Limitations of Use

XERAVA is not indicated for the treatment of complicated urinary tract infections (cUTI).

Usage

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. 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.

Important Safety Information

XERAVA is contraindicated for use in patients with known hypersensitivity to eravacycline, tetracycline-class antibacterial drugs, or to any of the excipients. Life-threatening hypersensitivity (anaphylactic) reactions have been reported with XERAVA.

The use of XERAVA during tooth development (last half of pregnancy, infancy and childhood to the age of 8 years) may cause permanent discoloration of the teeth (yellow-gray-brown) and enamel hypoplasia.

The use of XERAVA during the second and third trimester of pregnancy, infancy and childhood up to the age of 8 years may cause reversible inhibition of bone growth.

Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, and may range in severity from mild diarrhea to fatal colitis.

The most common adverse reactions observed in clinical trials (incidence ≥3%) were infusion site reactions (7.7%), nausea (6.5%), and vomiting (3.7%).

XERAVA is structurally similar to tetracycline-class antibacterial drugs and may have similar adverse reactions. Adverse reactions including photosensitivity, pseudotumor cerebri, and anti-anabolic action which has led to increased BUN, azotemia, acidosis, hyperphosphatemia, pancreatitis, and abnormal liver function tests, have been reported for other tetracycline-class antibacterial drugs, and may occur with XERAVA. Discontinue XERAVA if any of these adverse reactions are suspected.

To report SUSPECTED ADVERSE REACTIONS, contact Tetraphase Pharmaceuticals Inc., at 1-833-7-XERAVA (1-833-793-7282) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Please see full Prescribing Information for XERAVA.

Indications and Usage

XERAVA is 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.

Limitations of Use

XERAVA is not indicated for the treatment of complicated urinary tract infections (cUTI).

Usage

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. 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.

Important Safety Information

XERAVA is contraindicated for use in patients with known hypersensitivity to eravacycline, tetracycline-class antibacterial drugs, or to any of the excipients. Life-threatening hypersensitivity (anaphylactic) reactions have been reported with XERAVA.

The use of XERAVA during tooth development (last half of pregnancy, infancy and childhood to the age of 8 years) may cause permanent discoloration of the teeth (yellow-gray-brown) and enamel hypoplasia.

The use of XERAVA during the second and third trimester of pregnancy, infancy and childhood up to the age of 8 years may cause reversible inhibition of bone growth.

Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, and may range in severity from mild diarrhea to fatal colitis.

The most common adverse reactions observed in clinical trials (incidence ≥3%) were infusion site reactions (7.7%), nausea (6.5%), and vomiting (3.7%).

XERAVA is structurally similar to tetracycline-class antibacterial drugs and may have similar adverse reactions. Adverse reactions including photosensitivity, pseudotumor cerebri, and anti-anabolic action which has led to increased BUN, azotemia, acidosis, hyperphosphatemia, pancreatitis, and abnormal liver function tests, have been reported for other tetracycline-class antibacterial drugs, and may occur with XERAVA. Discontinue XERAVA if any of these adverse reactions are suspected.

To report SUSPECTED ADVERSE REACTIONS, contact Tetraphase Pharmaceuticals Inc., at 1-833-7-XERAVA (1-833-793-7282) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Please see full Prescribing Information for XERAVA.