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LIMITATIONS OF CURRENT TREATMENTS HAVE CREATED THE NEED FOR ALTERNATIVE choices

Before choosing a treatment for your patient with cIAI, consider the challenges presented by these therapies

  • Piperacillin/Tazobactam
  • Carbapenems
  • Fluoroquinolones

Excess mortality reported with piperacillin/tazobactam vs a carbapenem1

Rate of 30-day mortality (MERINO Trial), ESBL-producing bloodstream infections

There was no clear correlation between MICs and mortality in patients randomized to piperacillin/tazobactam1

Study reported the 30-day mortality rate for patients with bacteremia caused by E coli or K pneumoniae with ESBL-mediated resistance to ceftriaxone, but in vitro susceptibility to the study drugs, after patients were randomized to treatment with one of the study drugs.

The greater mortality rate associated with piperacillin/tazobactam may drive increased use of carbapenems when infection with ESBL-producing bacteria is suspected

Carbapenems are in need of protection and should be used sparingly

Perpetuation of progressively difficult-to-treat infections due to resistant pathogens

ESBL-producing strains that are resistant to multiple antibiotic classes (eg, beta-lactams, fluoroquinolones) are increasingly prevalent2-4

this leads to...

Increased carbapenem use5

which leads to...

Selection of carbapenem-resistant strains5

which results in...

Increased prevalence of MDR Gram-negative pathogens with limited to no treatment options6

Identifying carbapenem-sparing alternatives

to treat Gram-negative bacterial infections has proven to be challenging, with studies showing conflicting and/or inferior efficacy results with some alternative agents1,7

The importance of avoiding the overuse of carbapenems

  • Carbapenem use is a significant contributor to the development of carbapenem-resistant organisms5
  • According to a CDC report, carbapenems were the antibiotic class with the largest percentage increase in use within hospitals between 2006 and 20128
  • Carbapenem-sparing treatment is recommended by the World Society of Emergency Surgery, particularly where the incidence of carbapenem-resistant K pneumoniae is high9

There are good reasons to consider alternatives to fluoroquinolones

Low susceptibility vs ESBLs

Fluoroquinolone susceptibility rates in hospital-associated intra-abdominal infections caused by ESBL-producing Enterobacteriaceae were <20%, according to surveillance data from 21 geographically diverse US medical centers10

C difficile risk

As part of a stewardship initiative, curtailing fluoroquinolone use was the most significant factor in reducing C difficile infections11

Guidelines recommend limiting fluoroquinolone use to lower-risk adults

  • Exercise caution if using fluoroquinolones in areas with a high incidence of fluoroquinolone-resistant E coli12
  • Need to add metronidazole to cover anaerobes12

Safety concerns

  • Fluoroquinolones carry a boxed warning for tendinitis and tendon rupture, peripheral neuropathy, central nervous system effects, and exacerbation of myasthenia gravis13
  • The FDA recently warned health care providers that fluoroquinolones can increase the occurrence of rare but serious ruptures or tears in the aorta, which can lead to dangerous bleeding or death14

Why consider tetracyclines in patients at risk for C difficile infections?

A recent meta-analysis, which included 6 full-text studies, 5,322 CDI cases, and 412,208 controls, suggests that tetracycline use may be associated with a decreased risk for the development of CDI15

38% reduction

Tetracycline (particularly doxycycline) use was associated with a 38% reduction in the risk for developing CDI vs other antibiotics15

Protective effect against CDI

Subgroup analysis showed that the protective effect of tetracyclines against CDI may be greater in higher-risk inpatients vs lower-risk outpatients15

Additional comparative studies are needed to further determine the effects of tetracyclines in different subgroups, including outpatients vs inpatients and community- vs hospital-acquired CDI, and in reducing the risk for primary vs recurrent CDI.15

Supporting antibiotic innovation is key to future treatment success

SEE THE Future of Antibiotics

XERAVA has proven efficacy as monotherapy in patients with cIAI16-19

View clinical trial data

CDC, Centers for Disease Control and Prevention; CDI, Clostridium difficile infection; C difficile, Clostridioides (Clostridium) difficile; cIAI, complicated intra-abdominal infection; E coli, Escherichia coli; ESBL, extended-spectrum beta-lactamase; FDA, US Food and Drug Administration; K pneumoniae, Klebsiella pneumoniae; MIC, minimum inhibitory concentration; MDR, multidrug-resistant.

References: 1. Harris PNA, Tambyah PA, Lye DC, et al; for the MERINO Trial Investigators and the Australasian Society for Infectious Disease Clinical Research Network (ASID-CRN). Effect of piperacillin-tazobactam vs meropenem on 30-day mortality for patients with E coli or Klebsiella pneumoniae bloodstream infection and ceftriaxone resistance: a randomized clinical trial [published correction appears in JAMA. 2019;321(23):2370]. JAMA. 2018;320(10):984-994. 2. Babinchak T, Badal R, Hoban D, et al. Trends in susceptibility of selected gram-negative bacilli isolated from intra-abdominal infections in North America: SMART 2005-2010. Diagn Microbiol Infect Dis. 2013;76(3):379-381. 3. Hackel MA, Badal RE, Bouchillon SK, Biedenbach DJ, Hoban DJ. Resistance rates of intra-abdominal isolates from intensive care units and non-intensive care units in the United States: the Study for Monitoring Antimicrobial Resistance Trends 2010-2012. Surg Infect (Larchmt). 2015;16(3):298-304. 4. McDanel J, Schweizer M, Crabb V, et al. Incidence of extended-spectrum beta-lactamase (ESBL)-producing Escherichia coli and Klebsiella infections in the United States: a systematic literature review. Infect Control Hosp Epidemiol. 2017;38(10):1209-1215. 5. McLaughlin M, Advincula MR, Malczynski M, Qi C, Bolon M, Scheetz MH. Correlations of antibiotic use and carbapenem resistance in Enterobacteriaceae. Antimicrob Agents Chemother. 2013;57(10):5131-5133. 6. 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. 7. Tamma PD, Han JH, Rock C, et al. Carbapenem therapy is associated with improved survival compared with piperacillin-tazobactam for patients with extended-spectrum beta-lactamase bacteremia [published correction appears in Clin Infect Dis. 2015;61(1):143]. Clin Infect Dis. 2015;60(9):1319-1325. 8. Antibiotic use in hospitals, 2017. Centers for Disease Control and Prevention website. https://www.cdc.gov/antibiotic-use/stewardship-report/hospital.html. Updated August 9, 2019. Accessed October 29, 2019. 9. Sartelli M, Catena F, Abu-Zidan FM, et al. Management of intra-abdominal infections: recommendations by the WSES 2016 consensus conference. World J Emerg Surg. 2017;12:22. 10. 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. 11. Dingle KE, Didelot X, Quan TP, et al; Modernising Medical Microbiology Informatics Group. Effects of control interventions on Clostridium difficile infection in England: an observational study. Lancet Infect Dis. 2017;17(4):411-421. 12. Mazuski JE, Tessier JM, May AK, et al. The Surgical Infection Society revised guidelines on the management of intra-abdominal infection. Surg Infect (Larchmt). 2017;18(1):1-76. 13. Levofloxacin [prescribing information]. Lake Forest, IL: Hospira, Inc.; Rev. 2019. 14. FDA warns that fluoroquinolone antibiotics can cause aortic aneurysm in certain patients. FDA In Brief. https://www.fda.gov/news-events/fda-brief/fda-brief-fda-warns-fluoroquinolone-antibiotics-can-cause-aortic-aneurysm-certain-patients. Published December 20, 2018. Accessed October 29, 2019. 15. Tariq R, Cho J, Kapoor S, et al. Low risk of primary Clostridium difficile infection with tetracyclines: a systematic review and metaanalysis. Clin Infect Dis. 2018;66(4):514-522. 16. XERAVA. Prescribing information. Tetraphase Pharmaceuticals, Inc.; Rev. 06/2020. 17. Solomkin J, Evans D, Slepavicius A, et al. Assessing the efficacy and safety of eravacycline vs ertapenem in complicated intra-abdominal infections in the Investigating Gram-Negative Infections Treated with Eravacycline (IGNITE 1) trial: a randomized clinical trial. JAMA Surg. 2017;152(3):224-232. 18. Solomkin JS, Gardovskis J, Lawrence K, et al. IGNITE4: results of a phase 3, randomized, multicenter, prospective trial of eravacycline vs meropenem in the treatment of complicated intraabdominal infections. Clin Infect Dis. 2019;69(6):921-929. 19. Data on file. Watertown, MA: Tetraphase Pharmaceuticals, Inc.; 2018.

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.