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COMPREHENSIVE EMPIRIC COVERAGE IS NEEDED IN PATIENTS WITH cIAI WHO ARE AT RISK FOR RESISTANCE1

Delivering appropriate empiric treatment for cIAI is often challenging, given its polymicrobial nature2

Pathogens isolated from intraoperative peritoneal fluid, % (N=1,463)

Percentages may not total 100 due to rounding.

have polymicrobial infections, which may include many different bacteria and potentially resistant strains1

Resistance complicates empiric decisions

Any of these factors puts patients at risk for harboring resistant bacteria

Prolonged hospital stay3

Invasive procedures/devices4

ICU stay3,4

Recent travel to endemic area5,6

Recent antibiotic use4,7,8

Recent hospitalization8

Chronic hemodialysis8

Long-term care resident7

According to SIS and IDSA, intra-abdominal infections are the SECOND MOST COMMON cause of infectious MORTALITY in intensive care units.9 This underscores the need to carefully consider empiric antibiotic choices.

Delayed appropriate treatment in patients with cIAI is common and results in negative outcomes

Of 56,357 hospitalized patients with serious Gram-negative bacterial infections,

received delayed appropriate therapy10

An additional study showed isolation of an MDR pathogen was a significant risk factor for failure of initial antibiotic therapy in patients with health care-associated cIAI.11 This underscores the importance of assessing local epidemiology and patient history in empiric antibiotic choices.


Failure of initial antibiotic therapy increased risk of negative clinical and economic consequences12

Increased duration of IV antibiotic therapy by 5.6 days

Increased cost by $6,368

Increased hospital stay by 4.6 days

Increased mortality risk by nearly 4 times

Guideline recommendations for addressing the challenges posed by cIAI

The 2017 SIS guidelines recommend starting empiric treatment of cIAI with an antibiotic that provides polymicrobial coverage against Gram-negative, Gram-positive, and anaerobic pathogens.13-14

The 2016 Surviving Sepsis Campaign International Guidelines consider de-escalation a vital component of antimicrobial stewardship, associated with15:

  • Lower resistance
  • Fewer adverse effects
  • Decreased cost
  • Improved survival

Additional treatment consideration

STOP-IT trial demonstrated similar outcomes with shorter vs longer courses of antibiotic treatment

In patients with cIAIb who underwent an adequate source control procedure:

  • A fixed duration of approximately 4 days of antibiotic therapy produced similar outcomes to approximately 8 days of therapy16

A shorter duration of therapy:

  • May reduce the need for follow-up treatment with an oral antibiotic post discharge
  • Reduces the number of days of antimicrobial exposure16

aSurgical site infection, recurrent intra-abdominal infection, or death.16

bOnly a small number of immunocompromised patients were included. It is unclear whether these patients would have benefited from a longer duration of antimicrobial therapy.16

Alternative empiric treatments are needed to meet the challenge

LEARN ABOUT CURRENT TREATMENT LIMITATIONS

XERAVA is active against important resistant pathogens17

EXPLORE COVERAGE

cIAI, complicated intra-abdominal infection; ICU, intensive care unit; IDSA, Infectious Diseases Society of America; IV, intravenous; MDR, multidrug-resistant; SIS, Surgical Infection Society; STOP-IT, Study to Optimize Peritoneal Infection Therapy.

References: 1. Shah PM, Edwards BL, Dietch ZC, et al. Do polymicrobial intra-abdominal infections have worse outcomes than monomicrobial intra-abdominal infections? Surg Infect (Larchmt). 2016;17(1):27-31. 2. Sartelli M, Catena F, Ansaloni L, et al. Complicated intra-abdominal infections worldwide: the definitive data of the CIAOW Study. World J Emerg Surg. 2014;9:37. 3. Gupta N, Limbago BM, Patel JB, Kallen AJ. Carbapenem-resistant Enterobacteriaceae: epidemiology and prevention. Clin Infect Dis. 2011;53(1):60-67. 4. Falagas ME, Kopterides P. Risk factors for the isolation of multi-drug-resistant Acinetobacter baumannii and Pseudomonas aeruginosa: a systematic review of the literature. J Hosp Infect. 2006;64(1):7-15. 5. Reuland EA, Sonder GJB, Stolte I, et al. Travel to Asia and traveller’s diarrhoea with antibiotic treatment are independent risk factors for acquiring ciprofloxacin-resistant and extended spectrum beta-lactamase-producing Enterobacteriaceae—a prospective cohort study. Clin Microbiol Infect. 2016;22(8):731.e1-e7. 6. van der Bij AK, Pitout JDD. The role of international travel in the worldwide spread of multiresistant Enterobacteriaceae. J Antimicrob Chemother. 2012;67(9):2090-2100. 7. Bhargava A, Hayakawa K, Silverman E, et al. Risk factors for colonization due to carbapenem-resistant Enterobacteriaceae among patients exposed to long-term acute care and acute care facilities. Infect Control Hosp Epidemiol. 2014;35(4):398-405. 8. Labricciosa FM, Sartelli M, Abbo LM, et al. Epidemiology and risk factors for isolation of multi-drug–resistant organisms in patients with complicated intra-abdominal infections. Surg Infect (Larchmt). 2018;19(3):264-272. 9. Solomkin JS, Mazuski JE, Bradley JS, et al. Diagnosis and management of complicated intra-abdominal infection in adults and children: guidelines by the Surgical Infection Society and the Infectious Diseases Society of America [published correction appears in Clin Infect Dis. 2010;50(12):1695]. Clin Infect Dis. 2010;50(2):133-164. 10. Bonine NG, Berger A, Altincatal A, et al. Impact of delayed appropriate antibiotic therapy on patient outcomes by antibiotic resistance status from serious Gram-negative bacterial infections. Am J Med Sci. 2019;357(2):103-110. 11. Peeters P, Ryan K, Karve S, et al. The impact of initial antibiotic treatment failure: real-world insights in patients with complicated, health care-associated intra-abdominal infection. Infect Drug Resist. 2019;12:329-343. 12. Edelsberg J, Berger A, Schell S, Mallick R, Kuznik A, Oster G. Economic consequences of failure of initial antibiotic therapy in hospitalized adults with complicated intra-abdominal infections. Surg Infect (Larchmt). 2008;9(3):335-347. 13. 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. 14. Kaye KS. Antimicrobial de-escalation strategies in hospitalized patients with pneumonia, intra-abdominal infections, and bacteremia. J Hosp Med. 2012;7(suppl 1):S13-S21. 15. Rhodes A, Evans LE, Alhazzani W, et al. Surviving Sepsis Campaign: international guidelines for management of sepsis and septic shock: 2016. Crit Care Med. 2017;45(3):486-552. 16. Sawyer RG, Claridge JA, Nathens AB, et al; STOP-IT Trial Investigators. Trial of short-course antimicrobial therapy for intraabdominal infection. N Engl J Med. 2015;372(21):1996-2005. 17. XERAVA [prescribing information]. Watertown, MA: Tetraphase Pharmaceuticals, Inc.; Rev. 2019.

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.