Why Xerava
Antibiotic stewardship
without compromise
Antibiotic Stewardship
The CDC’s primary tenets
of stewardship
Appropriate antibiotics can reduce1:
Treatment failures
Adverse effects
Hospital
costs
C. difficile† infections
Antibiotic resistance
Lengths of stay
†Clostridioides difficile is the new nomenclature for Clostridium difficile.
CDC=Centers for Disease Control and Prevention.
XERAVA–consistent with good stewardship practices 1-3
XERAVA is safe and effective for a broad range of cIAI patients 7,8XERAVA is safe and effective for a broad range of cIAI patients 7,8
Treatment discontinuation due to an adverse reaction occurred in 2% of patients receiving XERAVA and 2% of patients receiving the comparator.
In Vitro Antimicrobial Activity
Broad-spectrum activity to
change the way you treat 3,4
Activity against important cIAI pathogens7,8
Slide table to view more
| Antibiotic activity | |||
|---|---|---|---|
| Aerobic Bacteria | Anaerobic Bacteria | ||
| Gram-positive bacteria | Gram-negative bacteria | Gram-positive bacteria | Gram-negative bacteria |
| Enterococcus faecalisEnterococcus faeciumStaphylococcus aureusStreptococcus anginosus groupStreptococcus salivarius group | Citrobacter freundiiEnterobacter cloacaeEscherichia coliKlebsiella oxytocaKlebsiella pneumoniaeCitrobacter koseriEnterobacter aerogenes | Clostridium perfringens | Bacteroides caccaeBacteroides fragilisBacteroides ovatus Bacteroides thetaiotaomicron Bacteroides uniformis Bacteroides vulgatus Parabacteroides distasonis |
Retains in vitro activity against highly resistant bacterial strains, such as ESBLs, VRE, and MRSA3 Retains in vitro activity against highly resistant bacterial strains, such as ESBLs, VRE, and MRSA3
| Potent in vitro activity compared to previous tetracyclines12 | |||
|---|---|---|---|
| Up to 8x more active4 | 10‑fold greater affinity with 4‑fold lower concentrations5 | C7 and C9 substitution protects against certain resistant mechanisms | Bactericidal vs. certain Gram‑negative bacteria; bacteriostatic vs. strains of certain Gram‑positive bacteria |
ESBL=extended-spectrum beta-lactamase;
MRSA=methicillin-resistant Staphylococcus aureus;
VRE=vancomycin resistant enterococci.
Fight resistance and reduce selective pressure of carbapenems and beta- lactams with XERAVA9,13Fight resistance and reduce selective pressure of carbapenems and beta-lactams with XERAVA9,13
Broad in vitro activity
Mic90 by pathogen
The following in vitro data are available
but their clinical significance is unknown14-16
Slide table to view more
| Gram-negative | Gram-positive | Anaerobe | |||
|---|---|---|---|---|---|
| Pathogen | (mcg/mL) | Pathogen | (mcg/mL) | Pathogen | (mcg/mL) |
| E. coli (n=2,033) | 0.25 | S. aureus, MRSA (n=1,030) | 0.12 | B. fragilis (n=198) | 2.0 |
| K. pneumoniae (n=2,040) | 1.0 | S. aureus, MSSA (n=1,128) | 0.06 | Bacteroides speciesa (n=131) | 2.0 |
| K. oxytoca (n=1,948) | 0.25 | E. faecium, VRE (n=588) | 0.06 | P. distasonis (n=22) | 1.0 |
| E. cloacae (n=1,881) | 1.0 | E. faecium, VSE (n=1,136) | 0.06 | C. perfingens (n=76) | 0.5 |
| C. freundii (n=1,542) | 0.5 | E. faecalis, VRE (n=59) | 0.12 | ||
| E. faecalis, VSE (n=1,817) | 0.06 | ||||
| S. anginosus group (n=273) | 0.03 | ||||
aIncludes B. ovatus, B. vulgatus, and B. thetaiotaomicron.
MIC=minimum inhibitory concentration; MSSA=methicillin-susceptibleStaphylococcus aureus; VRE=vancomycin-resistant enterococci; VSE=vancomycin-susceptible enterococci.
Help protect against resistance and support antibiotic stewardship with potent, broad-spectrum coverage 1,3,4Help protect against resistance and support antibioticstewardship with potent, broad-spectrum coverage 1,3,4
Patient Profiles
Take on even the most challenging cases
Resides in long-term care (LTC) facility
Current condition: Critically ill & hospitalized
Current diagnosis: Small-bowel perforation
Medical History: Ongoing renal insufficiency (CrCl 47mL/min). Resident of local long-term care facility that reported high rates of ESBL-producing pathogens
Antibiotic History: Treated with antibiotics in hospital for a cUTI 1 month ago then discharged to a skilled nursing facility. Developed diarrhea while on antibiotics
CrCI=creatinine clearance; cUTI=complicated urinary tract infection.
XERAVA is optimal for transitions of careXERAVA is optimal for transitions of care
Want to
know more?
Request to speak with a
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Lead the
charge
Choose broad-spectrum
coverage for a broad range of
cIAI patients with XERAVA.4
References:
- Centers for Disease Control and Prevention. Core elements of hospital antibiotic stewardship programs. Accessed November 28, 2023.
- Heaney M, Mahoney MV, Gallagher JC. Eravacycline: the tetracyclines strike back. Ann Pharmacother. 2019 Nov;53(11):1124-1135. doi: 10.1177/1060028019850173.
- Sutcliffe JA, O’Brien W, Fyfe C, Grossman TH. Antibacterial activity of eravacycline (TP-434), a novel fluorocycline, against hospital and community pathogens. Antimicrob Agents Chemother. 2013;57(11):5548-5558. doi: 10.1128/AAC.01288-13.
- Zhanel GG, Cheung D, Adam H, et al. Review of eravacycline, a novel fluorocycline antibacterial agent. Drugs. 2016;76(5):567-588. doi: 10.1007/s40265-016-0545-8.
- Scott LJ. Eravacycline: A review in complicated intra-abdominal infections. Drugs. 2019;79(3):315-324. doi: 10.1007/s40265-019-01067-3
- Grimaldi K. Executive summary: criteria for formulary consideration of tetracycline drug class. Nebraska Medicine. Published April 2020. Accessed November 28, 2023.
- 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. doi: 10.1093/cid/ciy1029.
- 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. doi: 10.1001/jamasurg.2016.4237.
- Eljaaly K, Ortwine JK, Shaikhomer M, et al. Efficacy and safety of eravacycline: a meta-analysis. JGAR. 2021;24:424-428. doi: 10.1016/j.jgar.2021.02.009.
- Kunz Coyne AJ, Alosaimy S, Lucas K, et al. Eravacycline, the first four years: health outcomes and tolerability for 19 hospitals in 5 U.S. regions from 2018 to 2022. Microbiol Spectr. 2024;12(1):1-14. doi: 10.1128/spectrum.02351-23.
- 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. doi: 10.1093/cid/cix833.
- Sauberan JB, Bradley JS. Antibacterial agents. In: Long SS, Prober CG, Fischer M, et al. Principles and Practice of Pediatric Infectious Diseases. ScienceDirect. 2023.
- LaPlante KL, Dhand A, Wright K. Re-establishing the utility of tetracycline-class antibiotics for current challenges with antibiotic resistance. Ann Med. 2022; 54(1)1686-1700. doi.org/10.1080/07853890.2022.2085881
- Hawser S, Kothari N, Monti F, et al. In vitro activity of eravacycline and comparators against Gram-negative and Gram-positive bacterial isolates collected from patients globally between 2017 and 2020. J. Glob. Antimicrob. Resist. 2023, 33, 304–320. doi: 10.1016/j.jgar.2023.04.017.
- Morrissey I, Sutcliffe J, Hackel M, et al. Activity of eravacycline against anaerobic bacteria from Europe collected in 2013-14. Presentation 784. Presented at 53rd Annual Infectious Disease Society of America (IDWeek), October 7-11, 2015, San Diego, CA.
- Goldstein EJ, Citron DM, Tyrrell KL. In vitro activity of eravacycline and comparator antimicrobials against 143 recent strains of Bacteroides and Parabacteroides species. Anaerobe. 2018;52:122-124. doi: 10.1016/j.anaerobe.2018.06.016.
Indications & Usage
Indications
XERAVA® (eravacycline) for injection 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.
You are encouraged to report negative side effects of prescription drugs to the FDA. To report SUSPECTED ADVERSE REACTIONS, please contact:
Innoviva Specialty Therapeutics, Inc.™
1‑800‑651‑3861
U.S. Food and Drug Administration
1‑800‑FDA‑1088
Before administering, please see the Full Prescribing Information for XERAVA.