KPC, ESBL
CLASS A
EMBLAVEO™ demonstrated
in vitro activity against
all 4 classes of
β-lactamases1,2
KPC, ESBL
CLASS A
NDM, IMP, VIM
CLASS B
AmpC
CLASS C
OXA-48–LIKE
CLASS D
CRE, carbapenem-resistant Enterobacterales; ESBL, extended-
spectrum β-lactamase; IMP, imipenemase; KPC, Klebsiella pneumoniae
carbapenemase; MBL, metallo-β-lactamase; NDM, New Delhi metallo-
β-lactamase; OXA, oxacillinase; VIM, Verona integron-encoded metallo-
β-lactamase.
CRE, carbapenem-resistant Enterobacterales; ESBL, extended-spectrum β-lactamase; IMP, imipenemase; KPC, Klebsiella pneumoniae carbapenemase; MBL, metallo-β-lactamase; NDM, New Delhi metallo-β-lactamase; OXA, oxacillinase; VIM, Verona integron-encoded metallo-β-lactamase.
In vitro activity against all
4 classes of β-lactamases1,2
In vitro data are derived from susceptibility testing of clinical isolates, including those producing MBL, collected from multiple infectious sources across 62 US medical centers from 2017 to 2022.2,3
In vitro activity does not necessarily correlate with clinical efficacy results.
Percentage of isolates susceptible2,3
Percentage of isolates susceptible2,3
column one | EMBLAVEO | Cefiderocol | Ceftazidime- avibactam | Meropenem- vaborbactam | Imipenem- relebactam | Amikacin | Tigecycline | Colistin |
---|---|---|---|---|---|---|---|---|
Enterobacterales* (N=54,576) |
99.9% | - | 99.9% | 99.8% | 92.4% | 99.5% | 94.9% | - |
All CRE (N=511) |
98.4% | 94.7% | 89.2% | 86.7% | 81.6% | 61.4% | 94.7% | 84.7% |
MBL (N=50) |
98.0% | 74.0% | 4.0% | 16.0% | 2.0% | 50.0% | 92.0% | 86.0% |
Carbapenemase negative (N=90) |
94.5% | 88.9% | 96.7% | 88.9% | 90.0% | 85.6% | 90.0% | 91.1% |
Serine carbapenemase (N=359) |
99.4% | 98.9% | 98.9% | 98.3% | 92.8% | 58.2% | 96.7% | 82.6% |
OXA-48–like (N=12) |
100% | 100% | 100% | 16.7% | 16.7% | 25.0% | 83.3% | 91.7% |
Study design
Data from a US surveillance study that assessed the in vitro activity of EMBLAVEO and comparator agents against gram-negative isolates collected over 6 years (2017-2022) from 62 medical centers. A total of 54,576 Enterobacterales strains were collected and tested, including 511 CRE.2
Gram-negative isolates were collected from hospitalized patients with pneumonia and patients with bloodstream infections, urinary tract infections, skin and soft tissue infections, intra-abdominal infections, and other infections and were tested centrally (JMI Laboratories, North Liberty, IA, USA). MICs were determined by standard Clinical and Laboratory Standards Institute (CLSI) microbroth dilution methods.3
In vitro data only. Some products are indicated for different pathogens and different indications. This information should not be used to make efficacy or safety comparisons between or among mentioned products. Please note that these products are not interchangeable.
Data for Enterobacterales (N=54,576) isolates represent in vitro susceptibility patterns reported in the International Network for Optimal Resistance Monitoring (INFORM) consolidated program collected from 62 medical centers in the United States from the years 2017 to 2022.3
*For key agents listed above, the numbers of Enterobacterales isolates tested were as follows: amikacin (54,573), tigecycline (54,562), colistin (54,266), meropenem-vaborbactam (32,358), imipenem-relebactam (13,605), and cefiderocol (511).3
Percent susceptible was interpreted according to CLSI M100—Performance Standards for Antimicrobial Susceptibility Testing, 32nd Edition, and/or US Food and Drug Administration (FDA)–recognized susceptibility testing interpretive criteria as applicable for each therapy shown above. Percent intermediate is reported for colistin in the absence of a susceptible breakpoint. Percent susceptible for EMBLAVEO is based on the US Food and Drug Administration (FDA)–recognized susceptible breakpoint of ≤4 mg/L.1-3
The addition of avibactam helps restore the activity of aztreonam
In vitro activity against certain CRE†
In vitro activity does not necessarily correlate with clinical efficacy results.
Data are based on 511 CRE isolates, a subset of 54,576 Enterobacterales isolates collected between 2017 and 2022 from 62 medical centers located in all 9 US Census Divisions.2,3
98.4% of CRE isolates were
inhibited by EMBLAVEO using
a susceptible breakpoint of
≤4 mg/L3
In vitro activity
demonstrated against
MBL-producing
Enterobacterales4
A study based on the Antimicrobial Testing Leadership Surveillance (ATLAS) database evaluated the in vitro activity of aztreonam-avibactam and comparator agents against 106,686 Enterobacterales isolates from 1117 sites across 63 countries between 2016 and 2020.
In vitro activity does not necessarily correlate with clinical efficacy results.
98.4%
98.4% of MBL-producing Enterobacterales tested globally were susceptible to EMBLAVEO
EMBLAVEO IN VITRO ACTIVITY
AGAINST CERTAIN MBL-PRODUCING
ENTEROBACTERALES ISOLATES
(N=1707)4
98.4%
98.1%
100.0%
100.0%
100.0%
99.4%
Of the 1707 MBL-producing Enterobacterales, 723 were collected in 2020. In this subset, the addition of avibactam improved the MIC90 of aztreonam from ≥128 mg/L to 2 mg/L8
The FDA-recognized susceptible breakpoint of ≤4 mg/L was used for susceptibility of aztreonam-avibactam.6
The efficacy of EMBLAVEO in treating clinical infections caused by Stenotrophomonas maltophilia has not been established in adequate and well-controlled clinical trials. No antimicrobial susceptibility testing interpretive criteria have been established for EMBLAVEO and S maltophilia.
With EMBLAVEO, in vitro activity has also been described against S maltophilia
Data are based on an in vitro study of S maltophilia isolates (N=47) that were not susceptible to levofloxacin and/or trimethoprim-sulfamethoxazole, collected worldwide between 2008 and 2018 through the SENTRY Antimicrobial Surveillance Program7
S maltophilia is intrinsically resistant to most β-lactam antibiotics, including carbapenems8-10
In vitro activity does not necessarily correlate with clinical efficacy results.
THE ADDITION OF AVIBACTAM IMPROVED THE MIC90 OF AZTREONAM FROM ≥256 MG/L TO 4 MG/L7
References: 1. EMBLAVEO. Prescribing information. AbbVie, Inc; 2025. 2. Castanheira M, Maher JM, Simpson K, Hubler C, Sader HS. Poster presented at: Infectious Disease Week 2023; October 11-15, 2023; Boston, MA. 3. Papp-Wallace KM, Sader HS, Maher JM, Kimbrough JH, Castanheira M. Open Forum Infect Dis. 2025;12(5):ofaf250. doi:10.1093/ofid/ofaf250 4. Rossolini GM, Arhin FF, Kantecki M. J Glob Antimicrob Resist. 2024;36:123-131. doi:10.1016/j.jgar.2023.12.027 5. Data on file. Pfizer, Inc. 6. Aztreonam and avibactam injection. US Food & Drug Administration. Updated February 7, 2025. https://www.fda.gov/drugs/development-resources/aztreonam-and-avibactam-injection 7. Biagi M, Lamm D, Meyer K, et al. Antimicrob Agents Chemother. 2020;64(12):e00297-20. doi:10.1128/AAC.00297-20 8. Mojica MF, Humphries R, Lipuma JJ, et al. JAC Antimicrob Resist. 2022;4(3):dlac040. doi:10.1093/jacamr/dlac040 9. Cai B, Tillotson G, Benjumea D, Callahan P, Echols R. Open Forum Infect Dis. 2020;7(5):ofaa141. doi:10.1093/ofid/ofaa141 10. Rhoads DD. J Clin Microbiol. 2021;59(9):e0109421. doi:10.1128/JCM.01094-21
EMBLAVEO, in combination with metronidazole, is indicated in patients 18 years and older who have limited or no alternative treatment options for the treatment of complicated intra-abdominal infections (cIAI) including those caused by the following susceptible gram-negative microorganisms: Escherichia coli, Klebsiella pneumoniae, Klebsiella oxytoca, Enterobacter cloacae complex, Citrobacter freundii complex, and Serratia marcescens. Approval of this indication is based on limited clinical safety and efficacy data for EMBLAVEO.
To reduce the development of drug-resistant bacteria and maintain the effectiveness of EMBLAVEO and other antibacterial drugs, EMBLAVEO should be used only to treat 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.
EMBLAVEO is contraindicated in patients with known hypersensitivity to the components of EMBLAVEO (aztreonam and avibactam).
Hypersensitivity Reactions
Hypersensitivity reactions were noted in patients treated with EMBLAVEO, including rash, flushing, and bronchospasm. Prior to treatment, it should be established if the patient has a history of hypersensitivity reactions to components of EMBLAVEO (aztreonam and avibactam). In case of hypersensitivity reactions, immediately discontinue EMBLAVEO and initiate appropriate medications and/or supportive care.
Serious Skin Disorders
Cases of toxic epidermal necrolysis have been reported in association with aztreonam (a component of EMBLAVEO) in patients undergoing bone marrow transplant with multiple risk factors including sepsis, radiation therapy, and other concomitantly administered drugs associated with toxic epidermal necrolysis. Discontinue EMBLAVEO if a serious skin reaction occurs.
Hepatic Adverse Reactions
Elevations in hepatic transaminases have been observed during treatment with EMBLAVEO. Monitoring of liver-related laboratory tests is recommended while on treatment, particularly in patients with baseline liver comorbidities or on concomitant hepatotoxic medications. If transaminase elevations are noted, consider discontinuing EMBLAVEO, if clinically indicated, and monitor the patient for resolution of any pertinent clinical and laboratory findings.
Clostridioides Difficile-Associated Diarrhea
Clostridioides difficile-associated diarrhea (CDAD) has been reported for nearly all systemic antibacterial drugs, including EMBLAVEO, and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial drugs alters the normal flora of the colon and may permit overgrowth of C. difficile. C. difficile produces toxins A and B which contribute to the development of CDAD. Hypertoxin producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea following antibacterial use. Careful medical history is necessary because CDAD has been reported to occur more than 2 months after the administration of antibacterial drugs. If CDAD is suspected or confirmed, antibacterial drugs not directed against C. difficile may need to be discontinued. Manage fluid and electrolyte levels as appropriate, supplement protein intake, monitor antibacterial treatment of C. difficile, and institute surgical evaluation as clinically indicated.
Development of Drug-Resistant Bacteria
Prescribing EMBLAVEO in the absence of a proven or strongly suspected bacterial infection is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria.
The most common adverse reactions occurring at an incidence of greater than 5% were hepatic adverse reactions, anemia, diarrhea, hypokalemia, and pyrexia.
Please see full Prescribing Information.
US-EMB-250040