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Adverse event reporting can be found at the bottom of the page
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Please find EMBLAVEO® (aztreonam-avibactam) Prescribing Information and Adverse Event reporting here
EMBLAVEO® is a combination of aztreonam and avibactam (ATM-AVI) active against most Enterobacterales* that may co-produce serine β-lactamases and MBLs as well as Stenotrophomonas maltophilia.1-4
Complicated intra-abdominal infection (cIAI)
Hospital-acquired pneumonia (HAP), including ventilator-associated pneumonia (VAP)
Complicated urinary tract infection (cUTi), including pyelonephritis
[image to be addded] EMBLAVEO® is also indicated for the treatment of infections due to aerobic Gram-negative organisms in adult patients with limited treatment options
EMBLAVEO® is also indicated for the treatment of infections due to aerobic Gram-negative organisms in adult patients with limited treatment options
Consideration should be given to official guidance on the appropriate use of antibacterial agents.
It is recommended that EMBLAVEO® should be used to treat infections due to aerobic Gram-negative organisms in adult patients with limited treatment options only after consultation with a physician with appropriate experience in the management of infectious diseases.
High in vitro activity against MBL-producting isolates of Enterobacterales and S. maltophilia1,6-10
Optimised dosing to achieve joint PTA above 90%1,11
Data supports the use of EMBLAVEO® against MDR Gram-negative pathogens, including MBL-producing Enterobacterales and S. maltophilia1,9,12-14
Generally well tolerated1,9,12-15
Footnotes:
*Aerobic Gram-negative organisms with in vitro susceptibility to Emblaveo: Citrobacter freundii complex, Citrobacter koseri, Escherichia coli, Enterobacter cloacae complex, Klebsiella aerogenes, Klebsiella pneumoniae, Klebsiella oxytoca, Morganella morganii, Proteus mirabilis, Proteus vulgaris, Providencia rettgeri, Providencia stuartii, Raoultella ornithinolytica, Serratia spp., Serratia marcescens.1
Abbreviations:
ATM, aztreonam; AVI, avibactam; cIAI, complicated intra-abdominal infection; cUTI, complicated urinary tract Infection; HAP, hospital-acquired pneumonia; MBL, metallo-β-lactamase; MDR, multi-drug resistant; PD, pharmacodynamics; PK, pharmacokinetics; PTA, probability of target attainment; S. maltophilia, Stenotrophomonas maltophilia; VAP, ventilator-associated pneumonia.
References:
1. EMBLAVEO® (aztreonam/avibactam). Summary of Product Characteristics. Pfizer.
2. Karlowsky JA, et al. Antimicrob Agents Chemother. 2017;61(9):e00472-17.
3. Rossolini GM, et al. J Glob Antimicrob Resist. 2022;30:214-221.
4. Biedenbach DJ, et al. Antimicrob Agents Chemother. 2015;59(7):4239-48.
5. EMBLAVEO® (aztreonam/avibactam). European Medicines Agency. EMA. Union Register of medicinal products - Public health - European Commission (europa.eu). Available at: https://www.ema.europa.eu/en/medicines. Last accessed January, 2025.
6. Sader HS, et al. JAC Antimicrob Resist. 2023;5(2):dlad032.
7. Rossolini GM, et al. J Glob Antimicrob Resist. 2024;36:123-131.
8. Antimicrobial Testing Leadership and Surveillance program (ATLAS) surveillance program 2012-2022. Available at: https://atlas-surveillance.com/#/login. Last accessed January, 2025.
9. Biagi M, et al. Antimicrob Agents Chemother. 2020;64(12):e00297-20.
10. Wise MG, et al. Eur J Clin Microbiol Infect Dis. 2023;42(9):1135-1143.
11. Das S, et al. Eur J Clin Pharmacol. 2024;80(4):529-543.
12. Cornely OA, et al. J Antimicrob Chemother. 2020;75:618–27.
13. Carmeli Y et al. Lancet Infect Dis. 2024 Oct 7:S1473-3099(24)00499-7
14. EMBLAVEO® (aztreonam-avibactam) Risk management plan. Available at: https://www.ema.europa.
eu/en/documents/rmp/emblaveo-epar-risk-management-plan_en.pdf. Last accessed January, 2025
15. European Medicines Agency. EMA. Last Updated March 2024. Last Accessed January 2025.
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Adverse events should also be reported to Pfizer Medical Information on 01304 616161
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