Avibactam

EMBLAVEO is an antibacterial drug [see Microbiology ( 12.4 )] .

• EMBLAVEO is a combination of aztreonam, a monobactam antibacterial, and avibactam, a beta-lactamase inhibitor, that when used in combination with metronidazole, is indicated in patients 18 years and older who have limited or no alternative 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.

• EMBLAVEO is contraindicated in patients with known hypersensitivity to the components of EMBLAVEO (aztreonam and avibactam) [see Warnings and Precautions ( 5.1 )] . Known hypersensitivity to the components of EMBLAVEO (aztreonam and avibactam).contraindicated

Recommended Dosage in Adults based on Estimated Creatinine Clearance (C Lcr ) ( 2.1 , 2.2 ) Estimated C Lcr (mL/min) a Dose b Infusion Time Dosing Interval c Loading Maintenance Greater than 50 mL/min EMBLAVEO 2.67 g (aztreonam 2 grams and avibactam 0.67 grams) EMBLAVEO 2 g (aztreonam 1.5 grams and avibactam 0.5 grams) 3 hours Every 6 hours Greater than 30 to less than or equal to 50 mL/min EMBLAVEO 2.67 g (aztreonam 2 grams and avibactam 0.67 grams) EMBLAVEO 1 g (aztreonam 0.75 grams and avibactam 0.25 grams) 3 hours Every 6 hours Greater than 15 to less than or equal to 30 mL/min EMBLAVEO 1.8 g (aztreonam 1.35 grams and avibactam 0.45 grams) EMBLAVEO 0.9 g (aztreonam 0.675 grams and avibactam 0.225 grams) 3 hours Every 8 hours Less than or equal to 15 mL/min, including on hemodialysis d EMBLAVEO 1.33 g (aztreonam 1 gram and avibactam 0.33 grams) EMBLAVEO 0.9 g (aztreonam 0.675 grams and avibactam 0.225 grams) 3 hours Every 12 hours a Calculated using the Cockcroft-Gault formula. b Aztreonam-avibactam is a combination product in a fixed 3:1 ratio. A single loading dose is followed by maintenance doses beginning at the next dosing interval. c Dosing interval is calculated from the start of one infusion to the start of the subsequent infusion. d Both aztreonam and avibactam are removed by hemodialysis; thus, administer EMBLAVEO after hemodialysis, on hemodialysis days. For treatment of cIAI, administer metronidazole concurrently. ( 2.1 , 2.2 ) Recommended duration of treatment for cIAI: 5 to 14 days.

Hypersensitivity Reactions : Hypersensitivity reactions were noted in patients treated with EMBLAVEO including rash, flushing, and bronchospasm. In case of hypersensitivity reactions, immediately discontinue EMBLAVEO and initiate appropriate medications and/or supportive care. ( 5.1 ) 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. Discontinue EMBLAVEO if serious skin reaction occurs. ( 5.2 ) Hepatic Adverse Reactions: Elevations in hepatic transaminases have been observed during treatment with EMBLAVEO. If transaminase elevations are noted, consider discontinuation of EMBLAVEO, if clinically indicated, and monitor the patient for resolution of any pertinent clinical and laboratory findings. ( 5.3 ) Clostridioides Difficile -Associated Diarrhea (CDAD): CDAD has been reported with nearly all systemic antibacterial agents, including EMBLAVEO. Evaluate if diarrhea occurs. ( 5.4 ) 5. 1 Hypersensitivity Reactions Hypersensitivity reactions were noted in patients treated with EMBLAVEO, including rash, flushing, and bronchospasm [see Adverse Reactions ( 6.1 )]. 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. 5.

The following adverse reactions are discussed in greater detail in the Warnings and Precautions section: Hypersensitivity Reactions [see Warnings and Precautions ( 5.1 )] Serious Skin Disorders [see Warnings and Precautions ( 5.2 )] Hepatic Adverse Reactions [see Warnings and Precautions ( 5.3 )] Clostridioides Difficile -Associated Diarrhea [see Warnings and Precautions ( 5.4 )] The most common adverse reactions occurring at an incidence of greater than 5% were hepatic adverse reactions, anemia, diarrhea, hypokalemia, and pyrexia. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact AbbVie Inc. at 1-800-633-9110 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Clinical Trials Experience in Adult Patients Three clinical trials, Trial 1, Trial 2, and Trial 3, underly the EMBLAVEO clinical development program. Trial 1 was a randomized, comparative trial conducted in patients with cIAI and hospital-acquired bacterial pneumonia/ventilator-associated bacterial pneumonia (HABP/VABP) (not an approved indication for EMBLAVEO), while Trials 2 and 3 were smaller, noncomparative trials conducted in patients with cIAI as well as other serious infections caused by gram negative pathogens expressing metallo-beta-lactamases. The safety data from Trial 1 are summarized below.

8.1 Pregnancy Risk Summary There are no data on the effects of EMBLAVEO use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes. Available data from case reports over several decades with aztreonam and over approximately a decade with avibactam have not identified a drug-associated risk of major birth defects, miscarriage or other maternal or fetal outcomes. Aztreonam Developmental toxicity studies in pregnant rats and rabbits with daily doses of aztreonam revealed no evidence of embryotoxicity, fetotoxicity, or fetal malformations at doses 2.7- and 3.6-fold greater, respectively, than the maximum recommended human dose (MRHD) for adults of 6.5 g per day. In a peri/postnatal development (PPND) study in rats, no aztreonam-induced changes in any maternal, fetal, or neonatal parameters were observed at a dose 2.7-fold greater than the MRHD. Avibactam Avibactam administered to pregnant rats was not associated with fetal malformations at doses 6 times the MRHD of 2.17 g per day. In pregnant rabbits, avibactam administered in doses greater than or equal to 5 times the MRHD was associated with increased post-implantation loss, lower mean fetal weights, delayed ossification of several bones and other anomalies.

Metabolism

Following single or multiple dosing, the C max and AUC of both aztreonam and avibactam (components of EMBLAVEO) increase in an approximate dose-proportional manner over a dose range of 500 mg to 2000 mg aztreonam (0.25 to 1 times the approved maximum recommended loading dose) and of 50 mg to 2000 mg avibactam (0.07 to 3 times the approved maximum recommended loading dose). Aztreonam and avibactam (components of EMBLAVEO) pharmacokinetic properties are summarized in Table 6.

There is no information on the clinical signs and symptoms associated with an overdose of EMBLAVEO. Aztreonam and avibactam can be partially removed by hemodialysis [see Clinical Pharmacology ( 12.3 )] . No clinical information is available on the use of hemodialysis to treat EMBLAVEO overdosage.

• Feb 25, 2015NDANDA206494Abbvie
• Feb 7, 2025NDANDA217906Abbvie

1. 1Off Label Use3220%
2. 2Drug Resistance117.0%
3. 3Product Storage Error117.0%
4. 4Respiratory Failure85.1%
5. 5Acute Kidney Injury74.4%
6. 6Mental Status Changes74.4%
7. 7Pyrexia74.4%
8. 8Death63.8%
9. 9Dyspnoea63.8%
10. 10Headache63.8%
11. 11Hypotension63.8%
12. 12Nausea63.8%
13. 13Drug Ineffective53.2%
14. 14Pneumonia53.2%
15. 15Abdominal Pain42.5%

The 10 most recently updated of 85 ClinicalTrials.gov registrations naming Avibactam as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• PK/PD Relationship of CAZ/AVI and FOS in the Treatment of Patients With Infections Due to CRE
  Recruiting · Observational · 60 enrolled · IRCCS Azienda Ospedaliero-Universitaria di Bologna
  NCT06717594updated 2026-06-12
• A Study to Learn About the Study Medicine Aztreonam-Avibactam (ATM-AVI) in Infants and Newborns Admitted in Hospitals With Bacterial Infection (CHERISH)
  Recruiting · Phase 2 · Interventional · 48 enrolled · Pfizer
  NCT06462235updated 2026-06-11
• Study of 2 Medicines (Aztreonam and Avibactam) Compared to Best Available Therapy for Serious Gram-negative Infections
  Recruiting · Phase 2 · Interventional · 48 enrolled · Pfizer
  NCT05639647updated 2026-06-11
• A Clinical Study of YK-1169 Versus Ceftazidime-Avibactam in Adults With Hospital-Acquired or Ventilator-Associated Bacterial Pneumonia
  Not yet recruiting · Phase 3 · Interventional · 590 enrolled · Nanjing Yoko Biomedical Co., Ltd.
  NCT07634198updated 2026-06-08
• A Study to Learn About the Study Medicine - Zavicefta in Patients With Sepsis or Loss of Kidney Function in Japan
  Not yet recruiting · Observational · 59 enrolled · Pfizer
  NCT06864585updated 2026-04-20
• Individualized Precision Therapy With Ceftazidime and Avibactam Guided by PK/PD in Geriatric Populations
  Not yet recruiting · Observational · 150 enrolled · Chinese PLA General Hospital
  NCT07494981updated 2026-03-27
• Real-World Effectiveness of Aztreonam-Avibactam Against MBL-Producing CRE
  Recruiting · Observational · 100 enrolled · Sir Run Run Shaw Hospital
  NCT07268560updated 2026-03-23
• Different Administration Regimens of CAZ-AVI in Combination With ATM for the Treatment of CR-GNB
  Recruiting · Phase 4 · Interventional · 144 enrolled · Jing Zhou
  NCT07478484updated 2026-03-17
• Safety, Pharmacokinetics and Efficacy of BV100 Plus Low Dose Polymyxin B Plus Ceftazidime/Avibactam, or Plus Cefiderocol in Patients With Pulmonary and Extrapulmonary Infections Due to Carbapenem-resistant Acinetobacter Baumannii-calcoaceticus Complex
  Not yet recruiting · Phase 2 · Interventional · 120 enrolled · BioVersys AG
  NCT07431307updated 2026-02-24
• A Study to Evaluate the Efficacy and Safety of Meropenem and Pralurbactam in HABP/VABP
  Recruiting · Phase 3 · Interventional · 420 enrolled · Qilu Pharmaceutical Co., Ltd.
  NCT07327619updated 2026-02-17

Frequently asked questions

How does Avibactam work?

EMBLAVEO is an antibacterial drug [see Microbiology ( 12.4 )] .

What is Avibactam used for?

According to FDA labeling, Avibactam carries indications including: EMBLAVEO is a combination of aztreonam, a monobactam antibacterial, and avibactam, a beta-lactamase inhibitor, that when used in combination with metronidazole, is indicated in patients 18 years and older who have limited or no alternative 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.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Avibactam?

Avibactam is classified as beta Lactamase Inhibitor, beta Lactamase Inhibitors.

What are the brand names for Avibactam?

Avibactam is marketed under brand names including Avycaz, Emblaveo.

What are the contraindications for Avibactam?

Avibactam labeling lists contraindications including: EMBLAVEO is contraindicated in patients with known hypersensitivity to the components of EMBLAVEO (aztreonam and avibactam) [see Warnings and Precautions ( 5.1 )] . Known hypersensitivity to the components of EMBLAVEO (aztreonam and avibactam).. Always consult the full prescribing information and a clinician.