DOSING AND ADMINISTRATION

Recommended dosing for EMBLAVEO^™ in adults with estimated CLcr greater than 50 mL/min¹

AFTER AN INITIAL LOADING DOSE, EMBLAVEO IS DOSED EVERY 6 HOURS FOR 5 TO 14 DAYS

2.67 g

Aztreonam 2 g Avibactam 0.67 g

2 g

Aztreonam 1.5 g Avibactam 0.5 g

INFUSION TIME: 3 HOURS

INTERVAL: EVERY 6 HOURS

DAILY TOTALS (DAY 2 ONWARD):

AZTREONAM: 6 g AVIBACTAM: 2 g

*For patients with CLcr ≤50 mL/min, see table below for dose adjustments.

EMBLAVEO dosing was supported by pharmacokinetic/pharmacodynamic modeling and simulations²
Metronidazole should be given concurrently¹

A single loading dose is followed by maintenance doses beginning at the next dosing interval.

DOSE ADJUSTMENTS

EMBLAVEO dosing should be adjusted based on the patient’s estimated creatinine clearance¹

ESTIMATED CLcr^†

^†Calculated using the Cockcroft–Gault formula.

^‡Aztreonam-avibactam is a combination product in a fixed 3:1 ratio.

^§Dosing interval is calculated from the start of one infusion to the start of the subsequent infusion.

^¶Both aztreonam and avibactam are removed by hemodialysis; EMBLAVEO should be administered after the hemodialysis session on hemodialysis days.

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References: 1.  EMBLAVEO. Prescribing Information. AbbVie, Inc; 2025. 2. Xie R, Rogers H, Chow JW, Soto E, Raber SR. Antimicrob Agents Chemother. 2025;e0195024. doi:10.1128/aac.01950-24

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EXPLORE MICROBIOLOGY

ORDER EMBLAVEO

INDICATIONS AND USAGE

Complicated Intra-abdominal Infections

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.

Usage to Reduce Development of Drug-Resistant Bacteria

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.

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

EMBLAVEO is contraindicated in patients with known hypersensitivity to the components of EMBLAVEO (aztreonam and avibactam).

WARNINGS AND PRECAUTIONS

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.

ADVERSE REACTIONS

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

INDICATIONS AND USAGE

Complicated Intra-abdominal Infections

EMBLAVEO, in combination with metronidazole, is indicated in adult patients with limited or no alternative treatment options for the treatment of cIAI caused by the designated susceptible gram-negative microorganisms as described below.

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

EMBLAVEO is contraindicated in patients with known hypersensitivity to the components of EMBLAVEO (aztreonam and avibactam).

INDICATIONS AND USAGE

Complicated Intra-abdominal Infections

EMBLAVEO, in combination with metronidazole, is indicated in adult patients with limited or no alternative treatment options for the treatment of cIAI caused by the designated susceptible gram-negative microorganisms as described below.

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

EMBLAVEO is contraindicated in patients with known hypersensitivity to the components of EMBLAVEO (aztreonam and avibactam).

INDICATIONS AND USAGE

Complicated Intra-abdominal Infections

EMBLAVEO, in combination with metronidazole, is indicated in adult patients with limited or no alternative treatment options for the treatment of cIAI caused by the designated susceptible gram-negative microorganisms as described below.

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

EMBLAVEO is contraindicated in patients with known hypersensitivity to the components of EMBLAVEO (aztreonam and avibactam).

INDICATIONS AND USAGE

Complicated Intra-abdominal Infections

EMBLAVEO, in combination with metronidazole, is indicated in adult patients with limited or no alternative treatment options for the treatment of cIAI caused by the designated susceptible gram-negative microorganisms as described below.

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

EMBLAVEO is contraindicated in patients with known hypersensitivity to the components of EMBLAVEO (aztreonam and avibactam).

INDICATIONS AND USAGE

Complicated Intra-abdominal Infections

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.

Usage to Reduce Development of Drug-Resistant Bacteria

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.

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

EMBLAVEO is contraindicated in patients with known hypersensitivity to the components of EMBLAVEO (aztreonam and avibactam).

WARNINGS AND PRECAUTIONS

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.

ADVERSE REACTIONS

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