INDICATIONS AND USAGE
Complicated Intra-Abdominal Infections (cIAI)
AVYCAZ® (ceftazidime and avibactam), in combination with metronidazole, is indicated for the treatment of complicated intra-abdominal infections (cIAI)
caused by the following susceptible Gram-negative microorganisms:
Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis,
Enterobacter cloacae, Klebsiella oxytoca, Citrobacter freundii
complex, and Pseudomonas aeruginosa in patients 18 years or older.
Complicated Urinary Tract Infections (cUTI), including Pyelonephritis
AVYCAZ is indicated for the treatment of complicated urinary tract infections (cUTI)
including pyelonephritis caused by the following susceptible Gram-negative microorganisms:
Escherichia coli, Klebsiella pneumoniae, Enterobacter cloacae, Citrobacter freundii
Proteus mirabilis, and Pseudomonas aeruginosa in patients 18 years or older.
To reduce the development of drug-resistant bacteria and maintain the effectiveness of AVYCAZ and other antibacterial
drugs, AVYCAZ should be used to treat only indicated infections that are proven or strongly suspected to be caused by
IMPORTANT SAFETY INFORMATION
AVYCAZ is contraindicated in patients with known serious hypersensitivity to the components of AVYCAZ (ceftazidime
and avibactam), avibactam-containing products, or other members of the cephalosporin class.
WARNINGS AND PRECAUTIONS
In a Phase 3 cIAI trial, clinical cure rates were lower in a subgroup of patients with baseline creatinine
clearance (CrCl) of 30 to less than or equal to 50 mL/min compared to those with CrCl greater than 50 mL/min.
The reduction in clinical cure rates was more marked in patients treated with AVYCAZ plus metronidazole compared
to meropenem-treated patients. Clinical cure rates in patients with normal renal function/mild renal impairment
(CrCl greater than 50 mL/min) was 85% (322/379) with AVYCAZ plus metronidazole vs 86% (321/373) with meropenem,
and clinical cure rates in patients with moderate renal impairment (CrCl 30 to less than or equal to 50 mL/min)
was 45% (14/31) with AVYCAZ plus metronidazole vs 74% (26/35) with meropenem. Within this subgroup, patients
treated with AVYCAZ received a 33% lower daily dose than is currently recommended for patients with CrCl of 30
to less than or equal to 50 mL/min. The decreased clinical response was not observed for patients with moderate
renal impairment at baseline (CrCl of 30 to less than or equal to 50 mL/min) in the Phase 3 cUTI trials. Monitor
CrCl at least daily in patients with changing renal function and adjust the dosage of AVYCAZ accordingly.
Serious and occasionally fatal hypersensitivity (anaphylactic) reactions and serious skin reactions have been
reported in patients receiving beta-lactam antibacterial drugs. Before therapy with AVYCAZ is instituted,
careful inquiry about previous hypersensitivity reactions to other cephalosporins, penicillins, or carbapenems
should be made. Exercise caution if this product is to be given to a penicillin or other beta-lactam-allergic
patient because cross sensitivity among beta-lactam antibacterial drugs has been established. Discontinue the
drug if an allergic reaction to AVYCAZ occurs.
Clostridium difficile-associated diarrhea (CDAD) has been reported for nearly all systemic antibacterial drugs,
including AVYCAZ, and may range in severity from mild diarrhea to fatal colitis. 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, antibacterials not directed against C. difficile should be discontinued, if possible.
Seizures, nonconvulsive status epilepticus (NCSE), encephalopathy, coma, asterixis, neuromuscular excitability, and
myoclonia have been reported in patients treated with ceftazidime, particularly in the setting of renal impairment.
Adjust dosing based on creatinine clearance.
Prescribing AVYCAZ 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 in cIAI patients (≥5% when used with metronidazole) were diarrhea (8%),
nausea (7%), and vomiting (5%). The most common adverse reactions in cUTI patients (3%) were diarrhea and nausea.
Please also see full Prescribing Information.