AVYCAZ

AVYCAZ- ceftazidime and avibactam sodium powder, for solution
Allergan, Inc.

1 INDICATIONS AND USAGE

1. 1 Complicated Intra- a bdominal Infections (cIAI)

AVYCAZ (ceftazidime and avibactam) in combination with metronidazole, is indicated for the treatment of complicated intra-abdominal infections (cIAI) in adult and pediatric patients (at least 31 weeks gestational age) caused by the following susceptible gram-negative microorganisms: Escherichia coli , Klebsiella pneumoniae , Proteus mirabilis, Enterobacter cloacae, Klebsiella oxytoca, Citrobacter freundii complex, and Pseudomonas aeruginosa .

1. 2 Complicated Urinary Tract Infections (cUTI), including Pyelonephritis

AVYCAZ (ceftazidime and avibactam) is indicated for the treatment of complicated urinary tract infections (cUTI) including pyelonephritis in adult and pediatric patients (at least 31 weeks gestational age) caused by the following susceptible gram-negative microorganisms: Escherichia coli , Klebsiella pneumoniae, Enterobacter cloacae, Citrobacter freundii complex, Proteus mirabilis , and Pseudomonas aeruginosa .

1.3 Hospital-acquired Bacterial Pneumonia and Ventilator-associated Bacterial Pneumonia (HABP/VABP)

AVYCAZ (ceftazidime and avibactam) is indicated for the treatment of hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP) in adult and pediatric patients (at least 31 weeks gestational age) caused by the following susceptible gram-negative microorganisms: Klebsiella pneumoniae, Enterobacter cloacae, Escherichia coli, Serratia marcescens, Proteus mirabilis, Pseudomonas aeruginosa, and Haemophilus influenzae.

1. 4 Usage

To reduce the development of drug-resistant bacteria and maintain the effectiveness of AVYCAZ and other antibacterial drugs, AVYCAZ should be used only to treat or prevent 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.

2 DOSAGE AND ADMINISTRATION

2.1 Recommended Dosage in Adult Patients

The recommended dosage of AVYCAZ is 2.5 grams (ceftazidime 2 grams and avibactam 0.5 grams) administered every 8 hours by intravenous (IV) infusion over 2 hours in patients 18 years of age and older with CrCl greater than 50 mL/min. For treatment of cIAI, metronidazole should be given concurrently. The guidelines for dosage of AVYCAZ in patients with creatinine clearance (CrCl) greater than 50 mL/min are listed in Table 1.

Table 1. Dosage of AVYCAZ 2.5 grams (ceftazidime 2 grams and avibactam 0.5 grams) by Indication in Adult Patients (18 years of age and older)
Infection Dos e Frequency Infusion Time (hours) Duration of Treatment
Complicated Intra-abdominalInfections (cIAI)* 2.5 grams Every 8 hours 2 cIAI: 5 to 14 dayscUTI: 7 to 14 daysHABP/VABP: 7 to 14 days
Complicated Urinary TractInfections including Pyelonephritis (cUTI)
Hospital-acquired BacterialPneumonia and Ventilator-associatedBacterial Pneumonia (HABP/VABP)
* Used in conjunction with metronidazole 0.5 g intravenously every 8 hours in adult cIAI patients [see Clinical Studies ( 14.1)].

2.2 Recommended Dosage in Pediatric Patients

The recommended dosage of AVYCAZ in pediatric patients aged 2 years to less than 18 years and an estimated glomerular filtration rate (eGFR) greater than 50 mL/min/1.73 m2 and in pediatric patients less than 2 years of age without renal impairment is described in Table 2. AVYCAZ is administered every 8 hours by intravenous infusion over 2 hours. For treatment of cIAI, metronidazole should be given concurrently.

Table 2. Dosage of AVYCAZ (ceftazidime and avibactam) in Pediatric Patients
Infection Age Range Dose Frequency Infusion Time (hours) Duration of treatment
cIAI*, cUTI including Pyelonephritis, and HABP/VABP 2 years to less than 18 yearsa AVYCAZ 62.5 mg/kg to a maximum of 2.5 grams (ceftazidime 50 mg/kg and avibactam 12.5 mg/kg to a maximum dose of ceftazidime 2 grams and avibactam 0.5 grams) Every 8 hours 2 cIAI: 5 to 14 dayscUTI: 7 to 14 days HABP/VABP: 7 to 14 days
6 months to less than 2 years AVYCAZ 62.5 mg/kg (ceftazidime 50 mg/kg and avibactam 12.5 mg/kg)
3 months to less than 6 months AVYCAZ 50 mg/kg (ceftazidime 40 mg/kg and avibactam 10 mg/kg)
Greater than 28 daysb to less than 3 months AVYCAZ 37.5 mg/kg (ceftazidime 30 mg/kg and avibactam 7.5 mg/kg)
Less than or equal to 28 daysc with GA 31 weeks and older AVYCAZ 25 mg/kg (ceftazidime 20 mg/kg and avibactam 5 mg/kg)
*AVYCAZ was used in conjunction with metronidazole 10 mg/kg intravenously every 8 hours in pediatric cIAI patients [see Clinical Studies ( 14.1) ] a For pediatric patients (aged 2 years and older) with eGFR less than or equal to 50 mL/min/1.73m2 ,dosage adjustments are recommended [ s ee Dosage and Administration ( 2.3)]. b Includes full-term infants with PNA > 28 days and pre-term infants with corrected age > 28 days. Corrected age is calculated by subtracting the number of weeks born before 40 weeks of gestation from the postnatal age.c Includes neonates PNA ≤ 28 days and pre-term infants with corrected age ≤ 28 days. GA = gestational age and PNA = postnatal age.

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