AVYCAZ

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

1 INDICATIONS AND USAGE

1.1 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 microorganisms: Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, Providencia stuartii, Enterobacter cloacae, Klebsiella oxytoca, and Pseudomonas aeruginosa in patients 18 years or older.

As only limited clinical safety and efficacy data for AVYCAZ are currently available, reserve AVYCAZ for use in patients who have limited or no alternative treatment options [see Clinical Studies (14) ].

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 caused by the following susceptible microorganisms: Escherichia coli, Klebsiella pneumoniae , Citrobacter koseri , Enterobacter aerogenes , Enterobacter cloacae , Citrobacter freundii , Proteus spp., and Pseudomonas aeruginosa in patients 18 years or older.

As only limited clinical safety and efficacy data for AVYCAZ are currently available, reserve AVYCAZ for use in patients who have limited or no alternative treatment options [see Clinical Studies (14) ].

1.3 Usage

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 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

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 in patients with normal renal function. 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
Infection Dosage Frequency Infusion Time(hours) Duration of Treatment
Complicated Intra-abdominal Infections [used in combination with metronidazole] 2.5 grams Every 8 hours 2 5 to14 days
Complicated Urinary Tract Infections including Pyelonephritis 2.5 grams Every 8 hours 2 7 to 14 days

2.2 Dosage Adjustments in Patients with Renal Impairment

The recommended AVYCAZ dosage in patients with varying degrees of renal function is presented in Table 2. For patients with changing renal function, monitor CrCl at least daily and adjust the dosage of AVYCAZ accordingly [see Warnings and Precautions (5.1), Use in Specific Populations (8.6) and Clinical Pharmacology (12.3)].

Table 2. Dosage of AVYCAZ in Patients with Renal Impairment

a As calculated using the Cockcroft-Gault formula.

b All doses of AVYCAZ are administered over 2 hours

c Both ceftazidime and avibactam are hemodialyzable; thus, administer AVYCAZ after hemodialysis on hemodialysis days.

Estimated Creatinine Clearance (mL/minute) a Recommended Dosage Regimen for AVYCAZ (ceftazidime and avibactam) b
31 to 50 AVYCAZ 1.25 grams (ceftazidime 1 gram and avibactam 0.25 grams) intravenously every 8 hours
16 to 30 AVYCAZ 0.94 grams (ceftazidime 0.75 grams and avibactam 0.19 grams) intravenously every 12 hours
6 to 15c AVYCAZ 0.94 grams (ceftazidime 0.75 grams and avibactam 0.19 grams) intravenously every 24 hours
Less than or equal to 5c AVYCAZ 0.94 grams (ceftazidime 0.75 grams and avibactam 0.19 grams) intravenously every 48 hours

2.3 Preparation of the AVYCAZ Solution for Administration

AVYCAZ is supplied as a dry powder, which must be constituted and subsequently diluted, using aseptic technique prior to intravenous infusion.

  1. Constitute the powder in the AVYCAZ vial with 10 mL of one of the following solutions:
    • sterile water for injection, USP
    • 0.9% of sodium chloride injection, USP (normal saline)
    • 5% of dextrose injection, USP
    • all combinations of dextrose injection and sodium chloride injection, USP, containing up to 2.5% dextrose, USP, and 0.45% sodium chloride, USP, or
    • lactated Ringer’s injection, USP
  2. Mix gently. The constituted AVYCAZ solution will have an approximate ceftazidime concentration of 0.167 grams/mL and an approximate avibactam concentration of 0.042 grams/mL. The final volume is approximately 12 mL. The constituted solution is not for direct injection. The constituted solution must be diluted before intravenous infusion.
  3. Prepare the required dose for intravenous infusion by withdrawing the appropriate volume determined from Table 3 from the constituted vial.
    Table 3. Preparation of AVYCAZ Doses
    AVYCAZ (ceftazidime and avibactam) Dose Volume to Withdraw from Constituted Vial for Further Dilution to 50 to 250 mL
    2.5 grams (2 grams and 0.5 grams) 12 mL (entire contents)
    1.25 grams (1 gram and 0.25 grams) 6 mL
    0.94 grams (0.75 grams and 0.19 grams) 4.5 mL
  4. Before infusion, dilute the withdrawn volume of the constituted AVYCAZ solution further with the same diluent used for constitution of the powder (except sterile water for injection), to achieve a total volume between 50 mL (ceftazidime 0.04 grams/mL and avibactam 0.01 grams/mL) to 250 mL (ceftazidime 0.008 grams/mL and avibactam 0.002 grams/mL) in an infusion bag. If sterile water for injection was used for constitution, use any of the other appropriate constitution diluents for dilution.
  5. Mix gently and ensure that the contents are dissolved completely. Visually inspect the diluted AVYCAZ solution (for administration) for particulate matter and discoloration prior to administration (the color of the AVYCAZ infusion solution for administration ranges from clear to light yellow).
  6. Use the diluted AVYCAZ solution in the infusion bags within 12 hours when stored at room temperature.
  7. The diluted AVYCAZ solution in the infusion bags may be stored under refrigeration at 2 to 8°C (36 to 46°F) up to 24 hours following dilution and used within 12 hours of subsequent storage at room temperature.

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