Emblaveo Dosage

2.1 Recommended Dosage in Adults with Estimated Creatinine Clearance Greater than 50 mL/min

Table 1 shows the recommended dosage to be administered by intravenous (IV) infusion over 3 hours in adults with estimated creatinine clearance (CLcr) greater than 50 mL/min.

2.2 Recommended Dosage in Adults with Estimated Creatinine Clearance Less than or Equal to 50 mL/min

Table 2 shows the recommended dosage to be administered by intravenous (IV) infusion over 3 hours in adults with estimated creatinine clearance (CLcr) less than or equal to 50 mL/min. In patients with renal impairment, close monitoring of estimated CLcr is advised. In some patients, the CLcr estimated from serum creatinine can change quickly, especially early in the course of treatment for the infection. For treatment of cIAI, administer metronidazole concurrently.

2.3 Preparation of EMBLAVEO Solution for Administration

EMBLAVEO is supplied as a lyophilized powder, which must be reconstituted and subsequently diluted, using aseptic technique prior to intravenous infusion. Prepare the reconstituted and diluted solutions of EMBLAVEO using the steps described below.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

a) Reconstitute the powder in the EMBLAVEO vial with 10 mL of Sterile Water for Injection.

b) Mix the reconstituted vial gently and ensure that the contents are dissolved completely.

• The reconstituted EMBLAVEO solution is not for direct injection. The reconstituted solution must be diluted before intravenous infusion.
  
• The reconstituted EMBLAVEO solution will have an approximate aztreonam concentration of 127 mg/mL and an approximate avibactam concentration of 42.3 mg/mL. The final volume is approximately 12 mL.

c) Prepare the required dose for intravenous infusion by withdrawing the appropriate volume determined from Table 3 from the reconstituted vial. Discard unused portion.

d) Before infusion, dilute the withdrawn volume of the reconstituted EMBLAVEO solution further to 50 mL to 250 mL in an infusion bag containing any of the following: 0.9 % sodium chloride for injection or 5% dextrose solution for injection or lactated Ringer’s injection, to achieve an aztreonam concentration of 2.7 mg/mL to 40 mg/mL and an avibactam concentration of 0.9 mg/mL to 13.3 mg/mL.

e) Mix gently and ensure that the contents are dissolved completely. Visually inspect the diluted EMBLAVEO solution for particulate matter and discoloration prior to administration (the color of the EMBLAVEO infusion solution for administration ranges from clear, colorless to yellow).

2.4 Drug Compatibility

The EMBLAVEO solution for administration is compatible with Sterile Water for Injection, for reconstitution and any of the following diluents for further dilution of the reconstituted solution:

• 0.9% Sodium chloride injection
  
• 5% Dextrose injection
  
• Lactated Ringer's injection

The compatibility of EMBLAVEO with other medicinal products has not been established. EMBLAVEO should not be mixed with or physically added to solutions containing other medicinal products.

2.5 Storage of Reconstituted and Diluted EMBLAVEO Solutions

Reconstituted Solution

Upon reconstitution with Sterile Water for Injection, the reconstituted EMBLAVEO solution may be held for up to 60 minutes at 30°C (86°F) under ambient light prior to transfer and dilution in a suitable infusion bag.

Diluted Reconstituted Solution

Following dilution of the reconstituted solution with 0.9% sodium chloride injection or 5 % dextrose injection or lactated Ringer’s injection, EMBLAVEO solution in the infusion bags may be stored based on conditions outlined in Table 4.