Meropenem and vaborbactam

Dosage Adjustments in Patients with Renal Impairment Dosage adjustment is recommended in patients with renal impairment who have an eGFR less than 50 mL/min/1.73m 2 . The recommended dosage of VABOMERE in patients with varying degrees of renal function is presented in Table 1. For patients with changing renal function, monitor serum creatinine concentrations and eGFR at least daily and adjust the dosage of VABOMERE accordingly [see Use in Specific Populations and Clinical Pharmacology ] .

Meropenem and vaborbactam are removed by hemodialysis [see Clinical Pharmacology ] . For patients maintained on hemodialysis, administer VABOMERE after a hemodialysis session. [See table below.] Less than 15 VABOMERE 1 gram (meropenem 0.5 grams and vaborbactam 0.5 grams) Every 12 hours

Preparation and Administration of VABOMERE for Intravenous Infusion Preparation VABOMERE is supplied as a dry powder in a single-dose vial that must be constituted and further diluted prior to intravenous infusion as outlined below. VABOMERE does not contain preservatives. Aseptic technique must be used for constitution and dilution. 1.

To prepare the required dose for intravenous infusion, constitute the appropriate number of vials, as determined from Table 2 below. Withdraw 20 mL of 0.9% Sodium Chloride Injection, USP, from an infusion bag and constitute each vial of VABOMERE. 2. Mix gently to dissolve. The constituted VABOMERE solution will have an approximate meropenem concentration of 0.05 gram/mL and an approximate vaborbactam concentration of 0.05 gram/mL.

The final volume is approximately 21.3 mL. The constituted solution is not for direct injection. 3. The constituted solution must be diluted further, immediately, in a 0.9% Sodium Chloride Injection, USP infusion bag before intravenous infusion. The intravenous infusion of the diluted solution must be completed within 4 hours if stored at room temperature or 22 hours if stored refrigerated at 2°C to 8°C (36°F to 46°F). 4.

To dilute the constituted solution, withdraw the full or partial constituted vial contents from each vial and add it back into the infusion bag in accordance with Table 2 below. [See table below.] 2 grams (1 gram-1 gram) 1 vial Entire contents (approximately 21 mL) 125 mL 16 mg/mL 250 mL 8 mg/mL 500 mL 4 mg/mL 1 gram (0.5 gram-0.5 gram) 1 vial 10.5 mL (discard unused portion) 70 mL 14.3 mg/mL 125 mL 8 mg/mL 250 mL 4 mg/mL 5.

Visually inspect the diluted VABOMERE solution for particulate matter and discoloration prior to administration (the color of the VABOMERE infusion solution for administration ranges from colorless to light yellow). Discard unused portion after use.

Drug Compatibility VABOMERE solution for administration by 3-hour infusion is only compatible with 0.9% Sodium Chloride Injection, USP. Compatibility of VABOMERE solution for administration with other drugs has not been established.