ASHP INJECTABLE DRUG INFORMATION –Vaborbactam 1031

Meropenem–Vaborbactam AHFS 8:12.07.08

Products Sodium Content The fixed combination of meropenem–vaborbactam is available Each 2-g vial of this fixed combination contains 0.25 g (10.9 as a powder in single-dose (preservative-free) vials containing 2 mEq) of sodium.3379 g (meropenem 1 g [as the trihydrate] plus vaborbactam 1 g) and Trade Name(s) sodium carbonate 0.575 g.3379 Vabomere The contents of each 2-g vial should be reconstituted with 20 mL of sodium chloride 0.9% (withdrawn from an infusion bag) Administration and mixed gently to dissolve the powder.3379 The reconstituted solution will have approximate meropenem and vaborbactam The diluted solution of meropenem–vaborbactam for infusion is 3379 concentrations of 50 mg/mL each.3379 The reconstituted solu- administered intravenously over 3 hours. The reconstituted 3379 tion is not suitable for direct injection.3379 solution is not suitable for direct injection. The reconstituted solution must be diluted immediately in the infusion bag containing sodium chloride 0.9% from which Stability the volume used for reconstitution of the appropriate dose was Meropenem–vaborbactam is a white to light yellow powder withdrawn.3379 The manufacturer’s instructions for preparing that forms a colorless to light yellow solution upon both recon- various doses of meropenem–vaborbactam from the reconsti- stitution and dilution.3379 Intact vials of meropenem–vabor- tuted solution are as follows:3379 bactam should be stored at controlled room temperature.3379 For 4 g (meropenem 2 g plus vaborbactam 2 g), withdraw Diluted solutions of meropenem–vaborbactam for infusion the entire contents (i.e., approximately 21 mL each) of 2 vials should be visually inspected for particulate matter and discol- and add to an infusion bag containing 250, 500, or 1000 mL of oration prior to administration.3379 Administration of the diluted sodium chloride 0.9% (less the 40 mL used for reconstitution). solution for infusion must be completed within 4 hours if stored at room temperature or 22 hours if stored at 2 to 8°C.3379 Any For 2 g (meropenem 1 g plus vaborbactam 1 g), withdraw the unused portions should be discarded.3379 entire contents (i.e., approximately 21 mL) of 1 vial and add to an infusion bag containing 125, 250, or 500 mL of sodium chloride Meropenem–vaborbactam reconstituted and diluted for 0.9% (less the 20 mL used for reconstitution). infusion demonstrated less than 10% loss of either drug when stored for up to 10 hours at room temperature and for up to 26 For 1 g (meropenem 0.5 g plus vaborbactam 0.5 g), withdraw hours under refrigeration (5°C); however, a degradation product 10.5 mL and add to an infusion bag containing 70, 125, or 250 formation assessment revealed that the solution did not consis- mL of sodium chloride 0.9% (less the 20 mL used for reconsti- tently meet impurity limits during this period.3381 tution).

Compatibility Information Solution Compatibility

Meropenem–vaborbactam

Test Soln Name Mfr Mfr Conc/L or % Remarks Ref C/I

Sodium chloride 0.9% MEL 2, 4, 7.15, and 8 ga Complete administration within 4 hr if stored at room 3379 C temperature or 22 hr if stored at 2 to 8°C

Sodium chloride 0.9% BAb MEL 2 ga Less than 6% loss of either component in 12 hr at 24°C; 3588 C calculated time to 10% loss was 21.4 hr

Sodium chloride 0.9% BAb MEL 2 ga Less than 9% loss of either component in 5 days at 4°C; 3588 C calculated time to 10% loss was 175.3 hr

Sodium chloride 0.9% BAb MEL 4 ga Less than 8% loss of either component in 12 hr at 24°C; 3588 C calculated time to 10% loss was 15.8 hr

Sodium chloride 0.9% BAb MEL 4 ga Less than 7% loss of either component in 6 days at 4°C; 3588 C calculated time to 10% loss was 223.8 hr

DOI: 10.37573/9781585286850.252 1032 Meropenem–Vaborbactam ASHP INJECTABLE DRUG INFORMATION

Solution Compatibility (Cont.)

Test Soln Name Mfr Mfr Conc/L or % Remarks Ref C/I

Sodium chloride 0.9% BAc MEL 5.7 ga Less than 8% loss of either component in 12 hr at 24°C; 3588 C calculated time to 10% loss was 14.8 hr

Sodium chloride 0.9% BAc MEL 5.7 ga Less than 9% loss of either component in 5 days at 4°C; 3588 C calculated time to 10% loss was 154.5 hr

Sodium chloride 0.9% BAb MEL 8 ga Less than 9% loss of either component in 12 hr at 24°C; 3588 C calculated time to 10% loss was 14.6 hr

Sodium chloride 0.9% BAb MEL 8 ga Less than 9% loss of either component in 6 days at 4°C; 3588 C calculated time to 10% loss was 172 hr a Meropenem component. Meropenem in a 1:1 fixed-ratio concentration with vaborbactam. b Tested in PVC containers. c Tested in Homepump Eclipse elastomeric pump reservoirs.

Y-Site Injection Compatibility (1:1 Mixture)

Meropenem–vaborbactam

Test Drug Mfr Conc Mfr Conc Remarks Ref C/I

Albumin human BXT 250 mg/mL TMC 8 mg/mLa i Measured turbidity increases immediately 3380 I

Amikacin sulfate FRK 5 mg/mLa TMC 8 mg/mLa i Physically compatible for 3 hr at 20 to 25°C 3380 C

Amiodarone HCl APP 2 mg/mLa TMC 8 mg/mLa i Measured turbidity increases immediately. pH 3380 I increased by >3 units within 3 hr

Ampicillin sodium– PF 20 mg/mLa b TMC 8 mg/mLa i Physically compatible for 3 hr at 20 to 25°C 3380 C sodium

Anidulafungin PF 0.77 mg/mLa TMC 8 mg/mLa i Immediate change in measured turbidity. pH 3380 I increased by >3 units within 3 hr

Azithromycin FRK 2 mg/mLa TMC 8 mg/mLa i Physically compatible for 3 hr at 20 to 25°C 3380 C

Aztreonam FRK 20 mg/mLa TMC 8 mg/mLa i Physically compatible for 3 hr at 20 to 25°C 3380 C

Bumetanide HOS 0.25 mg/mL TMC 8 mg/mLa i Physically compatible for 3 hr at 20 to 25°C 3380 C

Calcium chloride HOS 20 mg/mLa TMC 8 mg/mLa i Precipitation and increase in measured turbidity 3380 I within 30 min. pH increased by >3 units within 3 hr

Calcium gluconate FRK 20 mg/mLa TMC 8 mg/mLa i Physically compatible for 3 hr at 20 to 25°C 3380 C

Caspofungin acetate ME 0.5 mg/mLa TMC 8 mg/mLa i Measured turbidity increases immediately. pH 3380 I increased by >2 units within 3 hr

Cefazolin sodium SGT 20 mg/mLa TMC 8 mg/mLa i Physically compatible for 3 hr at 20 to 25°C 3380 C

Cefepime HCl HOS 40 mg/mLa TMC 8 mg/mLa i Physically compatible for 3 hr at 20 to 25°C 3380 C

Ceftaroline fosamil FOR 12 mg/mLa TMC 8 mg/mLa i Measured turbidity increases within 30 min. pH 3380 I increased by >2 units within 3 hr

Ceftazidime SGT 40 mg/mLa TMC 8 mg/mLa i Physically compatible for 3 hr at 20 to 25°C 3380 C

Ceftazidime– GSK 40 mg/mLa c TMC 8 mg/mLa i Physically compatible for 3 hr at 20 to 25°C 3380 C sodium

Ceftolozane sulfate– ME 20 mg/mLa d TMC 8 mg/mLa i Physically compatible for 3 hr at 20 to 25°C 3380 C sodium

Ceftriaxone sodium SGT 20 mg/mLa TMC 8 mg/mLa i Physically compatible for 3 hr at 20 to 25°C 3380 C

Cefuroxime sodium SGT 30 mg/mLa TMC 8 mg/mLa i Physically compatible for 3 hr at 20 to 25°C 3380 C