Vabomere (meropenem/vaborbactam)

Beta-Lactams Intravenous Vial (EA)

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Last reviewed · Source: First Databank (FDB) drug data

Overview

Meropenem and vaborbactam is a fixed combination of meropenem (a carbapenem beta-lactam antibiotic) and vaborbactam (a beta-lactamase inhibitor that prevents degradation of meropenem by certain serine beta-lactamases).

Meropenem and vaborbactam is a fixed combination of meropenem (a carbapenem) and vaborbactam (a non-beta-lactam beta-lactamase inhibitor). Vaborbactam inactivates certain bacterial beta-lactamases and expands meropenem's spectrum of activity against some bacteria that produce these beta-lactamases. Meropenem/vaborbactam is bactericidal in action.

Meropenem is a synthetic carbapenem antibiotic structurally and pharmacologically related to other carbapenems (e.g., doripenem, ertapenem, imipenem). Like other beta-lactam antibiotics, the antibacterial activity of meropenem results from inhibition of bacterial cell wall synthesis and is mediated through binding to penicillin-binding proteins (PBPs). Meropenem is stable to hydrolysis by most beta-lactamases, including penicillinases and cephalosporinases produced by gram-negative and gram-positive bacteria, but can be hydrolyzed by carbapenemases.

Vaborbactam is a cyclic boronic acid non-beta-lactam beta-lactamase inhibitor that protects meropenem from degradation by certain beta-lactamases, primarily Ambler class A serine carbapenemases (e.g., Klebsiella pneumoniae carbapenemase (KPC)) and some class C serine carbapenemases. Vaborbactam's boronate moiety forms a covalent bond with the catalytic serine side chain of the beta-lactamase, thereby inhibiting the enzyme from degrading meropenem. This mechanism of action differs from that of beta-lactam beta-lactamase inhibitors (e.g., clavulanic acid, sulbactam, tazobactam) and some other non-beta-lactam beta-lactamase inhibitors (e.g., avibactam).

In animal models of infection, vaborbactam restored activity of meropenem against some meropenem non-susceptible KPC-producing Enterobacteriaceae. The drug does not inhibit class D carbapenemases (e.g., OXA-48) or class B beta-lactamases (e.g., metallo beta-lactamases (MBLs)). Vaborbactam does not have antibacterial activity and does not decrease the activity of meropenem against meropenem-susceptible organisms.

Each single-dose vial of meropenem/vaborbactam contains 2 g (1 g of meropenem (equivalent to 1.14 g of meropenem trihydrate) and 1 g of vaborbactam) and also contains 575 mg of sodium carbonate. The total sodium content is approximately 250 mg (10.9 mEq) per single-dose vial.

Following IV administration of 4 g of meropenem/vaborbactam (meropenem 2 g and vaborbactam 2 g) given by IV infusion over 3 hours every 8 hours for 7 days in healthy adults with normal renal function, peak plasma concentrations of the drugs were 43.4 and 55.6 mcg/mL, respectively, and there was no accumulation of either drug. Meropenem is partially metabolized by hydrolysis of the beta-lactam ring to a microbiologically inactive hydrolysis product; vaborbactam is not metabolized. The plasma protein binding of meropenem is approximately 2% and the plasma protein binding of vaborbactam is approximately 33%.

Both drugs are principally eliminated by the kidneys. Approximately 40-60% of a meropenem dose is eliminated unchanged in urine, 22% is eliminated in urine as the microbiologically inactive hydrolysis product, and approximately 2% is eliminated in feces. Approximately 75-95% of a vaborbactam dose is eliminated unchanged in urine.

In healthy adults, meropenem has a plasma half-life of 1.2 hours and vaborbactam has a plasma half-life of 1.7 hours.

USES: This product is used to treat a variety of bacterial infections. It contains 2 different medications: meropenem and vaborbactam. Meropenem is a carbapenem-type antibiotic that works by stopping the growth of bacteria.

Vaborbactam is an enzyme inhibitor (beta-lactamase inhibitor) that helps meropenem work better.

Generic name: meropenem/vaborbactam
Pronunciation: (MER-oh-PEN-em/VA-bor-BAK-tam)
Drug class: Beta-Lactams
Therapeutic class: Anti-Infective Agents

Reference product & biosimilars

No reference, biosimilar or interchangeable associated with this drug.

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Indications

The following indications are listed for Vabomere:

  • Complicated E. Coli Uti
  • Enterobacter Complicated Uti
  • Klebsiella Complicated Uti

Also known as: Complicated Urinary Tract Infection Due To Aerobacter, Complicated Urinary Tract Infection Due To Enterobacter, Complicated Urinary Tract Infection Due To Escherichia Coli, Complicated Urinary Tract Infection Due To Klebsiella, Complicated Uti Due To E. Coli, Complicated Uti Due To Enterobacter Species, Complicated Uti Due To Klebsiella Species.

Dosing

Meropenem/vaborbactam is a fixed combination containing a 1:1 ratio of meropenem to vaborbactam.

The meropenem component is provided as meropenem trihydrate (dosage of this component is expressed in terms of meropenem).

Dosage of the fixed combination of meropenem and vaborbactam is expressed in terms of the total of the meropenem and vaborbactam content.

Each single-dose vial of meropenem/vaborbactam contains a total of 2 g (i.e., 1 g of meropenem and 1 g of vaborbactam).

Drug interactions

Meropenem and vaborbactam do not inhibit cytochrome P-450 (CYP) isoenzymes 1A2, 2B6, 2C8, 2C9, 2C19, 2D6, or 3A4 in vitro at therapeutic concentrations. Meropenem may weakly induce CYP1A2, and meropenem and vaborbactam may weakly induce CYP3A4, and potentially other pregnane X-receptor (PXR)-regulated enzymes and transporters. Meropenem and vaborbactam are substrates of organic anion transporter (OAT)3 but not OAT1. At clinically relevant concentrations, meropenem and vaborbactam inhibit OAT3 and do not inhibit OAT1. In vitro, meropenem and vaborbactam are not substrates or inhibitors of P-glycoprotein (P-gp), breast cancer resistance protein (BCRP), or organic cation transporter (OCT)2. Meropenem and vaborbactam are also not substrates of multidrug and toxin extrusion protein (MATE)1 or MATE2-K. Meropenem and vaborbactam do not inhibit OCT1, organic anion transporting polypeptide (OATP) 1B1 or 1B3, or bile salt export pump (BSEP).

Contraindications

*Hypersensitivity to any component of meropenem/vaborbactam or other drugs in the same class.

*History of anaphylactic reactions to beta-lactam antibacterials.

Adverse reactions

The most commonly reported adverse reactions (>=3%) of patients treated with meropenem/vaborbactam include headache, phlebitis/infusion site reactions, and diarrhea.

Precautions

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ICD codes

CodeTypeDescription
Complicated e. coli UTI
B96.2ICD10CMEscherichia coli [e. coli ] as the cause of diseases classified elsewhere
B96.20ICD10CMUnspecified escherichia coli [e. coli] as the cause of diseases classified elsewhere
B96.29ICD10CMOther escherichia coli [e. coli] as the cause of diseases classified elsewhere
N39.0ICD10CMUrinary tract infection, site not specified
O23.0ICD10CMInfections of kidney in pregnancy
O23.00ICD10CMInfections of kidney in pregnancy, unspecified trimester
O23.01ICD10CMInfections of kidney in pregnancy, first trimester
O23.02ICD10CMInfections of kidney in pregnancy, second trimester
O23.03ICD10CMInfections of kidney in pregnancy, third trimester
O23.1ICD10CMInfections of bladder in pregnancy
O23.10ICD10CMInfections of bladder in pregnancy, unspecified trimester
O23.11ICD10CMInfections of bladder in pregnancy, first trimester
O23.12ICD10CMInfections of bladder in pregnancy, second trimester
O23.13ICD10CMInfections of bladder in pregnancy, third trimester
O23.2ICD10CMInfections of urethra in pregnancy
O23.20ICD10CMInfections of urethra in pregnancy, unspecified trimester
O23.21ICD10CMInfections of urethra in pregnancy, first trimester
O23.22ICD10CMInfections of urethra in pregnancy, second trimester
O23.23ICD10CMInfections of urethra in pregnancy, third trimester
O23.3ICD10CMInfections of other parts of urinary tract in pregnancy
O23.30ICD10CMInfections of other parts of urinary tract in pregnancy, unspecified trimester
O23.31ICD10CMInfections of other parts of urinary tract in pregnancy, first trimester
O23.32ICD10CMInfections of other parts of urinary tract in pregnancy, second trimester
O23.33ICD10CMInfections of other parts of urinary tract in pregnancy, third trimester
O23.4ICD10CMUnspecified infection of urinary tract in pregnancy
O23.40ICD10CMUnspecified infection of urinary tract in pregnancy, unspecified trimester
O23.41ICD10CMUnspecified infection of urinary tract in pregnancy, first trimester
O23.42ICD10CMUnspecified infection of urinary tract in pregnancy, second trimester
O23.43ICD10CMUnspecified infection of urinary tract in pregnancy, third trimester
T83.5ICD10CMInfection and inflammatory reaction due to prosthetic device, implant and graft in urinary system
T83.51ICD10CMInfection and inflammatory reaction due to urinary catheter
T83.510ICD10CMInfection and inflammatory reaction due to cystostomy catheter
T83.510AICD10CMInfection and inflammatory reaction due to cystostomy catheter, initial encounter
T83.511ICD10CMInfection and inflammatory reaction due to indwelling urethral catheter
T83.511AICD10CMInfection and inflammatory reaction due to indwelling urethral catheter, initial encounter
T83.512ICD10CMInfection and inflammatory reaction due to nephrostomy catheter
T83.512AICD10CMInfection and inflammatory reaction due to nephrostomy catheter, initial encounter
T83.518ICD10CMInfection and inflammatory reaction due to other urinary catheter
T83.518AICD10CMInfection and inflammatory reaction due to other urinary catheter, initial encounter
T83.59ICD10CMInfection and inflammatory reaction due to prosthetic device, implant and graft in urinary system
T83.590ICD10CMInfection and inflammatory reaction due to implanted urinary neurostimulation device
T83.590AICD10CMInfection and inflammatory reaction due to implanted urinary neurostimulation device, initial encounter
T83.591ICD10CMInfection and inflammatory reaction due to implanted urinary sphincter
T83.591AICD10CMInfection and inflammatory reaction due to implanted urinary sphincter, initial encounter
T83.592ICD10CMInfection and inflammatory reaction due to indwelling ureteral stent
T83.592AICD10CMInfection and inflammatory reaction due to indwelling ureteral stent, initial encounter
T83.593ICD10CMInfection and inflammatory reaction due to other urinary stents
T83.593AICD10CMInfection and inflammatory reaction due to other urinary stents, initial encounter
T83.598ICD10CMInfection and inflammatory reaction due to other prosthetic device, implant and graft in urinary system
T83.598AICD10CMInfection and inflammatory reaction due to other prosthetic device, implant and graft in urinary system, initial encounter
Enterobacter complicated UTI
B96.89ICD10CMOther specified bacterial agents as the cause of diseases classified elsewhere
N39.0ICD10CMUrinary tract infection, site not specified
O23.0ICD10CMInfections of kidney in pregnancy
O23.00ICD10CMInfections of kidney in pregnancy, unspecified trimester
O23.01ICD10CMInfections of kidney in pregnancy, first trimester
O23.02ICD10CMInfections of kidney in pregnancy, second trimester
O23.03ICD10CMInfections of kidney in pregnancy, third trimester
O23.1ICD10CMInfections of bladder in pregnancy
O23.10ICD10CMInfections of bladder in pregnancy, unspecified trimester
O23.11ICD10CMInfections of bladder in pregnancy, first trimester
O23.12ICD10CMInfections of bladder in pregnancy, second trimester
O23.13ICD10CMInfections of bladder in pregnancy, third trimester
O23.2ICD10CMInfections of urethra in pregnancy
O23.20ICD10CMInfections of urethra in pregnancy, unspecified trimester
O23.21ICD10CMInfections of urethra in pregnancy, first trimester
O23.22ICD10CMInfections of urethra in pregnancy, second trimester
O23.23ICD10CMInfections of urethra in pregnancy, third trimester
O23.3ICD10CMInfections of other parts of urinary tract in pregnancy
O23.30ICD10CMInfections of other parts of urinary tract in pregnancy, unspecified trimester
O23.31ICD10CMInfections of other parts of urinary tract in pregnancy, first trimester
O23.32ICD10CMInfections of other parts of urinary tract in pregnancy, second trimester
O23.33ICD10CMInfections of other parts of urinary tract in pregnancy, third trimester
O23.4ICD10CMUnspecified infection of urinary tract in pregnancy
O23.40ICD10CMUnspecified infection of urinary tract in pregnancy, unspecified trimester
O23.41ICD10CMUnspecified infection of urinary tract in pregnancy, first trimester
O23.42ICD10CMUnspecified infection of urinary tract in pregnancy, second trimester
O23.43ICD10CMUnspecified infection of urinary tract in pregnancy, third trimester
T83.5ICD10CMInfection and inflammatory reaction due to prosthetic device, implant and graft in urinary system
T83.51ICD10CMInfection and inflammatory reaction due to urinary catheter
T83.510ICD10CMInfection and inflammatory reaction due to cystostomy catheter
T83.510AICD10CMInfection and inflammatory reaction due to cystostomy catheter, initial encounter
T83.511ICD10CMInfection and inflammatory reaction due to indwelling urethral catheter
T83.511AICD10CMInfection and inflammatory reaction due to indwelling urethral catheter, initial encounter
T83.512ICD10CMInfection and inflammatory reaction due to nephrostomy catheter
T83.512AICD10CMInfection and inflammatory reaction due to nephrostomy catheter, initial encounter
T83.518ICD10CMInfection and inflammatory reaction due to other urinary catheter
T83.518AICD10CMInfection and inflammatory reaction due to other urinary catheter, initial encounter
T83.59ICD10CMInfection and inflammatory reaction due to prosthetic device, implant and graft in urinary system
T83.590ICD10CMInfection and inflammatory reaction due to implanted urinary neurostimulation device
T83.590AICD10CMInfection and inflammatory reaction due to implanted urinary neurostimulation device, initial encounter
T83.591ICD10CMInfection and inflammatory reaction due to implanted urinary sphincter
T83.591AICD10CMInfection and inflammatory reaction due to implanted urinary sphincter, initial encounter
T83.592ICD10CMInfection and inflammatory reaction due to indwelling ureteral stent
T83.592AICD10CMInfection and inflammatory reaction due to indwelling ureteral stent, initial encounter
T83.593ICD10CMInfection and inflammatory reaction due to other urinary stents
T83.593AICD10CMInfection and inflammatory reaction due to other urinary stents, initial encounter
T83.598ICD10CMInfection and inflammatory reaction due to other prosthetic device, implant and graft in urinary system
T83.598AICD10CMInfection and inflammatory reaction due to other prosthetic device, implant and graft in urinary system, initial encounter
Klebsiella complicated UTI
B96.1ICD10CMKlebsiella pneumoniae [k. pneumoniae] as the cause of diseases classified elsewhere
N39.0ICD10CMUrinary tract infection, site not specified
O23.0ICD10CMInfections of kidney in pregnancy
O23.00ICD10CMInfections of kidney in pregnancy, unspecified trimester
O23.01ICD10CMInfections of kidney in pregnancy, first trimester
O23.02ICD10CMInfections of kidney in pregnancy, second trimester
O23.03ICD10CMInfections of kidney in pregnancy, third trimester
O23.1ICD10CMInfections of bladder in pregnancy
O23.10ICD10CMInfections of bladder in pregnancy, unspecified trimester
O23.11ICD10CMInfections of bladder in pregnancy, first trimester
O23.12ICD10CMInfections of bladder in pregnancy, second trimester
O23.13ICD10CMInfections of bladder in pregnancy, third trimester
O23.2ICD10CMInfections of urethra in pregnancy
O23.20ICD10CMInfections of urethra in pregnancy, unspecified trimester
O23.21ICD10CMInfections of urethra in pregnancy, first trimester
O23.22ICD10CMInfections of urethra in pregnancy, second trimester
O23.23ICD10CMInfections of urethra in pregnancy, third trimester
O23.3ICD10CMInfections of other parts of urinary tract in pregnancy
O23.30ICD10CMInfections of other parts of urinary tract in pregnancy, unspecified trimester
O23.31ICD10CMInfections of other parts of urinary tract in pregnancy, first trimester
O23.32ICD10CMInfections of other parts of urinary tract in pregnancy, second trimester
O23.33ICD10CMInfections of other parts of urinary tract in pregnancy, third trimester
O23.4ICD10CMUnspecified infection of urinary tract in pregnancy
O23.40ICD10CMUnspecified infection of urinary tract in pregnancy, unspecified trimester
O23.41ICD10CMUnspecified infection of urinary tract in pregnancy, first trimester
O23.42ICD10CMUnspecified infection of urinary tract in pregnancy, second trimester
O23.43ICD10CMUnspecified infection of urinary tract in pregnancy, third trimester
T83.5ICD10CMInfection and inflammatory reaction due to prosthetic device, implant and graft in urinary system
T83.51ICD10CMInfection and inflammatory reaction due to urinary catheter
T83.510ICD10CMInfection and inflammatory reaction due to cystostomy catheter
T83.510AICD10CMInfection and inflammatory reaction due to cystostomy catheter, initial encounter
T83.511ICD10CMInfection and inflammatory reaction due to indwelling urethral catheter
T83.511AICD10CMInfection and inflammatory reaction due to indwelling urethral catheter, initial encounter
T83.512ICD10CMInfection and inflammatory reaction due to nephrostomy catheter
T83.512AICD10CMInfection and inflammatory reaction due to nephrostomy catheter, initial encounter
T83.518ICD10CMInfection and inflammatory reaction due to other urinary catheter
T83.518AICD10CMInfection and inflammatory reaction due to other urinary catheter, initial encounter
T83.59ICD10CMInfection and inflammatory reaction due to prosthetic device, implant and graft in urinary system
T83.590ICD10CMInfection and inflammatory reaction due to implanted urinary neurostimulation device
T83.590AICD10CMInfection and inflammatory reaction due to implanted urinary neurostimulation device, initial encounter
T83.591ICD10CMInfection and inflammatory reaction due to implanted urinary sphincter
T83.591AICD10CMInfection and inflammatory reaction due to implanted urinary sphincter, initial encounter
T83.592ICD10CMInfection and inflammatory reaction due to indwelling ureteral stent
T83.592AICD10CMInfection and inflammatory reaction due to indwelling ureteral stent, initial encounter
T83.593ICD10CMInfection and inflammatory reaction due to other urinary stents
T83.593AICD10CMInfection and inflammatory reaction due to other urinary stents, initial encounter
T83.598ICD10CMInfection and inflammatory reaction due to other prosthetic device, implant and graft in urinary system
T83.598AICD10CMInfection and inflammatory reaction due to other prosthetic device, implant and graft in urinary system, initial encounter

ICD code information from First Databank (FDB).

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Last reviewed · Source: First Databank (FDB) drug data