Vabomere (meropenem/vaborbactam)
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)
Reference product & biosimilars
No reference, biosimilar or interchangeable associated with this drug.
Today’s intelligence on Vabomere
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).
The fixed combination of meropenem and vaborbactam (meropenem/vaborbactam) is administered by IV infusion.
Meropenem/vaborbactam powder for injection must be reconstituted and further diluted prior to IV infusion.
Store unopened vials at 20-25degreesC (excursions permitted to 15-30degreesC).
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No dosing information is available for this tab.
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).
There are no contraindication interactions for this drug.
There are no severe interactions for this drug.
There are no moderate interactions for this drug.
Contraindications
*Hypersensitivity to any component of meropenem/vaborbactam or other drugs in the same class.
*History of anaphylactic reactions to beta-lactam antibacterials.
There are no contraindication contraindications for this drug.
There are no severe contraindications for this drug.
There are no moderate contraindications for this drug.
Adverse reactions
The most commonly reported adverse reactions (>=3%) of patients treated with meropenem/vaborbactam include headache, phlebitis/infusion site reactions, and diarrhea.
There are no severe adverse reactions for this drug.
There are no less severe adverse reactions for this drug.
Precautions
No enhanced messaging available.
Safety and efficacy of meropenem/vaborbactam have not been established in pediatric patients younger than 18 years of age.
Fetal malformations (e.g., supernumerary lung lobes, interventricular septal defect) were observed in rabbits receiving IV vaborbactam during organogenesis at doses approximately equivalent to or greater than the maximum recommended human dose. Similar malformations or fetal toxicity were not observed in offspring from pregnant rats receiving IV vaborbactam during organogenesis or from late pregnancy and through lactation at doses equivalent to approximately 1.6 times the maximum recommended human dose. No fetal toxicity or malformations were observed in pregnant rats or cynomolgus monkeys receiving IV meropenem during organogenesis at doses up to 1.6 or 1.2 times the maximum recommended human dose, respectively.
Human data are insufficient to determine whether there is a drug-associated risk of major birth defects or miscarriages if the fixed combination of meropenem and vaborbactam, meropenem alone, or vaborbactam alone is used in pregnant women.
Meropenem has been reported to be distributed into human milk. It is not known whether vaborbactam is distributed into human milk.
The benefits of breast-feeding and the importance of meropenem and vaborbactam to the woman should be considered along with potential adverse effects on the breast-fed child from the drug or from the underlying maternal condition.
Dosage adjustments are not needed when meropenem/vaborbactam is used in geriatric patients. However, because geriatric patients are more likely to have decreased renal function and dosage of meropenem/vaborbactam needs to be adjusted based on renal impairment, select dosage with caution and monitor renal function.
No overall differences in safety and efficacy of meropenem/vaborbactam were observed in patients 65 years of age and older compared with younger adults, but greater sensitivity in some older individuals cannot be ruled out.
Meropenem is substantially eliminated by the kidneys, and the risk of adverse reactions to the drug may be greater in patients with renal impairment. Because geriatric patients are more likely to have decreased renal function, dosage should be selected with caution and renal function monitoring should be considered. Dosage adjustments in geriatric patients should be based on renal function.
Population pharmacokinetic analysis indicates that the pharmacokinetics of meropenem/vaborbactam in geriatric patients is similar to that in younger adults.
ICD codes
No ICD codes are available for this drug.
Formulary status
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Last reviewed · Source: First Databank (FDB) drug data
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