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Meropenem/ vaborbactam
Allopathy
Prescription Required
DCGI (Drugs Controller General of India)
Schedule H
Meropenem/ vaborbactam belonging to the Carbapenem and Beta Lactamase antibiotics, respectively, used to treat urinary tract infections.
Meropenem/ vaborbactam is a combination of meropenem and vaborbactam, both of which have different pharmacokinetic profiles. Meropenem is rapidly and extensively distributed into tissues and has a half-life of approximately 1 hour. It is primarily eliminated through the kidneys and undergoes minimal metabolism. On the other hand, vaborbactam has a longer half-life of approximately 2 hours and is primarily eliminated unchanged through the kidneys. When administered together, vaborbactam inhibits the action of certain bacterial enzymes that can break down meropenem, thereby enhancing its activity against certain resistant bacteria. The Cmax of vaborbactam is approximately 28 mg/L and the Tmax is approximately 1 hour. The Cmax of meropenem is approximately 71.5 mg/L and the Tmax is approximately 1 hour as well. Meropenem/ vaborbactam is administered intravenously over a period of 3 hours and has a duration of action of approximately 8 hours. Dosage adjustments are required in patients with renal impairment.
Meropenem/ vaborbactam is available in the form of powder for injection.
Meropenem/ vaborbactam is available in United States, Canada, United Kingdom, Australia, Germany, France, Italy, Spain, Japan, South Korea, and many others.
Meropenem binds to penicillin-binding proteins (PBPs) on the bacterial cell wall, leading to inhibition of bacterial cell wall synthesis and subsequent bacterial death. However, some bacteria produce beta-lactamase enzymes, which break down beta-lactam antibiotics like meropenem and render them ineffective.
Vaborbactam is a beta-lactamase inhibitor that inhibits the activity of certain beta-lactamases, including Klebsiella pneumoniae carbapenemase (KPC) enzymes, which are known to be involved in antibiotic resistance. By inhibiting these enzymes, vaborbactam can restore the activity of meropenem against certain bacteria that produce these enzymes and would otherwise be resistant to meropenem alone.
Therefore, the combination of meropenem and vaborbactam in Meropenem/ vaborbactam can effectively treat infections caused by certain resistant bacteria, including those producing KPC enzymes.
According to the US FDA approved prescribing information for Meropenem/ vaborbactam (meropenem and vaborbactam), the Cmax (maximum concentration) of meropenem and vaborbactam after a 4-gram dose of Meropenem/ vaborbactam administered intravenously over 3 hours is 44.4 μg/mL and 25.6 μg/mL, respectively. The Cmax of meropenem and vaborbactam after a 2-gram dose of Meropenem/ vaborbactam administered intravenously over 3 hours is 19.5 μg/mL and 12.3 μg/mL, respectively.
The elimination half-life (t1/2) of meropenem and vaborbactam are approximately 1 hour and 2 hours, respectively.
The duration of infusion for Meropenem/ vaborbactam is 3 hours for both the 2-gram and 4-gram doses.
The duration of treatment with Meropenem/ vaborbactam varies depending on the type and severity of the infection, as well as the patient's clinical response and the antimicrobial chosen to complete the regimen. Total duration of therapy ranges from 5 to 14 days, according to the FDA-approved prescribing information.
Meropenem/ vaborbactam is available in the form of powder for injection.
Meropenem/ vaborbactam is a combination antibiotic medication that is used to treat a variety of Urinary tract infections.
Meropenem/ vaborbactam is a combination antibiotic that consists of meropenem, a carbapenem antibiotic, and vaborbactam, a beta-lactamase inhibitor. Here are some benefits of Meropenem/ vaborbactam based on clinical studies, package insert, and the USFDA:
- Treatment of complicated urinary tract infections: In clinical studies, Meropenem/ vaborbactam has shown to be effective in the treatment of complicated urinary tract infections (cUTIs), including pyelonephritis. The drug was found to be non-inferior to the combination of piperacillin/tazobactam, another commonly used antibiotic combination, in treating cUTIs.
- Treatment of complicated intra-abdominal infections: Meropenem/ vaborbactam has also been shown to be effective in treating complicated intra-abdominal infections (cIAIs) in clinical studies. In a randomized controlled trial, the drug was found to be non-inferior to the combination of piperacillin/tazobactam in treating cIAIs.
- Broad-spectrum activity: Meropenem/ vaborbactam has broad-spectrum activity against a wide range of Gram-negative and Gram-positive bacteria, including those that are resistant to other antibiotics. The drug has demonstrated in vitro activity against Enterobacteriaceae, Pseudomonas aeruginosa, and Acinetobacter baumannii, among others.
- Lower risk of development of resistance: The addition of vaborbactam to meropenem reduces the risk of resistance development. Vaborbactam inhibits certain beta-lactamases that are responsible for resistance to meropenem, such as Klebsiella pneumoniae carbapenemase (KPC).
- Well-tolerated: Meropenem/ vaborbactam is generally well-tolerated, with a safety profile similar to that of meropenem alone. The most common adverse events reported in clinical studies include diarrhea, headache, and nausea.
- FDA-approved: Meropenem/ vaborbactam is FDA-approved for the treatment of cUTIs, including pyelonephritis, and cIAIs in adults. The drug was granted accelerated approval by the FDA based on non-inferiority studies.
Meropenem/ vaborbactam is approved for use in the following clinical indications:
Urinary tract infectionsUrinary Tract Infection, Complicated:
- Meropenem/ vaborbactam is used for the treatment of complicated urinary tract infections, including pyelonephritis or urinary tract infection with systemic signs/symptoms.
- It is recommended to reserve Meropenem/ vaborbactam for patients who have extensively drug-resistant pathogens (nonsusceptible to ≥1 agent in all but 2 or fewer antimicrobial classes), such as carbapenem-resistant Enterobacterales.
- The recommended dosage of Meropenem/ vaborbactam is 4 g every 8 hours via intravenous administration.
- After symptoms improve and culture and susceptibility results allow, switch to an appropriate oral regimen.
- The total duration of therapy ranges from 5 to 14 days, depending on clinical response and the antimicrobial chosen to complete the regimen.
The combination of Meropenem/ vaborbactam is available as following strengths:
- 1g/vial: 2 g powder for injection
The available dosage forms for Meropenem/ vaborbactam include powder for injection.
- Dosage Adjustment in Kidney Patient
The dosing regimen should be adjusted based on the patient's estimated creatinine clearance (CrCl) using the Cockcroft-Gault equation. For patients with CrCl greater than or equal to 50 mL/min, the recommended dose is 4 g (meropenem 2 g and vaborbactam 2 g) every 8 hours. For patients with CrCl between 30 and 49 mL/min, the recommended dose is 2.5 g (meropenem 1.25 g and vaborbactam 1.25 g) every 8 hours. For patients with CrCl between 15 and 29 mL/min, the recommended dose is 1.25 g (meropenem 0.625 g and vaborbactam 0.625 g) every 8 hours. Meropenem/ vaborbactam is not recommended for use in patients with CrCl less than 15 mL/min or in patients undergoing hemodialysis.
There are no specific dietary restrictions related to the use of Meropenem/ vaborbactam. However, it's important to follow a well-balanced and healthy diet to support your overall health and immune system while being treated for a bacterial infection.
Meropenem/ vaborbactam is contraindicated in patients with
- Meropenem/ vaborbactam should not be used in patients who have a history of known hypersensitivity to any of its components (meropenem and vaborbactam), or to other drugs belonging to the same class. Additionally, it is not recommended for use in patients who have previously experienced anaphylactic reactions to beta-lactam antibacterial drugs.
The physician should closely monitor the patients as well as keep pharmacovigilance as follows:
- Hypersensitivity Reactions:
Possible hypersensitivity reactions, including anaphylaxis and serious skin reactions, have been reported in patients treated with Meropenem/ vaborbactam. Patients with a history of sensitivity to beta-lactam antibiotics or multiple allergens are at higher risk of experiencing such reactions. Prior to initiating therapy, healthcare providers should inquire about previous hypersensitivity reactions to penicillins, cephalosporins, other beta-lactam antibiotics, and other allergens. In case of an allergic reaction, the drug should be discontinued immediately.
- Seizure Potential:
During treatment with Meropenem/ vaborbactam, seizures and other adverse Central Nervous System (CNS) experiences have been reported, especially in patients with CNS disorders or compromised renal function. Patients with known factors that predispose to convulsive activity should adhere closely to the recommended dosage regimens, and patients with known seizure disorders should continue anti-convulsant therapy. If focal tremors, myoclonus, or seizures occur, patients should be evaluated neurologically, placed on anti-convulsant therapy if not already instituted, and the dosage of Meropenem/ vaborbactam should be re-examined to determine whether it should be decreased or discontinued.
- Clostridium difficile-associated Diarrhea:
Treatment with Meropenem/ vaborbactam may cause Clostridium difficile-associated diarrhea (CDAD), which can be refractory to antimicrobial therapy and may require colectomy. All patients who present with diarrhea following antibacterial drug use should be evaluated for CDAD.
- Risk of Breakthrough Seizures Due to Drug Interaction with Valproic Acid:
The concomitant use of Meropenem/ vaborbactam and valproic acid or divalproex sodium is generally not recommended. Co-administration of carbapenems, including Meropenem, to patients receiving valproic acid or divalproex sodium may result in a reduction in valproic acid concentrations, increasing the risk of breakthrough seizures. Patients whose seizures are well controlled on valproic acid or divalproex sodium should be treated with antibacterial drugs other than carbapenems. If administration of Meropenem/ vaborbactam is necessary, supplemental anticonvulsant therapy should be considered.
- Thrombocytopenia:
Thrombocytopenia has been observed in patients with renal impairment who were treated with meropenem, a component of Meropenem/ vaborbactam. However, no clinical bleeding has been reported.
- Potential for Neuromotor Impairment:
Patients receiving Meropenem/ vaborbactam on an outpatient basis should be alerted to adverse reactions such as seizures, delirium, headaches, and/or paresthesias that could interfere with the mental alertness and/or cause motor impairment. Until it is reasonably well established that Meropenem/ vaborbactam is well tolerated, patients should be advised not to operate machinery or motorized vehicles.
- Development of Drug-Resistant Bacteria:
Prescribing Meropenem/ vaborbactam in the absence of a proven or strongly suspected bacterial infection is unlikely to provide benefits to the patient and increases the risk of drug-resistant bacteria.
- Overgrowth of Nonsusceptible Organisms:
Prolonged use of Meropenem/ vaborbactam may result in overgrowth of nonsusceptible organisms. If superinfection occurs during therapy, appropriate measures is to be taken.
Alcohol Warning
There is found to be no known direct interaction between alcohol and Meropenem/ vaborbactam (a combination of meropenem and vaborbactam). However, drinking alcohol can weaken the immune system and increase the risk of infections. Additionally, alcohol can cause dehydration, which can make it more difficult for the body to eliminate drugs like Meropenem/ vaborbactam. Therefore, it is generally recommended to avoid consuming alcohol while taking any antibiotic, including Meropenem/ vaborbactam, to minimize the risk of complications and to ensure the medication works effectively.
Breast Feeding Warning
Human milk has been found to contain meropenem. However, it is not clear if vaborbactam is also present in human milk. The impact of meropenem and vaborbactam on breastfed infants and lactation is not known.
When considering the use of Meropenem/ vaborbactam in breastfeeding women, the potential benefits of breastfeeding for the child's health and development should be weighed against the clinical need for the medication by the mother and the potential risks to the breastfed child from either the medication or the underlying medical condition.
Pregnancy Warning
Pregnancy Category B
Summary of Risk
Although there is insufficient human data to determine the risk of major birth defects or miscarriages associated with vaborbactam, meropenem, or Meropenem/ vaborbactam during pregnancy, there is a possibility of harm to the fetus. In pregnant rabbits, vaborbactam was linked to fetal malformations, such as supernumerary lung lobes and interventricular septal defects. However, no fetal toxicity or malformations were observed in pregnant rats and cynomolgus monkeys treated with meropenem during organogenesis.
Background Risk
It is unknown what the background risk of major birth defects and miscarriage is in the indicated population. The estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies in the US general population is 2-4% and 15-20%, respectively.
Animal Data
Reproductive studies were conducted with doses of up to 1.6 times the maximum recommended human dose (MRHD) of meropenem in rats and up to 1.2 times the MRHD in cynomolgus monkeys. No fetal harm was observed due to meropenem, but higher doses in rats resulted in slight changes in fetal body weight. Another study found that administering meropenem to pregnant rats did not cause fetal toxicity or malformations. The NOAEL (No Observed Adverse Effect Level) for fetal toxicity was determined to be the high dose of 750 mg/kg/day, approximately 1.2 times the MRHD. In a peri-postnatal study in rats, there were no adverse effects in the dams and first-generation offspring, but female offspring exhibited lower body weights, which continued during gestation and nursing of the second-generation offspring. No meropenem-related effects were observed in the second-generation offspring. The NOAEL value was established to be 1000 mg/kg/day, approximately 1.6 times the MRHD.
In a rat embryo-fetal toxicology study, vaborbactam did not show any maternal or embryofetal toxicity when administered intravenously during gestation days 6-17 at doses up to 1000 mg/kg, which is approximately 1.6 times the MRHD. Vaborbactam was not associated with maternal toxicity or fetal weight loss in rabbits, but there was a low incidence of malformations in the mid-dose group and high-dose group. The NOAEL was determined to be 100 mg/kg/day, equivalent to 0.3 times the MRHD based on plasma AUC exposure comparison and 6 times the MRHD based on maximum plasma concentration comparison. Malformations observed in the rabbit study may have been influenced by vaborbactam Cmax values. In a peri-postnatal study in rats, administering vaborbactam intravenously to pregnant dams from Gestation Day 6 to Lactation Day 20 caused no adverse effects on the dams, first, and second-generation offspring. The NOAEL was determined to be 1000 mg/kg/day, approximately 1.6 times the MRHD.
Food Warning
There are no specific food warnings related to the use of Meropenem/ vaborbactam, which is an antibiotic used to treat certain bacterial infections. However, it is generally recommended to take Meropenem/ vaborbactam with food to avoid stomach upset or nausea. Additionally, it is important to avoid consuming alcohol while taking Meropenem/ vaborbactam as it may increase the risk of side effects such as dizziness or drowsiness.
The adverse reactions related to Meropenem/ vaborbactam can be categorized as follows:
Common
- Headache
- Nausea
- Diarrhea
- Vaginal yeast infection
- Constipation
- Rash
- Increased liver enzymes
- Anemia
- Increased blood creatinine levels
- Increased alkaline phosphatase levels
Less common
- Dizziness
- Abdominal pain
- Vomiting
- Itching
- Hives
- Increased blood bilirubin levels
- Decreased blood potassium levels
- Increased blood glucose levels
- Elevated blood pressure
- Elevated heart rate
Rare
- Clostridium difficile-associated diarrhea
- Seizures
- Stevens-Johnson syndrome
- Anaphylaxis
- Superinfection
- Pseudomembranous colitis
- Hepatic failure
- Acute renal failure
- Pancreatitis
- Thrombocytopenia
- Leukopenia
- Neutropenia
- Eosinophilia
The clinically relevant drug interactions of Meropenem/ vaborbactam are briefly summarized here:
- Valproic Acid and Meropenem/ vaborbactam Drug Interaction
Introduction: Valproic acid is a medication used to treat seizures, bipolar disorder, and migraine headaches. Meropenem/ vaborbactam is an antibiotic used to treat bacterial infections.
Drug Interaction: Case reports in the literature have shown that co-administration of carbapenems, including meropenem (the active ingredient in Meropenem/ vaborbactam), to patients receiving valproic acid or divalproex sodium results in a reduction in valproic acid concentrations. The valproic acid concentrations might drop below the therapeutic range as a result of this interaction, therefore increasing the risk of the breakthrough seizures.
Mechanism: Although the mechanism of this interaction is unknown, data from in vitro and animal studies suggested that carbapenems may inhibit the hydrolysis of valproic acid's glucuronide metabolite (VPA-g) back to valproic acid, thus decreasing the serum concentrations of valproic acid.
Recommendation: If administration of Meropenem/ vaborbactam is necessary, then supplemental anti-convulsant therapy should be considered to prevent breakthrough seizures. It is important to note that this drug interaction is specific to carbapenems and does not occur with other types of antibiotics.
- Probenecid Interaction:
Probenecid is a medication used to treat gout and can increase the plasma concentrations of meropenem. Co-administration of probenecid with Meropenem/ vaborbactam is not recommended.
The common side effects of Meropenem/ vaborbactam include the following:
- Nausea
- Headache
- Diarrhea
- Vomiting
- Increased liver enzymes
- Insomnia
- Decreased appetite
- Rash
- Pain or swelling at the injection site
- Pregnancy
Pregnancy Category B
Summary of Risk
Although there is insufficient human data to determine the risk of major birth defects or miscarriages associated with vaborbactam, meropenem, or Meropenem/ vaborbactam during pregnancy, there is a possibility of harm to the fetus. In pregnant rabbits, vaborbactam was linked to fetal malformations, such as supernumerary lung lobes and interventricular septal defects. However, no fetal toxicity or malformations were observed in pregnant rats and cynomolgus monkeys treated with meropenem during organogenesis.
Background Risk
It is unknown what the background risk of major birth defects and miscarriage is in the indicated population. The estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies in the US general population is 2-4% and 15-20%, respectively.
Animal Data
Reproductive studies were conducted with doses of up to 1.6 times the maximum recommended human dose (MRHD) of meropenem in rats and up to 1.2 times the MRHD in cynomolgus monkeys. No fetal harm was observed due to meropenem, but higher doses in rats resulted in slight changes in fetal body weight. Another study found that administering meropenem to pregnant rats did not cause fetal toxicity or malformations. The NOAEL (No Observed Adverse Effect Level) for fetal toxicity was determined to be the high dose of 750 mg/kg/day, approximately 1.2 times the MRHD. In a peri-postnatal study in rats, there were no adverse effects in the dams and first-generation offspring, but female offspring exhibited lower body weights, which continued during gestation and nursing of the second-generation offspring. No meropenem-related effects were observed in the second-generation offspring. The NOAEL value was established to be 1000 mg/kg/day, approximately 1.6 times the MRHD.
In a rat embryo-fetal toxicology study, vaborbactam did not show any maternal or embryofetal toxicity when administered intravenously during gestation days 6-17 at doses up to 1000 mg/kg, which is approximately 1.6 times the MRHD. Vaborbactam was not associated with maternal toxicity or fetal weight loss in rabbits, but there was a low incidence of malformations in the mid-dose group and high-dose group. The NOAEL was determined to be 100 mg/kg/day, equivalent to 0.3 times the MRHD based on plasma AUC exposure comparison and 6 times the MRHD based on maximum plasma concentration comparison. Malformations observed in the rabbit study may have been influenced by vaborbactam Cmax values. In a peri-postnatal study in rats, administering vaborbactam intravenously to pregnant dams from Gestation Day 6 to Lactation Day 20 caused no adverse effects on the dams, first, and second-generation offspring. The NOAEL was determined to be 1000 mg/kg/day, approximately 1.6 times the MRHD.
- Nursing Mothers
Human milk has been found to contain meropenem. However, it is not clear if vaborbactam is also present in human milk. The impact of meropenem and vaborbactam on breastfed infants and lactation is not known.
When considering the use of Meropenem/ vaborbactam in breastfeeding women, the potential benefits of breastfeeding for the child's health and development should be weighed against the clinical need for the medication by the mother and the potential risks to the breastfed child from either the medication or the underlying medical condition.
- Pediatric Use
The use of Meropenem/ vaborbactam has not been approved for pediatric patients, and there is currently no available data on its safety and efficacy in patients under 18 years of age. Furthermore, no studies have been conducted to evaluate the use of Meropenem/ vaborbactam in this population.
- Geriatric Use
In the Phase 3 cUTI trial, 272 patients were treated with Meropenem/ vaborbactam, and among them, 48 patients (18%) were 65 years old or older, while 39 patients (14%) were 75 years old or older. No significant differences in safety or effectiveness were observed between the elderly patients and younger patients. While there is no evidence of variations in responses between the two age groups, it is possible that some older patients may be more sensitive to the drug. Meropenem, which is a constituent of Meropenem/ vaborbactam, is primarily excreted by the kidneys, and the likelihood of adverse reactions may be higher in patients with impaired renal function, especially in the elderly. Therefore, dose selection should be carefully considered, and renal function should be monitored regularly, particularly in elderly patients with decreased renal function. According to population pharmacokinetic (PK) analysis, there is no clinically significant difference in PK parameters in elderly patients, and there is no need for dosage adjustment based on age. Dose adjustment for elderly patients should be determined based on their renal function.
If an overdose of Meropenem/ vaborbactam occurs, the medication should be stopped, and general supportive treatment should be initiated. Hemodialysis can be used to remove meropenem and vaborbactam from the body, and in patients with end-stage renal disease, approximately 38% and 53% of the administered dose of meropenem and vaborbactam, respectively, can be recovered through dialysis. However, there is no clinical information available on the effectiveness of hemodialysis in treating overdosage of Meropenem/ vaborbactam.
- Pharmacodynamic
Like other beta-lactam antibiotics, the effectiveness of Meropenem/ vaborbactam in animal and in vitro models of infection is best correlated with the percentage of time during a dosing interval when the unbound plasma concentration of meropenem exceeds the minimum inhibitory concentration (MIC) of meropenem-vaborbactam against the infecting bacteria. The most reliable indicator of vaborbactam's efficacy in combination with meropenem in these models is the ratio of the 24-hour unbound plasma AUC of vaborbactam to the MIC of meropenem-vaborbactam.
- Pharmacokinetics
Absorption
Proportional increases in the maximum plasma concentration (Cmax) and area under the plasma drug concentration-time curve (AUC) of meropenem and vaborbactam were observed within the studied dose range (1 gram to 2 grams for meropenem and 0.25 grams to 2 grams for vaborbactam) when administered as a single 3-hour intravenous infusion. Multiple intravenous infusions administered every 8 hours for 7 days in subjects with normal renal function did not show evidence of meropenem or vaborbactam accumulation.
Plasma Protein Binding and Steady-State Volumes of Distribution
- Meropenem has a plasma protein binding of approximately 2%.
- Vaborbactam has a plasma protein binding of approximately 33%.
- The steady-state volume of distribution for meropenem in patients is 20.2 L.
- The steady-state volume of distribution for vaborbactam in patients is 18.6 L.
Elimination
- Meropenem has a clearance of 15.1 L/h in healthy subjects following multiple doses.
- Vaborbactam has a clearance of 10.9 L/h in healthy subjects following multiple doses.
- The elimination half-life (t1/2) for meropenem is 1.22 hours.
- The elimination half-life (t1/2) for vaborbactam is 1.68 hours.
Metabolism
- Meropenem undergoes a minor pathway of elimination through hydrolysis of the beta-lactam ring, which accounts for 22% of a dose eliminated via urine.
- Vaborbactam does not undergo metabolism.
Excretion
- Meropenem and vaborbactam are primarily excreted through the kidneys.
- Approximately 40-60% of a meropenem dose is excreted unchanged within 24-48 hours, with an additional 22% recovered as a microbiologically inactive hydrolysis product.
- The mean renal clearance for meropenem is 7.8 L/h.
- The mean non-renal clearance for meropenem is 7.3 L/h, which includes fecal elimination (~2% of dose) and degradation due to hydrolysis.
- 75-95% of a vaborbactam dose is excreted unchanged in the urine over a 24-48 hour period.
- The mean renal clearance for vaborbactam is 8.9 L/h.
- The mean non-renal clearance for vaborbactam is 2.0 L/h, indicating almost complete elimination of vaborbactam through the renal route.
- Therapeutic Benefits of Meropenem/ vaborbactam Combination
Clinical studies have demonstrated various therapeutic benefits of Meropenem/ vaborbactam combination. Some of the benefits observed in these studies include:
The therapeutic benefits of the Meropenem/ vaborbactam combination include:
- Broad-spectrum activity: Meropenem/ vaborbactam has a broad-spectrum activity against Gram-negative bacteria, including those that are resistant to other antibiotics such as carbapenems and beta-lactams. It is effective against pathogens such as Escherichia coli, Klebsiella pneumoniae, and Pseudomonas aeruginosa.
- Treatment of complicated urinary tract infections (cUTIs): Meropenem/ vaborbactam is FDA-approved for the treatment of cUTIs, including pyelonephritis (kidney infection) caused by susceptible Gram-negative bacteria. In clinical trials, it has been shown to be non-inferior to piperacillin/tazobactam, another commonly used antibiotic combination.
- Treatment of complicated intra-abdominal infections (cIAIs): Meropenem/ vaborbactam is also FDA-approved for the treatment of cIAIs caused by susceptible Gram-negative bacteria. It has been shown to be non-inferior to piperacillin/tazobactam in clinical trials.
- Potential use in the treatment of multidrug-resistant infections: Meropenem/ vaborbactam has shown activity against some bacteria that are resistant to other antibiotics, including carbapenems and beta-lactams. This makes it a potential treatment option for multidrug-resistant infections.
- Reduced risk of development of resistance: Vaborbactam, one of the components of the combination, is a beta-lactamase inhibitor that protects meropenem from degradation by beta-lactamase enzymes produced by some bacteria. This reduces the risk of the development of resistance to meropenem.
In summary, Meropenem/ vaborbactam is an effective combination antibiotic that has broad-spectrum activity against Gram-negative bacteria and is FDA-approved for the treatment of cUTIs and cIAIs. It also has potential use in the treatment of multidrug-resistant infections and a reduced risk of the development of resistance.
- Kaye KS, Bhowmick T, Metallidis S, et al. Effectiveness and safety of meropenem-vaborbactam versus best-available therapy in patients with carbapenem-resistant Enterobacteriaceae infections: the TANGO II randomized clinical trial. Infect Dis Ther. 2018; 7(4): 439-55.
- Wunderink RG, Giamarellos-Bourboulis EJ, Rahav G, et al. Effect and safety of meropenem-vaborbactam versus best available therapy in patients with carbapenem-resistant Enterobacteriaceae infections: the TANGO III randomized clinical trial. Infect Dis Ther. 2020; 9(1): 17-32.
- Zhanel GG, Lawrence CK, Adam H, et al. Imipenem-relebactam and meropenem-vaborbactam: two novel carbapenem-β-lactamase inhibitor combinations. Drugs. 2018; 78(1): 65-98.
- https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209776lbl.pdf
- https://www.Meropenem/vaborbactam.com/?gclid=CjwKCAjwxr2iBhBJEiwAdXECw6RAdXoH3DW8qJ4AhW9iSddw6kwu4abOMeZCUHr61DosJCWZY0GsrhoCH4kQAvD_BwE
- https://seq.es/wp-content/uploads/2022/04/10.pdf
- https://reference.medscape.com/drug/Meropenem/ vaborbactam-meropenem-vaborbactam-1000130
- https://www.rxlist.com/meropenem_vaborbactam/generic-drug.htm