VABOMERE® has 32-fold more in vitro activity than meropenem alone1*

Adding vaborbactam significantly reduces the MIC of meropenem alone1

  • Meropenem alone and in combination with vaborbactam was evaluated against KPC-producing strains of Enterobacteriaceae involving >1900 isolates1

MIC90 FOR MEROPENEM VS VABOMERE® (MEROPENEM AND VABORBACTAM)1†

*In vitro activity does not necessarily correlate with clinical efficacy.

Study description

The activity of meropenem in combination with vaborbactam against >1900 KPC-producing clinical isolates of Enterobacteriaceae was evaluated in both prospective and retrospective in vitro studies. Vaborbactam potentiated the activity of meropenem in these studies; lowest concentrations of the antibiotic at which 90% of the isolates were inhibited (MIC90s) were >32 μg/mL for meropenem alone and were reduced to 0.5 to 1 μg/mL in the presence of vaborbactam. This activity was consistent across different studies.1

VABOMERE restored activity of meropenem against select KPC-producing isolates2

Over 90% of the 135 KPC-producing isolates had an MIC <1 μg/mL2*

MICs OF VABOMERE AND MEROPENEM2,3*

*In vitro activity does not necessarily correlate with clinical efficacy.

  • 135 KPC-producing Enterobacteriaceae clinical isolates were evaluated, in a study of >14,000 gram-negative clinical isolates, from 82 hospitals worldwide in 20142
  • A total of 135 (50.9% of the CRE isolates; 1.3% of the overall population) isolates carried blaKPC genes, including 60 blaKPC-2, 74 blaKPC-3, and 1 blaKPC-4 gene2
  • In this study, 133 of the 135 organisms of the KPC-producing isolates were inhibited by meropenem-vaborbactam at ≤2 μg/mL, and all isolates were inhibited by this combination at ≤8 μg/mL2

Study description

A total of 14,304 gram-negative bacterial clinical isolates were consecutively collected in 82 worldwide hospitals. All isolates were tested for susceptibility against meropenem-vaborbactam and comparators using the reference broth microdilution method as described by the Clinical and Laboratory Standards Institute (CLSI). Meropenem was combined with vaborbactam at a fixed concentration of 8 μg/mL.2

VABOMERE was designed to address the challenge of resistant Enterobacteriaceae1

Vaborbactam inhibits a number of β-lactamases including KPC-2 and KPC-33

  • VABOMERE demonstrated in vitro activity against Enterobacteriaceae in the presence of some β-lactamases and ESBLs of the KPC, SME, TEM, SHV, CTX-M, CMY, and ACT groups3*

VABOMERE RESTORES THE POTENCY OF MEROPENEM1†

Potency of VABOMERE vs Meropenem alone.

*In vitro activity does not necessarily correlate with clinical efficacy.

39 KPC-producing isolates of Enterobacteriaceae were obtained from JMI Laboratories (SENTRY surveillance program). Strains presented above are representative of the broad distribution of meropenem MIC values in the presence of vaborbactam 8 μg/mL.1

See the clinical data of VABOMERE

References: 1. Data on file: Melinta Therapeutics, Inc. 2. Castanheira M, Huband MD, Mendes RE, Flamm RK. Meropenem-vaborbactam tested against contemporary gram-negative isolates collected worldwide during 2014, including carbapenem-resistant, KPC-producing, multidrug-resistant, and extensively drug-resistant Enterobacteriaceae. Antimicrob Agents Chemother. 2017;61(9). doi:10.1128/AAC.00567-17. 3. Hecker SJ, Reddy KR, Totrov M, et al. Discovery of a cyclic boronic acid β-lactamase inhibitor (RPX7009) with utility vs class A serine carbapenemases. J Med Chem. 2015;58(9).

+ - INDICATIONS AND USAGE

VABOMERE® (meropenem and vaborbactam) is indicated for the treatment of patients 18 years of age and older with complicated urinary tract infections (cUTI) including pyelonephritis caused by the following susceptible microorganisms: Escherichia coli, Klebsiella pneumoniae, and Enterobacter cloacae species complex.

To reduce the development of drug-resistant bacteria and maintain the effectiveness of VABOMERE and other antibacterial drugs, VABOMERE should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria.

IMPORTANT SAFETY INFORMATION

Contraindications

VABOMERE is contraindicated in patients with known hypersensitivity to any components of VABOMERE (meropenem and vaborbactam), or to other drugs in the same class or in patients who have demonstrated anaphylactic reactions to beta-lactam antibacterial drugs.

Warnings and Precautions

  • Hypersensitivity reactions were reported in patients treated with VABOMERE in the clinical trials. Serious and occasionally fatal hypersensitivity (anaphylactic) reactions and serious skin reactions have been reported in patients receiving therapy with beta-lactam antibacterial drugs. There have been reports of individuals with a history of penicillin hypersensitivity who have experienced severe hypersensitivity reactions when treated with another beta-lactam antibacterial drug. If an allergic reaction to VABOMERE occurs, discontinue the drug immediately.
  • Seizures and other adverse Central Nervous System (CNS) experiences have been reported during treatment with meropenem, which is a component of VABOMERE. Close adherence to the recommended dosage regimens is urged, especially in patients with known factors that predispose to convulsive activity.
  • Clostridium difficile-associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including VABOMERE, and may range in severity from mild diarrhea to fatal colitis. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents. If CDAD is suspected or confirmed, ongoing antibacterial drug use not directed against C. difficile may need to be discontinued.
  • The concomitant use of VABOMERE and valproic acid or divalproex sodium is generally not recommended. Case reports in the literature have shown that co-administration of carbapenems, including meropenem, to patients receiving valproic acid or divalproex sodium results in a reduction in valproic acid concentrations. The valproic acid concentrations may drop below the therapeutic range as a result of this interaction, therefore increasing the risk of breakthrough seizures. If administration of VABOMERE is necessary, consider supplemental anticonvulsant therapy.
  • In patients with renal impairment, thrombocytopenia has been observed in patients treated with meropenem, but no clinical bleeding has been reported.
  • Alert patients receiving VABOMERE on an outpatient basis regarding adverse reactions such as seizures, delirium, headaches and/or paresthesias that could interfere with mental alertness and/or cause motor impairment.
  • Prescribing VABOMERE in the absence of a proven or strongly suspected bacterial infection is unlikely to provide benefit to the patient and increases the risk of drug-resistant bacteria.
  • As with other antibacterial drugs, prolonged use of VABOMERE may result in overgrowth of nonsusceptible organisms.

Adverse Reactions

The most frequently reported adverse reactions occurring in ≥3% of patients treated with VABOMERE were headache, phlebitis/infusion site reactions, and diarrhea.

Please see full Prescribing Information.