VABOMERE®: a combination of meropenem and vaborbactam designed to address resistant Enterobacteriaceae1

VABOMERE® (meropenem and vaborbactam) is specifically designed to optimize the utility of meropenem1

Adding vaborbactam significantly reduces the MIC of meropenem alone in KPC-producing strains of Enterobacteriaceae1*

VABOMERE maintains the well established safety profile of meropenem2-4

Common adverse reactions for VABOMERE in the TANGO I trial were consistent with those reported for meropenem alone2-4

Vaborbactam inhibits a number of β-lactamases2

VABOMERE demonstrated in vitro activity against Enterobacteriaceae in the presence of a number of β-lactamases and ESBLs of the KPC, SME, TEM, SHV, CTX-M, CMY, and ACT groups2*

VABOMERE demonstrated a greater overall success rate in a clinical trial than a widely used cUTI treatment1,2,4†

98.4% with VABOMERE vs 94.3% with piperacillin/tazobactam1,2

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

Composite of both a clinical outcome of cure or improvement and a microbiologic outcome of eradication.2

cUTIs due to gram-negative bacteria are increasing mainly because of ESBL*-producing Enterobacteriaceae5

The most common causes of cUTI are gram-negative bacteria6

*ESBL=extended spectrum ß-lactamase.

  • Compared to younger patients, elderly patients are more likely to have a cUTI due to K. pneumoniae or P. aeruginosa7

ESBL-producing Enterobacteriaceae pose a serious threat8:

140,000
infections caused

26,000
resistant infections

1,700
deaths per year

Account for $40,000
in excess medical costs
per each infection per year

The threat of carbapenem-resistant Enterobacteriaceae (CRE) is serious and growing6,8

CRE are largely the result of the spread of KPC producers6

  • The threat of CRE has emerged due to the prevalence of Klebsiella pneumoniae carbapenemases (KPC)6
  • KPC is the most clinically relevant carbapenemase in the United States, accounting for >90% of carbapenemase-producing CRE9

Carbapenem-nonsusceptible Enterobacteriaceae continue to rise1

PERCENT OF CARBAPENEM-NONSUSCEPTIBLE
ENTEROBACTERIACEAE OVER TIME1

*National trend based on BD Insights Research Database.

Study description

A multicenter, large-scale retrospective data set of electronically captured microbiology and susceptibility results from 192 facilities that consecutively reported data during 2011 and 2017. The data set was stored in the BD Insights Research Database (Becton, Dickinson, and Company, Franklin Lakes, NJ). Nonduplicate isolates from urine, intra-abdominal, respiratory, skin, blood, and “other” sources from inpatients who had susceptibility results for Enterobacteriaceae were included.

First isolate of a species per 30 days.

VABOMERE patient profiles

Daisy, 70 yr

patient portrait

cUTI with a history of
significant bacterial infections
and recent broad-spectrum
antibiotics exposure

cUTI with a history of significant bacterial infections and recent broad-spectrum antibiotics exposure

Jackson, 75 yr

patient portrait

cUTI post-radical
prostatectomy and
indwelling catheter

cUTI post-radical prostatectomy and indwelling catheter

Steve, 61 yr

patient portrait

cUTI in a patient with a
history of chronic
lymphocytic leukemia (CLL)
and multiple hospitalizations

cUTI in a patient with a history of chronic lymphocytic leukemia (CLL) and multiple hospitalizations

These hypothetical case studies are meant to be illustrative. They are not intended to offer medical advice. Determination of
appropriate treatment is at the discretion of the physician. Treatment results may vary by patient.

References: 1. Data on file: Melinta Therapeutics, Inc. 2. VABOMERE [package insert]: Melinta Therapeutics, Inc. 3. Merrem I.V. [package insert]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; 2014. 4. Kaye KS, Bhowmick T, Metallidis S, et al. Effect of meropenem-vaborbactam vs piperacillin-tazobactam on clinical cure or improvement and microbial eradication in complicated urinary tract infection: The TANGO I randomized clinical trial. JAMA. 2018;319(8):788-799. doi: 10.1001/jama.2018.0438. 5. Pallett A, Hand K. Complicated urinary tract infections: practical solutions for the treatment of multiresistant gram‑negative bacteria. J Antimicrob Chemother. 2010;65(suppl3):iii25-iii33. 6. Flores‑Mireles AL, Walker JN, Caparon M, et al. Urinary tract infections: epidemiology, mechanisms of infection and treatment options. Nat Rev Microbiol. 2015;13(5):269-284. 7. Mocarski M, Zhao Q, Ding M, et al. Comparative epidemiology of complicated urinary tract infections (cUTI) by age among US hospitals. Abstract presented at: ID Week; October 10, 2014; Philadelphia, PA. 8. Centers for Disease Control and Prevention. Antibiotic/antimicrobial Resistance. Biggest Threats. Atlanta, GA: Centers for Disease Control and Prevention, US Dept of Health and Human Services; 2017. 9. Pollett S, Miller S, Hindler J, et al. Phenotypic and molecular characteristics of carbapenem‑resistant Enterobacteriaceae in a health care system in Los Angeles, California, from 2011 to 2013. J Clin Microbiol. 2014;52(11):4003‑4009.

Review the pharmacokinetics of VABOMERE

+ - 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.