VABOMERE®: A combination of meropenem and vaborbactam designed to address resistant Enterobacterales1

VABOMERE® (meropenem and vaborbactam) is specifically designed to restore the power of meropenem against KPC-producing Enterobacterales1

VABOMERE combines meropenem, a trusted carbapenem, with vaborbactam, a unique β-lactamase inhibitor1*

VABOMERE maintains the well established safety profile of meropenem1-3

Common adverse reactions for VABOMERE in the TANGO I trial were consistent with those reported for meropenem alone1-3

VABOMERE demonstrates activity against a broad spectrum of gram-negative pathogens1

In vitro activity against Enterobacter cloacae species complex, E coli, K pneumoniae, P aeruginosa, and ESBLs1*

VABOMERE demonstrated a greater overall success rate in a clinical trial than a widely used cUTI treatment1,3†

98.4% with VABOMERE vs 94.3% with piperacillin/tazobactam1

*The efficacy of VABOMERE in treating clinical infections due to these bacteria has not been established in adequate and well-controlled clinical trials, and 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.1

Infectious Diseases Society of America (IDSA) recommendations for the use of VABOMERE4

Recommendations from 2023 IDSA Guidance, CRE section, Questions 3.3, 3.4, and 3.5

  • VABOMERE® (meropenem and vaborbactam) is a preferred treatment option for cUTI caused by CRE
  • VABOMERE is a preferred treatment option for infections caused by CRE when carbapenemase testing results are either not available or negative
  • VABOMERE is slightly favored for KPC-producing infections, followed by ceftazidime-avibactam, and then imipenem-cilastatin-relebactam based on available data regarding clinical outcomes and emergence of resistance
    • IDSA noted that, in an observational study, clinical cure and 30-day mortality rates between patients who received VABOMERE and patients who received ceftazidime-avibactam numerically favored VABOMERE
    • IDSA suggests reserving cefiderocol for the treatment of infections caused by metallo-β- lactamase-producing Enterobacterales or glucose non-fermenting gram-negative organisms

Emergence of resistance to novel β-lactam antibiotics4

While the emergence of resistance is a concern with all of the novel β-lactams used to treat CRE infections, IDSA notes that the frequency may be highest for ceftazidime-avibactam.

~3%

with VABOMERE

10-20%

with ceftazidime-
avibactam

IDSA recommends always repeating susceptibility testing for patients previously infected with CRE who present with symptoms suggestive of a new or relapsed infection. Patients recently treated with ceftazidime-avibactam may be treated with a different novel β-lactam agent such as VABOMERE at least until culture and susceptibility data are available.

Development of clinical resistance in real-world use

In support of its findings, IDSA discussed a single observational study comparing the clinical outcomes of 26 patients who received VABOMERE and 105 patients who received ceftazidime-avibactam for at least 72 hours for the treatment of CRE infections.

Percentage of patients with recurrent CRE infections who developed resistance to initial therapy:
0% with VABOMERE (n= 0/3) vs. 20% with ceftazidime-avibactam (n=3/15)

These statements are not intended to imply comparable safety or effectiveness between VABOMERE and ceftazidime-avibactam. Consult the respective products’ Prescribing Information for further details, including complete indication and Important Safety Information. Observational studies contain material limitations and their results should be considered in light of the entire body of available evidence, including clinical trial data.

cUTIs due to gram-negative bacteria are increasing mainly because of ESBL-producing Enterobacterales5

The most common causes of cUTI are gram-negative bacteria5

ESBL=extended spectrum ß-lactamase.

  • Compared to younger patients, elderly patients are more likely to have a cUTI due to K pneumoniae or P aeruginosa6

Antibiotic resistance is a serious threat in the US7

Estimated numbers of infections and deaths caused by antibiotic resistance*:

bacteria
>2.8 million

infections

skull
>35,000

deaths

*Includes bacterial and fungal infections.

The 2019 CDC Antibiotic Resistance Threats in the United States report includes 18 antibiotic-resistant bacteria and fungi—classified as serious, urgent, or concerning. The report classifies carbapenem-resistant Enterobacterales (CRE) as urgent and ESBL-producing Enterobacterales as serious.7

KPC-producing CRE are prevalent in the US8,9

KPC was the most common gene detected among CRE isolates8

pie-chart

42,006 CRE isolates were tested from January 2017 through December 2019 by the Antibiotic Resistance Lab Network8

KPC-producing CRE have been identified in every state9

world-map

CRE—an urgent threat to your most vulnerable patients10

CRE infections are significantly more likely in patients with the following risk factors:

renal-icon

Chronic moderate-to-severe renal insufficiency3,10,11

renal-icon

≥3 comorbidities3,10

renal-icon

Prior CRE
infection10,11

renal-icon

Immune
compromise10-12

renal-icon

Prolonged hospitalization or antibiotic therapy10-13

renal-icon

Indwelling
catheters3,10,12

renal-icon

Long-term care
in a nursing facility11,12

High-risk patients frequently experience poor outcomes10

Vulnerable patients experience lower rates of clinical cure and higher rates of 28-day mortality.10

Delaying appropriate treatment of CRE infections can contribute to poor outcomes among critically ill patients.14,15

VABOMERE patient profiles

Donna, 70 yrs

patient portrait

Immunocompromised due to
ongoing immunotherapy and
chemotherapy, history of CRE
infection, admitted to ICU
for suspected cUTI

Immunocompromised due to ongoing immunotherapy and chemotherapy, history of CRE infection, admitted to ICU for suspected cUTI

Martin, 68 yrs

patient portrait

Admitted to ICU post
CABG with suspected cUTI
2 days post-urinary catheter
removal, multiple comorbid conditions

Admitted to ICU post CABG with suspected cUTI 2 days post-urinary catheter removal, multiple comorbid conditions

Timothy, 81 yrs

patient portrait

Nursing home resident
with indwelling catheter,
admitted to ICU with elevated
fever and confusion believed
to be related to cUTI

Nursing home resident with indwelling catheter, admitted to ICU with elevated fever and confusion believed to be related to cUTI

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.

Review the pharmacokinetics of VABOMERE

References: 1. VABOMERE [package insert]: Melinta Therapeutics, LLC. 2. Merrem IV [package insert]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; 2014. 3. 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. 4. Tamma PD, Aitken SL, Bonomo RA, et al. Infectious diseases society of America 2023 guidance on the treatment of antimicrobial resistant gram-negative infections. Infectious Diseases Society of America. Published June 7, 2023. Accessed June 27, 2023. https://www.idsociety.org/practice-guideline/amr-guidance/ 5. Flores-Mireles AL, Walker JN, Caparon M, Hultgren SJ. Urinary tract infections: epidemiology, mechanisms of infection and treatment options. Nat Rev Microbiol. 2015;13(5):269-284. 6. Mocarski M, Zhao Q, Ding M, Dixit S, Lodise T. Comparative epidemiology of complicated urinary tract infections (cUTI) by age among US hospitals. Abstract presented at: ID Week; October 10, 2014; Philadelphia, PA. 7. Antibiotic resistance threats in the United States 2019. Centers for Disease Control and Prevention. Accessed November 4, 2022. https://www.cdc.gov/drugresistance/biggest-threats.html 8. Sabour S, Huang JY, Bhatnagar A, et al. Detection and characterization of targeted carbapenem-resistant health care associated threats: findings from the antibiotic resistance laboratory network, 2017 to 2019. Antimicrob Agents Chemother. 2021;65(12):e0110521. 9. Hansen GT. Continuous evolution: perspective on the epidemiology of carbapenemase resistance among Enterobacterales and other gram-negative bacteria. Infect Dis Ther. 2021;10:75-92. 10. Alexander EL, Loutit J, Tumbarello M, et al. Carbapenem-resistant Enterobacteriaceae infections: results from a retrospective series and implications for the design of prospective clinical trials. Open Forum Infect Dis. 2017;4(2):ofx063. Published June 1, 2017. doi:10.1093/ofi d/ofx063 11. Alosaimy S, Lagnf AM, Morrisette T, et al. Real-world, multicenter experience with meropenem-vaborbactam for gram-negative bacterial infections including carbapenem-resistant Enterobacterales and Pseudomonas aeruginosa. Open Forum Infect Dis. 2021;8(8):ofab371. Published July 14, 2021. doi: 10.1093/ofi d/ofab371 12. Patients: information about CRE. Centers for Disease Control and Prevention. Updated November 13, 2019. Accessed November 4, 2022. https://www.cdc.gov/hai/organisms/cre/cre-patients.html 13. 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 II randomized clinical trial. Infect Dis Ther. 2018;7(4):439-455. 14. Lodise TP, Berger A, Altincatal A, et al. Antimicrobial resistance or delayed appropriate therapy-does one influence outcomes more than the other among patients with serious infections due to carbapenem-resistant versus carbapenem-susceptible Enterobacteriaceae? Open Forum Infect Dis. 2019;6(6):ofz194. Published April 23, 2019. doi:10.1093/ofi d/ofz194 15. Morill HJ, Pogue JM, Kaye KS, LaPlante KL. Treatment options for carbapenem resistant Enterobacteriaceae infections. Open Forum Infect Dis. 2015;2(2):ofv050. Published May 5, 2015. doi:10.1093/ofi d/ofv050

+ - 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.
  • Clostridioides 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.