TANGO I: A multicenter clinical trial in which the efficacy of VABOMERE® was evaluated against a widely used cUTI treatment1

VABOMERE® (meropenem and vaborbactam) demonstrated an overall success rate of 98.4% vs 94.3% with piperacillin/tazobactam1-3

  • Overall success at the end of intravenous treatment (EOIVT) included clinical cure or improvement and microbiological eradication1,2*
  • Clinical cure and microbiological eradication was assessed at the test of cure (TOC) visit approximately 7 days after completion of treatment1‡§

CLINICAL AND MICROBIOLOGICAL RESPONSE RATES (m-MITT)

clinical and microbiological response rates

*EOIVT includes patients with organisms resistant to piperacillin/tazobactam at baseline.2,3

Primary endpoint: 4.1% treatment difference (95% CI, 0.3%&-8.8%) exceeded the lower limit for both noninferiority and superiority.2,3

TOC visit excludes patients with organisms resistant to piperacillin/tazobactam at baseline in both arms.2,3

§3.3% treatment difference (95% CI, -6.2%&-13%).2,3

TANGO I Study description

A double-blind, double-dummy, randomized, multicenter noninferiority clinical trial evaluated 545 adult patients with cUTI, including acute pyelonephritis. Patients were treated with VABOMERE (meropenem 2 g/vaborbactam 2 g) or piperacillin/tazobactam (piperacillin 4 g/tazobactam 0.5 g) every 8 hours. After a minimum of 15 doses of IV therapy, patients who met prespecified criteria of improvement could be switched to oral levofloxacin.1,2

Primary endpoint: Overall success at the EOIVT (composite of both a clinical outcome of cure or improvement and a microbiologic outcome of eradication) in the m-MITT population.1,2

Clinical and microbiological response was also assessed at the TOC visit (approximately 7 days after completion of treatment) in the m-MITT population and required both a clinical outcome of cure and a microbiological outcome of eradication.1,2

See examples of VABOMERE patients

VABOMERE demonstrated the efficacy needed to meet the challenges of cUTI, including pyelonephritis1

OVERALL SUCCESS RATE AT EOIVT BY INFECTION TYPE (m-MITT)1,3*

Overall success rate at EOIVT by infection type (mMITT)

*Includes patients with organisms resistant to piperacillin/tazobactam at baseline.1

Proven safety and tolerability in the TANGO I trial1,2

ADVERSE REACTIONS OCCURRING IN 1% OR GREATER OF PATIENTS
RECEIVING VABOMERE IN THE PHASE 3 CLINICAL TRIAL IN cUTI1,2

Adverse Reactions

aPiperacillin/tazobactam 4.5 grams (piperacillin 4 g/tazobactam 0.5 g) IV infused over 30 minutes every 8 hours.

bInfusion site reactions include infusion/injection site phlebitis, infusion site thrombosis, and infusion site erythema.

cHypersensitivity includes hypersensitivity, drug hypersensitivity, anaphylactic reaction, rash urticaria, and bronchospasm.

The majority of adverse events with VABOMERE were either mild or moderate in severity3

Fewer discontinuations due to adverse reactions with VABOMERE than with piperacillin/tazobactam1

  • Adverse reactions leading to discontinuation were reported in 2.9% (8/272) vs 5.1% (14/273) of patients receiving VABOMERE vs patients receiving piperacillin/tazobactam, respectively1
  • The most frequently reported adverse reactions leading to discontinuation of VABOMERE were hypersensitivity (1.1%; 3/272) and infusion‑related reactions (0.7%; 2/272)1

VABOMERE maintains the well‑established safety profile of meropenem1,2,4

  • The most common adverse reactions for VABOMERE, as seen in the Phase 3 clinical trials, were consistent with those reported for meropenem alone1,2,4

Study description

A double-blind, double dummy, randomized, multicenter noninferiority clinical trial evaluated 545 adult patients with cUTI, including acute pyelonephritis. Patients were treated with VABOMERE (meropenem 2 g-vaborbactam 2 g) or piperacillin/tazobactam (piperacillin 4 g/tazobactam 0.5 g) every 8 hours. After a minimum of 15 doses of IV therapy, patients who met prespecified criteria of improvement could be switched to oral levofloxacin.1,2

Learn about dosing and administration

References: 1. 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. 2. Vabomere [package insert]. Melinta Therapeutics, Inc. 3. Data on file: Melinta Therapeutics, Inc. 4. Merrem I.V. [package insert]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; 2014.

+ - 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.

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