Vaborbactam

VABOMERE is an antibacterial drug [see Microbiology (12.4) ] .

• VABOMERE (meropenem and vaborbactam) is a combination of meropenem, a penem antibacterial, and vaborbactam, a beta-lactamase inhibitor, indicated for the treatment of patients 18 years and older with complicated urinary tract infections (cUTI) including pyelonephritis caused by designated susceptible bacteria. ( 1.1 ) 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.ICD-10: N39.0

• 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 [see Warnings and Precautions (5.1) ] . Known hypersensitivity to the components of VABOMERE (meropenem and vaborbactam) or anaphylactic reactions to beta-lactams.contraindicated

Administer VABOMERE 4 grams (meropenem 2 grams and vaborbactam 2 grams) every 8 hours by intravenous infusion over 3 hours for up to 14 days, in patients 18 years of age and older with an estimated glomerular filtration rate (eGFR) ≥50 mL/min/1.73m 2 . ( 2.1 ) Dosage adjustment is recommended in patients with renal impairment who have an eGFR less than 50 mL/min/ 1.73m 2 . ( 2.2 ) eGFR As calculated using the Modification of Diet in Renal Disease (MDRD) formula; (mL/min/ 1.73m 2 ) Recommended Dosage Regimen for VABOMERE (meropenem and vaborbactam) All doses of VABOMERE are administered intravenously over 3 hours; , Doses adjusted for renal impairment should be administered after a hemodialysis session; , The total duration of treatment is for up to 14 days. Dosing Interval 30 to 49 VABOMERE 2 grams (meropenem 1 gram and vaborbactam 1 gram) Every 8 hours 15 to 29 VABOMERE 2 grams (meropenem 1 gram and vaborbactam 1 gram) Every 12 hours Less than 15 VABOMERE 1 gram (meropenem 0.5 grams and vaborbactam 0.5 grams) Every 12 hours See Full Prescribing Information for instructions for constituting supplied dry powder and subsequent required dilution. ( 2.3 ) See Full Prescribing Information for drug compatibilities. ( 2.4 ) 2.1 Recommended Dosage The recommended dosage of VABOMERE is 4 grams (meropenem 2 grams and vaborbactam 2 grams) administered every 8 hours by intravenous (IV) infusion over 3 hours in patients 18 years of age and older with an estimated glomerular filtration rate (eGFR) greater than or equal to 50 mL/min/1.73m 2 .

Hypersensitivity reactions were reported with the use of VABOMERE. Serious and occasionally fatal hypersensitivity (anaphylactic) reactions have been reported in patients receiving beta-lactam antibacterial drugs. Discontinue infusion if signs of acute hypersensitivity occur. ( 5.1 ) Seizures and other adverse Central Nervous System experiences have been reported during treatment with meropenem, a component of VABOMERE. ( 5.2 ) Rhabdomyolysis: If signs or symptoms of rhabdomyolysis are observed, discontinue VABOMERE and initiate appropriate therapy. ( 5.3 ) Clostridioides difficile -associated diarrhea has been reported with nearly all systemic antibacterial agents, including VABOMERE. Evaluate patients if diarrhea occurs. ( 5.4 ) Co-administration of meropenem with valproic acid or divalproex sodium reduces the serum concentration of valproic acid potentially increasing the risk of breakthrough seizures. ( 5.5 , 7.1 ) 5.1 Hypersensitivity Reactions Hypersensitivity reactions were reported in patients treated with VABOMERE in the clinical trials [see Adverse Reactions (6.1) ] . Serious and occasionally fatal hypersensitivity (anaphylactic) reactions and serious skin reactions have been reported in patients receiving therapy with beta-lactam antibacterial drugs. These reactions are more likely to occur in individuals with a history of sensitivity to multiple allergens. 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.

The following adverse reactions are discussed in greater detail in the Warnings and Precautions section: Hypersensitivity Reactions [see Warnings and Precautions (5.1) ] Seizure Potential [see Warnings and Precautions (5.2) ] Rhabdomyolysis [see Warnings and Precautions (5.3) ] Clostridioides difficile -associated Diarrhea [see Warnings and Precautions (5.4) ] Risk of Breakthrough Seizures Due to Drug Interaction with Valproic Acid [see Warnings and Precautions (5.5) ] Thrombocytopenia [see Warnings and Precautions (5.6) ] Potential for Neuromotor Impairment [see Warnings and Precautions (5.7) ] Development of Drug-Resistant Bacteria [see Warnings and Precautions (5.8) ] Overgrowth of Non-susceptible Organisms [see Warnings and Precautions (5.9) ] The most frequently reported adverse reactions occurring in ≥3% of patients treated with VABOMERE were headache, phlebitis/infusion site reactions, and diarrhea. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Melinta Therapeutics at 1-844-633-6568 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

8.1 Pregnancy Risk Summary Fetal malformations were observed in vaborbactam-treated rabbits, therefore advise pregnant women of the potential risks to the fetus. There are insufficient human data to establish whether there is a drug-associated risk of major birth defects or miscarriages with VABOMERE, meropenem, or vaborbactam in pregnant women. Malformations (supernumerary lung lobes, interventricular septal defect) were observed in offspring from pregnant rabbits administered intravenous vaborbactam during the period of organogenesis at doses approximately equivalent to or above the maximum recommended human dose (MRHD) based on plasma AUC comparison. The clinical relevance of the malformations is uncertain. No similar malformations or fetal toxicity were observed in offspring from pregnant rats administered intravenous vaborbactam during organogenesis or from late pregnancy and through lactation at a dose equivalent to approximately 1.6 times the MRHD based on body surface area comparison [see Data ] . No fetal toxicity or malformations were observed in pregnant rats and cynomolgus monkeys administered intravenous meropenem during organogenesis at doses up to 1.6 and 1.2 times the MRHD based on body surface area comparison, respectively.

Metabolism

Pharmacokinetic (PK) Parameters The mean PK parameters of meropenem and vaborbactam in healthy adults with normal renal function after single and multiple 3-hour infusions of VABOMERE 4 grams (meropenem 2 grams and vaborbactam 2 grams) administered every 8 hours are summarized in Table 4. The PK parameters of meropenem and vaborbactam were similar for single and multiple dose administration of VABOMERE.

In the event of overdose, discontinue VABOMERE and institute general supportive treatment. Meropenem and vaborbactam can be removed by hemodialysis. In subjects with end-stage renal disease (ESRD) administered meropenem 1 gram and vaborbactam 1 gram, the mean total recovery in dialysate following a hemodialysis session was 38% and 53% of the administered dose of meropenem and vaborbactam, respectively. No clinical information is available on the use of hemodialysis to treat VABOMERE overdosage.

• Aug 29, 2017NDANDA209776Rempex

1. 1Off Label Use1939%
2. 2Drug Ineffective For Unapproved Indication714%
3. 3Death510%
4. 4Erythema36.1%
5. 5Hypersensitivity36.1%
6. 6Rash36.1%
7. 7Acute Kidney Injury24.1%
8. 8Blood Culture Positive24.1%
9. 9Condition Aggravated24.1%
10. 10Creatinine Renal Clearance Increased24.1%
11. 11Drug Eruption24.1%
12. 12Drug Ineffective24.1%
13. 13Drug Resistance24.1%
14. 14Headache24.1%
15. 15Inflammation24.1%

The 10 most recently updated of 11 ClinicalTrials.gov registrations naming Vaborbactam as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• Dose-finding, Pharmacokinetics, and Safety of VABOMERE in Pediatric Subjects With Bacterial Infections
  Active not recruiting · Phase 1 · Interventional · 39 enrolled · Rempex (a wholly owned subsidiary of Melinta Therapeutics, LLC)
  NCT02687906updated 2026-06-04
• A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Meropenem-Vaborbactam in Children With Complicated Urinary Tract Infection, Including Acute Pyelonephritis
  Active not recruiting · Phase 2 · Interventional · 66 enrolled · Rempex (a wholly owned subsidiary of Melinta Therapeutics, LLC)
  NCT06672978updated 2026-06-03
• A Study to Assess How Vaborem® is Taking up in the Body and Tolerated in Paediatric Patients With Gram Negative Infections, Including But Not Restricted to Complicated Urinary Tract Infections
  Recruiting · Phase 2 · Interventional · 44 enrolled · Menarini Group
  NCT06828848updated 2026-02-04
• Microbiological and Clinical Characteristics of Severe Infections Caused by Carbapenem-Resistant Enterobacterales
  Not yet recruiting · Observational · 100 enrolled · Fondazione Policlinico Universitario Agostino Gemelli IRCCS
  NCT07160569updated 2025-09-08
• Optimising TREATment for Severe Gram-Negative Bacterial Infections
  Recruiting · Phase 4 · Interventional · 600 enrolled · National University of Singapore
  NCT07004049updated 2025-06-04
• Nosocomial Infections in ECMO Patients
  Recruiting · Observational · 200 enrolled · Policlinico Hospital
  NCT05566665updated 2024-07-10
• Use of New Antibiotics in Sweden
  Completed · Observational · 41 enrolled · Uppsala University
  NCT05048693updated 2024-06-18
• Efficacy, Safety, Tolerability of Vabomere Compared to Best Available Therapy in Treating Serious Infections in Adults
  Completed · Phase 3 · Interventional · 77 enrolled · Rempex (a wholly owned subsidiary of Melinta Therapeutics, Inc.)
  NCT02168946updated 2019-03-04
• A Study of Meropenem-Vaborbactam Versus Piperacillin/Tazobactam in Participants With Hospital-Acquired and Ventilator-Associated Bacterial Pneumonia
  Withdrawn · Phase 3 · Interventional · 0 enrolled · Melinta Therapeutics, Inc.
  NCT03006679updated 2019-01-11
• Evaluate Effects of Meropenem-Vaborbactam on QT/QTc in Healthy Volunteers
  Completed · Phase 1 · Interventional · 53 enrolled · Rempex (a wholly owned subsidiary of Melinta Therapeutics, Inc.)
  NCT03564158updated 2019-01-10

Frequently asked questions

How does Vaborbactam work?

VABOMERE is an antibacterial drug [see Microbiology (12.4) ] .

What is Vaborbactam used for?

According to FDA labeling, Vaborbactam carries indications including: VABOMERE (meropenem and vaborbactam) is a combination of meropenem, a penem antibacterial, and vaborbactam, a beta-lactamase inhibitor, indicated for the treatment of patients 18 years and older with complicated urinary tract infections (cUTI) including pyelonephritis caused by designated susceptible bacteria. ( 1.1 ) 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.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Vaborbactam?

Vaborbactam is classified as beta Lactamase Inhibitor, beta Lactamase Inhibitors.

What are the brand names for Vaborbactam?

Vaborbactam is marketed under brand names including Vabomere.

What are the contraindications for Vaborbactam?

Vaborbactam labeling lists contraindications including: 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 [see Warnings and Precautions (5.1) ] . Known hypersensitivity to the components of VABOMERE (meropenem and vaborbactam) or anaphylactic reactions to beta-lactams.. Always consult the full prescribing information and a clinician.