Brand Name
Vabomere
Generic Name
Meropenem-Vaborbactam
View Brand Information FDA approval date: October 02, 2017
Classification: Penem Antibacterial
Form: Injection
What is Vabomere (Meropenem-Vaborbactam)?
VABOMERE 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 including pyelonephritis caused by designated susceptible bacteria.
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An Open-label, Multicentre, Single-Arm Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of VaboremⓇ (Meropenem-Vaborbactam) in Paediatric Population With Suspected or Confirmed Gram Negative Infections, Including But Not Restricted to Complicated Urinary Tract Infections
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Brand Information
VABOMERE (Meropenem-Vaborbactam)
1DOSAGE FORMS AND STRENGTHS
VABOMERE 2 grams (meropenem and vaborbactam) for injection, is supplied as a white to light yellow sterile powder for constitution in single-dose, clear glass vials containing meropenem 1 gram (equivalent to 1.14 grams meropenem trihydrate) and vaborbactam 1 gram.
2CONTRAINDICATIONS
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
3ADVERSE REACTIONS
The following adverse reactions are discussed in greater detail in the Warnings and Precautions section:
- Hypersensitivity Reactions
- Seizure Potential
- Rhabdomyolysis
- Clostridioides difficile-associated Diarrhea [see
- Risk of Breakthrough Seizures Due to Drug Interaction with Valproic Acid
- Thrombocytopenia
- Potential for Neuromotor Impairment
- Development of Drug-Resistant Bacteria
- Overgrowth of Non-susceptible Organisms
3.1Clinical 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.
VABOMERE was evaluated in a Phase 3 comparator-controlled clinical trial in cUTI, including pyelonephritis, which included 272 patients treated with VABOMERE and 273 patients treated with the comparator piperacillin/tazobactam 4.5 grams (piperacillin 4 g/tazobactam 0.5 g) every 8 hours. After a minimum of 15 doses of IV therapy, patients could be switched to oral levofloxacin (500 mg daily every 24 hours) to complete the treatment course. Mean duration of IV therapy was 8 days in both treatment groups. Mean duration of IV and oral therapy was 10 days; patients with baseline bacteremia could receive up to 14 days of treatment.
The mean age of patients treated with VABOMERE was 53 years (range 18 to 92 years), and 32% of patients were 65 years of age or older. Patients were predominantly female (66.5%) and White (93.4%). Most patients were enrolled in Europe (89.7%).
3.2Postmarketing Experience
The following adverse reactions have been identified during postapproval use of meropenem, a component of VABOMERE. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Musculoskeletal Disorders: rhabdomyolysis
4OVERDOSAGE
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.
5DESCRIPTION
VABOMERE (meropenem and vaborbactam) for injection is a combination product that contains meropenem, a synthetic penem antibacterial drug and vaborbactam, a cyclic boronic acid beta-lactamase inhibitor, for intravenous administration.
Meropenem, present as a trihydrate, is a white to light yellow crystalline powder, with a molecular weight of 437.52. The chemical name for meropenem trihydrate is (4
Figure 1: Structure of Meropenem Trihydrate
Vaborbactam is a white to off-white powder, with a molecular weight of 297.14. The chemical name for vaborbactam is (3
Figure 2: Structure of Vaborbactam
VABOMERE is supplied as a white to light yellow sterile powder for constitution that contains meropenem trihydrate, vaborbactam, and sodium carbonate. Each 50 mL glass vial contains 1 gram of meropenem (equivalent to 1.14 grams of meropenem trihydrate), 1 gram of vaborbactam, and 0.575 gram of sodium carbonate. The total sodium content of the mixture is approximately 0.25 grams (10.9 mEq)/vial.
Each vial is constituted and further diluted with 0.9% Sodium Chloride Injection, USP. Both the constituted solution and the diluted solution for intravenous infusion should be a colorless to light yellow solution
6REFERENCES
- Kawamura S, Russell AW, Freeman SJ, and Siddall, RA: Reproductive and Developmental Toxicity of Meropenem in Rats. Chemotherapy, 40:S238-250 (1992).
7HOW SUPPLIED/STORAGE AND HANDLING
VABOMERE 2 grams (meropenem and vaborbactam) for injection is supplied as a white to light yellow sterile powder for constitution in single-dose, clear glass vials (NDC 70842-120-01) sealed with a rubber stopper (not made with natural rubber latex) and an aluminum overseal. Each vial is supplied in cartons of 6 vials (NDC 70842-120-06).
Each vial contains 1 gram of meropenem (equivalent to 1.14 grams of meropenem trihydrate), 1 gram of vaborbactam, and 0.575 gram of sodium carbonate.
8PRINCIPAL DISPLAY PANEL - 2 g Vial Carton
Rx only
VABOMERE
2 g per vial*
*Meropenem 1 gram (equivalent
For Intravenous Infusion Only
MUST BE CONSTITUTED THEN DILUTED
Each vial contains meropenem 1 g,
Storage:
MEL042-R004
Contains 6 single dose 2 g vials
