Company: The Medicines Company
Approval Status: Approved August 2017
Specific Treatments: complicated urinary tract infections
Vabomere is a combination of meropenem, a penem antibacterial, and vaborbactam, a beta-lactamase inhibitor.
Vabomere is specifically indicated for the treatment of patients 18 years and older with complicated urinary tract infections (cUTI) including pyelonephritis caused by designated susceptible bacteria.
Vabomere is supplied as an injection for intravenous administration. 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/1.73m2. Dosage adjustment is recommended in patients with renal impairment who have an eGFR less than 50 mL/min/ 1.73m2. Please see drug label for specific adjustments.
The FDA approval of Vabomere was based on TANGO-1, a Phase III, multi-center, randomized, double-blind, double-dummy study to evaluate the efficacy, safety and tolerability of Vabomere compared to piperacillin-tazobactam in the treatment of cUTI, including acute pyelonephritis, in adults. The trial enrolled 550 adult patients who were randomized 1:1 to receive VAabomere (meropenem 2g – vaborbactam 2g) as a three-hour IV infusion every eight hours, or piperacillin 4g – tazobactam 500mg as a 30-minute IV infusion every eight hours, each for up to 10 days. The primary assessment was performed in the microbiologic modified intent-to-treat (mMITT) patient population, and was defined as overall success of clinical outcome (cure or improvement) and microbiologic outcome of eradication (baseline bacterial pathogen reduced to < 104 CFU/ml). Overall success was observed in 183/186 patients (98.4%) in the meropenem-vaborbactam group and in 165/175 patients (94.3%) in the piperacillin-tazobactam group – a difference of 4.1% (95% CI: 0.3% to 8.8%).
Adverse effects associated with the use of Vabomere may include, but are not limited to, the following:
- phlebitis/infusion site reactions
Mechanism of Action
Vabomere is a combination of meropenem and vaborbactam. The meropenem component of Vabomere is a penem antibacterial drug. The bactericidal action of meropenem results from the inhibition of cell wall synthesis. Meropenem penetrates the cell wall of most gram-positive and gram-negative bacteria to bind penicillin-binding protein targets. Meropenem is stable to hydrolysis by most beta-lactamases, including penicillinases and cephalosporinases produced by gram-negative and gram-positive bacteria, with the exception of carbapenem hydrolyzing beta-lactamases. The vaborbactam component of Vabomere is a non-suicidal beta-lactamase inhibitor that protects meropenem from degradation by certain serine beta-lactamases such as Klebsiella pneumoniae carbapenemase. Vaborbactam does not have any antibacterial activity. Vaborbactam does not decrease the activity of meropenem against meropenem-susceptible organisms.
For additional information regarding Vabomere or complicated urinary tract infections, please visit http://www.vabomere.com/