Medication Monitor

Generic Name (Trade Name—Company)
August 30, 2017

Meropenem, Vaborbactam

(Vabomere—Rempex Pharmaceuticals)
New antibacterial agent targets complicated urinary tract infections

FDA has approved Vabomere, a new agent containing meropenem, an antibacterial, and vaborbactam, which inhibits certain types of resistance mechanisms used by bacteria, for treatment of adults with complicated urinary tract infections (cUTI), including pyelonephritis caused by specific bacteria.

Safety and efficacy were evaluated in a clinical trial with 545 adults with cUTI, including those with pyelonephritis. At the end of I.V. treatment with the agent, approximately 98% of patients treated with Vabomere compared with approximately 94% of patients treated with piperacillin/tazobactam, another antibacterial drug, had cure/improvement in symptoms and a negative urine culture test.

Approximately seven days after completing treatment, approximately 77% of patients treated with Vabomere compared with approximately 73% of patients treated with piperacillin/tazobactam had resolved symptoms and a negative urine culture. 

The most common adverse reactions in patients taking Vabomere were headache, infusion site reactions, and diarrhea. The drug is associated with serious risks, including allergic reactions and seizures. It should not be used in patients with a history of anaphylaxis to beta-lactams.

To reduce the development of drug-resistant bacteria and maintain the effectiveness of antibacterial drugs, Vabomere should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria.