Dec 082017

Intensivists have another antibiotic combination to treat severe infections caused by gram-negative bacteria with the FDA’s approval of Vabomere (meropenem, combined with the beta-lactamase inhibitor called vaborbactam). FDA approved Vabomere only for the treatment of complicated urinary tract infections (such as pyelonephritis). However, licensed U.S. physicians routinely prescribe FDA-approved antibiotics “off-label” for other indications.

Meropenem-vaborbactam is the first carbapenem-based beta-lactamase inhibitor combination product in the U.S. Beta-lactamases are included in multiple penicillin-based combination products (Unasyn, Zosyn, Augmentin, et al).

Vabomere’s safety and efficacy were demonstrated among 545 patients with complicated UTIs randomized to meropenem-vaborbactam or piperacillin/tazobactam (Zosyn). A week after completing intravenous antibotic treatment, about 77% of patients treated with Vabomere had resolved symptoms and a negative urine culture, compared to 73% taking pip/tazo.

Vabomere was approved through the FDA’s new fast-track program for antibiotics, Generating Antibiotic Incentives Now (GAIN), after being designated as a “qualified infectious disease product.”

The drug's adverse reactions included infusion site reactions, diarrhea, and headache. Allergic reactions and seizures have been reported. Patients with a history of anaphylaxis after taking penicillin or other beta-lactams should not receive meropenem-vaborbactam.

To prevent (or slow) the emergence and spread of multi-drug resistant organisms, FDA cautioned physicians not to over-use meropenem-vaborbactam, advising it “ should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria.”

Hopefully physicians will heed that call, as carbapenem-resistant organisms are on the rise in the U.S.

Read more: FDA website

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Meropenem-vaborbactam (Vabomere), a new combination antibiotic + inhibitor, now available