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

Get our weekly email update, and explore our library of practice updates and review articles.

PulmCCM is an independent publication not affiliated with or endorsed by any organization, society or journal referenced on the website. (Terms of Use | Privacy Policy)

0 Comments

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