Medication Monitor

Generic Name (Trade Name—Company)
August 28, 2018


(Xerava—Tetraphase Pharmaceuticals)
New agent approved for treatment of cIAI in patients aged 18 years and older

Tetraphase Pharmaceuticals announced FDA approval of eravacycline for the treatment of complicated intra-abdominal infections (cIAI) in patients aged 18 years and older.

In clinical trials, eravacycline was well tolerated and achieved high clinical cure rates in patients with cIAI, demonstrating statistical noninferiority to two widely used comparators—ertapenem and meropenem.

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

Eravacycline is contraindicated for use in patients with known hypersensitivity to eravacycline or to tetracycline-class antibacterial drugs. Life-threatening hypersensitivity reactions have been reported with use of the drug.

The most common adverse reactions observed in clinical trials (incidence ≥ 3%) were infusion-site reactions, nausea, and vomiting.