Medication Monitor

Generic Name (Trade Name—Company)
August 21, 2019


(Xenleta—Nabriva Therapeutics )
New antibiotic targets community-acquired bacterial pneumonia in adults

On August 19, FDA approved lefamulin to treat adults with community-acquired bacterial pneumonia. According to CDC data, each year in the United States about 1 million people are hospitalized with community-acquired pneumonia, and 50,000 people die from the disease.

Lefamulin's safety and efficacy, taken either orally or intravenously, was evaluated in two clinical trials with 1,289 patients who had CABP. Treatment with lefamulin was compared with treatment using another antibiotic, moxifloxacin, with or without linezolid. The trials showed that patients treated with lefamulin had similar rates of clinical success as those treated with moxifloxacin with or without linezolid. 

The most common adverse reactions reported in patients taking lefamulin included diarrhea, nausea, injection-site reactions, elevated liver enzymes, and vomiting.

Lefamulin may cause prolonged QT interval. Patients with prolonged QT interval, certain arrhythmias, receiving antiarrhythmic agents for certain irregular heart rhythms, or receiving other drugs that prolong the QT interval should avoid lefamulin. In addition, patients should not use the drug if they have a known hypersensitivity to lefamulin (or any of its components) or to any other members of the pleuromutilin antibiotic class.

Pregnant women and women who could become pregnant should be advised of the potential risks to a fetus. Women who could become pregnant should be advised to use effective contraception during treatment and for 2 days after the final dose.