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Xenleta (léfamuline) has been approved to treat adults with bacterial pneumonia acquired in the community, the US Food and Drug Administration said Tuesday.
The dose of Xenleta is either 600 mg once every 12 hours or 150 mg once every 12 hours for five to seven days. Patients can start intravenous or oral therapy, or can switch from intravenous to oral treatment to speed up discharge.
The approval was based on data from two clinical trials involving 1,289 patients with community-acquired bacterial pneumonia, comparing Xenleta taken orally or intravenously with moxifloxacin with or without linezolid. The clinical success rates of patients treated with Xenleta were similar to those of patients treated with moxifloxacin with or without linezolid.
The most common side effects reported with Xenleta are diarrhea, nausea, injection site reactions, elevated liver enzymes and vomiting. The FDA notes that Xenleta can cause a lengthening of the QT interval. Therefore, patients with arrhythmia, those taking antiarrhythmic agents and patients receiving other drugs lengthening the QT interval should avoid Xenleta.
Patients with known hypersensitivity to lecmaulin, other pleuromutilin antibiotics or any of the Xenleta components are also contraindicated. Healthcare providers should inform pregnant women and women who may become pregnant of the risk of adverse effects to the fetus associated with Xenleta, as shown by animal studies. Women who may become pregnant should use effective contraception during and two days after taking Xenleta.
Xenleta's approval was granted to Nabriva Therapeutics. The drug is expected to be available in mid-September at a wholesale purchase price of $ 205 per day intravenous treatment and $ 275 per day oral treatment.
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