STEPS

New Drug Reviews

Lefamulin (Xenleta) for the Treatment of Community-Acquired Bacterial Pneumonia

 

Am Fam Physician. 2020 Sep 15;102(6):373-374.

Lefamulin (Xenleta) is an antibiotic recently developed for treating community-acquired bacterial pneumonia in adults. It is a pleuromutilin, a class of antibiotic that inhibits bacterial protein synthesis. Although not recommended by the Infectious Diseases Society of America guidelines for community-acquired pneumonia, it is mentioned as an option that requires further research.1,2

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DrugDosageDose formCost*

Lefamulin (Xenleta) oral tablets

600 mg orally every 12 hours for five days

600-mg tablets

$1,360


*—Estimated lowest GoodRx price for five-day course of treatment. Actual cost will vary with insurance and by region. Information obtained at https://www.goodrx.com (accessed July 31, 2020; zip code: 66211).

DrugDosageDose formCost*

Lefamulin (Xenleta) oral tablets

600 mg orally every 12 hours for five days

600-mg tablets

$1,360


*—Estimated lowest GoodRx price for five-day course of treatment. Actual cost will vary with insurance and by region. Information obtained at https://www.goodrx.com (accessed July 31, 2020; zip code: 66211).

Safety

Similar to azithromycin (Zithromax), clarithromycin (Biaxin), and fluoroquinolones, lefamulin has the potential to prolong the QT interval and should not be used in patients taking medications that also affect the QT interval or cardiac conduction. Lefamulin has been shown to cause risk of fetal harm in animal studies, and it should not be used in pregnant patients.

Lefamulin has the potential to interact with multiple medications metabolized in the liver with the CYP3A4 enzyme, including phenytoin (Dilantin), rifampin, and azole antifungals. This may decrease the effectiveness of lefamulin and increase the risk of adverse effects.3

Tolerability

In clinical studies, diarrhea, nausea, and vomiting were more common with oral lefamulin than with oral moxifloxacin (Avelox). Diarrhea occurred in 12% of patients treated with oral lefamulin compared with 1% of patients receiving oral moxifloxacin. Administration site reactions with intravenous lefamulin occurred in 7.7% of patients vs. 3.7% of patients treated with intravenous moxifloxacin.

Overall, adverse effects are mild to moderate in severity. In clinical trials, about 3.3% of patients discontinued treatment because of adverse effects.35

Effectiveness

In laboratory testing, lefamulin is effective against typical and atypical pathogens in patients with community-acquired bacterial pneumonia, including Streptococcus pneumoniae, methicillin-sus

Address correspondence to Todd M. Felix, MD, at tfelix@pennstatehealth.psu.edu. Reprints are not available from the authors.

Author disclosure: No relevant financial affiliations.

References

show all references

1. Metlay JP, Waterer GW, Long AC, et al. Diagnosis and treatment of adults with community-acquired pneumonia. An official clinical practice guideline of the American Thoracic Society and Infectious Diseases Society of America. Am J Respir Crit Care Med. 2019;200(7):e45–e67....

2. Rodvold KA. Introduction: lefamulin and pharmacokinetic/pharmacodynamic rationale to support the dose selection of lefamulin. J Antimicrob Chemother. 2019;74(suppl 3):iii2–iii4.

3. Daily Med. Drug label information: Xenleta—lefamulin acetate injection, solution and lefamulin acetate tablet, coated. Updated February 12, 2020. Accessed August 12, 2020. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=101db63d-2fe2-48df-8506-1382d6dcd4a3

4. File TM, Goldberg L, Das A, et al. Efficacy and safety of intravenous-to-oral lefamulin, a pleuromutilin antibiotic, for the treatment of community-acquired bacterial pneumonia: the Phase III Lefamulin Evaluation Against Pneumonia (LEAP 1) trial [published correction appears in Clin Infect Dis. 2020;70(11):2459]. Clin Infect Dis. 2019;69(11):1856–1867.

5. Alexander E, Goldberg L, Das AF, et al. Oral lefamulin vs moxifloxacin for early clinical response among adults with community-acquired bacterial pneumonia: the LEAP 2 randomized clinical trial. JAMA. 2019;322(17):1661–1671.

STEPS new drug reviews cover Safety, Tolerability, Effectiveness, Price, and Simplicity. Each independent review is provided by authors who have no financial association with the drug manufacturer.

This series is coordinated by Allen F. Shaughnessy, PharmD, MMedEd, assistant medical editor.

A collection of STEPS published in AFP is available at https://www.aafp.org/afp/steps.

 

 

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