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Xenleta Approval History

Reviewed by J.Stewart BPharm Last updated on Sep 9, 2019.

FDA Approved: Yes (First approved August 19, 2019)
Brand name: Xenleta
Generic name: lefamulin
Dosage form: Tablets and Injection
Company: Nabriva Therapeutics plc
Treatment for: Pneumonia

Xenleta (lefamulin) is a first-in-class, semi-synthetic pleuromutilin antibiotic for the treatment of community-acquired bacterial pneumonia (CABP).

  • Xenleta is administered via intravenous infusion or oral tablets.
    • Intravenous Infusion: every 12 hours over 60 minutes for 5 to 7 days (with the option to switch to oral tablets to complete the course).
    • Tablets: every 12 hours for 5 days. The tablets should be taken at least one hour before a meal or two hours after a meal and should be swallowed whole with water.
  • Serious allergic reactions can occur in patients taking Xenleta, and any allergic reaction requires immediate treatment. Xenleta should not be used in patients with known hypersensitivity to Xenleta or pleuromutilins.
  • Xenleta may cause harm to a developing fetus. Females of reproductive potential should use effective contraception during treatment with Xenleta, and for two days after the final dose. Breastfeeding women should pump and discard milk during treatment with Xenleta, and for two days after the final dose.
  • Clostridium difficile-associated diarrhea (CDAD) has been reported with nearly all systemic antibacterial agents, including Xenleta. Severity can range from mild diarrhea to fatal colitis, even as late as two or more months after having taken the last dose. Patients should contact their healthcare provider as soon as possible if they experience diarrhea.
  • Common side effects for Xenleta Injection include administration site reactions, hepatic enzyme elevation, nausea, hypokalemia, insomnia, and headache.
    Common side effects for Xenleta Tablets include diarrhea, nausea, vomiting, and hepatic enzyme elevation.

Development History and FDA Approval Process for Xenleta

DateArticle
Aug 19, 2019Approval FDA Approves Xenleta (lefamulin) to Treat Community-Acquired Bacterial Pneumonia (CABP)
Feb 19, 2019Nabriva Therapeutics Announces Acceptance of New Drug Applications by the FDA for Intravenous and Oral Lefamulin to Treat Community-Acquired Bacterial Pneumonia in Adults
Dec 20, 2018Nabriva Therapeutics Submits New Drug Applications to U.S. Food and Drug Administration for Intravenous and Oral Lefamulin to Treat Community-Acquired Bacterial Pneumonia in Adults
May 21, 2018Nabriva Therapeutics Announces Positive Topline Results from Pivotal Phase 3 Clinical Trial of Oral Lefamulin for the Treatment of Community-Acquired Bacterial Pneumonia
Sep 18, 2017Nabriva Therapeutics Announces Positive Topline Results from Global, Phase 3 Clinical Trial Evaluating IV and Oral Lefamulin for the Treatment of Community-Acquired Bacterial Pneumonia
Apr 11, 2016Nabriva Initiates Second Phase 3 Clinical Trial of Lefamulin (“LEAP 2”) in Patients with Community-Acquired Bacterial Pneumonia (CABP)

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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