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As antibiotic resistance continues to rise,1-3* so does the need for newer alternatives to older antibiotics—and this means that at-risk patients could use a closer look.3,4 That's where XENLETA, the first and only oral pleuromutilin for patients with community-acquired bacterial pneumonia (CABP), comes in.5 XENLETA is a treatment with a novel mechanism of action, which gives it a low risk of resistance and low probability of cross-resistance.5 As a fluoroquinolone alternative, XENLETA is a treatment option for CABP patients at risk that offers4,5: |
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Proven efficacy in as little as 5 days of oral therapy, with results sustained at Test of Cure (5 to 10 days after the last dose)5 |
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Coverage against Gram-positive, Gram-negative, and atypical pathogens as an empiric monotherapy5 |
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Demonstrated safety profile, with no dose adjustments needed for renal impairment or mild hepatic impairment5 |
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* Resistance rates have been documented from 2010 to 2019 (for tetracyclines, from 2015 to 2019) by JMI Labs and the SENTRY Antimicrobial Surveillance Program; dataset available at sentry-mvp.com/jmilabs.com (accessed December 3, 2019). |
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Indication and Important Safety InformationIndicationXENLETA is a pleuromutilin antibacterial indicated for the treatment of adults withcommunity-acquired bacterial pneumonia (CABP) caused by the following susceptible microorganisms: Streptococcus pneumoniae, Staphylococcus aureus (methicillin-susceptible isolates), Haemophilus influenzae, Legionella pneumophila, Mycoplasma pneumoniae, and Chlamydophila pneumoniae. UsageTo reduce the development of drug-resistant bacteria and maintain the effectiveness of XENLETA and other antibacterial drugs, XENLETA should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. Important Safety InformationCONTRAINDICATIONSXENLETA is contraindicated in patients with known hypersensitivity to XENLETA or pleuromutilins. XENLETA tablets are contraindicated for use with CYP3A4 substrates that prolong the QT interval. WARNINGS AND PRECAUTIONSXENLETA has the potential to prolong the QT interval. Avoid XENLETA in patients with known QT prolongation, ventricular arrhythmias, and patients receiving drugs that may prolong the QT interval. Based on animal studies, XENLETA may cause fetal harm. Advise females of reproductive potential of the potential risk to the fetus and to use effective contraception. Clostridium difficile-associated diarrhea (CDAD) has been reported with nearly all systemic antibacterial agents, including XENLETA, with severity ranging from mild diarrhea to fatal colitis. Evaluate if diarrhea occurs. ADVERSE REACTIONSThe most common adverse reactions (≥2%) for (a) XENLETA Injection are administration site reactions, hepatic enzyme elevation, nausea, hypokalemia, insomnia, and headache and (b) XENLETA Tablets are diarrhea, nausea, vomiting, and hepatic enzyme elevation. USE IN SPECIFIC POPULATIONSIn patients with severe hepatic impairment, reduce the dosage of XENLETA Injection to 150 mg infused over 60 minutes every 24 hours. XENLETA Tablets are not recommended in patients with moderate or severe hepatic impairment due to insufficient information to provide dosing recommendations. Avoid XENLETA Injection and Tablets with concomitant strong or moderate CYP3A or P-gp inducers. Monitor for reduced efficacy of XENLETA. Avoid XENLETA Tablets with strong CYP3A or P-gp inhibitors. Monitor for adverse reactions of sensitive CYP3A substrates administered with XENLETA Tablets. XENLETA has not been studied in pregnant women. Verify pregnancy status in females prior to initiating XENLETA and advise females to use contraception during treatment and for 2 days after the final dose. Lactating women should pump and discard milk for the duration of treatment with XENLETA and for 2 days after the final dose. To report SUSPECTED ADVERSE REACTIONS, or administration during pregnancy, contact Nabriva Therapeutics US, Inc. at 1-855-5NABRIVA or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. Please click here for Full Prescribing Information for XENLETA. |
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