Study Demonstrates Macrolide-Resistance in S. pneumoniae in the United States Exceeds 25 Percent Threshold Set in Current Community-Acquired Bacterial Pneumonia (CABP) Treatment Guidelines
Contemporary data demonstrate macrolide resistance in S. pneumoniae is 39.5 percent overall and greater than 25 percent in most regions of the country
Macrolide resistance shown to be significantly more common in outpatients vs. inpatients, with rates as high as 45.3 percent vs. 37.8 percent respectively
Findings underscore need for new monotherapy alternatives to macrolides in the management of CABP
The retrospective cohort study assessed 3,626 patients with a positive S. pneumoniae blood or respiratory culture evaluated between
Macrolide-resistant S. pneumoniae is designated as a serious public health threat according to the
“The high rates of macrolide-resistant S. pneumoniae throughout
“The findings from this study demonstrate the importance of contemporary, local epidemiology data to optimize the selection of empiric therapy for patients with CABP in accordance with 2019 guidelines issued by the IDSA/ATS,” said
XENLETA is a first-in-class systemic pleuromutilin antibiotic for the intravenous (IV) and oral treatment of CABP in adults. XENLETA offers an effective and well tolerated empiric monotherapy for CABP with a treatment duration as short as five days and the potential to address the limitations of existing agents.
XENLETA has a novel mechanism of action that targets a binding site on bacteria that is different from existing antibiotics. It has been shown to result in no cross resistance to other antibiotic classes commonly prescribed for CABP and a low potential for the development of resistance. XENLETA is also convenient for patients being treated in the hospital, transitioning treatment out of the hospital or initiating treatment in the community.
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INDICATION AND IMPORTANT SAFETY INFORMATION
XENLETA is a pleuromutilin antibacterial indicated for the treatment of adults with community-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.
To 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 INFORMATION
XENLETA 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 PRECAUTIONS
XENLETA 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.
The 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 POPULATIONS
In 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
Please see Full Prescribing Information for XENLETA.
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Source: Nabriva Therapeutics US, Inc