Nabriva’s XENLETA™ (lefamulin) for the Treatment of Community-Acquired Bacterial Pneumonia (CABP) Now Available in the U.S.
“The lack of innovative treatment options for CABP over the past two decades has resulted in increasing resistance in the most common bacteria causing CABP to multiple classes of antibiotics,” said
XENLETA is the first oral and IV treatment in the pleuromutilin class of antibiotics. XENLETA has in vitro activity and demonstrated clinical efficacy against the most common pathogens that cause CABP. XENLETA has a novel mechanism of action that targets a binding site on bacterial cells that is different from existing antibiotics, resulting in a low propensity for the development of resistance, as well as a lack of cross-resistance with antibiotic classes commonly used for the treatment of CABP.
“XENLETA is now available to healthcare providers for the treatment of CABP patients in the hospital, during transition from the hospital to home, and for patients in the ambulatory care setting,” said
Nabriva has efficiently expanded its commercialization, medical affairs, and supply chain infrastructure to help ensure that clinicians are informed of XENLETA’s availability and patients have easy access. The company also plans to kick-off a targeted outreach program in the ambulatory care setting, where there is a significant unmet medical need for the treatment of CABP. The program is scheduled to commence in
XENLETA is available for oral (600 mg every 12 hours) and IV (150 mg every 12 hours) administration with a short 5-to-7-day course of therapy. Clinicians can initiate patients on IV or oral therapy, allowing for potential avoidance of hospitalization, or can transition from IV to oral therapy, which may expedite discharge from the hospital. The opportunity to avoid a hospital admission or to discharge a patient earlier on oral therapy may benefit patients and could result in significant savings to the health system.
In addition, Nabriva has partnered with
XENLETA is available through the major U.S. specialty distributors: McKesson Plasma and Biologics,
|XENLETA (lefamulin) tablets, 600 mg||XENLETA (lefamulin) Injection, 150 mg||XENLETA diluent,
Telephone, Fax and Web Ordering Information
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|McKesson Plasma and Biologics
XENLETA (lefamulin) is a first-in-class semi-synthetic pleuromutilin antibiotic for systemic administration in humans discovered and developed by the
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.
Any statements in this press release about future expectations, plans and prospects for
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Source: Nabriva Therapeutics US, Inc