WEP Clinical (WEP) and Nabriva Therapeutics (Nabriva) are pleased to announce the expansion of the XENLETA® (lefamulin) Named Patient Program (NPP) into Australia, New Zealand, Singapore and South Africa. NPP is designed to ensure that physicians can request IV or oral XENLETA on behalf of individual patients who have an unmet medical need that XENLETA might meet, but who live in countries where XENLETA is not yet commercially available. The XENLETA NPP is also available in the European Union, along with United Kingdom, Iceland, Norway, Switzerland and Liechtenstein. WEP has an exclusive agreement with Nabriva Therapeutics plc (Nabriva) to supply XENLETA on a named patient basis.
XENLETA is approved by the U.S. Food and Drug Administration for the treatment of adults with community-acquired bacterial pneumonia caused by susceptible microorganisms including: Streptococcus pneumoniae, Staphylococcus aureus (methicillin-susceptible isolates), Haemophilus influenzae, Legionella pneumophila, Mycoplasma pneumoniae, and Chlamydophila pneumoniae. Marketing authorization approval for XENLETA has not yet been granted in Australia, New Zealand, Singapore or South Africa.
Under the terms of the NPP, XENLETA will be made available in two formulations – 150mg injection for intravenous administration and 600mg oral tablets – using the named patient program managed by WEP to enable healthcare professionals to access XENLETA for patients that have an unmet clinical need. Once a request is approved, WEP will manage the distribution of XENLETA to the treating physician and will provide any necessary follow-up support and services.
For physicians who are interested in further information on the XENLETA Named Patient Program, please contact:
Tel: +44 208 004 8185
About WEP Clinical
Established in 2008, WEP Clinical is a specialist services company that works with drug developers to help patients and physicians gain early access to medicines when no other treatment options are available. We have offices located in London, United Kingdom; RTP North Carolina, United States; Lisbon, Portugal; and Dublin, Ireland and possess all the necessary licenses allowing us to meet drug access and distribution needs across all regions, worldwide.
We are passionate about helping those in need. For more information, please visit www.wepclinical.com.
About Nabriva Therapeutics
Nabriva Therapeutics is a biopharmaceutical company engaged in the commercialization and development of innovative anti-infective agents to treat serious infections. Nabriva Therapeutics received U.S. Food and Drug Administration approval for XENLETA® (lefamulin) injections and tablets, the first systemic pleuromutilin antibiotic for community-acquired bacterial pneumonia. XENLETA® was discovered in Nabriva Therapeutics laboratories in Vienna, Austria. For more information, please visit www.nabriva.com.
INDICATION AND IMPORTANT SAFETY INFORMATION INDICATION
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 CONTRAINDICATIONS
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 Nabriva Therapeutics US, Inc. at 1-855-5NABRIVA or FDA at 1-800-FDA-1088 or https://www.fda.gov/safety/medwatch.
Please see Full Prescribing Information for XENLETA at XENLETA.com