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XENLETA® (lefamulin) 150mg injection | 600mg tablets

In addition to your clinical judgment when evaluating your patients with CABP, tools like PSI/PORT can help you determine one of the most important factors: whether patients require hospitalization or if they can be treated safely in the outpatient setting.1

In fact, ATS/IDSA guidelines recommend evaluation tools, preferentially PSI/PORT, to help assess severity of disease and the need for hospitalization.1

Hospitalizing patients with CABP—especially those with comorbidities such as COPD, type 2 diabetes, and asthma—increases the following:

Risk of
thromboembolic events2
Risk of “superinfection” by resistant hospital bacteria3
Cost of
treatment4
When choosing site of care, consider XENLETA

XENLETA provides patients with CABP early and effective clinical response in as little as 5 days of oral therapy—even in those who are older or have asthma, COPD, or diabetes.5,6

A high percentage of patients responded to XENLETA regardless of PORT status.6

PORT Risk Class I/II

PORT Risk Class III

PORT Risk Class IV/V

XENLETA is different from older antibiotics5:

• A pleuromutilin with a chemical structure distinct from existing classes
• Unique mechanism of action offers low propensity for resistance and low probability of cross-resistance
• May remain active against isolates that are resistant to: β-lactams, macrolides, quinolones, tetracyclines, and others
To learn more about XENLETA or receive sample packs, request a visit from a sales representative.
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ATS=American Thoracic Society; CABP=community-acquired bacterial pneumonia; COPD=chronic obstructive pulmonary disease; IDSA=Infectious Disease Society of America; PORT=Pneumonia Patient Outcomes Research Team; PSI=Pneumonia Severity Index.

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.

Usage

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.

Clostridioides 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 REACTIONS

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 www.fda.gov/medwatch.

Please click here for Full Prescribing Information for XENLETA.

References:

  1. Metlay JP, Waterer GW, Long AC, et al. Diagnosis and treatment of adults with community-acquired pneumonia: an official clinical practice guideline of the American Thoracic Society and Infectious Diseases Society of America. Am J Respir Crit Care Med. 2019;200(7):e45-e67.
  2. Alikhan R, Cohen AT, Combe S, et al; MEDENOX Study. Risk factors for venous thromboembolism in hospitalized patients with acute medical illness: analysis of the MEDENOX Study. Arch Intern Med. 2004;164(9):963-968.
  3. Smith T, Salgado C, Mauldin PD, Zhang J, Bosso JA. Relationship between days in hospital and infection with a multidrug resistant gram-negative pathogen. Presented at: 54th Interscience Conference on Antimicrobial Agents and Chemotherapy; September 7, 2014; Washington, DC. https://www.abstractsonline.com/Plan/ViewAbstract.aspx?sKey=c078207d-b6d7-499c-9415-97c7fb0642da&cKey=579d7da7-c6b5-4c99-8a15-6ac05370d929&mKey=%7b5D6B1802-E453-486B-BCBB-B11D1182D8BB%7d. Accessed November 17, 2021.
  4. Niederman MS, McCombs JS, Unger AM, Kumar A, Popovian R. The cost of treating community-acquired pneumonia. Clin Ther. 1998;20(4):820-837.
  5. XENLETA® (lefamulin) [package insert]. Fort Washington, PA: Nabriva Therapeutics.
  6. File TM Jr, Alexander E, Goldberg L, et al. Lefamulin efficacy and safety in a pooled phase 3 clinical trial population with community-acquired bacterial pneumonia and common clinical comorbidities. BMC Pulm Med. 2021;21:154. https://doi.org/10.1186/s12890-021-01472-z
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PM-US-LEF-0366 NOV 2021