How do you select a therapy for patients with CABP?

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XENLETA™ (lefamulin) 150mg injection | 600mg tablets NOW AVAILABLE

When selecting a therapy for community-acquired bacterial pneumonia (CABP), there are considerations for high-risk patients: recent antibiotic use, allergies, and resistance patterns, among other risk factors.^2-9

Because of these considerations, some patients with CABP may benefit from another option.
Consider these patients:

61-year-old diabetic female with a 2-day history of: cough, chest pain, fatigue, and fever

Medical history shows:
Evaluated HbA1c level, non-compliance with oral hypoglycemia medication, hypertension

64-year-old male with COPD and a 3-day history of: cough with increased sputum, chest pain, and fever

Medical history shows:
1-2 exacerbations per year not requiring hospitalization along with recent treatment with azithromycin for bronchitis

XENLETA could benefit the patients who deserve a closer look in CABP: those most at risk.

CABP=community-acquired bacterial pneumonia; CAP=community-acquired pneumonia.

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.	File TM Jr. Treatment of community-acquired pneumonia in adults in the outpatient setting. UpToDate^®. Updated November 25, 2019. https://uptodate.com/contents/treatment-of-community-acquired-pneumonia-in-adults-in-the-outpatient-setting. Accessed May 14, 2021.
2.	Harding JL, Benoit SR, Gregg EW, et al. Trends in rates of infections requiring hospitalization among adults with versus without diabetes in the U.S., 2000-2015. Diabetes Care. 2020;43:106-116.
3.	Ramirez JA, Wiemken TL, Peyrani P, et al; for the University of Louisville Pneumonia Study Group. Adults hospitalized with pneumonia in the United States: incidence, epidemiology, and mortality. Clin Infect Dis. 2017;65:1806-1812.
4.	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.
5.	Food and Drug Administration News Release. July 10, 2018. https://www.fda.gov/news-events/press-announcements/fda-updates-warnings-fluoroquinolone-antibiotics-risks-mental-health-and-low-blood-sugar-adverse. Accessed May 14, 2021.
6.	Food and Drug Administration In Brief. December 20, 2018. https://www.fda.gov/drugs/drug-safety-and-availability/fda-warns-about-increased-risk-ruptures-or-tears-aorta-blood-vessel/fluoroquinolone-antibiotics. Accessed May 14, 2021.
7.	FDA Drug Safety Communication. July 26, 2016. https://www.fda.gov/drugs/drug-safety-and-availability/fda-drug-safety-communication-fda-updates-warnings-oral-and-injectable-fluoroquinolone-antibiotics. Accessed May 26, 2021.
8.	Park MA, Koch CA, Klemawesch P, Joshi A, Li JT. Increased adverse drug reactions to cephalosporins in penicillin allergy patients with positive penicillin skin test. Int Arch Allergy Immunol. 2010;153(3):268-273.
9.	Ray WA, Murray KT, Hall K, Arbogast PG, Stein CM. Azithromycin and the risk of cardiovascular death. N Engl J Med. 2012;366:1881-1890.
10.	XENLETA^® (lefamulin) [package insert]. Fort Washington, PA: Nabriva Therapeutics.

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