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

Viral and bacterial co-infections can occur.¹ Guidelines support empiric antibiotic therapy to cover community-acquired pneumonia suspected to be caused by viral respiratory infections, especially if severe.^2,3 Consider XENLETA for the treatment of CABP in the setting of viral respiratory infections such as COVID-19. XENLETA Tablets are contraindicated for use with CYP3A4 substrates that prolong the QT interval.⁴

When selecting an empiric antibacterial treatment, consider the clinical diagnosis (including community-acquired pneumonia), local epidemiology and susceptibility data, and national treatment guidelines.^2,3

XENLETA—the first and only oral and IV pleuromutilin antibiotic that acts against the pathogens that commonly cause CABP^4,5

.	A novel mechanism of action with a low propensity for resistance and low probability of cross-resistance
.	As empiric monotherapy, XENLETA achieved early and effective clinical response in as short as 5 days
.	Proven microbiologic activity in Gram-positive, Gram-negative, and other respiratory bacteria
.	Effective penetration into the lungs at the site of infection
.	Start patients on intravenous therapy, then switch to oral—or start with oral

Choose a different option. Choose XENLETA.

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.

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.

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 see Full Prescribing Information for XENLETA.

References:

1.	Jain S, Self WH, Wunderink RG, et al. Community-acquired pneumonia requiring hospitalization among U.S. adults. N Engl J Med. 2015;373(5):415-427.
2.	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.
3.	World Health Organization. Clinical Management of Severe Acute Respiratory Infection (SARI) When COVID-19 Disease Is Suspected. World Health Organization; 2020.
4.	XENLETA™ (lefamulin) [package insert]. King of Prussia, PA: Nabriva Therapeutics; 2019.
5.	Nabriva Therapeutics receives U.S. FDA approval of Xenleta™ (lefamulin) to treat community-acquired bacterial pneumonia (CABP) [news release]. Dublin, Ireland: Nabriva Therapeutics plc; August 19, 2019. https://investors.nabriva.com/news-releases/news-release-details/nabriva-therapeutics-receives-us-fda-approval-xenleta. Accessed March 27, 2020.

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PM-US-LEF-0256 MAR 2020