XENLETA is supplied in the following strengths and package configurations:
XENLETA Injection
How Supplied
XENLETA Injection is a clear, colorless, sterile, nonpyrogenic solution for intravenous administration containing 150 mg of lefamulin in 15 mL 0.9% sodium chloride in a single-dose vial intended for dilution in 250 mL of 10 mM citrate buffered (pH 5) 0.9% sodium chloride. The drug product is provided in a clear type I glass 15 mL vial with a gray rubber stopper, aluminum seal and flip off cap. The diluent is provided in infusion bags containing 250 mL of sterile, nonpyrogenic 10 mM citrate buffered (pH 5) 0.9% sodium chloride solution. The vial stopper and infusion bag are not made with natural rubber latex.
They are supplied as follows:
150 mg single dose lefamulin vials (NDC 72000-120-06); packed in cartons of 6.
250 mL citrate buffer diluent bags (NDC 72000-030-06); packed in cartons of 6.
Storage and Handling
XENLETA Injection should be stored at 2�C to 8�C (36�F to 46�F). Store in a refrigerator. Do not freeze. The diluent bags should be stored at 20�C to 25�C (68�F to 77�F); excursions permitted between 15�C and 30�C (59�F and 86�F) [see USP Controlled Room Temperature] [see Dosage and Administration (2.5)].
XENLETA Tablets
How Supplied
XENLETA Tablets are available as blue, oval, film-coated tablets containing 600 mg lefamulin. The tablets are printed with �LEF 600� in black on one side.
They are supplied as follows:
HDPE bottles of 30 tablets with Child-resistant Closure (NDC 72000-110-30).
Storage and Handling
XENLETA Tablets should be stored at 20�C to 25�C (68�F to 77�F); excursions permitted to 15�C to 30�C (59�F to 86�F) [see USP Controlled Room Temperature]. These highlights do not include all the information needed to use XENLETA� safely and effectively. See full prescribing information for XENLETA.
XENLETA (lefamulin) injection, for intravenous use
XENLETA (lefamulin) tablets, for oral use
Initial U.S. Approval: 2019
INDICATIONS AND USAGE
XENLETA is a pleuromutilin antibacterial indicated for the treatment of adults with community-acquired bacterial pneumonia (CABP) caused by susceptible microorganisms. (1.1)
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 bacteria. (1.2)
DOSAGE AND ADMINISTRATION
For treatment of adults with CABP, the recommended dosage of XENLETA is as follows:
*With the option to switch to XENLETA Tablets 600 mg every 12 hours to complete the treatment course.
Dosage Treatment Duration
150 mg every 12 hours by intravenous infusion over 60 minutes* (2.1) 5 to 7 days
600 mg orally every 12 hours.(2.1) 5 days
Patients with Hepatic Impairment: Reduce the dosage of XENLETA Injection to 150 mg infused over 60 minutes every 24 hours in patients with severe hepatic impairment (Child-Pugh Class C). XENLETA Tablets have not been studied in and are not recommended for patients with moderate (Child-Pugh Class B) or severe hepatic impairment (2.2).
Administration Instruction for XENLETA Tablets: Take at least 1 hour before a meal or 2 hours after a meal. Swallow XENLETA Tablets whole with water (6 to 8 ounces). (2.3)
Administration Instruction for XENLETA Injection: Infuse over 60 minutes. (2.3)
See Full Prescribing Information for additional information on the administration and preparation of XENLETA Tablets and Injection. (2.4)
DOSAGE FORMS AND STRENGTHS
Injection
A single-dose clear glass vial containing 150 mg of lefamulin in 15 mL of 0.9% sodium chloride for further dilution prior to intravenous infusion. (3)
Tablets
600 mg of lefamulin. (3)
CONTRAINDICATIONS
XENLETA is contraindicated in patients with known hypersensitivity to lefamulin, pleuromutilin class drugs, or any of the components of XENLETA. (4.1)
Concomitant use of XENLETA tablets with CYP3A substrates that prolong the QT interval is contraindicated. (4.2)
WARNINGS AND PRECAUTIONS
QT Prolongation: Avoid use in patients with known QT prolongation, ventricular arrhythmias including torsades de pointes, and patients receiving drugs that prolong the QT interval such as antiarrhythmic agents. (5.1)
Embryo-Fetal Toxicity: May cause fetal harm. Advise females of reproductive potential of the potential risk to the fetus and to use effective contraception. (5.2, 8.1, 8.3)
Clostridium difficile-associated Diarrhea (CDAD): Evaluate patients who develop diarrhea. (5.3)
ADVERSE REACTIONS
Most common adverse reactions (incidence ?2%) are:
XENLETA Injection: administration site reactions, hepatic enzyme elevation, nausea, hypokalemia, insomnia, headache. (6.1)
XENLETA Tablets: diarrhea, nausea, vomiting, hepatic enzyme elevation. (6.1)
To report SUSPECTED ADVERSE REACTIONS, contact Nabriva Therapeutics US, Inc. at 1-855-5NABRIVA or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
DRUG INTERACTIONS
XENLETA Injection
Strong or moderate CYP3A inducers or P-gp inducers Avoid XENLETA unless the benefit outweighs the risk. Monitor for reduced efficacy. (7.1)
XENLETA Tablets
Strong or moderate CYP3A inducers or P-gp inducers Avoid XENLETA unless the benefit outweighs the risk. Monitor for reduced efficacy. (7.1)
Strong CYP3A inhibitors or P-gp inhibitors Avoid XENLETA. (7.1)
Moderate CYP3A inhibitors or P-gp inhibitors Monitor for adverse reactions. (7.1)
CYP3A substrates that prolong the QT interval Concomitant use is contraindicated. (4.2, 7.2)
Midazolam and other sensitive CYP3A substrates Monitor for adverse reactions. (7.2)
USE IN SPECIFIC POPULATIONS
Lactation: A lactating woman should pump and discard human milk for the duration of treatment with XENLETA and for 2 days after the final dose. (8.2)
See 17 for PATIENT COUNSELING INFORMATION.
Revised: 8/2019
