xenleta

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 ) 2.1 Recommended Dosage For treatment of adults with CABP, the recommended dosage of XENLETA is described in Table 1 below. For patients with severe hepatic impairment, dosage adjustment is required [see Dosage and Administration ( 2.2 )] . Table 1: Dosage of XENLETA in Adult CABP Patients *With the option to switch to…

The following clinically significant adverse reactions are described elsewhere in the labeling: QT Prolongation [see Warnings and Precautions ( 5.1 )] . Clostridioides difficile -associated Diarrhea [see Warnings and Precautions ( 5.3 )] . 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 Meitheal Pharmaceuticals Inc. at 1-888-808-5529 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. XENLETA was evaluated in two clinical trials in CABP patients (Trial 1 and Trial 2). Across the two trials, a total of 641 patients were treated with XENLETA. Trial 1 (intravenous [IV] to oral dosing switch trial) enrolled 551 adult patients, 276 randomized to XENLETA (273 received at least one dose of XENLETA) and 275 randomized to moxifloxacin (273 received at least one dose of moxifloxacin). Trial 2 (oral dosing only trial) enrolled 738 adult patients,…

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 ) 4.1 Hypersensitivity XENLETA is contraindicated in patients with known hypersensitivity to lefamulin, pleuromutilin class drugs, or any of the components of XENLETA. 4.2 CYP3A4 Substrates That Prolong the QT Interval XENLETA Tablets are contraindicated with sensitive CYP3A4 substrates that prolong the QT interval (for example, pimozide). Concomitant administration of oral XENLETA with sensitive CYP3A4 substrates may result in increased plasma concentrations of these drugs, leading to QT prolongation and cases of torsades de pointes [see Warnings and Precautions ( 5.1 ), Drug Interactions ( 7.2 ), and Clinical Pharmacology ( 12.3 )] .

Treatment of overdose with XENLETA should consist of observation and general support measures. Lefamulin and its primary metabolite are not dialyzable.

U.S. Poison Control: call or text 1-800-222-1222 (free, 24/7). In an emergency call 911. From the FDA label; not medical advice.

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 ) 7.1 Effect of Other Drugs on XENLETA Strong and Moderate CYP3A Inducers or P-gp Inducers Concomitant use of oral or intravenous XENLETA with strong CYP3A4 inducers or P-gp inducers decreases lefamulin AUC and C max [see Clinical Pharmacology ( 12.3 )] , which may reduce the efficacy of XENLETA. Avoid concomitant use of XENLETA Injection and XENLETA Tablets with strong and moderate CYP3A4 inducers or P-gp inducers unless the benefit outweighs the risks. Strong and Moderate CYP3A Inhibitors or P-gp Inhibitors Concomitant use of XENLETA Tablets with strong CYP3A inhibitors or P-gp inhibitors increases lefamulin AUC [see Clinical Pharmacology ( 12.3 )] , which may increase the risk of adverse reactions with XENLETA Tablets. Avoid concomitant use of XENLETA Tablets with strong CYP3A inhibitors or P-gp inhibitors. Monitor for adverse effects of XENLETA Tablets when administered concomitantly with moderate CYP3A inhibitors or P-gp inhibitors. 7.2 Effect of XENLETA on Other Drugs CYP3A4 Substrates Concomitant use of XENLETA Tablets with sensitive CYP3A4 substrates increases the AUC and C max of CYP3A4 substrates [see Clinical Pharmacology ( 12.3 )] , which may increase the risk of toxicities associated with cardiac conduction. Concomitant use with CYP3A substrates known to prolong the QT interval is contraindicated [see Contraindications ( 4.2 )] . Concomitant use of sensitive CYP3A substrates with XENLETA Tablets requires close monitoring for adverse effects of these drugs (for example, alprazolam, diltiazem, verapamil, simvastatin, vardenafil). Concomitant use of XENLETA Injection with CYP3A4 substrates does not affect the exposure of CYP3A4 substrates. 7.3 Drugs that Prolong QT The pharmacodynamic interaction potential to prolong the QT interval of the electrocardiogram between XENLETA and other drugs that effect cardiac conduction is unknown. Therefore, avoid concomitant use of XENLETA Injection and XENLETA Tablets with such drugs (for example, Class IA and III antiarrhythmics, antipsychotics, erythromycin, moxifloxacin, tricyclic antidepressants).