XENLETA Solution for injection / Film-coated tablet Ref.[10114] Active ingredients: Lefamulin

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 XENLETA Tablets 600 mg every 12 hours to complete the treatment course.

2.2 Dosage Adjustment for Patients with Hepatic Impairment

Monitor patients with hepatic impairment for adverse reactions associated with XENLETA Injection and Tablets throughout the treatment period [see Use in Specific Populations (8.6) and Clinical Pharmacology (12.3)].

XENLETA Injection

Reduce the dosage of XENLETA Injection to 150 mg infused intravenously over 60 minutes every 24 hours for patients with severe hepatic impairment (Child-Pugh Class C). No dosage adjustment of XENLETA Injection is needed for patients with mild (Child-Pugh Class A) or moderate (Child-Pugh Class B) hepatic impairment.

XENLETA Tablets

XENLETA Tablets have not been studied in and are not recommended for patients with moderate (Child-Pugh Class B) or severe (Child-Pugh Class C) hepatic impairment. No dosage adjustment of XENLETA Tablets is needed for patients with mild hepatic impairment (Child-Pugh Class A).

2.3 Important Administration Instructions

XENLETA Injection

Administer XENLETA Injection by intravenous infusion over 60 minutes. Must dilute in a 250 mL solution of 10 mM citrate buffered 0.9% sodium chloride for injection supplied with XENLETA Injection before use [see Dosage and Administration (2.4)].

XENLETA Tablets

Take XENLETA Tablets at least 1 hour before a meal or 2 hours after a meal. Swallow XENLETA Tablets whole with water (6 to 8 ounces). Do not crush or divide XENLETA Tablets [see Clinical Pharmacology (12.3)].

Missed Dose

If a dose is missed, the patient should take the dose as soon as possible and anytime up to 8 hours prior to the next scheduled dose. If less than 8 hours remain before the next scheduled dose, do not take the missed dose, and resume dosing at the next scheduled dose.

2.4 Preparation of XENLETA Injection for Intravenous Infusion

• Dilute the entire 15 mL vial of XENLETA Injection into the diluent bag supplied with XENLETA injection that contains 250 mL of 10 mM citrate buffered 0.9% sodium chloride.
• Use aseptic technique when adding XENLETA Injection into the diluent bag. Mix thoroughly.
• Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Use the diluent bag only if the solution is clear and the container is undamaged.
• Do not use the diluent bag in series connections.
• Do not add other additives to the diluent bag because their compatibilities with XENLETA Injection have not been established.

2.5 Storage of XENLETA Injection After Dilution

After dilution, XENLETA Injection can be stored for up to 24 hours at room temperature and up to 48 hours when refrigerated at 2°C to 8°C (36°F to 46°F).

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

XENLETA Injection: 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 in barrier overwrap at 2°C to 25°C (36°F to 77°F) until ready to use. [see Dosage and Administration (2.5)].

XENLETA Tablets: 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].