Source: European Medicines Agency (EU) Revision Year: 2021 Publisher: Nabriva Therapeutics Ireland DAC, Alexandra House, Office 225/227, The Sweepstakes Ballsbridge, Dublin 4, D04 C7H2, Ireland
Xenleta is indicated for the treatment of community-acquired pneumonia (CAP) in adults when it is considered inappropriate to use antibacterial agents that are commonly recommended for the initial treatment of CAP or when these have failed (see section 5.1).
Consideration should be given to official guidance on the appropriate use of antibacterial agents.
The recommended dosage of Xenleta is described in Table 1.
Patients may be treated throughout with oral lefamulin according to their clinical condition. Patients who commence treatment by the intravenous route (see the Summary of Product Characteristics for Xenleta solution for infusion) may be switched to the oral tablets when clinically indicated.
Table 1. Dosage of Xenleta:
| Dosage | Treatment duration |
|---|---|
| Oral lefamulin only: 600 mg Xenleta tablet orally every 12 hours | 5 days |
| Intravenous lefamulin with option to switch to oral lefamulin: 150 mg of Xenleta every 12 hours by intravenous infusion over 60 minutes with option to switch to 600 mg Xenleta tablet orally every 12 hours | 7 days total treatment by the intravenous or combined intravenous and oral routes |
No dosage adjustment is required for the elderly (see section 5.2).
No dosage adjustment is required in renally impaired patients, including those receiving haemodialysis (see sections 4.4 and 5.2).
No dosage adjustment is required in patients with hepatic impairment (see sections 4.4 and 5.2).
The safety and efficacy of lefamulin in children and adolescents less than 18 years of age have not yet been established. No data are available.
Oral use.
The tablets should be swallowed whole with water. Xenleta should be taken on an empty stomach
The highest single doses of lefamulin administered in clinical trials were 750 mg oral in healthy subjects which were not associated with any serious adverse reactions. The QT interval may increase with increasing exposure to lefamulin. Treatment of overdose with lefamulin should consist of observation and general support measures. Haemodialysis will not significantly remove lefamulin from the systemic circulation.
4 years.
This medicinal product does not require any special storage conditions.
One pack contains: PVC/PE/PCTFE / Aluminium blisters with 10 film-coated tablets.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
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