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 intravenous lefamulin according to their clinical condition. Patients who commence treatment by the intravenous route may be switched to the oral tablets (see the Summary of Product Characteristics for Xenleta 600 mg tablets) when clinically indicated.
Table 1. Dosage of Xenleta:
| Dosage | Treatment duration |
|---|---|
| Intravenous lefamulin only: 150 mg of Xenleta every 12 hours by intravenous infusion over 60 minutes | 7 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.
Intravenous use.
Xenleta is administered by intravenous infusion over 60 minutes in an infusion volume of 250 mL.
The recommended infusion rate should not be exceeded.
For instructions on dilution of the medicinal product before administration, see section 6.6.
The highest single doses of lefamulin administered in clinical trials were 400 mg intravenous 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.
After dilution:
The chemical and physical in-use stability of the diluted solution has been demonstrated for 24 hours at room temperature and 48 hours at 2°C to 8°C. From a microbiological point of view the product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2°C to 8°C, unless dilution has taken place in controlled and validated aseptic conditions.
Concentrate:
Store in a refrigerator (2°C to 8°C). Do not freeze.
Solvent:
Store below 25°C. Do not freeze.
For storage conditions after dilution of the medicinal product, see section 6.3.
One pack contains:
Type I glass, closed with a stopper (chlorobutyl rubber) and sealed with a flip off cap, 2 vials with 15 mL concentrate.
Polypropylene (PP) infusion bags, 2 bags with 250 mL solvent.
Each vial and infusion bag are for single use only. Standard aseptic techniques should be used for solution preparation and administration.
Xenleta concentrate must be mixed into the bag of solvent containing 250 mL solution of 10mM citrate buffered saline and administered by infusion.
1. Aseptically withdraw 15 mL of Xenleta from the concentrate vial.
2. Transfer concentrate to the bag of solvent containing 250 mL solution of 10mM citrate buffered 0.9% sodium chloride injection.
3. Discard any unused portion from the concentrate vial. The vial of concentrate and the bag of solvent solution is single-use only.
4. The diluted solution should be clear and colourless. Parenteral medicinal products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
5. Administer by intravenous infusion over a period of 60 minutes by direct infusion or through a Y-type intravenous infusion set which may already be in place. Avoid rapid or bolus intravenous infusion.
6. Administer by intravenous infusion only.
The compatibility of reconstituted Xenleta with intravenous medicinal products, additives, or substances other than 10mM citrate buffered 0.9% sodium chloride intravenous infusion and 0.9% sodium chloride intravenous infusion has not been established. If a common intravenous line is being used to administer other medicinal products in addition to Xenleta, the line should be flushed before and after each Xenleta administration with 0.9% sodium chloride intravenous infusion.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
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