Xenleta

Xenleta is prescribed for treating adults with community-acquired bacterial pneumonia (CABP) caused by specific susceptible microorganisms: Streptococcus pneumonia, methicillin-susceptible Staphylococcus aureus, Haemophilus influenza, Legionella hemophilia, Mycoplasma pneumonia, and Chlamydophila pneumonia.

Pharmacology of Xenleta:

Xenleta, a semi-synthetic antibacterial agent, is available for oral and intravenous use.

It features a novel mechanism of action that is effective against resistant pneumonia-causing bacteria. As a systemic pleuromutilin antibacterial, it inhibits bacterial protein synthesis through hydrogen bonds, hydrophobic interactions, and Van der Waals forces at the A- and P-sites of the peptidyl transferase center within domain V of the 23S rRNA of the 50S ribosomal subunit.

Dosage & Administration of Xenleta: 

Adult CABP Patients: Administer 150 mg of Lefamulin via intravenous infusion every 12 hours, over a 60-minute period, for 5 to 7 days. Transition to 600 mg Lefamulin tablets every 12 hours as needed to complete the regimen. Alternatively, administer 600 mg Lefamulin tablets orally every 12 hours for five days. Adjust the dosage for patients with severe hepatic impairment.

Hepatic Impairment Adjustments:

Injection: Reduce the Lefamulin Injection dose to 150 mg intravenously every 24 hours for severe hepatic impairment.

No adjustment is required for mild or moderate impairment.
Tablets: Lefamulin Tablets are not recommended for moderate or severe hepatic impairment. No adjustment is needed for mild impairment.

Administration Instructions:

Injection: Administer by intravenous infusion over 60 minutes. Dilute in a 250 ml citrate-buffered 0.9% sodium chloride solution before use.

Tablets: Take at least 1 hour before or 2 hours after meals. Do not crush or divide.
Missed Dose: If you miss the dose, take it as soon as possible, within 8 hours before the next scheduled dose. If less than 8 hours remain, skip the missed dose.

Preparation for Intravenous Infusion:
Dilute the 15 ml vial of Lefamulin Injection into the provided 250 ml diluent bottle.
Use an aseptic technique to mix thoroughly.
Ensure clarity of the solution and integrity of the container before use.

Interaction
With Medicine: Avoid concomitant use of Lefamulin with strong CYP3A4 or P-glycoprotein inducers, as they can decrease its efficacy.

With Food and Others: Avoid grapefruit products, as they may increase Lefamulin serum concentration by inhibiting CYP3A.

Contraindications

Xenleta is contraindicated in patients with hypersensitivity to it or pleuromutilin class drugs and in conjunction with CYP3A4 substrates that prolong the QT interval.

It’s not recommended for pregnant women or those under 18.

Side Effects of Xenleta

Lefamulin may prolong the QT interval. Avoid use in patients with QT prolongation, ventricular arrhythmias, or those on drugs prolonging the QT interval. Clitorides difficile-associated diarrhea (CDAD) is a potential risk with systemic antibacterial agents, including Lefamulin.

Pregnancy & Lactation

Pregnancy: Animal studies show increased stillbirth incidence and malformations at lower systemic exposures than in CAP patients. During pregnancy, use this only if the benefits are greater than the risks.

Lactation: No data on Lefamulin presence in human milk.

Animal studies show concentration in rat milk. Women should pump and discard milk during and for 2 days after Lefamulin treatment due to potential adverse reactions.

Precautions & Warnings

Consider the risk of CDAD, ranging from mild diarrhea to severe colitis.

Lefamulin IV may prolong the QT interval. Avoid use in patients with QT prolongation, ventricular arrhythmias, or those on QT-prolonging drugs.

Overdose Effects

In case of overdose, provide general support and monitor ECG. Empty the stomach, ensure adequate hydration and monitor electrolytes.

Hemodialysis is not effective for Lefamulin removal.

Storage Conditions
IV Infusion: Refrigerate at 2°C to 8°C, do not freeze, and protect from light. Keep out of children’s reach.
Tablets: Store below 30°C in a dry place, away from light. Do not refrigerate or freeze.

Keep out of children’s reach.
Dosage & Administration
Lefamulin IV should be given as a single dose of 150 mg infused over one hour, every 12 hours for 5 to 7 days.

Potential Side Effects
Precautions
It is important to inform your healthcare provider if you have a history of heart problems or are taking any medications that may affect your heart rhythm, such as ventricular arrhythmias or QT-prolonging medications.

Pregnancy and Breastfeeding
Lefamulin IV should not use during pregnancy, unless the potential benefits outweigh the risks. so breastfeeding women should consult their healthcare provider before using this medication.

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