Lefamulin

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Lefamulin structure

What is Lefamulin?

• Lefamulin (brand name: XENLETA) is a pleuromutilin antibacterial.

What are the uses of this medicine?

Lefamulin is indicated for the treatment of adults with community-acquired bacterial pneumonia (CABP) caused by the following susceptible microorganisms:

• Streptococcus pneumoniae
• Staphylococcus aureus
• Haemophilus influenzae
• Legionella pneumophila
• Mycoplasma pneumoniae
• Chlamydophila pneumoniae

How does this medicine work?

• XENLETA is antibacterial drug that inhibits bacterial protein synthesis through interactions with the A- and P-sites of the peptidyl transferase center (PTC).
• To reduce the development of drug resistant bacteria and maintain the effectiveness of XENLETA and other antibacterial drugs, XENLETA should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.

Who should not use this medicine?

This medicine cannot be used if you have a known hypersensitivity to:

• lefamulin
• pleuromutilin class drugs
• any of the components of XENLETA

Is this medicine FDA approved?

• Lefamulin was approved for use in the United States in 2019 under the brand name XENLETA.

How should this medicine be administered?

For treatment of adults with CABP:

• Administer 150 mg every 12 hours by intravenous infusion over 60 minutes for 5 to 7 days.
• The option to switch to XENLETA Tablets of 600 mg every 12 hours to complete the treatment course is allowed.
• XENLETA Tablets should be taken 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.

For patients with severe hepatic impairment:

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.
• No dosage adjustment of XENLETA Injection is needed for patients with mild or moderate hepatic impairment.

XENLETA Tablets

• XENLETA Tablets have not been studied in and are not recommended for patients with moderate or severe hepatic impairment.
• No dosage adjustment of XENLETA Tablets is needed for patients with mild hepatic impairment.

What are the dosage forms and brand names of this medicine?

This medicine is available in the following dosage form and strengths:

• Injection: Clear, colorless solution in a single-dose clear glass vial. Each vial contains 150 mg of lefamulin in 15 mL of 0.9% sodium chloride for further dilution prior to intravenous infusion.

• Tablets: Blue, oval, film-coated tablet with ‘LEF 600’ printed in black on one side. Each tablet contains 600 mg of lefamulin.

This medicine is available in the following brand name: XENLETA

What side effects can this medication cause?

Most common adverse reactions (incidence ≥ 2%) are:

XENLETA Injection

• administration site reactions
• hepatic enzyme elevation
• nausea
• hypokalemia
• insomnia
• headache

XENLETA Tablets

• diarrhea
• nausea
• vomiting
• hepatic enzyme elevation

What special precautions should I follow?

• XENLETA has the potential to prolong the QT interval of the electrocardiogram (ECG) in some patients. Avoid XENLETA use in patients with known QT prolongation, ventricular arrhythmias including torsades de pointes, and patients receiving drugs that prolong the QT interval such as antiarrhythmic agents.
• XENLETA may cause fetal harm. Females of reproductive potential are advised of the potential risk to the fetus and to use effective contraception.
• Clostridioides difficile-associated diarrhea (CDAD) has been reported with use of XENLETA and may range in severity from mild diarrhea to fatal colitis. If CDAD is suspected or confirmed, ongoing antibacterial drug use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibacterial drug treatment of C. difficile, and surgical evaluation should be instituted as clinically indicated.

What to do in case of emergency/overdose?

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

Can this medicine be used in pregnancy?

• Lefamulin may cause fetal harm when administered to a pregnant woman.
• If XENLETA is inadvertently administered during pregnancy or if you become pregnant while receiving XENLETA, you are advised to call 1-855-5NABRIVA to enroll in a surveillance program by Nabriva Therapeutics.

Can this medicine be used in children?

• The safety and effectiveness of XENLETA in patients less than 18 years of age has not yet been established.

What should I know about storage of this medication?

XENLETA Injection

• After dilution, the 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).
• 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.

XENLETA Tablets

• The 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).

What are the active and inactive ingredients in this medicine?

Injection

• Active ingredient: lefamulin acetate

• Inactive ingredients: sodium chloride and water

Tablets

• Active ingredient: lefamulin acetate

• Inactive ingredients: mannitol, povidone K30, water, microcrystalline cellulose, croscarmellose, talc, silicon dioxide, and magnesium stearate.

• Dailymed label info on Lefamulin
• FDA Lefamulin

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