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This document outlines vital safety information and warnings associated with the use of Xenleta (lefamulin). It is crucial to understand these details to ensure safe and effective use of the medication. If you have any concerns, please discuss them with your healthcare provider.

• Risk of Serious Heart Rhythm Issues (QT Prolongation): Xenleta may significantly impact heart rhythm, potentially leading to severe and life-threatening conditions like QT prolongation. Individuals at higher risk include those aged 65 and older, those with low potassium or magnesium levels, a history of heart problems, slow heart rate, other arrhythmias, a personal or family history of long QT syndrome, or those taking other medications that prolong QT interval.

• Potential Harm to an Unborn Baby: The use of Xenleta during pregnancy can be harmful to the unborn baby. Animal studies have shown an increase in pregnancy losses, stillbirths, and developmental issues in unborn animals. It is important to discuss pregnancy plans with your healthcare provider before starting this medication.

• Risk of Clostridioides difficile Infection: Using Xenleta may increase the risk of developing an infection caused by C. difficile, a bacteria that can result in severe diarrhea. This occurs because antibiotics can disrupt the normal bacterial balance in the gut, allowing C. difficile to thrive.

• Risk of Drug-Resistant Bacteria: It is important to adhere strictly to the prescribed dosage and duration of Xenleta. Misuse or overuse can lead to the development of drug-resistant bacteria, increasing the risk of severe infections. Consult your healthcare provider if you have questions regarding the correct usage of this medication.

• Contraindications: Xenleta should not be used in conjunction with certain medications that can exacerbate heart rhythm issues, such as pimozide. If you are taking any medications that might interact with Xenleta, consult your healthcare provider before starting this antibiotic.

Always follow your healthcare provider’s guidance and immediately report any unusual symptoms or side effects. In case of an overdose or severe reaction, seek emergency medical attention.

When taking this medication, some individuals may experience common side effects such as nausea or diarrhea. These effects are generally mild, but if they persist or worsen, consulting a healthcare provider is advisable. Reactions at the injection site, such as pain or swelling, are also possible.

In rare instances, more severe side effects may occur. Seek immediate medical attention if you experience symptoms such as fast or irregular heartbeat, severe dizziness, or fainting. There is a risk, though infrequent, of developing a serious intestinal condition caused by C. difficile bacteria, which may manifest as persistent diarrhea, abdominal pain, or blood and mucus in the stool. It's crucial not to use anti-diarrhea or opioid products in this case, as they may exacerbate the condition.

Prolonged use of this medication may lead to oral thrush or a new yeast infection, identified by symptoms like white patches in the mouth or changes in vaginal discharge. Be alert for signs of a serious allergic reaction, such as rash, itching or swelling, particularly of the face, tongue, or throat, severe dizziness, or trouble breathing, and seek medical help immediately if these occur.

This summarization includes the main side effects, but other unlisted effects may occur. Always remain observant and consult a healthcare provider if you notice any additional symptoms.