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The following safety and warning details are crucial for understanding the potential risks and necessary precautions associated with the use of Rukobia (fostemsavir). Please read attentively and discuss with your healthcare provider if you have any questions or concerns.

• Immune System Changes: Rukobia (fostemsavir) may trigger immune reconstitution syndrome, a condition where your immune system strengthens and begins combating various infections that it couldn't previously. In rare instances, this may lead to the immune system attacking healthy cells, resulting in autoimmune issues. Symptoms such as anxiety, hair loss, bulging eyes, or increased sweating may appear shortly after beginning treatment or even months later. Promptly inform your healthcare provider if these symptoms occur.

• Heart Rhythm Concerns (QT Prolongation): This medication may impact your heart rhythm, potentially leading to severe and life-threatening conditions. The risk increases if you have a history of heart rhythm disorders, are taking other heart-affecting medications, or are over 65. Seek immediate medical attention if you experience chest pounding, difficulty breathing, chest pain, or feelings of faintness or lightheadedness.

• Liver Health: Individuals with hepatitis B or C have reported liver issues after starting Rukobia (fostemsavir). Your healthcare provider will conduct blood tests before and during treatment to ensure liver safety. Notify your provider immediately if you notice symptoms like drowsiness, nausea, appetite loss, light-colored stools, pain in the upper right abdomen, yellowing skin or eyes, or dark urine.

• Drug Interactions: Some medications can alter how your body processes Rukobia (fostemsavir), affecting its effectiveness and the likelihood of side effects. Notably, this drug can remain in your system for up to nine months after the last dose.

• Contraindications: Avoid using Rukobia (fostemsavir) if you are taking certain CYP3A inducers, such as carbamazepine (Tegretol), rifampin (Rifadin), or phenytoin (Dilantin), as these can decrease its efficacy and pose health risks. Consult your healthcare provider if any of these apply to you.

In the event of an overdose or if you need further guidance, seek immediate medical assistance. Always adhere to your healthcare provider's recommendations to ensure safe and effective use of Rukobia (fostemsavir).

When taking this medication, some common side effects may include nausea and drowsiness. These are generally mild but should be discussed with a healthcare professional if they persist or worsen. Additional mild side effects reported by some users include high creatinine levels, high liver function tests, high cholesterol, diarrhea, headache, stomach pain, indigestion, fatigue, rash, trouble sleeping, and weakness. These typically do not require urgent medical attention but should be monitored.

However, there are rare but serious side effects that demand immediate medical care. These include severe liver issues, characterized by persistent nausea, vomiting, loss of appetite, stomach pain, yellowing of the skin or eyes, dark urine, and light-colored stool. Abnormal heart rhythms may present as a pounding chest, trouble breathing, chest pain, or fainting. Furthermore, any signs of an allergic reaction, such as rash, itching, swelling, severe dizziness, or breathing difficulty, should prompt urgent medical evaluation.

Additionally, as the immune system strengthens, it might combat existing infections, leading to a resurgence of symptoms. This can cause unexplained weight loss, severe fatigue, persistent muscle aches, headaches, joint pain, numbness or tingling in extremities, vision changes, and signs of infection or overactive thyroid. In rare cases, nerve problems like Guillain-Barre syndrome or signs of liver disease may occur. Immediate medical attention is crucial for these severe reactions.