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This document outlines important safety information regarding the use of Edurant (rilpivirine). It is crucial to understand these warnings and consult with your healthcare provider if you have any questions or concerns.

• Severe Skin and Allergic Reactions: Edurant (rilpivirine) can cause rashes and other serious skin issues, potentially leading to hospitalization. These reactions are more likely within the first 4 to 6 weeks of treatment but can occur at any time. Seek immediate medical attention if you experience rashes, blistering, peeling skin, mouth sores, swelling, or difficulty breathing.

• Liver Issues: There is a risk of liver problems, particularly if you have a history of liver conditions such as hepatitis B or C. It is important to discuss your medical history with your healthcare team before starting Edurant. Regular blood tests will be necessary to monitor liver health. Contact your healthcare provider if you notice symptoms of liver damage, including fatigue, abdominal pain, jaundice, or dark urine.

• Mental Health Concerns: Depression and mood changes, including thoughts of self-harm, have been reported by some individuals taking Edurant. If you experience any changes in mood or mental health, inform your healthcare team immediately. In cases of suicidal thoughts or behavior, call emergency services right away.

• Immune System Activation: Edurant may cause immune reconstitution syndrome, a condition where the immune system becomes overly active as it begins to fight infections after starting HIV treatment.

• Drug Interactions: Edurant interacts with various medications, which can lower its effectiveness. Avoid taking medications such as certain anti-seizure drugs (e.g., carbamazepine), multiple doses of dexamethasone, St. John’s wort, and certain antibiotics like rifampin.

In terms of contraindications, Edurant should not be taken if you are using any medications that significantly reduce its concentration in your body, as this can diminish its effectiveness. Always consult your healthcare provider if you are taking any of these medications before starting Edurant.

When taking this medication, some common side effects you might encounter include headache, trouble sleeping, and rash. These effects are generally mild but should be discussed with your healthcare provider if they persist or worsen. Additionally, some individuals may experience higher liver function tests, higher cholesterol and creatinine levels, or feelings of depression.

In some cases, users have reported experiencing belly pain, nausea, vomiting, diarrhea, low appetite, fatigue, dizziness, abnormal dreams, and anxiety. These side effects, though typically not severe, should be monitored and communicated to your healthcare provider if they cause concern.

There are also more serious side effects that, although rare, necessitate immediate medical attention. These include suicidal thoughts or behaviors and severe allergic reactions, which may present as mouth sores, difficulty breathing, rash, fever, or swelling of the face, lips, or tongue. Additionally, liver problems can manifest as upper right stomach pain, persistent nausea, yellowing of the skin or eyes, and dark urine.

It is crucial to be vigilant about your body's reactions to the medication, as your immune system may become more active, potentially leading to symptoms like unexplained weight loss, severe fatigue, persistent muscle aches or headaches, joint pain, numbness or tingling, vision changes, signs of infection, or signs of an overactive thyroid. In rare instances, some may experience signs of Guillain-Barre syndrome or liver disease. Contact your healthcare provider immediately if you notice any severe symptoms.

Rilpivirine, marketed as Edurant, can interact with various medications and supplements. It's important to inform your healthcare provider about all drugs you are currently using, including prescription, over-the-counter, vitamins, and herbal supplements.

Certain medications should not be used with rilpivirine, or your doctor might need to adjust your treatment. These include Carbamazepine, cisapride, Dexamethasone, Dexlansoprazole, esomeprazole, fosphenytoin, Lansoprazole, Omeprazole, Oxcarbazepine, Pantoprazole, Phenobarbital, Phenytoin, Primidone, Rabeprazole, Rifampin, rifapentine, saquinavir, and St. John's wort. These drugs can interfere with how rilpivirine is metabolized, potentially reducing its efficacy.

Some drugs, like abametapir, aluminum compounds, Anagrelide, Efavirenz, Nevirapine, and Orlistat, may require caution. If both rilpivirine and these medications are necessary, your doctor may adjust doses or frequency to minimize interaction risks.

Additionally, combining rilpivirine with boceprevir may increase the likelihood of side effects, but such combinations might be needed for optimal treatment. Your healthcare provider might modify dosages or usage schedules to manage this risk effectively.

Always consult your doctor or pharmacist before starting or stopping any medication while on rilpivirine.