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This document outlines critical safety warnings and precautions related to the use of etravirine (Intelence). It is essential to review this information carefully and consult your healthcare provider should you have any questions or concerns.

• Severe Skin and Allergic Reactions: Etravirine (Intelence) may lead to severe skin or allergic reactions, which can be life-threatening. Females and children may be at higher risk. Symptoms, such as a rash accompanied by fever, general discomfort, muscle or joint pain, mouth sores, blisters, or facial swelling, require immediate discontinuation of the medication and prompt medical attention.

• Overactive Immune System: This medication, when used in combination with other antiretroviral (ARV) therapies, may result in immune reconstitution syndrome. This condition occurs when the immune system becomes more active and starts to combat infections it previously could not. In rare instances, the immune system may begin to attack normal cells. New symptoms, such as fever, pain, hair loss, bulging eyes, or sweating, that arise after initiating treatment should be reported to your healthcare provider immediately.

• Changes in Body Fat: Although uncommon, individuals taking HIV medications, including etravirine (Intelence), have reported changes in body fat distribution. These changes may include fat accumulation in the neck, breasts, and abdomen, or fat loss in the legs, arms, and face. The cause and long-term health implications of these changes are not well understood. Inform your healthcare provider if you notice such changes.

• Drug Interactions: Certain medications can alter how etravirine (Intelence) is metabolized by your body, potentially impacting its effectiveness and increasing the risk of side effects. Discuss all medications you are taking with your healthcare provider to manage potential interactions effectively.

In the event of an overdose, seek emergency medical assistance immediately. It is crucial to adhere to the prescribed dosage and consult your healthcare provider regularly to ensure safe and effective treatment.

When taking this medication, you may experience some common side effects which are typically mild and can include nausea, upset stomach, gas, constipation, vomiting, blurry vision, dry mouth, dry skin, excessive sweating, dizziness, fatigue, and trouble sleeping. Some patients might notice changes in body fat distribution, such as increased fat in the upper back and stomach or decreased fat in the arms and legs. Additionally, some men may experience larger breasts. A mild rash may also develop, usually resolving within one to two weeks. However, if the rash occurs with fever, joint pain, or swollen eyes, it's important to seek medical attention promptly.

More significant side effects, although rare, require immediate medical assistance. These include severe allergic reactions characterized by fever, rash, joint pain, or swelling of the face. Liver injury is another serious concern and can present symptoms such as persistent nausea, abdominal pain, yellowing of the skin or eyes, and dark urine. Other serious side effects that warrant prompt medical intervention include unexplained weight loss, severe tiredness, persistent muscle aches, headaches, joint pain, numbness, vision changes, or symptoms indicative of a kidney problem.

While higher levels of fats, blood sugar, and creatine kinase, as well as abnormal liver lab results, have been reported, they are generally less common. If you notice significant changes or experience severe discomfort, contact your healthcare provider to discuss your symptoms. Always remain vigilant about any side effects and report them to your healthcare provider to ensure safe and effective use of the medication.

Etravirine, known by the brand name Intelence, can interact with various medications and supplements. It is crucial to keep your doctor and pharmacist informed about all the prescription drugs, over-the-counter medications, vitamins, and herbal supplements you are currently using.

Interactions with Etravirine can alter how the drug or the other medications work, potentially leading to side effects or reduced effectiveness. It's important to note that the following interactions are not exhaustive:

1. Not Recommended Combinations: Etravirine should not be used with Dasabuvir or Maraviroc as these combinations are not recommended.

2. Caution Advised Combinations: Some medications should ordinarily be avoided with Etravirine unless necessary. If prescribed together, your healthcare provider might adjust the dosage or frequency. These include numerous medications such as Alfentanil, Amiodarone, Atazanavir, Clarithromycin, Clopidogrel, Cobicistat, Disopyramide, and many others. It's vital to consult your healthcare provider for guidance specific to your medication regimen.

3. Increased Side Effect Risk: Etravirine may increase the risk of certain side effects when used with drugs like Atorvastatin, Boceprevir, Digoxin, Sildenafil, among others. Your doctor may need to adjust doses for safety and effectiveness.

Additionally, some drugs can affect how Etravirine is processed in your body. These include macrolide antibiotics like erythromycin, rifamycins like rifampin, and seizure medicines like carbamazepine and phenytoin. Conversely, Etravirine can influence the elimination of other medications, potentially altering their effectiveness. This includes drugs for heart rhythm, blood thinners like warfarin, and certain cholesterol medications.

Always consult with your healthcare provider before starting or stopping any medications while on Etravirine to ensure safe and effective treatment.