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The following safety information outlines essential warnings and precautions for individuals considering or currently using fosamprenavir (Lexiva). Please review these details thoroughly and consult your healthcare provider with any questions or concerns.

• Drug Interactions: Some medications can affect how your body processes fosamprenavir, potentially altering its effectiveness and increasing the risk of side effects. Ensure you inform your healthcare provider about all medications you are taking.

• Severe Skin and Allergic Reactions: If you have a sulfa allergy, be aware that fosamprenavir can cause rashes and severe skin reactions. Continue taking the medication if you experience a mild or moderate rash, but inform your provider. Seek immediate medical attention if you develop a severe rash, especially if accompanied by fever, discomfort, muscle or joint pain, mouth sores, blisters, or facial swelling, as these may indicate a serious condition like Stevens-Johnson Syndrome (SJS).

• Liver Problems: Individuals with a history of hepatitis, liver issues, or those taking high doses of fosamprenavir with ritonavir (Norvir) are at increased risk for liver problems. Regular blood tests will be conducted to monitor liver health. Report symptoms such as fatigue, nausea, loss of appetite, light-colored stools, upper right abdominal pain, yellowing skin or eyes, or dark urine to your provider immediately.

• High Blood Sugar: Fosamprenavir, particularly when used with certain HIV medications, can raise blood sugar levels. If you have diabetes or a history of high blood sugar, inform your provider before starting treatment, as dose adjustments for diabetic medications might be necessary. You may need to monitor your blood sugar levels at home.

• Overactive Immune System: Combination antiretroviral therapy can trigger immune reconstitution syndrome, where the immune system becomes overly active. New symptoms such as fever, pain, hair loss, bulging eyes, or sweating should be reported to your provider promptly.

• Changes in Body Fat: Some individuals may experience changes in body fat distribution, including increased fat in certain areas and loss in others. The cause and long-term effects are unclear, so notify your provider if these changes occur.

• Higher Cholesterol Levels: Fosamprenavir can increase cholesterol and triglyceride levels, heightening the risk of heart attack or stroke. Your provider will check your cholesterol levels and may prescribe medications to manage them. Avoid certain cholesterol medications like lovastatin and simvastatin while taking fosamprenavir to prevent adverse effects.

• Risk of Bleeding: Individuals with hemophilia or a history of bleeding problems may experience increased bleeding. It's important to inform your provider of any unusual bleeding occurrences.

• Risk of Kidney Stones: Though rare, kidney stones have been reported. Discontinue use and contact your provider if you experience lower abdominal or back pain, nausea, or vomiting.

• Contraindications: Avoid using fosamprenavir with certain medications, including alfuzosin, rifampin, St. John’s wort, lovastatin, simvastatin, and triazolam, as these can significantly increase the risk of serious side effects. Consult your healthcare provider if you are taking or considering taking these medications.

When taking this medication, some common side effects may occur, such as diarrhea, nausea, vomiting, headache, and fatigue. These effects are usually mild and temporary, but if they persist or worsen, you should seek advice from a healthcare provider. Another common side effect is a rash, which is typically not serious. However, it's important to differentiate it from a rare, severe rash that requires immediate medical attention.

Other side effects can include changes in body fat distribution, such as increased fat in the upper back and stomach areas and decreased fat in the arms and legs. The long-term effects of these changes are unknown, so discussing possible management strategies, such as exercise, with your healthcare provider may be beneficial.

This medication may also cause more serious side effects that need urgent medical attention. These include severe allergic reactions characterized by facial swelling, hives, and difficulty breathing; severe skin reactions with symptoms like fever and peeling skin; and serious liver issues, which can present as persistent nausea, vomiting, abdominal pain, jaundice, and dark urine. Rarely, symptoms of an overactive immune response, such as unexplained weight loss, severe tiredness, or signs of infection, may occur after starting treatment. Immediate medical help is crucial if these symptoms arise.

Finally, some individuals might experience increased thirst or urination, or signs of kidney stones, such as pain in the abdomen or blood in the urine. Although these side effects are less common, they still warrant prompt consultation with a healthcare provider. Always report any new or worsening symptoms to ensure appropriate care.

Fosamprenavir may interact with certain medications, which can influence how it works or how other drugs perform. For instance, it can interact with specific HIV protease inhibitors like lopinavir and tipranavir, as well as orlistat. Other medications, such as apalutamide, etravirine, rifampin, and St. John's wort, can alter the way fosamprenavir is removed from your body, affecting its effectiveness.

Additionally, fosamprenavir can impact the metabolism of other drugs, potentially speeding up or slowing down their removal from your system. This interaction could affect medications such as alpha blockers (e.g., alfuzosin), certain benzodiazepines (e.g., midazolam, triazolam), ergot alkaloids (e.g., dihydroergotamine, ergotamine), fluticasone, pimozide, ranolazine, rivaroxaban, and drugs used for erectile dysfunction or pulmonary hypertension (e.g., sildenafil, vardenafil). It can also affect drugs for irregular heartbeat (e.g., flecainide, propafenone), some statins (e.g., lovastatin, simvastatin), and salmeterol.

Moreover, fosamprenavir may reduce the effectiveness of hormonal birth control methods like pills, patches, or rings, increasing the risk of unintended pregnancy. It is important to consult with your doctor or pharmacist about using reliable backup birth control methods. If you notice new spotting or breakthrough bleeding, inform your doctor, as these might indicate reduced effectiveness of your birth control.