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The following safety information outlines the potential risks and precautions associated with the use of fosamprenavir (Lexiva). Patients and healthcare providers should review these details carefully to ensure the medication is used safely and effectively.

• Drug Interactions: Be aware that some medications can affect how fosamprenavir (Lexiva) is metabolized in your body, altering its effectiveness and increasing the risk of side effects. Discuss all medications you are taking with your healthcare provider.

• Severe Skin and Allergic Reactions: Individuals with sulfa allergies should be cautious, as fosamprenavir (Lexiva), particularly when combined with ritonavir (Norvir), can cause serious skin reactions, including rashes. If a mild or moderate rash appears, continue the medication and inform your provider. However, if the rash is severe or accompanied by fever, pain, mouth sores, blisters, or facial swelling, stop taking the medication and seek immediate medical attention due to the risk of Stevens-Johnson Syndrome (SJS).

• Liver Health: Fosamprenavir (Lexiva) can potentially cause liver issues, especially in those with a history of liver disease or hepatitis, or when taken with high doses of ritonavir (Norvir). Regular blood tests will be necessary to monitor liver function. Report any symptoms such as fatigue, nausea, loss of appetite, pale stools, upper right abdominal pain, jaundice, or dark urine to your provider promptly.

• Blood Sugar Levels: This medication can increase blood sugar levels, especially in individuals taking certain HIV antiretroviral drugs, which may worsen diabetes. It's crucial for those with a history of diabetes to inform their healthcare provider and monitor blood sugar levels regularly.

• Immune System Changes: Use of fosamprenavir (Lexiva) with other HIV medications may lead to immune reconstitution syndrome, where the immune system becomes overly active. This can result in new symptoms such as fever or pain, which should be reported immediately.

• Body Fat Changes: Some patients may experience changes in body fat distribution, such as accumulation in certain areas and loss in others. Report any noticeable changes to your healthcare provider.

• Cholesterol Levels: Treatment with fosamprenavir (Lexiva) can increase cholesterol and triglyceride levels, raising the risk of cardiovascular events. Regular monitoring by your provider is necessary, and certain cholesterol medications should be avoided to prevent adverse effects.

• Bleeding Risk: Patients with hemophilia or a history of bleeding disorders should be cautious and report any unusual bleeding events.

• Kidney Stones: Although rare, kidney stones have been reported. Discontinue use and consult your healthcare provider if you experience symptoms like pain in the lower abdomen or back, nausea, or vomiting.

• Contraindications: Do not use fosamprenavir (Lexiva) if you are taking medications like alfuzosin, rifampin, St. John’s wort, lovastatin, simvastatin, or triazolam, as they can significantly increase the risk of serious side effects.

Patients should always consult their healthcare provider to discuss any concerns or questions about their treatment with fosamprenavir (Lexiva).

Common side effects:

• Diarrhea
• Nausea
• Vomiting
• Headache
• Tiredness
• Rash

Less common but important to monitor:

• Changes in body fat distribution
• Higher levels of body fats
• Liver function changes

Serious side effects:

• Severe allergic reactions
• Serious skin reactions
• Serious liver issues
• Overactive immune response
• Heart attack symptoms
• Nerve problems (e.g., Guillain-Barre syndrome)

Interactions with high risk of serious adverse effects and should be avoided:

• lopinavir
• tipranavir
• orlistat
• apalutamide
• etravirine
• rifampin
• St. John's wort

Interactions with moderate risk that may require dose adjustment, closer monitoring, or timing changes:

• alfuzosin
• midazolam
• triazolam
• dihydroergotamine
• ergotamine
• fluticasone
• pimozide
• ranolazine
• rivaroxaban
• sildenafil
• vardenafil
• flecainide
• propafenone
• lovastatin
• simvastatin
• salmeterol