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This document outlines essential safety warnings and precautions for using Atazanavir (Reyataz). It is crucial to review this information carefully and discuss any questions or concerns with your healthcare provider.

• Heart Rhythm Disturbances: Atazanavir can potentially disrupt heart rhythms, potentially leading to severe and life-threatening conditions. Individuals with a history of heart issues, imbalanced electrolyte levels, or those taking other heart-affecting medications like digoxin (Lanoxin) are at increased risk. Seek immediate medical help if you experience chest pounding, difficulty breathing, chest pain, or feel faint or dizzy.

• Severe Skin and Allergic Reactions: Users may develop rashes or severe skin conditions, especially within the first 8 weeks. Mild to moderate rashes should be reported to your healthcare provider, but continuation of the medication is usually possible. However, if a severe rash is accompanied by fever, discomfort, muscle or joint pain, mouth sores, blisters, or facial swelling, discontinue the medication and seek medical attention immediately.

• Liver Complications: Atazanavir may cause serious liver issues, including an increase in bilirubin levels leading to jaundice. Healthcare providers will conduct blood tests before and during treatment to monitor liver health. Report any symptoms such as drowsiness, nausea, loss of appetite, pale stools, upper right abdominal pain, jaundice, or dark urine promptly. Individuals with hepatitis B or C or a history of liver problems are at higher risk.

• Kidney Concerns: This medication can harm the kidneys, making it unsuitable for those with existing kidney problems or at risk of them. Regular blood tests will monitor kidney function. Inform your provider about all medications you're taking, including over-the-counter ones, as many can negatively impact kidney health. Avoid Atazanavir if undergoing dialysis.

• Risk of Stones: There is a rare risk of developing kidney stones or gallstones. If you experience lower abdominal or back pain, nausea, or vomiting, contact your provider immediately.

• Elevated Blood Sugar: Atazanavir, particularly when combined with certain HIV medications, can increase blood sugar levels or exacerbate diabetes. Inform your provider if you have a history of diabetes, as adjustments to diabetes medications may be necessary. Regular blood sugar monitoring may be advised.

• Overactive Immune System: Atazanavir may induce immune reconstitution syndrome, where the immune system becomes overly active and may attack healthy cells. This can occur shortly after beginning treatment or months later. Report any new symptoms like fever, pain, hair loss, bulging eyes, or sweating to your healthcare provider.

• Body Fat Changes: In rare cases, Atazanavir may cause changes in body fat distribution. Notify your healthcare provider if you notice unusual fat accumulation or loss.

• Bleeding Risks: Those with hemophilia or bleeding disorders may experience increased bleeding after starting Atazanavir. Approximately half the time, treatment can continue after bleeding ceases. Report any unexpected bleeding or difficulties in stopping bleeding to your provider.

• Drug Interactions: Certain medications can affect how Atazanavir is metabolized, altering its efficacy and side effect profile.

Contraindications: Do not use this medication if you are taking certain other drugs metabolized by liver enzymes CYP3A4 or UGT1A1, such as alfuzosin (Uroxatral), rifampin (Rifadin), lovastatin, or simvastatin (Zocor).

Consultation with a healthcare provider is crucial before starting Atazanavir, especially if any of the above risks or conditions apply to you.

Common side effects:

• Headaches
• Nausea
• Vomiting
• Belly pain
• Nerve pain
• Diarrhea
• Increased liver enzyme levels
• Increased cholesterol levels
• Jaundice
• Rash

Less common but important to monitor:

• Trouble sleeping
• Dizziness
• Fever
• Feelings of depression

Serious side effects:

• Severe allergic reactions
• Serious liver issues
• Abnormal heart rhythms
• Overactive immune response
• Overactive thyroid
• Guillain-Barre syndrome
• Changes in body fat distribution

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

• Alfuzosin
• Dihydroergotamine
• Ergotamine
• Lovastatin
• Simvastatin
• Midazolam
• Triazolam
• Pimozide
• Sildenafil
• Rifampin
• St. John's Wort
• Rifapentine

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

• Elbasvir/Grazoprevir
• Glecaprevir/Pibrentasvir
• Elvitegravir/Cobicistat/Emtricitabine/Tenofovir
• Nevirapine
• Orlistat
• Apalutamide
• Bosentan
• Efavirenz
• Etravirine
• Lumacaftor
• Carbamazepine
• Phenobarbital
• Phenytoin
• Primidone
• Avanafil
• Irinotecan
• Lomitapide
• Salmeterol
• Famotidine
• Lansoprazole
• Omeprazole