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The following safety information outlines important precautions and risks associated with Evotaz (atazanavir / cobicistat). Please read carefully and discuss any concerns with your healthcare provider.

• Heart Rhythm Issues: Evotaz may impact your heart rhythm, potentially causing serious problems, especially if you have a history of heart rhythm disorders or are taking other medications that affect heart rhythm. Inform your healthcare providers about your health conditions and medications. Immediate medical attention is necessary if you experience symptoms such as chest pounding, difficulty breathing, chest pain, or feeling faint.

• Skin Reactions: Notify your provider of any new rashes after starting Evotaz. While mild-to-moderate rashes typically resolve within a week, severe rashes accompanied by fever, muscle or joint pain, mouth sores, blisters, or peeling skin require immediate discontinuation of the medication and medical attention.

• Kidney Concerns: Evotaz can alter blood test results related to kidney function, potentially indicating kidney damage. This risk is heightened if you have a history of kidney issues or are taking tenofovir disoproxil fumarate. Report any signs of kidney stones or gallstones, such as unusual abdominal pain, nausea, difficulty urinating, or blood in the urine.

• Liver Health: Elevated liver enzyme levels may occur, suggesting potential liver damage. Individuals with liver conditions, such as hepatitis B or C, should inform their healthcare providers, who may conduct regular liver function tests.

• High Bilirubin Levels: Evotaz may increase bilirubin levels, causing jaundice. Discuss alternative medications with your provider if this occurs, but do not stop Evotaz without medical advice to ensure continuous HIV treatment.

• Drug Interactions: Evotaz interacts with numerous medications, potentially causing harmful side effects or reducing its efficacy. Ensure your healthcare provider is aware of all medications you are taking.

• Immune System Changes: Combination ARV therapy, including Evotaz, may cause immune reconstitution syndrome, where an activated immune system attacks normal cells. Report any new symptoms such as fever, pain, or sudden health changes to your provider.

• Blood Sugar Levels: Evotaz may increase blood sugar levels, potentially leading to or exacerbating diabetes. Those with a history of diabetes should inform their provider, who may recommend regular blood sugar monitoring.

• Body Fat Changes: Some users of HIV medications like Evotaz have experienced changes in body fat distribution. Report any noticeable changes to your provider.

• Bleeding Risk for Hemophilia Patients: Individuals with hemophilia may experience increased bleeding. Inform your healthcare provider of your condition prior to starting Evotaz.

Contraindications: Do not use Evotaz if you have had an allergic reaction to atazanavir or cobicistat, or if you are taking medications that interact with it. Always consult your healthcare provider in these situations.

When taking this medication, some common side effects may occur but are usually mild and manageable. These include nausea, diarrhea, headache, rash, and jaundice, which is the yellowing of the skin or eyes. While these effects are generally not a cause for concern, it is advisable to contact a healthcare provider if they persist or worsen.

More serious side effects require immediate medical attention. These include severe skin reactions such as red, raised areas, blistering, or peeling skin, as well as heart rhythm problems characterized by dizziness, lightheadedness, or an irregular heartbeat. Additionally, symptoms of kidney or gallstones, like severe stomach pain, nausea, vomiting, difficulty urinating, fever, or bloody urine, should prompt urgent care.

Other serious symptoms warrant immediate medical help, such as unexplained weight loss, severe tiredness, persistent muscle aches or weakness, severe headaches, vision changes, and signs of infection, like fever or trouble breathing. Signs of an overactive immune response or thyroid issues, including irritability, nervousness, or a fast heartbeat, should also be monitored closely. Rare but very serious allergic reactions can occur, presenting as rash, itching, swelling, severe dizziness, or trouble breathing. Immediate medical attention is crucial if these symptoms appear. While changes in body fat distribution may occur, their long-term effects are not fully understood. Discuss with your healthcare provider about managing these changes, possibly with exercise.

Some medications that may interact with this drug include drospirenone/estradiol, elvitegravir, certain chronic hepatitis C treatments (such as elbasvir/grazoprevir and glecaprevir/pibrentasvir), orlistat, and ritonavir. This drug can slow down the elimination of other medications from your body, potentially altering their effectiveness. Affected drugs include certain alpha blockers (like alfuzosin and silodosin), benzodiazepines (such as midazolam and triazolam), dronedarone, ergot alkaloids (like dihydroergotamine and ergotamine), irinotecan, lurasidone, pimozide, ranolazine, rivaroxaban, salmeterol, some erectile dysfunction or pulmonary hypertension medications (such as avanafil and sildenafil), and specific cholesterol-lowering statins (like lovastatin and simvastatin).

Other drugs can influence how this medication is removed from your body, affecting its effectiveness. These include apalutamide, lumacaftor, mitotane, certain HIV NNRTIs (such as efavirenz, etravirine, and nevirapine), rifamycins (like rifampin and rifapentine), medications for seizures (such as carbamazepine, phenobarbital, phenytoin, and primidone), and St. John's wort.

Additionally, prescription and nonprescription drugs for heartburn, indigestion, or ulcers, including H2 blockers like famotidine and proton pump inhibitors such as lansoprazole and omeprazole, can reduce stomach acid, decreasing the absorption and effectiveness of atazanavir. Consult your doctor or pharmacist to safely manage these medications.

This drug may reduce the effectiveness of hormonal birth control methods like pills, patches, or rings, which could result in pregnancy. Discuss with your healthcare provider whether you need an additional reliable birth control method while using this medication. Notify your doctor if you experience new spotting or breakthrough bleeding, as these could indicate reduced birth control effectiveness.

Avoid using this medication with other products containing atazanavir or cobicistat.