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The following information highlights vital safety precautions and potential risks associated with the use of Prezista (darunavir). Please review this carefully and consult your healthcare provider with any questions or concerns.

• Liver Issues: Prezista may lead to serious liver complications, particularly within the initial months of treatment. Your healthcare provider will conduct blood tests prior to and during treatment to monitor liver health. Immediate medical consultation is required if you experience symptoms like drowsiness, nausea, loss of appetite, pale stools, upper right abdominal pain, jaundice, or dark urine. Individuals with Hepatitis B or C, or a history of liver problems, are at elevated risk.

• Severe Skin and Allergic Reactions: Individuals with sulfa allergies or those taking Isentress (raltegravir) alongside Prezista and ritonavir (Norvir) are at risk of developing rashes or severe skin reactions, typically within the first four weeks of treatment. Mild to moderate rashes should be reported to your provider but may resolve independently. A severe rash, especially with fever, discomfort, muscle or joint pain, mouth sores, blisters, or facial swelling, necessitates immediate cessation of the medication and urgent medical attention.

• Body Fat Alterations: Rarely, changes in body fat distribution may occur in those using HIV medications like Prezista. This includes increased fat in areas such as the neck, breast, and abdomen, and fat loss from the limbs and face. The cause and long-term health implications are unclear, so report any changes to your healthcare provider.

• Immune System Activation: Combination antiretroviral therapy, including Prezista, can cause immune reconstitution syndrome, where the immune system becomes overly active. This might lead to it attacking healthy cells in rare cases. New symptoms such as fever, pain, hair loss, bulging eyes, or sweating should be reported to your provider immediately.

• Bleeding Risks: People with hemophilia or a history of bleeding issues may experience increased bleeding with protease inhibitors like Prezista. If you notice joint pain and swelling or bruising, contact your healthcare provider as these might indicate bleeding complications.

• Drug Interactions: Certain medications may affect how Prezista is metabolized, altering its effectiveness and increasing side effect risks. It is crucial to discuss all medications you are taking with your healthcare provider to prevent interactions.

• Contraindications: Avoid using Prezista with medications that can heighten the risk of serious side effects, including alfuzosin, Multaq (dronedarone), lovastatin, simvastatin, and triazolam. Consult your healthcare provider if you are on any of these medications.

In case of an overdose, seek emergency medical attention immediately. Always follow your healthcare provider’s instructions when using Prezista to ensure safe and effective treatment.

Darunavir, used in combination with other HIV medications, can cause several common side effects, including diarrhea, nausea, vomiting, stomach pain, and headache. These effects are generally mild and often resolve on their own, but if they persist or worsen, consulting a healthcare provider is advisable. Rash is another common side effect, usually not serious, although any rash accompanied by fever, tiredness, or muscle and joint pain should be evaluated by a doctor to rule out a severe reaction.

In rare cases, darunavir may lead to more significant side effects that require immediate medical attention. Serious allergic reactions can manifest as facial swelling, hives, or difficulty breathing. Liver issues, potentially life-threatening, are characterized by persistent nausea, loss of appetite, abdominal pain, jaundice, or dark urine. An increase in blood sugar levels is possible, potentially exacerbating diabetes, and should be monitored closely.

Other side effects reported include muscle pain, excessive gas, tiredness, irregular dreams, and indigestion. Some individuals may experience changes in body fat distribution, though the long-term impact of this is not well understood. If you experience severe symptoms such as unexplained weight loss, severe headaches, or signs of infection, prompt medical consultation is essential. Overall, while darunavir can cause side effects, many users do not experience serious issues, and the benefits of the medication often outweigh the risks.

Prezista (darunavir) can interact with several medications and supplements, potentially altering their effects. It is important to inform your healthcare provider about all the medications and supplements you are taking, including prescription, over-the-counter, and herbal products.

Some medications should not be used with darunavir due to significant interactions. These include alfuzosin, astemizole, carbamazepine, cisapride, colchicine, dihydroergotamine, domperidone, dronedarone, ergonovine, ergotamine, grazoprevir, lovastatin, lurasidone, maraviroc, methylergonovine, midazolam, phenobarbital, phenytoin, pimozide, ranolazine, rifampin, sildenafil, simvastatin, St. John's Wort, terfenadine, and triazolam.

Other medications may be used with darunavir but require caution and possible dose adjustments. These include alfentanil, alprazolam, amineptine, amiodarone, amitriptyline, amitriptylinoxide, amobarbital, amoxapine, aprobarbital, atazanavir, atomoxetine, atorvastatin, avanafil, benzhydrocodone, boceprevir, bosentan, budesonide, buprenorphine, butabarbital, butalbital, cabotegravir, ceritinib, clomipramine, clozapine, codeine, conivaptan, cyclophosphamide, dabigatran etexilate, dasabuvir, delavirdine, desipramine, desogestrel, dexamethasone, dextromethorphan, dibenzepin, didanosine, dienogest, dihydrocodeine, doxepin, doxorubicin, drospirenone, duloxetine, duvelisib, efavirenz, elvitegravir, erythromycin, estradiol, ethinyl estradiol, ethynodiol, etonogestrel, fentanyl, fluvastatin, fosamprenavir, fosnetupitant, gestodene, glecaprevir, haloperidol, hydrocodone, idelalisib, ifosfamide, imipramine, ivosidenib, larotrectinib, lefamulin, lemborexant, levonorgestrel, lofepramine, lopinavir, lorlatinib, lumacaftor, medroxyprogesterone, melitracen, meperidine, mephobarbital, mestranol, methadone, methohexital, modafinil, nafcillin, naloxegol, nelfinavir, netupitant, nevirapine, nomegestrol, norelgestromin, norethindrone, norgestimate, norgestrel, nortriptyline, olaparib, ombitasvir, ondansetron, opipramol, orlistat, oxcarbazepine, oxycodone, paritaprevir, pentazocine, pentobarbital, perphenazine, pibrentasvir, piperaquine, pitavastatin, pravastatin, prednisolone, prednisone, primidone, propranolol, protriptyline, quetiapine, rifabutin, rifapentine, rivaroxaban, rosuvastatin, saquinavir, secobarbital, segesterone, simeprevir, sufentanil, tacrolimus, tadalafil, tamoxifen, telaprevir, thiopental, tianeptine, tipranavir, tramadol, trazodone, trimipramine, ulipristal, vardenafil, venlafaxine, vinblastine, and vincristine.

Additionally, some medications may increase the risk of side effects when taken with darunavir, but may still be prescribed if deemed the best treatment. These include clarithromycin, cobicistat, digoxin, indinavir, ketoconazole, and tenofovir disoproxil fumarate.

Darunavir can also reduce the effectiveness of hormonal birth control methods like pills, patches, or rings, which might result in pregnancy. It is advisable to consult your doctor about using reliable backup birth control methods and report any unusual bleeding, which could indicate reduced birth control efficacy.

Lastly, avoid using other products that contain darunavir concurrently.