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The following information outlines essential safety and warning details related to the use of Prezcobix (darunavir / cobicistat). Please review these carefully and discuss any concerns with your healthcare provider.

• Liver Problems: There is a rare risk of life-threatening liver issues with Prezcobix, especially if taken with ritonavir (Norvir). Your healthcare provider will conduct liver function tests before and during the initial months of treatment, especially if you have hepatitis B or C, or a history of liver issues.

• Severe Skin and Allergic Reactions: A rash may occur within the first four weeks of treatment. If it is mild or moderate, continue taking the medication but inform your provider. For severe or worsening rashes, contact your provider immediately. This risk is higher in individuals with sulfa allergies or those taking ritonavir (Norvir).

• Kidney Function Changes: Prezcobix may affect kidney function tests. Your provider will monitor your kidney health with blood tests before and during treatment. If combined with tenofovir disoproxil fumarate (TDF), additional urine tests may be required. Depending on your kidney health, alternative medications might be considered.

• High Blood Sugar: Some patients may experience elevated blood sugar levels, potentially leading to or worsening diabetes. Inform your provider if you have a history of diabetes, as your blood sugar levels may need monitoring and diabetes medication adjustments might be necessary.

• Body Fat Changes: Rarely, changes in body fat distribution may occur. Report any noticeable changes to your provider as it is unclear if these changes directly impact health.

• Overactive Immune System: Combination ARV therapy can trigger immune reconstitution syndrome, where the immune system becomes overactive. Report new symptoms like fever, pain, or hair loss immediately.

• Bleeding Risk in Hemophilia: Individuals with hemophilia may experience increased bleeding. Notify your provider if you experience joint pain, swelling, or unusual bruising.

• Medication Interactions: Prezcobix interacts with various medications, which can reduce its efficacy. Avoid medications like efavirenz (Sustiva) and carbamazepine (Tegretol). Discuss all current medications with your provider to avoid serious side effects.

Consult your healthcare provider if any contraindications apply to your situation. Always inform them of other medications you are taking to ensure safe treatment with Prezcobix.

When taking this medication, you may experience some common side effects such as diarrhea, nausea, stomach pain, vomiting, headache, and rash. These symptoms are usually mild, but it is important to contact a healthcare provider if they persist or worsen.

In some cases, individuals might notice changes in body fat distribution, which could include increased fat in areas like the upper back and stomach or reduced fat in the arms and legs. While the long-term effects of these changes are not well understood, discussing them with a healthcare provider can help manage any concerns.

Serious side effects, although rare, require immediate medical attention. These include symptoms of severe liver problems such as persistent nausea, vomiting, loss of appetite, abdominal pain, jaundice (yellowing of the skin or eyes), and dark urine. Additionally, be alert to signs of severe allergic reactions, such as facial swelling, hives, trouble breathing, and fever, as these warrant urgent medical care.

An overactive immune response may occur, potentially leading to symptoms of previous infections re-emerging or causing new symptoms such as unexplained weight loss, severe fatigue, muscle weakness, and vision changes. Moreover, there is a risk of increased blood sugar levels, which can exacerbate or lead to diabetes. Symptoms like increased thirst and urination should be promptly discussed with a healthcare provider.

Lastly, if any rash appears, especially if accompanied by fever, tiredness, or blisters, seek medical help to ensure it is not a severe reaction. Always stay informed about your health and communicate with your healthcare provider regarding any unusual symptoms.

This medication can interact with several other drugs, potentially altering their effectiveness or how they are cleared from your body. Notable drugs that may interact include elvitegravir, orlistat, and ritonavir. The medication can slow the elimination of certain drugs like alpha blockers (e.g., alfuzosin, tamsulosin), benzodiazepines (e.g., midazolam, triazolam), dronedarone, ergot alkaloids (e.g., dihydroergotamine, ergotamine), lomitapide, quinidine, pimozide, ranolazine, rivaroxaban, salmeterol, drugs for erectile dysfunction or pulmonary hypertension (e.g., avanafil, sildenafil), and some "statin" cholesterol medications (e.g., lovastatin, simvastatin). This slowdown can influence their function in your body.

Conversely, certain medications can alter how this drug is removed from your body, impacting its effectiveness. These include apalutamide, medications for seizures (e.g., carbamazepine, phenobarbital, phenytoin, primidone), garlic supplements, specific HIV NNRTI drugs (e.g., efavirenz, etravirine, nevirapine), rifamycins (e.g., rifampin, rifapentine), mitotane, and St. John's wort.

Additionally, this medication may reduce the effectiveness of hormonal birth control methods like pills, patches, or rings, which could result in pregnancy. It is important to consult your doctor or pharmacist about using additional reliable birth control methods while on this medication. If you notice any new spotting or breakthrough bleeding, inform your doctor as these could indicate your birth control is less effective.

Lastly, avoid taking this medication with other products containing darunavir or cobicistat.