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The following safety information outlines important warnings associated with the use of Tybost (cobicistat). Please read carefully and discuss any concerns with your healthcare provider.

• Kidney Function Changes: Tybost (cobicistat) may lead to alterations in kidney function or cause kidney damage, especially in individuals with a history of kidney issues or those taking older versions of tenofovir as part of their HIV antiretroviral therapy (ARV) regimen. Regular monitoring through blood tests is advised to assess kidney function. Increased risk is associated with a history of kidney damage and the use of Viread (tenofovir).

• Drug Interactions: Tybost (cobicistat) can interact with a wide range of medications, potentially increasing the levels of these drugs in the body, which may result in serious or life-threatening side effects. Conversely, some medications can reduce the effectiveness of Tybost (cobicistat) and the ARVs it boosts. It is crucial to consult your healthcare provider or pharmacist before beginning or discontinuing any medications or supplements.

• Use with Other HIV ARVs: Tybost (cobicistat) can enhance your HIV ARV regimen but is only approved for use with certain protease inhibitors, such as atazanavir (Reyataz) and once-daily darunavir (Prezista). It is not suitable for use with twice-daily darunavir or many NNRTIs, including Sustiva (efavirenz). Although similar to Norvir (ritonavir) as a booster, Tybost (cobicistat) cannot replace Norvir (ritonavir) in an HIV treatment plan. It is important not to combine Tybost (cobicistat) with Norvir (ritonavir) in any regimen.

Please follow all instructions provided by your healthcare provider to ensure safe and effective use of Tybost (cobicistat).

When taking this medication, some individuals may experience common side effects that are generally mild, such as nausea and diarrhea. If these persist or worsen, it is advisable to consult with a healthcare provider. Additionally, headaches and high blood sugar have been reported by some users. A small percentage of individuals may notice a rash or yellowing of the skin and eyes; monitor these symptoms and seek advice if they become concerning.

In some cases, the immune system may become overactive, which can lead to the reemergence of previous infections or the onset of new symptoms. Serious symptoms requiring immediate medical attention include unexplained weight loss, persistent severe tiredness, muscle aches, ongoing headaches, joint pain, and numbness or tingling in the extremities. Vision changes and signs of an infection, such as fever or swollen lymph nodes, also warrant prompt medical evaluation.

Rare but severe side effects include allergic reactions characterized by rash, itching, hives, or swelling of the face, lips, tongue, or throat. Kidney injuries, indicated by a decrease in urine output and swelling of the ankles, hands, or feet, are serious and require urgent care. Unusual thyroid activity, marked by irritability and a fast or irregular heartbeat, should be addressed immediately. Always seek medical help if you notice any severe or unusual symptoms not listed here.

Certain medications can interact with this drug, potentially altering its effectiveness or the way it works in your body. Some drugs that may be affected by this medication include elvitegravir, orlistat, and ritonavir. This medication may slow the elimination of other drugs from your system, influencing their performance. Affected medications can include specific alpha blockers (like alfuzosin and tamsulosin), benzodiazepines (such as midazolam and triazolam), dronedarone, ergot alkaloids (including dihydroergotamine and ergotamine), quinidine, pimozide, ranolazine, rivaroxaban, salmeterol, drugs for erectile dysfunction or pulmonary hypertension (such as avanafil and sildenafil), and certain cholesterol-lowering statins (like lovastatin and simvastatin).

Additionally, some medications may impact how this drug, cobicistat, is processed in your body, thereby affecting its function. Examples include certain seizure medications (such as carbamazepine, phenobarbital, phenytoin, and primidone), enzalutamide, certain HIV NNRTI medications (like efavirenz, etravirine, and nevirapine), mitotane, rifampin, and St. John's wort.

It's important to note that this medication might reduce the effectiveness of hormonal birth control methods, such as pills, patches, or rings, potentially leading to pregnancy. Discuss with your healthcare provider whether you should use an additional, reliable form of birth control while taking this medication. Inform your doctor if you experience any unusual spotting or breakthrough bleeding, as this could indicate that your birth control is not functioning properly.

Lastly, avoid using this medication alongside any other products that contain cobicistat.