Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.
Allergy: Some people who are allergic to sulfonamide antibiotics also experience allergic reactions to darunavir. Before you take this medication, inform your doctor about any previous adverse reactions you have had to medications, especially sulfonamide antibiotics such as sulfamethoxazole-trimethoprim. Contact your doctor at once if you experience signs of an allergic reaction, such as skin rash, itching, difficulty breathing, or swelling of the face and throat.
Bleeding: Darunavir may cause a reduced number of platelets in the blood, which can make it difficult to stop cuts from bleeding. If you notice any signs of bleeding, such as frequent nosebleeds, unexplained bruising, or black and tarry stools, notify your doctor as soon as possible. Your doctor will order routine blood tests to make sure potential problems are caught early. The risk of bleeding may be increased in people who have hemophilia. Discuss any concerns you may have with your doctor.
Blood tests: Darunavir can cause changes in your blood test results, such as red blood cell count, platelet count, cholesterol level, and sugar level. Your doctor will explain these to you and monitor your blood levels.
Diabetes: Antiretroviral medications such as darunavir may increase blood sugar levels. If you have diabetes or are at risk for developing diabetes, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is required.
Fat redistribution: Over time, this medication may change how fat is distributed in your body and may change your body shape. You may notice increased fat in the upper back and neck, breast, around the back, chest, and stomach area. Or you may notice loss of fat from the legs, arms, and face. The long-term effects of this are not known.
Immune reconstitution syndrome: This medication may cause immune reconstitution syndrome, where signs and symptoms of inflammation from previous infections appear. These symptoms occur soon after starting anti-HIV medications and can vary. They are thought to occur as a result of the immune system improving and being able to fight infections that have been present without symptoms, such as pneumonia, herpes, or tuberculosis. Report any new symptoms to your doctor immediately.
Liver function: Liver disease or reduced liver function may cause this medication to build up in the body, causing side effects. If you have liver problems, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed. Your doctor may want to test your liver function regularly with blood tests while you are taking this medication. People with severe liver disease should not take cobicistat-darunavir.
There have been reports of serious liver problems while taking darunavir. People with liver problems (including hepatitis B or hepatitis C infection) are at a risk of experiencing worsening of these problems while taking this medication. If you experience symptoms of liver problems (e.g., abdominal pain, persistent vomiting, feeling unwell, fever, itching, yellowing of the skin and eyes, dark urine), contact your doctor immediately.
Pancreatitis: This medication may cause inflammation of the pancreas (pancreatitis). If you have a history of or are at risk for developing pancreatitis, you should be closely monitored by your doctor while taking this medication. Discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is required.
If you develop signs of pancreatitis (e.g., upper left abdominal pain, back pain, nausea, fever, chills, rapid heartbeat, swollen abdomen), contact your doctor.
Skin rashes: This medication can cause skin rash, which is usually mild or moderate. However, darunavir can cause severe skin reactions. If you develop a skin rash with fever, fatigue, blisters, muscle aches, or sores in and around the mouth, stop taking this medication and contact your doctor immediately
Stopping the medication: If you stop taking this medication, your HIV infection could get worse. Take the medication exactly as prescribed by your doctor, and do not stop taking the medication without checking with your doctor first.
Pregnancy: The medication should not be used during pregnancy unless the benefits outweigh the risks. If you become pregnant while taking this medication, contact your doctor immediately.
Breast-feeding: It is not known if darunavir passes into breast milk. Women who have HIV infection are cautioned against breast-feeding because of the risk of passing HIV to a baby who does not have the infection.
Children: The safety and effectiveness of using this medication have not been established for children.