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.
Bone effects: Tenofovir alafenamide may reduce bone strength and bone growth in adolescents. The effect of tenofovir alafenamide on bone density and risk of fractures is not known, but other forms of tenofovir appear to be associated with decreased bone density. If you experience bone pain or a bone fracture while taking this medication, contact your doctor. Your doctor may do tests to monitor the effect of this medication on your bones. If you have concerns regarding bone health, discuss this with your doctor.
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 loss of fat from the legs, arms, and face. The long-term effects of this are not known.
Hepatitis B: For patients with hepatitis B, your doctor will talk to you about HIV treatment before you begin taking this medication. The safety and effectiveness of taking this medication if you have both HIV and hepatitis B have not been determined. People with hepatitis B who have taken emtricitabine or tenofovir (two of the medications in this product) have experienced severe recurrences of hepatitis B when the emtricitabine or tenofovir have been stopped.
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 medication 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.
Kidney function: This medication has been reported to cause changes in kidney function. If you have reduced kidney function or kidney disease, 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.
Lactic acidosis and enlarged liver: This medication can cause a rare but serious condition called lactic acidosis (buildup of lactic acid), together with an enlarged fatty liver. Your doctor will periodically monitor you and perform laboratory tests to check your liver function. If you notice any symptoms of this condition such as nausea, vomiting, stomach pain, weakness, tiredness, feeling cold, dizziness, lightheadedness, or irregular heartbeat, seek immediate medical attention.
Liver function: Elvitegravir and cobicistat are removed from the body by the liver and may cause liver problems. If you have liver disease or decreased liver function, 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.
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 (inflammation of the pancreas): Tenofovir may cause or worsen 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. If you develop signs of pancreatitis (e.g., upper left abdominal pain, back pain, nausea, fever, chills, rapid heartbeat, swollen abdomen), contact your doctor.
Stopping the medication: If you stop taking this medication, your HIV infection could get worse. Some people who also have hepatitis B infection experience a flare-up of the hepatitis B when tenofovir or emtricitabine are discontinued. Take the medication exactly as prescribed by your doctor, and do not stop taking the medication without checking with your doctor first.
Pregnancy: This 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 cobicistat, elvitegravir, or tenofovir alafenamide passes into breast milk. Emtricitabine passes into breast milk and may affect your baby. 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 who are less than 12 years of age or weigh less than 35 kg.