Darunavir-cobicistat-emtricitabine-tenofovir alafenamide is a combination medication used to treat human immunodeficiency virus (HIV) infection and help prevent the human immunodeficiency virus (HIV) from reproducing. HIV is the virus responsible for acquired immune deficiency syndrome (AIDS). HIV infection destroys CD4 (T) cells, which are important to the immune system. The immune system helps fight infections. Darunavir-cobicistat-emtricitabine-tenofovir reduces the amount of HIV in the blood and increases CD4 (T) cell counts.
Emtricitabine and tenofovir belong to a class of medications known as nucleoside reverse transcriptase inhibitors (NRTI). Reverse transcriptase is an enzyme that is needed by HIV for reproduction. Emtricitabine and tenofovir block the action of this enzyme. Darunavir belongs to the class of medications known as protease inhibitors. It works by blocking an enzyme called protease, which the virus needs to multiply.
Cobicistat belongs to the class of medications called pharmacokinetic enhancers. It works by slowing down the enzyme that breaks down the other medications which causes an increased amount, or a "boost" of the other medications in the body. Cobicistat slows down the speed at which the body gets rid of these medications. It is included in this medication to increase the length of time that the body is exposed to these medications with each dose.
This medication does not cure AIDS and does not prevent it from being spread to others. It is used in to slow further growth or reproduction of HIV and seems to slow down the destruction of the immune system. This may help to delay the development of problems such as infections related to AIDS or HIV disease.
This medication may be available under multiple brand names and/or in several different forms. Any specific brand name of this medication may not be available in all of the forms or approved for all of the conditions discussed here. As well, some forms of this medication may not be used for all of the conditions discussed here.
Your doctor may have suggested this medication for conditions other than those listed in these drug information articles. If you have not discussed this with your doctor or are not sure why you are taking this medication, speak to your doctor. Do not stop taking this medication without consulting your doctor.
Do not give this medication to anyone else, even if they have the same symptoms as you do. It can be harmful for people to take this medication if their doctor has not prescribed it.
Each yellow-to-yellowish-brown, capsule-shaped tablet of 22 mm by 10 mm, debossed with "8121" on one side and "JG" on the opposite side, contains 800 mg of darunavir, 150 mg of cobicistat, 200 mg of emtricitabine and 10 mg of tenofovir alafenamide. Nonmedicinal ingredients: colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, and microcrystalline cellulose; film coating: polyethylene glycol (macrogol), polyvinyl alcohol (partially hydrolyzed), talc, titanium dioxide, and yellow ferric oxide.
The recommended adult dose of this medication is one tablet (containing 150 mg of cobicistat, 800 mg of darunavir, 200 mg of emtricitabine and 10 mg of tenofovir alafenamide) taken by mouth, once daily.
This medication should be taken with food. Swallow the tablet whole. Do not crush or chew this medication.
Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.
It is important to take this medication exactly as prescribed by your doctor.
If you miss a dose and it is less than 12 hours since the missed dose, take it as soon as possible with some food and continue with your regular schedule. If it is less than 12 hours until your next dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.
Store this medication at room temperature, protect it from light and moisture, and keep it out of the reach of children.
Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.
Do not take this medication if you:
Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.
The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.
The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.
Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.
Although most of the side effects listed below don’t happen very often, they could lead to serious problems if you do not seek medical attention.
Check with your doctor as soon as possible if any of the following side effects occur:
Stop taking the medication and seek immediate medical attention if any of the following occur:
Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.
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.
Allergies: People who are allergic to sulfonamide medications may experience an allergic reaction to darunavir. Advise your doctor of any allergies to any medications before taking this medication.
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.
Bone effects: Tenofovir may reduce bone mineral density and should not be taken by anyone who is at risk for bone problems. 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.
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.
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 and 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 severely reduced kidney function, including kidney failure. 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: 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 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, darunavir or tenofovir pass 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 less than 12 years of age or weighing less than 40 kg.
There may be an interaction between darunavir-cobicistat-emtricitabine-tenofovir and any of the following:
If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:
An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.
Medications other than those listed above may interact with this medication. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.
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