This is a combination product that contains two medications: emtricitabine and tenofovir alafenamide. Both of these medications belong to a class of medications called antiretrovirals, more specifically nucleoside analog reverse transcriptase inhibitors (NRTIs). Reverse transcriptase is an enzyme needed by HIV to multiply and infect other cells. These two medications prevent reverse transcriptase from working properly.
This combination product is used along with other antiretroviral medications to treat HIV-1 infections in adults and children who weigh more than 25 kg, and have not developed resistance to either of these individual medications for HIV. HIV is the virus responsible for acquired immune deficiency syndrome (AIDS).
This medication does not cure AIDS and does not reduce the risk of passing HIV to others through sexual contact or blood contamination. It is used in combination with other anti-HIV medications to slow further growth or reproduction of HIV. It also 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.
200 mg/10 mg
Each rectangular, film-coated, grey tablet debossed "GSI" on one side and "210" on the other contains 200 mg of emtricitabine and 10 mg of tenofovir alafenamide. Nonmedicinal ingredients: microcrystalline cellulose, croscarmellose sodium, and magnesium stearate; film coating: polyvinyl alcohol, titanium dioxide, polyethylene glycol, talc, and iron oxide black.
200 mg/25 mg
Each rectangular, film-coated, blue tablet debossed "GSI" on one side and "225" on the other contains 200 mg of emtricitabine and 25 mg of tenofovir alafenamide. Nonmedicinal ingredients: microcrystalline cellulose, croscarmellose sodium, and magnesium stearate; film coating: polyvinyl alcohol, titanium dioxide, polyethylene glycol, talc, and indigo carmine aluminum lake.
The dose of emtricitabine – tenofovir alafenamide depends on which other medications you are using to treat your HIV infection. For people taking an HIV-1 protease inhibitor in addition to ritonavir or cobicistat, the recommended dose is 200 mg of emtricitabine and 10 mg of tenofovir alafenamide taken once daily by mouth.
For people taking other anti-HIV medications, the recommended dose is 200 mg of emtricitabine and 25 mg of tenofovir alafenamide taken once daily by mouth.
This medication may be taken with food or on an empty stomach and should be taken at approximately the same time each day.
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, take it as soon as possible and continue with your regular schedule. If it is more than 18 hours since your missed 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, in the original container. 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 are allergic to emtricitabine or tenofovir alafenamide or any ingredients of the medication.
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.
Bones: Emtricitabine – tenofovir alafenamide may weaken bones. Your doctor may monitor your bone mass while you are taking this medication, especially if you are at risk for bone fracture or bone disease. If you experience unexplained bone pain or break a bone, contact your doctor. Your doctor may want you to start taking vitamin D and calcium supplements.
Diabetes: Emtricitabine – tenofovir alafenamide may cause an increase in blood sugar levels (may cause a loss of blood glucose control) and glucose tolerance may change. If you have diabetes, you may find it necessary to monitor your blood sugar more frequently while using this medication.
Hepatitis B: The safe use of this medication has not been established for people who also have hepatitis B. Your doctor may test you for hepatitis B before starting you on this medication. If this medication is used to treat HIV for people who also have hepatitis B, their hepatitis B may get worse. Your doctor will monitor your liver function closely while you are taking emtricitabine – tenofovir alafenamide.
Immune reconstitution inflammatory 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, hepatitis, or tuberculosis). Report any new symptoms to your doctor immediately.
Kidney function: Kidney disease or reduced kidney function may cause emtricitabine – tenofovir alafenamide to build up in the body, causing side effects. 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. Your doctor may also need to change the dosing schedule of this medication if you have existing kidney problems.
Tenofovir can cause kidney problems, including severe kidney damage and kidney failure. Your doctor may monitor your kidney function with blood tests while you are taking this medication. Additional tests may be needed if you have a history of kidney problems or if you need to take another medication that can cause kidney problems.
If you experience signs of reduced kidney function, such as decreased urination, nausea, vomiting, or swelling of the feet and ankles, contact your doctor as soon as possible.
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. Seek immediate medical attention if you notice any symptoms of this condition, such as:
Liver problems: Emtricitabine – tenofovir alafenamide has been reported to cause decreased liver function. 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 monitor your liver function while you are taking this medication, especially if you have risk factors for liver problems. If you experience symptoms of liver problems such as fatigue, feeling unwell, loss of appetite, nausea, yellowing of the skin or whites of the eyes, dark urine, pale stools, abdominal pain or swelling, and itchy skin, contact your doctor immediately. Emtricitabine – tenofovir alafenamide is not recommended for people with severely decreased liver function.
Pancreatitis: This medication may cause inflammation of the pancreas (pancreatitis). If you have a history of or are at risk for developing pancreatitis, your doctor should closely monitor your condition while you are taking this medication. Contact your doctor if you develop signs of pancreatitis, such as:
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 emtricitabine or tenofovir alafenamide 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 this medication have not been determined for children who weigh less than 25 kg. Emtricitabine – tenofovir alafenamide is not recommended for this age group.
There may be an interaction between emtricitabine – tenofovir alafenamide 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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