Emtricitabine – rilpivirine – 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. Emtricitabine – rilpivirine – tenofovir alafenamide reduces the amount of HIV in the blood and increases CD4 (T) cell counts.
Emtricitabine and tenofovir alafenamide 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 alafenamide block the action of this enzyme. Rilpivirine belongs to a class of medications known as non-nucleoside reverse transcriptase inhibitors (NNRTI). It also blocks the action of this enzyme, but works at a different site from the other medications.
This medication does not cure AIDS and does not prevent it from being spread to others. It is used 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.
Each grey, capsule-shaped, film-coated tablet debossed with "GSI" on one side and "255" on the other contains 200 mg of emtricitabine, 25 mg of rilpivirine (as 27.5 mg of rilpivirine hydrochloride), and 25 mg of tenofovir alafenamide (as 28 mg of tenofovir alafenamide hemifumarate). Nonmedicinal ingredients: croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polysorbate 20, and povidone; film coating: polyvinyl alcohol, titanium dioxide, macrogol/polyethylene glycol, talc, and iron oxide black.
The recommended dose of emtricitabine – rilpivirine – tenofovir alafenamide is one tablet taken once daily. This medication should be taken with a meal to allow your body to absorb as much of the medication as possible. Swallow the tablet whole with water.
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 remember within 12 hours of the usual time that you take the dose, take the missed dose as soon as possible with a meal, and then continue with your regular schedule. If you miss a dose by more than 12 hours, 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 vomit less than 4 hours after taking a dose of this medication, take another tablet with a meal. If you are not sure what to do after missing a dose or if you vomit a dose, contact your doctor or pharmacist for advice.
Store this medication at room temperature, in its original container, protect it from light and moisture, and keep it out of the reach of children.
Do not take this medication if you:
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:
Abnormal heart rhythms: This medication can cause abnormal heart rhythms. Certain medications (e.g., sotalol, quinidine, thioridazine, chlorpromazine, pimozide, moxifloxacin, mefloquine, tacrolimus) can increase the risk of a type of abnormal heart rhythm called QT prolongation, and should not be used in combination with emtricitabine – rilpivirine – tenofovir alafenamide.
If you have heart disease and abnormal heart rhythms, or are taking certain medications that can affect heart rhythm, 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.
Bone loss/osteoporosis: This medication may cause increased breakdown of bone by the body. If this happens, bones lose strength and bone fractures may occur. If you have osteoporosis or bone loss, 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.
Depression: Antiretroviral medications have been known to cause mood swings and symptoms of depression. If you have depression or a history of depression, 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 depression such as poor concentration, changes in weight, changes in sleep, and decreased interest in activities, or notice them in a family member who is taking this medication, contact your doctor as soon as possible.
Diabetes: This medication 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: There have been reports of serious liver problems while taking emtricitabine or tenofovir alafenamide, two of the ingredients in this medication. If you are also infected with hepatitis B, you may experience flare-ups of hepatitis B when you stop taking this medication. Do not stop taking this medication without first consulting with your doctor. The safety and effectiveness of this medication when used by people with hepatitis B has not been determined.
Hypersensitivity reactions: A severe allergic reaction called hypersensitivity syndrome has occurred for some people taking this medication. This reaction involves a number of organs in the body and may be fatal if not treated quickly. Stop taking the medication and get immediate medical attention if you have symptoms of a severe allergic reaction, including fever, swollen glands, yellowing of the skin or eyes, or flu-like symptoms with skin rash or blistering.
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: Kidney failure and severe kidney damage have been reported by people using tenofovir alafenamide. Kidney disease or reduced kidney function may cause this medication to build up in the body, causing side effects.
If you have reduced kidney 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.
People with severely reduced kidney function should not take this medication.
Lactic acidosis and enlarged fatty liver: Tenofovir alafenamide, an ingredient in this medication, can cause a rare but serious condition called lactic acidosis (a build-up of lactic acid in the blood) together with an enlarged fatty liver. This tends to occur more often in women, especially if they are overweight. If you experience any of the following symptoms, call your doctor immediately:
Lactose: This medication is prepared with lactose. If you have lactose or galactose intolerance you should not take this medication.
Liver function: Rilpivirine, one of the ingredients in this medication, is mostly 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.
Other HIV medications: Emtricitabine – rilpivirine – tenofovir alafenamide is a combination medication that should not be taken at the same time as any other medication that contains the same active ingredients. This medication should also not be taken at the same time as medications containing lamivudine or adefovir.
Pancreatitis (inflammation of the pancreas): Medications to treat HIV are associated with developing pancreatitis. If you have had pancreatitis or are at risk for developing it, your doctor should closely monitor you while you are 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 needed.
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. 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 emtricitabine – rilpivirine – 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 using this medication have not been established for children.
Seniors: The effects of this medication on seniors have not been well studied. It is likely that people over the age of 65 will experience more side effects and should report any unusual symptoms to their doctor as soon as possible.
There may be an interaction between emtricitabine – rilpivirine – tenofovir alafenamide and any of the following:
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