em-trye-SYE-ta-been, ten-OF-oh-vir dye-soe-PROX-il FUE-ma-rate
Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogues, including tenofovir disoproxil fumarate, a component of emtricitabine/tenofovir disoproxil fumarate. Not indicated for the treatment of chronic hepatitis B virus (HBV) infection and the safety and efficacy have not been established in patients co-infected with HBV and HIV. Severe acute exacerbations of hepatitis B have been reported in patients who have discontinued emtricitabine/tenofovir; monitor hepatic function upon discontinuation of therapy .
Commonly used brand name(s):
In the U.S.
Available Dosage Forms:
Therapeutic Class: Antiretroviral Agent
Pharmacologic Class: Nucleoside Reverse Transcriptase Inhibitor
Emtricitabine and tenofovir combination is used with other anti-HIV medicines in the treatment of human immunodeficiency virus (HIV) infection. HIV is the virus that causes acquired immune deficiency syndrome (AIDS).
Emtricitabine and tenofovir combination will not cure or prevent HIV infection or the symptoms of AIDS; however, it helps keep HIV from reproducing, and appears to slow down the destruction of the immune system. This may help delay the development of serious health problems usually related to AIDS or HIV infection. Emtricitabine and tenofovir combination will not keep you from spreading HIV to other people. People who receive emtricitabine and tenofovir may continue to have other problems usually related to AIDS or HIV infection.
emtricitabine and tenofovir is available only with your doctor's prescription.
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For emtricitabine and tenofovir, the following should be considered:
Tell your doctor if you have ever had any unusual or allergic reaction to emtricitabine and tenofovir or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Appropriate studies have not been performed on the relationship of age to the effects of emtricitabine and tenofovir combination in the pediatric population. Safety and efficacy have not been established.
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of emtricitabine and tenofovir combination in the elderly. However, elderly patients are more likely to have age-related liver, kidney, or heart problems, which may require caution in patients receiving emtricitabine and tenofovir combination.
|All Trimesters||B||Animal studies have revealed no evidence of harm to the fetus, however, there are no adequate studies in pregnant women OR animal studies have shown an adverse effect, but adequate studies in pregnant women have failed to demonstrate a risk to the fetus.|
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Using emtricitabine and tenofovir with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
Using emtricitabine and tenofovir with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.
The presence of other medical problems may affect the use of emtricitabine and tenofovir. Make sure you tell your doctor if you have any other medical problems, especially:
It is important to take emtricitabine and tenofovir in combination with another anti-HIV medicine and to take it exactly as your doctor tells you to. You should take your medicine at the same time every day to avoid missing doses. It is very important that you do not miss any doses of emtricitabine and tenofovir or of your other anti-HIV medicines.
Do not take other medicines unless they have been discussed with your doctor. Tell your doctor about all of the medicines and dietary supplements that you take. Keep a complete list of all the medications that you take. Make a new list when medications are added or stopped. Make sure you show this list to your doctor or pharmacist each time you have a visit or refill a prescription.
When your emtricitabine and tenofovir combination supply runs low, get more from your pharmacy or from your doctor. This is very important because the amount of virus in your blood may increase if the medicine is stopped, even for a short time. The virus may develop resistance to emtricitabine or tenofovir and be harder to treat.
emtricitabine and tenofovir can be taken with or without food.
emtricitabine and tenofovir comes with a patient information leaflet. Read and follow these instructions carefully. Read it again each time you refill your prescription in case there is new information. You should talk to your doctor if you have any questions.
The dose of emtricitabine and tenofovir will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of emtricitabine and tenofovir. If your dose is different, do not change it unless your doctor tells you to do so.
The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
If you miss a dose of emtricitabine and tenofovir, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.
Call your doctor or pharmacist if you are not sure what to do.
Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.
Keep out of the reach of children.
Do not keep outdated medicine or medicine no longer needed.
Ask your healthcare professional how you should dispose of any medicine you do not use.
It is very important that your doctor check your progress at regular visits to make sure that emtricitabine and tenofovir is working properly. Blood tests may be needed to check for unwanted effects. You should remain under the care of a doctor while taking emtricitabine and tenofovir.
You should not use emtricitabine and tenofovir if you are also taking adefovir (Hepsera®), Atripla™, Emtriva®, or Viread®. Do not use emtricitabine and tenofovir if you are also using medicines containing lamivudine (such as Combivir®, Epivir®, Epivir-HBV®, Epzicom®, Trizivir®). Tell your doctor right away if you are using any of these medicines. Do not start using emtricitabine and tenofovir combination until your doctor tells you to.
Two rare but serious reactions to emtricitabine and tenofovir are lactic acidosis (too much acid in the blood) and liver toxicity, which includes an enlarged liver. These are more common if you are female, very overweight (obese), or have been taking anti-HIV medicines for a long time. Check with your doctor immediately if you notice abdominal discomfort; decreased appetite; diarrhea; fast, shallow breathing; general feeling of discomfort; muscle pain or cramping; nausea; shortness of breath; sleepiness; or unusual tiredness or weakness or if your skin or eyes have turned yellow.
emtricitabine and tenofovir is not for the treatment of hepatitis B virus infection. Patients infected with both HBV and HIV who take emtricitabine and tenofovir combination need close medical follow-up for several months after stopping treatment to make sure their hepatitis B does not get worse.
emtricitabine and tenofovir may also increase your risk of developing bone fractures. Ask your doctor about this if you have any concerns.
emtricitabine and tenofovir may cause you to have excess body fat. Tell your doctor if you notice changes in your body shape, such as an increased amount of fat in the upper back and neck, or around the chest and stomach area. You might also lose fat from the legs, arms, and face.
When you start taking HIV medicines, your immune system may get stronger. If you have infections that are hidden in your body, such as pneumonia or tuberculosis, you may notice new symptoms when your body tries to fight them. If this occurs, tell your doctor immediately.
You should avoid breastfeeding if you have HIV or AIDS, because you may give the infection to your baby through your breast milk.
Emtricitabine and tenofovir combination does not decrease the risk of transmitting the HIV infection to others through sexual contact or by contamination through blood. HIV may be acquired from or spread to others through infected body fluids, including blood, vaginal fluid, or semen. If you are infected, it is best to avoid any sexual activity involving an exchange of body fluids with other people. If you do have sex, always wear (or have your partner wear) a condom (“rubber”). Only use condoms made of latex or polyurethane and use them every time you have contact with semen, vaginal secretions, or blood. Also, do not share needles or equipment with anyone or use dirty needles. If you have any questions about this, check with your doctor.
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur:Less common
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:Less common
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
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