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Emtricitabine and Tenofovir Disoproxil Fumarate

Generic Name: Emtricitabine and Tenofovir Disoproxil Fumarate (em trye SYE ta been & ten OF oh vir dye soe PROX il FUE ma rate)
Brand Name: Truvada

For all patients taking this medicine:
  • Hepatitis B has gotten worse when emtricitabine and tenofovir disoproxil fumarate was stopped in some people with hepatitis B. Close follow-up for a few months is needed when therapy is stopped in people who have hepatitis B. Do not stop taking this medicine without calling your doctor. Talk with your doctor.
  • This medicine is not approved to treat hepatitis B. Hepatitis B testing needs to be done before taking emtricitabine and tenofovir disoproxil fumarate. Talk with your doctor.
For HIV negative patients taking this medicine to lower the chance of getting HIV through sex:
  • You must have a negative HIV test before taking this medicine and at least every 3 months while you take it. Tell your doctor if you think you have been exposed to HIV. Call your doctor right away if you have fever, headache, feel tired, joint or muscle aches, throwing up, loose stools (diarrhea), sore throat, rash, night sweats, or swollen glands. Call your doctor right away if you had any of these signs within 1 month before you start taking emtricitabine and tenofovir disoproxil fumarate. Talk with your doctor.

Uses of Emtricitabine and Tenofovir Disoproxil Fumarate:

  • It is used to treat HIV infection.
  • It is used in HIV negative patients to lower the chance of getting HIV infection through sex.

What do I need to tell my doctor BEFORE I take Emtricitabine and Tenofovir Disoproxil Fumarate?

  • If you have an allergy to emtricitabine, tenofovir, or any other part of this medicine.
  • If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
  • If you have kidney disease.
  • If you are taking another drug that has the same drug in it.
  • If you are taking any of these drugs: Adefovir or lamivudine.
  • If you are taking any drugs that can raise the chance of kidney problems. There are many drugs that can do this. Ask your doctor or pharmacist if you are not sure.
  • If you are breast-feeding. Do not breast-feed while you take emtricitabine and tenofovir disoproxil fumarate.

This is not a list of all drugs or health problems that interact with this medicine.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take emtricitabine and tenofovir disoproxil fumarate with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take Emtricitabine and Tenofovir Disoproxil Fumarate?

For all patients taking this medicine:

  • Tell all of your health care providers that you take emtricitabine and tenofovir disoproxil fumarate. This includes your doctors, nurses, pharmacists, and dentists.
  • Bone problems like bone pain, soft bones, and thin bones have happened with this medicine. This may lead to broken bones. You may need to have a test to check your bones. Talk with your doctor.
  • Take calcium and vitamin D as you were told by your doctor.
  • Have blood work checked as you have been told by the doctor. Talk with the doctor.
  • If you are 65 or older, use emtricitabine and tenofovir disoproxil fumarate with care. You could have more side effects.
  • This medicine does not stop the spread of diseases like HIV or hepatitis that are passed through blood or having sex. Do not have any kind of sex without using a latex or polyurethane condom. Do not share needles or other things like toothbrushes or razors. Talk with your doctor.
  • This medicine may rarely cause swollen liver and an acid health problem in the blood. This may be deadly in some cases. The chance may be higher in women, in overweight people, and in people who have taken drugs like this one for a long time. Talk with your doctor.
  • Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using this medicine while you are pregnant.

For patients taking emtricitabine and tenofovir disoproxil fumarate to treat HIV infection:

  • This medicine is not a cure for HIV. Stay under the care of your doctor.

For HIV negative patients taking this medicine to lower the chance of getting HIV through sex:

  • This medicine does not always prevent HIV. It needs to be used as part of a program that has other measures like safer sex habits and testing for diseases passed by having sex. Talk with the doctor.

How is this medicine (Emtricitabine and Tenofovir Disoproxil Fumarate) best taken?

Use emtricitabine and tenofovir disoproxil fumarate as ordered by your doctor. Read all information given to you. Follow all instructions closely.

  • Take this medicine at the same time of day.
  • Take with or without food.
  • Keep taking emtricitabine and tenofovir disoproxil fumarate as you have been told by your doctor or other health care provider, even if you feel well.
  • It is important that you do not miss or skip a dose of this medicine during treatment.

What do I do if I miss a dose?

  • Take a missed dose as soon as you think about it.
  • If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
  • Do not take 2 doses at the same time or extra doses.
  • Do not take more than 1 dose of emtricitabine and tenofovir disoproxil fumarate in the same day.
  • If you are not sure what to do if you miss a dose, call your doctor.

See also: Dosage Information (in more detail)

What are some side effects that I need to call my doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

For all patients taking this medicine:

  • Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
  • Signs of kidney problems like unable to pass urine, change in how much urine is passed, blood in the urine, or a big weight gain.
  • Signs of liver problems like dark urine, feeling tired, not hungry, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or eyes.
  • Signs of too much lactic acid in the blood (lactic acidosis) like fast breathing, fast heartbeat, a heartbeat that does not feel normal, very bad upset stomach or throwing up, feeling very sleepy, shortness of breath, feeling very tired or weak, very bad dizziness, feeling cold, or muscle pain or cramps.
  • Low mood (depression).
  • Bone pain.
  • Muscle pain or weakness.
  • Pain in arms or legs.
  • A burning, numbness, or tingling feeling that is not normal.
  • Anxiety.

For patients taking emtricitabine and tenofovir disoproxil fumarate to treat HIV infection:

  • This medicine may help the immune system work. If you have an infection that you did not know you had, it may show up when you take this medicine. Tell your doctor right away if you notice any signs of infection like fever, sore throat, weakness, cough, or shortness of breath after you start emtricitabine and tenofovir disoproxil fumarate.

What are some other side effects of Emtricitabine and Tenofovir Disoproxil Fumarate?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

  • Upset stomach.
  • Loose stools (diarrhea).
  • Not able to sleep.
  • Dizziness.
  • Headache.
  • Strange or odd dreams.
  • Feeling tired or weak.

For HIV negative patients taking this medicine to lower the chance of getting HIV through sex:

  • Weight loss.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

See also: Side effects (in more detail)

If OVERDOSE is suspected:

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

How do I store and/or throw out Emtricitabine and Tenofovir Disoproxil Fumarate?

  • Store in the original container at room temperature.
  • Store in a dry place. Do not store in a bathroom.
  • Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
  • Check with your pharmacist about how to throw out unused drugs.

Consumer Information Use and Disclaimer

  • If your symptoms or health problems do not get better or if they become worse, call your doctor.
  • Do not share your drugs with others and do not take anyone else's drugs.
  • Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
  • Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
  • This medicine comes with an extra patient fact sheet called a Medication Guide. Read it with care. Read it again each time emtricitabine and tenofovir disoproxil fumarate is refilled. If you have any questions about this medicine, please talk with the doctor, pharmacist, or other health care provider.
  • If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take emtricitabine and tenofovir disoproxil fumarate or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to emtricitabine and tenofovir disoproxil fumarate. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.

Review Date: September 6, 2017

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