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Information

An Overview of Truvada (Tenofovir/FTC)

March 13, 2018

Brand Name: Truvada
Other Name(s): FTC/TDF, emtricitabine/tenofovir DF
Drug Class: Nucleoside Reverse Transcriptase Inhibitors


WARNING:

Truvada pill

Truvada can cause serious, life-threatening side effects. These include a buildup of lactic acid in the blood (lactic acidosis) and liver problems.

Contact your health care provider right away if you have any of the following symptoms that could be signs of lactic acidosis:

  • Weakness or tiredness
  • Unusual (not normal) muscle pain
  • Shortness of breath or fast breathing
  • Stomach pain with nausea and vomiting
  • Hands or feet that feel cold or turn blue
  • Dizziness or lightheadedness
  • Fast or irregular heartbeat

Contact your health care provider right away if you have any of the following symptoms that could be signs of liver problems:

  • Yellowing of your skin or the whites of your eyes (jaundice)
  • Dark-colored urine
  • Light-colored bowel movements
  • Loss of appetite for several days or longer
  • Nausea.
  • Pain in the stomach area (abdominal pain)

Truvada is not approved for the treatment of chronic hepatitis B virus (HBV) infection. In people with both HIV and HBV infection who are treated with Truvada, stopping Truvada may cause their HBV infection to flare up (get worse). Before starting Truvada, talk to your health care provider about getting tested for HBV infection.

Do not take Truvada to reduce the risk of getting HIV -- also called pre-exposure prophylaxis or PrEP -- unless you are confirmed to be HIV negative.

While taking Truvada, it is important to keep all of your appointments with your health care provider.


What Is Truvada?

Truvada is a prescription medicine approved by the U.S. Food and Drug Administration (FDA) for the following uses:

  • To treat HIV infection in adults and children who weigh at least 37 pounds (17 kilograms). Truvada for HIV treatment is always used in combination with other HIV medicines. HIV medicines can't cure HIV/AIDS, but taking a combination of HIV medicines (called an HIV treatment regimen) every day helps people with HIV live longer, healthier lives and also reduces the risk of HIV transmission.
  • To reduce the risk of HIV infection in adults who are HIV-negative and at high risk of getting HIV infection. This method to prevent HIV infection is called pre-exposure prophylaxis or PrEP. Always combine use of PrEP with condoms and other HIV prevention methods. Read the AIDSinfo fact sheet on PrEP for more information, including information on who should consider taking PrEP.

Truvada contains two different HIV medicines combined in one pill: emtricitabine and tenofovir disoproxil fumarate. Both medicines belong to the class (group) of HIV medicines called nucleoside reverse transcriptase inhibitors (NRTIs). NRTIs block an HIV enzyme called reverse transcriptase. (An enzyme is a protein that starts or increases the speed of a chemical reaction.) By blocking reverse transcriptase, the two drugs in combination prevent HIV from multiplying and can reduce the amount of HIV in the body.

Whether you are taking Truvada for HIV prevention or in combination with other HIV medicines for HIV treatment, don't cut down on, skip, or stop taking your HIV medicine(s) unless your health care provider tells you to.


What Should I Tell My Health Care Provider Before Taking Truvada?

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Before taking Truvada, tell your health care provider:

  • If you are allergic to either of the HIV medicines in Truvada (emtricitabine or tenofovir disoproxil fumarate) or any other medicines.
  • If you have liver problems, including HBV infection.
  • If you have kidney problems or receive kidney dialysis treatment.
  • If you have bone problems.
  • If you have any other medical conditions.
  • If you are pregnant or plan to become pregnant. Whether Truvada can harm an unborn baby is unknown. Truvada should be used during pregnancy only if clearly needed. Talk to your health care provider about possible risks with taking Truvada when pregnant. If you become pregnant while taking PrEP, talk to your health care provider about whether to continue taking Truvada.
  • If you are breastfeeding or plan to breastfeed. Do not breastfeed if you have HIV or are taking Truvada.
  • If you are using hormone-based birth control (such as pills, implants, or vaginal rings). For more information about using birth control and HIV medicines at the same time, view the AIDSinfo HIV and Birth Control infographic.
  • About other prescription and nonprescription medicines, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Truvada may affect the way other medicines or products work, and other medicines or products may affect how Truvada works. Taking Truvada together with certain medicines or products may cause serious side effects.

Before taking Truvada to reduce your risk of getting HIV, you must get tested to be sure you are HIV negative. Do not take Truvada to reduce the risk of getting HIV unless you are confirmed to be HIV negative.

Before taking Truvada for PrEP, also tell your health care provider:

  • If you had a flu-like illness within the last month before starting Truvada (or at any time while taking Truvada). If you have flu-like symptoms, you could have recently become infected with HIV. Symptoms of new HIV infection include: tiredness, fever, nighttime sweating, rash, vomiting, diarrhea, joint or muscle aches, headache, sore throat, or enlarged lymph nodes in the neck or groin.
  • If you think that you were exposed to HIV. Your health care provider may want to do more tests to be sure you are still HIV negative.

While taking Truvada for PrEP, you will get tested for HIV at least every 3 months.


How Should I Take Truvada?

Truvada comes in tablet form in the following strengths:

  • 200 mg emtricitabine (brand name: Emtriva) and 300 mg tenofovir disoproxil fumarate (brand name: Viread)
  • 167 mg emtricitabine and 250 mg tenofovir disoproxil fumarate
  • 133 mg emtricitabine and 200 mg tenofovir disoproxil fumarate
  • 100 mg emtricitabine and 150 mg tenofovir disoproxil fumarate

Take Truvada according to your health care provider's instructions.

Take Truvada with or without food at the same time each day.

If you take Truvada for PrEP, take it every day and not just when you think that you were exposed to HIV. Always combine use of PrEP with condoms and other HIV prevention methods.

If you take too much Truvada, contact your health care provider or local poison control center (1-800-222-1222) right away, or go to the nearest hospital emergency room.

For more information on how to take Truvada, see the FDA drug label from DailyMed. (DailyMed is a federal website that includes the most recent drug labels submitted to FDA.)


What Should I Do if I Forget a Dose?

If you miss a dose of Truvada, take the missed dose as soon as you remember it. But if it is almost time for your next dose, skip the missed dose and just take your next dose at the regular time. Do not take more than one dose of Truvada in a day. Do not take two doses at the same time to make up for a missed dose.


What Side Effects Can Truvada Cause?

Truvada may cause side effects. Many side effects from HIV medicines, such as nausea or occasional dizziness, are manageable. See the AIDSinfo fact sheet on HIV Medicines and Side Effects for more information.

Some side effects from Truvada can be serious. Serious side effects of Truvada include buildup of lactic acid in the blood (lactic acidosis) and liver problems. (See the WARNING box above.)

Other possible side effects of Truvada include:

  • New or worsening kidney problems, including kidney failure.
  • Bone problems (bone pain, softening, or thinning [osteopenia]).
  • Changes in your immune system (called immune reconstitution inflammatory syndrome or IRIS). IRIS is a condition that sometimes occurs when the immune system begins to recover after treatment with an HIV medicine. As the immune system gets stronger, it may have an increased response to a previously hidden infection.
  • Changes in body fat (including gain or loss of fat).

Tell your health care provider if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of Truvada. To learn more about possible side effects of Truvada, read the drug label or package insert or talk to your health care provider or pharmacist.

You can report side effects to FDA at 1-800-FDA-1088 (1-800-332-1088) or online at www.accessdata.fda.gov/scripts/medwatch/.


How Should Truvada Be Stored?

  • Store Truvada at room temperature, 68°F to 77°F (20°C to 25°C).
  • Keep Truvada in its original container and keep the container tightly closed. 
  • Do not use Truvada if the original seal over the container opening is broken or missing.
  • Throw away Truvada that is no longer needed or expired (out of date). Follow FDA guidelines on how to safely dispose of unused medicine.
  • Keep Truvada and all medicines out of reach of children.


Where Can I Find More Information About Truvada?

More information about Truvada is available:

  • The Truvada drug label, from DailyMed. The Patient Counseling Information section of the label includes information for people taking Truvada.
  • Truvada-related research studies, from the AIDSinfo database of ClinicalTrials.gov study summaries.
  • A fact sheet about PrEP, from AIDSinfo.
  • A list of FDA-approved HIV medicines, from AIDSinfo.


Manufacturer Information

Gilead Sciences, Inc.
Main number: 800-445-3235
Patient assistance: 800-226-2056

The above Patient Version drug summary is based on the following FDA label(s): Tablet (film coated).

[Note from TheBody: This article was created by AIDSinfo, who last updated it on March 13, 2018. We have cross-posted it with their permission.]


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More on Truvada (Tenofovir/FTC)


  
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This article was provided by AIDSinfo. Visit the AIDSinfo website to find out more about their activities and publications.
 

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