April 23, 2015
Brand Name: Truvada
Other Name(s): emtricitabine/tenofovir, FTC/TDF
Drug Class: Nucleoside Reverse Transcriptase Inhibitors
Approved Use: Treatment of HIV Infection; Pre-Exposure Prophylaxis (PrEP) to Reduce the Risk of HIV Infection
tenofovir disoproxil fumarate
Truvada can cause serious, life-threatening side effects. These include lactic acidosis (buildup of lactic acid in the blood) 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:
Contact your health care provider right away if you have any of the following symptoms that could be signs of liver problems:
Truvada is not approved for the treatment of chronic hepatitis B virus (HBV) infection. If you have both HIV and HBV infection and take Truvada, your HBV infection may get worse (flare up) if you stop taking Truvada. But do not stop taking Truvada without first talking to your health care provider. If your health care provider tells you to stop Truvada, you will be monitored closely for several months to check your HBV infection, or you may receive a medicine to treat your 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.
Truvada is a prescription medicine approved by the U.S. Food and Drug Administration (FDA) for the following uses:
Truvada is a single pill that contains the following two different HIV medicines:
Both HIV medicines belong to a class (group) of HIV drugs 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.
HIV medicines can't cure HIV/AIDS, but taking a combination of HIV medicines (called an HIV regimen) every day helps people with HIV live longer, healthier lives. 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.
Before taking Truvada, tell your health care provider:
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:
Truvada comes in tablet form. Each tablet contains:
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 to reduce your risk of getting HIV, you will get tested for HIV at least every 3 months. Truvada used for PrEP must be taken every day to give the best protection against HIV infection. Always combine use of Truvada with other prevention methods, such as condoms.
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.)
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.
Truvada can cause serious, life-threatening side effects. These include lactic acidosis (buildup of lactic acid in the blood) and liver problems. (See the WARNING above.)
Other possible side effects of Truvada include:
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.
The AIDSinfo fact sheet on HIV Medicines and Side Effects also includes information that may apply to Truvada.
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/.
More information about Truvada is available:
Gilead Sciences, Inc.
The above Patient Version drug summary is based on the following FDA label(s): Tablet (film coated).