An Overview of Truvada (Tenofovir/FTC)

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Brand Name: Truvada
Other Name(s): FTC/TDF
Drug Class: Nucleoside Reverse Transcriptase Inhibitors
Approved Use: Treatment of HIV Infection; Pre-Exposure Prophylaxis (PrEP) to Reduce the Risk of Sexually Acquired HIV Infection

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 adolescents 12 years of age or older. When Truvada is used to treat HIV infection, the medicine is always used in combination with other anti-HIV medicines.
• To reduce the risk of sexually acquired HIV infection in adults who do not have HIV but are at high risk. This is called pre-exposure prophylaxis or PrEP. Because Truvada does not always prevent HIV infections, Truvada for PrEP must be used in combination with safer sex practices at all times.

Truvada contains the following two anti-HIV medicines combined in one pill: emtricitabine and tenofovir disoproxil fumarate. Emtricitabine and tenofovir disoproxil fumarate are types of anti-HIV medicines called nucleoside analog reverse transcriptase inhibitors (NRTIs). NRTIs work by blocking HIV reverse transcriptase, an HIV enzyme. This prevents HIV from replicating and lowers the amount of HIV in the blood.

Truvada does not cure HIV/AIDS. It is not known if Truvada reduces the risk of passing HIV to other people.

What should I tell my health care provider before taking Truvada?

Before taking Truvada, tell your health care provider:

• If you are allergic to Truvada or any other medicines.
• If you have liver problems, including HBV infection.
• If you have kidney problems or are undergoing kidney dialysis.
• 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.
• If you are breastfeeding or plan to breastfeed. Do not breastfeed if you are infected with HIV or are taking Truvada.
• 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 to reduce your risk of getting HIV, tell your health care provider:

• If you have any of the following symptoms within the last month before you start taking Truvada: tiredness, fever, sweating a lot (especially at night), rash, vomiting, diarrhea, joint or muscle aches, headache, sore throat, enlarged lymph nodes in the neck or groin. These may be signs of HIV infection. You may need to have a different kind of test to check if you are HIV infected.
• If you think that you were exposed to HIV.

How should I take Truvada?

Truvada comes in tablet form. Each tablet contains:

• 200 mg emtricitabine (brand name: Emtriva).
• 300 mg tenofovir disoproxil fumarate (brand name: Viread).

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, get tested for HIV at least every 3 months while you are taking Truvada. Always combine use of Truvada with other prevention methods, such as safer sex practices.

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

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?

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 two doses at the same time to make up for a missed dose.

What side effects can Truvada cause?

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

Other possible side effects of Truvada include:

• Kidney problems.
• Bone problems (softening or thinning).
• Changes in the immune system (immune reconstitution inflammatory syndrome).
• Changes in body fat (lipodystrophy).

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. Ask your health care provider or pharmacist for more information on side effects of Truvada.

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.
• Safely throw away Truvada that is no longer needed or expired (out of date).
• 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 list of FDA-approved generics for anti-HIV medicines, from FDA.

Manufacturer Information

Gilead Sciences
800-445-3235