An Overview of Truvada (Tenofovir/FTC)

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Brand Name: Truvada
Other Name(s): Emtricitabina/ Fumarato de disoproxilo de tenofovir
Drug Class: Nucleoside Reverse Transcriptase Inhibitors

TRUVADA^® (tru-VAH-dah) tablets
Generic name: emtricitabine and tenofovir disoproxil fumarate

Read the Patient Information that comes with TRUVADA before you start taking it and each time you get a refill. There may be new information. This information does not take the place of talking to your health care provider about your medical condition or treatment. You should stay under a health care provider's care when taking TRUVADA.

Do not change or stop your medicine without first talking with your health care provider. Talk to your health care provider or pharmacist if you have any questions about TRUVADA.

What is the most important information I should know about TRUVADA?

• Some people who have taken medicine like TRUVADA (nucleoside analogs) have developed a serious condition called lactic acidosis (build-up of an acid in the blood). Lactic acidosis can be a medical emergency and may need to be treated in the hospital. Call your health care provider right away if you get the following signs or symptoms of lactic acidosis.
  • You feel very weak or tired.
  • You have unusual (not normal) muscle pain.
  • You have trouble breathing.
  • You have stomach pain with nausea and vomiting.
  • You feel cold, especially in your arms and legs.
  • You feel dizzy or lightheaded.
  • You have a fast or irregular heartbeat.
• Some people who have taken medicines like TRUVADA have developed serious liver problems called hepatotoxicity, with liver enlargement (hepatomegaly) and fat in the liver (steatosis). Call your health care provider right away if you get the following signs or symptoms of liver problems.
  • Your skin or the white part of your eyes turns yellow (jaundice).
  • Your urine turns dark.
  • Your bowel movements (stools) turn light in color.
  • You don't feel like eating food for several days or longer.
  • You feel sick to your stomach (nausea).
  • You have lower stomach area (abdominal) pain.
• You may be more likely to get lactic acidosis or liver problems if you are female, very overweight (obese), or have been taking nucleoside analog medicines, like TRUVADA, for a long time.
• If you are also infected with the hepatitis B virus (HBV), you need close medical follow-up for several months after stopping treatment with TRUVADA. Follow-up includes medical exams and blood tests to check for HBV that could be getting worse. Patients with hepatitis B virus infection who take TRUVADA and then stop it may get "flare-ups" of their hepatitis. A "flare-up" is when the disease suddenly returns in a worse way than before.

What is TRUVADA?

TRUVADA is a type of medicine called an HIV-1 (human immunodeficiency virus) nucleoside analog reverse transcriptase inhibitor (NRTI). TRUVADA contains 2 medicines, EMTRIVA^® (emtricitabine) and VIREAD^® (tenofovir disoproxil fumarate, or tenofovir DF) combined in one pill. TRUVADA is always used with other anti-HIV-1 medicines to treat people with HIV-1 infection. TRUVADA is for adults and pediatric patients 12 years of age and older. TRUVADA has not been studied in children under age 12 or weighing less than 35 kg (77 lb) or in adults over age 65.

HIV infection destroys CD4+ T cells, which are important to the immune system. The immune system helps fight infection. After a large number of T cells are destroyed, acquired immune deficiency syndrome (AIDS) develops.

TRUVADA helps block HIV-1 reverse transcriptase, a chemical in your body (enzyme) that is needed for HIV-1 to multiply. TRUVADA lowers the amount of HIV-1 in the blood (viral load). TRUVADA may also help to increase the number of T cells (CD4+ cells). Lowering the amount of HIV-1 in the blood lowers the chance of death or infections that happen when your immune system is weak (opportunistic infections).

TRUVADA does not cure HIV-1 infection or AIDS. The long-term effects of TRUVADA are not known at this time. People taking TRUVADA may still get opportunistic infections or other conditions that happen with HIV-1 infection. Opportunistic infections are infections that develop because the immune system is weak. Some of these conditions are pneumonia, herpes virus infections, and Mycobacterium avium complex (MAC) infection. It is very important that you see your health care provider regularly while taking TRUVADA.

TRUVADA does not lower your chance of passing HIV-1 to other people through sexual contact, sharing needles, or being exposed to your blood. For your health and the health of others, it is important to always practice safer sex by using a latex or polyurethane condom or other barrier to lower the chance of sexual contact with semen, vaginal secretions, or blood. Never use or share dirty needles.

Who should not take TRUVADA?

• Do not take TRUVADA if you are allergic to TRUVADA or any of its ingredients. The active ingredients of TRUVADA are emtricitabine and tenofovir DF. See the end of this leaflet for a complete list of ingredients.
• Do not take TRUVADA if you are already taking ATRIPLA^®, Combivir (lamivudine/zidovudine), EMTRIVA, Epivir or Epivir-HBV (lamivudine), Epzicom (abacavir sulfate/lamivudine), Trizivir (abacavir sulfate/lamivudine/zidovudine), or VIREAD because these medicines contain the same or similar active ingredients.
• Do not take TRUVADA to treat your HIV infection if you are also taking HEPSERA^® to treat your HBV infection.

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

Tell your health care provider if you:

• are pregnant or planning to become pregnant. We do not know if TRUVADA can harm your unborn child. You and your healthcare provider will need to decide if TRUVADA is right for you. If you use TRUVADA while you are pregnant, talk to your healthcare provider about how you can be on the TRUVADA Antiviral Pregnancy Registry.
• are breastfeeding. You should not breast feed if you are HIV-positive because of the chance of passing the HIV virus to your baby. Also, it is not known if TRUVADA can pass into your breast milk and if it can harm your baby. If you are a woman who has or will have a baby, talk with your health care provider about the best way to feed your baby.
• have kidney problems or are undergoing kidney dialysis treatment.
• have bone problems.
• have liver problems including hepatitis B virus infection.

Tell your health care provider about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your health care provider if you take:

• Videx, Videx EC (didanosine). Tenofovir DF (a component of TRUVADA) may increase the amount of Videx in your blood. You may need to be followed more carefully if you are taking TRUVADA and Videx together. Also, the dose of didanosine may need to be reduced.
• Reyataz (atazanavir sulfate) or Kaletra (lopinavir/ritonavir). These medicines may increase the amount of tenofovir DF (a component of TRUVADA) in your blood, which could result in more side effects. You may need to be followed more carefully if you are taking TRUVADA and Reyataz or Kaletra together. TRUVADA may decrease the amount of Reyataz in your blood. If you are taking TRUVADA and Reyataz together, you should also be taking Norvir (ritonavir).

Keep a complete list of all the medicines that you take. Make a new list when medicines are added or stopped. Give copies of this list to all of your health care providers and pharmacist every time you visit your health care provider or fill a prescription.

How should I take TRUVADA?

• Take TRUVADA exactly as your health care provider prescribed it. Follow the directions from your health care provider, exactly as written on the label.
• The usual dose of TRUVADA is 1 tablet once a day. TRUVADA is always used with other anti-HIV-1 medicines. If you have kidney problems, you may need to take TRUVADA less often.
• TRUVADA may be taken with or without a meal. Food does not affect how TRUVADA works. Take TRUVADA at the same time each day.
• If you forget to take TRUVADA, take it as soon as you remember that day. Do not take more than 1 dose of TRUVADA in a day. Do not take 2 doses at the same time. Call your health care provider or pharmacist if you are not sure what to do. It is important that you do not miss any doses of TRUVADA or your anti-HIV-1 medicines.
• When your TRUVADA supply starts to run low, get more from your health care provider or pharmacy. This is very important because the amount of virus in your blood may increase if the medicine is stopped for even a short time. The virus may develop resistance to TRUVADA and become harder to treat.
• Do not change your dose or stop taking TRUVADA without first talking with your health care provider. Stay under a health care provider's care when taking TRUVADA.
• If you take too much TRUVADA, call your local poison control center or emergency room right away.