Truvada is used for:

Treating HIV infection in combination with other medicines. Truvada is not a cure for HIV or AIDS. It may also be used for other conditions as determined by your doctor.

Truvada is an antiviral combination of 2 reverse transcriptase inhibitors. It works by reducing the amount of HIV in the body by blocking its ability to multiply.

Do NOT use Truvada if:

• you are allergic to any ingredient in Truvada
• you have a history of abnormal liver function tests, severe liver problems, severe kidney problems, or lactic acidosis
• you are taking adefovir, lamivudine, or another medicine that contains emtricitabine or tenofovir
• you take a medicine that may harm your kidneys (eg, an aminoglycoside antibiotic [eg, gentamicin], amphotericin B, cyclosporine, a nonsteroidal anti-inflammatory drug [NSAID] [eg, ibuprofen], tacrolimus, vancomycin). Ask you doctor if you are not sure if any of your medicines might harm your kidneys

Contact your doctor or health care provider right away if any of these apply to you.

Before using Truvada :

Some medical conditions may interact with Truvada . Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding
• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
• if you have allergies to medicines, foods, or other substances
• if you have bone problems or kidney problems, including dialysis treatment
• if you have liver problems, including HBV infection

Some MEDICINES MAY INTERACT with Truvada . Tell your health care provider if you are taking any other medicines, especially any of the following:

• Acyclovir, cidofovir, ganciclovir, valacyclovir, valganciclovir, or medicines that may harm your kidneys (eg, an aminoglycoside antibiotic [eg, gentamicin], amphotericin B, cyclosporine, an NSAID eg, [ibuprofen], tacrolimus, vancomycin) because they may increase the risk of Truvada 's side effects. Ask your doctor or pharmacist if you are not sure if any of your medicines may affect your kidneys
• Adefovir, other medicines that contain emtricitabine or tenofovir, or lamivudinebecause they may increase the risk of Truvada 's side effects
• HIV protease inhibitors (eg, atazanavir) or lopinavir/ritonavir because they may increase the risk of Truvada 's side effects
• Didanosine because the risk of its side effects may be increased by Truvada

This may not be a complete list of all interactions that may occur. Ask your health care provider if Truvada may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Truvada :

Use Truvada as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• An extra patient leaflet is available with Truvada . Talk to your pharmacist if you have questions about this information.
• Take Truvada by mouth with or without food.
• Continue to take Truvada even if you feel well. Do not miss any doses.
• Do not suddenly stop taking Truvada without checking with your doctor. This may cause the virus to become less sensitive to this or other medicines. Some conditions (eg, hepatitis B) could become worse if you suddenly stop taking Truvada .
• Taking Truvada at the same time each day will help you remember to take it.
• If you miss a dose of Truvada , take it as soon as possible. If you do not remember until the next day, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once. Do not take more than 1 dose in the same day.

Ask your health care provider any questions you may have about how to use Truvada .

Important safety information:

• Truvada may cause dizziness or lightheadedness. These effects may be worse if you take it with alcohol or certain medicines. Use Truvada with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
• You should be tested for HBV infection before you start to take Truvada .
• Keep a list of all the medicines that you take. Make a new list each time medicines are added or stopped. Find out about medicines that should not be taken while you are using Truvada . Be sure that each of your health care providers knows all the medicines that you are taking.
• When your medicine supply is low, get more from your doctor or pharmacist as soon as you can. Do not stop taking Truvada , even for a short period of time. If you do, the virus may grow resistant to the medicine and become harder to treat.
• Truvada is not a cure for HIV infection. Patients may still get illnesses and infections associated with HIV. Remain under the care of your doctor.
• Truvada does not stop the spread of HIV to others through blood or sexual contact. Use barrier methods of birth control (eg, condoms) if you have HIV infection. Do not share needles, injection supplies, or items like toothbrushes or razors.
• Truvada is not for the treatment of HBV. If you have HBV and HIV, you will 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 infection that could be getting worse.
• The risk of severe side effects (eg, lactic acidosis, severe liver problems) may be greater in women, patients who are very overweight (obese), and patients who have taken reverse transcriptase inhibitors (eg, emtricitabine, tenofovir) for a long time. Talk with your doctor if you have questions about your risk for severe side effects from Truvada .
• Changes in body fat (eg, an increased amount of fat in the upper back, neck, breast, and trunk, and loss of fat from the legs, arms, and face) may occur in some patients taking Truvada . The cause and long-term effects of these changes are unknown. Discuss any concerns with your doctor.
• Truvada may improve immune system function. This may reveal hidden infections in some patients. Tell your doctor right away if you notice symptoms of infection (eg, fever, sore throat, weakness, cough, shortness of breath) after you start Truvada .
• Ask your doctor if you should take a calcium and vitamin D supplement while you are taking Truvada .
• Lab tests, including liver function, kidney function, and bone mineral density, may be performed while you use Truvada . These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
• Truvada should not be used in CHILDREN younger than 18 years old; safety and effectiveness in these children have not been confirmed.
• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Truvada while you are pregnant. It is not known if Truvada is found in breast milk. Mothers infected with HIV should not breast-feed. There is a risk of passing the HIV infection or Truvada to the baby. Do not breast-feed while taking Truvada .

Possible side effects of Truvada :

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Abnormal skin sensations; back pain; cough; darkened skin color on the palms of hands or soles of feet; diarrhea; dizziness; gas; headache; indigestion; loss of appetite; nausea; sinus drainage; skin discoloration (small spots or freckles); strange dreams; sweating; tiredness; trouble sleeping; vomiting; weakness; weight loss.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); bone pain; chest pain; mental or mood changes (eg, depression); muscle pain or weakness; numbness, burning, pain, or tingling in the hands or feet; severe or persistent dizziness; severe or persistent nausea or vomiting; shortness of breath; stomach pain; symptoms of kidney problems (eg, increased or decreased urination, increase thirst); symptoms of lactic acidosis (eg, unusual weakness or tiredness; unusual muscle pain; fast or difficult breathing; stomach pain with nausea and vomiting; feeling cold, especially in the arms and legs; dizziness or lightheadedness; fast or irregular heartbeat); symptoms of liver problems (eg, yellowing of the skin or eyes; dark urine; pale stools; persistent loss of appetite).

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects.

PATIENT COUNSELING INFORMATION and FDA-APPROVED PATIENT LABELING

Information for Patients

Patients should be advised that:

• Truvada is not a cure for HIV-1 infection and patients may continue to experience illnesses associated with HIV-1 infection, including opportunistic infections. Patients should remain under the care of a physician when using Truvada.
• The use of Truvada has not been shown to reduce the risk of transmission of HIV-1 to others through sexual contact or blood contamination. Patients should be advised to continue to practice safer sex and to use latex or polyurethane condoms to lower the chance of sexual contact with any body fluids such as semen, vaginal secretions or blood. Patients should be advised never to re-use or share needles.
• The long term effects of Truvada are unknown.
• Truvada tablets are for oral ingestion only.
• It is important to take Truvada with combination therapy on a regular dosing schedule to avoid missing doses.
• Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported. Treatment with Truvada should be suspended in any patients who develop clinical symptoms suggestive of lactic acidosis or pronounced hepatotoxicity (including nausea, vomiting, unusual or unexpected stomach discomfort, and weakness) [See Warnings and Precautions (5.1)].
• All patients with HIV-1 should be tested for hepatitis B virus (HBV) before initiating antiretroviral therapy.
• Severe acute exacerbations of hepatitis B have been reported in patients who are coinfected with HBV and HIV-1 and have discontinued Truvada.
• Renal impairment, including cases of acute renal failure and Fanconi syndrome, has been reported in association with the use of VIREAD. Truvada should be avoided with concurrent or recent use of a nephrotoxic agent [See Warnings and Precautions (5.3)]. Dosing interval of Truvada may need adjustment in patients with renal impairment [See Dosage and Administration (2.1)].
• Truvada should not be coadministered with ATRIPLA, EMTRIVA, or VIREAD; or with drugs containing lamivudine, including Combivir (lamivudine/zidovudine), Epivir or Epivir-HBV (lamivudine), Epzicom (abacavir sulfate/lamivudine), or Trizivir (abacavir sulfate/lamivudine/zidovudine) [See Warnings and Precautions (5.4)].
• Truvada should not be administered with HEPSERA [See Warnings and Precautions (5.4)].
• Decreases in bone mineral density have been observed with the use of VIREAD. Bone monitoring should be considered in patients who have a history of pathologic bone fracture or at risk for osteopenia [See Warnings and Precautions (5.5)].

FDA-Approved Patient Labeling

Truvada® (tru-VAH-dah) tablets

Generic Name: emtricitabine and tenofovir disoproxil fumarate
(em tri SIT uh bean and te NOE' fo veer dye soe PROX il FYOU mar ate)

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 healthcare provider about your medical condition or treatment. You should stay under a healthcare provider's care when taking Truvada. Do not change or stop your medicine without first talking with your healthcare provider. Talk to your healthcare 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 healthcare 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 healthcare 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 age 18 and older. Truvada has not been studied in children under age 18 or 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 healthcare 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 healthcare provider before taking Truvada?

Tell your healthcare 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 breast-feeding. 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 healthcare 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 healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your healthcare 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 healthcare providers and pharmacist every time you visit your healthcare provider or fill a prescription.

How should I take Truvada?

• Take Truvada exactly as your healthcare provider prescribed it. Follow the directions from your healthcare 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 healthcare 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 healthcare 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 healthcare provider. Stay under a healthcare provider's care when taking Truvada.
• If you take too much Truvada, call your local poison control center or emergency room right away.

What should I avoid while taking Truvada?

• Do not breast-feed. See "What should I tell my healthcare provider before taking Truvada?"
• Avoid doing things that can spread HIV infection since Truvada does not stop you from passing the HIV infection to others.
  • Do not share needles or other injection equipment.
  • Do not share personal items that can have blood or body fluids on them, like toothbrushes or razor blades.
  • Do not have any kind of sex without protection. Always practice safer sex by using a latex or polyurethane condom or other barrier to reduce the chance of sexual contact with semen, vaginal secretions, or blood.
• ATRIPLA, Combivir (lamivudine/zidovudine), EMTRIVA, Epivir or Epivir-HBV (lamivudine), Epzicom (abacavir sulfate/lamivudine), Trizivir (abacavir sulfate/lamivudine/zidovudine), or VIREAD.
  Truvada should not be used with these medicines.
• Truvada should not be used with HEPSERA.

What are the possible side effects of Truvada?

Truvada may cause the following serious side effects (see "What is the most important information I should know about Truvada?"):

• Lactic acidosis (buildup of an acid in the blood). Lactic acidosis can be a medical emergency and may need to be treated in the hospital. Call your doctor right away if you get signs of lactic acidosis. (See "What is the most important information I should know about Truvada?")
• Serious liver problems (hepatotoxicity), with liver enlargement (hepatomegaly) and fat in the liver (steatosis). Call your healthcare provider right away if you get any signs of liver problems. (See "What is the most important information I should know about Truvada?")
• "Flare-ups" of hepatitis B virus infection, in which the disease suddenly returns in a worse way than before, can occur if you stop taking Truvada. Your healthcare provider will monitor your condition for several months after stopping Truvada if you have both HIV-1 and HBV infection. Truvada is not approved for the treatment of hepatitis B virus infection. If you have advanced liver disease and stop treatment with Truvada, the "flare-up" of hepatitis B may cause your liver function to decline.
• Kidney problems. If you have had kidney problems in the past or take other medicines that can cause kidney problems, your healthcare provider should do regular blood tests to check your kidneys.
• Changes in bone mineral density (thinning bones). Laboratory tests show changes in the bones of patients treated with VIREAD, a component of Truvada. Some HIV patients treated with VIREAD developed thinning of the bones (osteopenia) which could lead to fractures. If you have had bone problems in the past, your healthcare provider may need to do tests to check your bone mineral density or may prescribe medicines to help your bone mineral density. Additionally, bone pain and softening of the bone (which may contribute to fractures) may occur as a consequence of kidney problems.

Other side effects with Truvada when used with other anti-HIV-1 medicines include:

• Changes in body fat have been seen in some patients taking Truvada and other anti-HIV-1 medicines. These changes may include increased amount of fat in the upper back and neck ("buffalo hump"), breast, and around the main part of your body (trunk). Loss of fat from the legs, arms and face may also happen. The cause and long term health effect of these conditions are not known at this time.
• In some patients with advanced HIV infection (AIDS), signs and symptoms of inflammation from previous infections may occur soon after anti-HIV treatment is started. It is believed that these symptoms are due to an improvement in the body's immune response, enabling the body to fight infections that may have been present with no obvious symptoms. If you notice any symptoms of infection, please inform your doctor immediately.

The most common side effects of EMTRIVA or VIREAD when used with other anti-HIV-1 medicines are: diarrhea, dizziness, nausea, headache, fatigue, abnormal dreams, sleeping problems, rash, depression, and vomiting. Additional side effects are lactic acidosis, kidney problems (including decline or failure of kidney function), inflammation of the pancreas, inflammation of the liver, allergic reaction (including swelling of the face, lips, tongue, or throat), shortness of breath, pain, fatty liver, stomach pain, weakness, indigestion, intestinal gas, and high volume of urine and thirst caused by kidney problems. Muscle pain and muscle weakness, bone pain, and softening of the bone (which may contribute to fractures) as a consequence of kidney problems have been reported. Skin discoloration (small spots or freckles) may also happen with Truvada.

These are not all the side effects of Truvada. If you have questions about side effects, ask your healthcare provider. Report any new or continuing symptoms to your healthcare provider right away. Your healthcare provider may be able to help you manage these side effects.

How do I store Truvada?

• Keep Truvada and all other medicines out of reach of children.
• Store Truvada at room temperature 77 °F (25 °C).
• Keep Truvada in its original container and keep the container tightly closed.
• Do not keep medicine that is out of date or that you no longer need. If you throw any medicines away make sure that children will not find them.

General information about Truvada:

Medicines are sometimes prescribed for conditions that are not mentioned in patient information leaflets. Do not use Truvada for a condition for which it was not prescribed. Do not give Truvada to other people, even if they have the same symptoms you have. It may harm them.

This leaflet summarizes the most important information about Truvada. If you would like more information, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about Truvada that is written for health professionals. For more information, you may also call 1-800-GILEAD-5 or access the Truvada website at www.Truvada.com.

Do not use Truvada if seal over bottle opening is broken or missing.

What are the ingredients of Truvada?

Active Ingredients: emtricitabine and tenofovir disoproxil fumarate

Inactive Ingredients: Croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and pregelatinized starch (gluten free). The tablets are coated with Opadry II Blue Y-30-10701 containing FD&C Blue #2 aluminum lake, hydroxypropyl methylcellulose 2910, lactose monohydrate, titanium dioxide, and triacetin.

Rx Only

Truvada, EMTRIVA, HEPSERA and VIREAD are registered trademarks of Gilead Sciences, Inc. ATRIPLA is a trademark of Bristol-Myers Squibb & Gilead Sciences, LLC. All other trademarks referenced herein are the property of their respective owners.

This Product was Repackaged By:

PRINCIPAL DISPLAY PANEL - Tablet, Label

NDC 53808-0805-1

Truvada®

(emtricitabine and tenofovir
disoproxil fumarate)
Tablets x 30 tablets

Rx only