Medication Guide
TRUVADA™ (tru-VAH-dah)
(emtricitabine and tenofovir disoproxil fumarate)
tablets

Read this Medication Guide before you start taking TRUVADA 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 your treatment.

This Medication Guide provides information about two different ways that TRUVADA may be used. See the section "What is TRUVADA?" for important information about how TRUVADA may be used.

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

TRUVADA can cause serious side effects, including:

• Worsening of hepatitis B virus infection (HBV). Your healthcare provider will test you for HBV before start or when you start treatment with TRUVADA. If you have HBV infection and take TRUVADA, your HBV may get worse (flare-up) if you stop taking TRUVADA. A "flare-up" is when your HBV infection suddenly returns in a worse way than before.
  • Do not run out of TRUVADA. Refill your prescription or talk to your healthcare provider before your TRUVADA is all gone.
  • Do not stop taking TRUVADA without first talking to your healthcare provider.
  • If you stop taking TRUVADA, your healthcare provider will need to check your health often and do blood tests regularly for several months to check your HBV infection, or give you a medicine to treat hepatitis B. Tell your healthcare provider about any new or unusual symptoms you may have after you stop taking TRUVADA.

For more information about side effects, see the section "What are the possible side effects of TRUVADA?"

Other important information for people who take TRUVADA to help reduce their risk of getting human immunodeficiency virus-1 (HIV-1) infection, also called pre-exposure prophylaxis or "PrEP":

Before taking TRUVADA to reduce your risk of getting HIV-1 infection:

• You must be HIV-1 negative to start TRUVADA. You must get tested to make sure that you do not already have HIV-1 infection.
• Do not take TRUVADA for HIV-1 PrEP unless you are confirmed to be HIV-1 negative.
• Some HIV-1 tests can miss HIV-1 infection in a person who has recently become infected. If you have flu-like symptoms, you could have recently become infected with HIV-1. Tell your healthcare provider if you had a flu-like illness within the last month before starting TRUVADA or at any time while taking TRUVADA. Symptoms of new HIV-1 infection include:

  tiredness fever joint or muscle aches headache sore throat

  vomiting or diarrhea rash night sweats enlarged lymph nodes in the neck or groin

While you are taking TRUVADA for HIV-1 PrEP:

• TRUVADA does not prevent other sexually transmitted infections (STIs). Practice safer sex by using a latex or polyurethane condom to reduce the risk of getting STIs.
• You must stay HIV-negative to keep taking TRUVADA for HIV-1 PrEP.
  • Know your HIV-1 status and the HIV-1 status of your partners.
  • Ask your partners with HIV-1 if they are taking anti-HIV-1 medicines and have an undetectable viral load. An undetectable viral load is when the amount of virus in the blood is too low to be measured in a lab test. To maintain an undetectable viral load, your partners must keep taking HIV-1 medicines every day. Your risk of getting HIV-1 is lower if your partners with HIV-1 are taking effective treatment.
  • Get tested for HIV-1 at least every 3 months or when your healthcare provider tells you.
  • Get tested for other STIs such as syphilis, chlamydia, and gonorrhea. These infections make it easier for HIV-1 to infect you.
  • If you think you were exposed to HIV-1, tell your healthcare provider right away. They may want to do more tests to be sure you are still HIV-1 negative.
  • Get information and support to help reduce sexual risk behaviors.
  • Do not miss any doses of TRUVADA. Missing doses increases your risk of getting HIV-1 infection.
• If you do become HIV-1 positive, you need more medicine than TRUVADA alone to treat HIV-1. TRUVADA by itself is not a complete treatment for HIV-1.
• If you have HIV-1 and take only TRUVADA, over time your HIV-1 may become harder to treat.

What is TRUVADA?

TRUVADA is a prescription medicine that may be used in two different ways. TRUVADA is used:

• to treat HIV-1 infection when used with other anti-HIV-1 medicines in adults and children aged 12 years and older.
• for HIV-1 PrEP to reduce the risk of getting HIV-1 infection in adults and adolescents who weigh at least 35 kg (at least 77 pounds).

HIV-1 is the virus that causes Acquired Immune Deficiency Syndrome (AIDS).

TRUVADA contains the prescription medicines emtricitabine and tenofovir disoproxil fumarate.

It is not known if TRUVADA is safe and effective in children with HIV-1 infection who are under 12 years of age or who weigh less than 35 kg (77 pounds).

It is not known if TRUVADA is safe and effective in reducing the risk of HIV-1 infection in people who weigh less than 35 kg (77 pounds).

For people taking TRUVADA forHIV-1 PrEP:

Do not take TRUVADA for HIV-1 PrEP if:

• you already have HIV-1 infection. If you are HIV-1 positive, you need to take other medicines with TRUVADA to treat HIV-1. TRUVADA by itself is not a complete treatment for HIV-1.
• you do not know your HIV-1 infection status. You may already be HIV-1 positive. You need to take other HIV-1 medicines with TRUVADA to treat HIV-1.
• TRUVADA can only help reduce your risk of getting HIV-1 before you are infected.

What should I tell my healthcare provider before taking TRUVADA?

Before taking TRUVADA, tell your healthcare provider about all of your medical conditions, including if you:

• have liver problems, including HBV infection
• have kidney problems or receive kidney dialysis treatment
• have bone problems
• are pregnant or plan to become pregnant. It is not known if TRUVADA can harm your unborn baby. Tell your healthcare provider if you become pregnant during treatment with TRUVADA.
  Pregnancy Registry: There is a pregnancy registry for people who take TRUVADA during pregnancy. The purpose of this registry is to collect information about the health of you and your baby. Talk with your healthcare provider about how you can take part in this registry.
• are breastfeeding or plan to breastfeed. TRUVADA can pass to your baby in your breast milk.
  • Do not breastfeed if you have HIV-1 or if you think you have recently become infected with HIV-1 because of the risk of passing HIV-1 to your baby.
  • If you take TRUVADA for HIV-1 PrEP, talk with your healthcare provider about the best way to feed your baby.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Some medicines may interact with TRUVADA. Keep a list of your medicines and show it to your healthcare provider and pharmacist when you get a new medicine.

• You can ask your healthcare provider or pharmacist for a list of medicines that interact with TRUVADA.
• Do not start a new medicine without telling your healthcare provider. Your healthcare provider can tell you if it is safe to take TRUVADA with other medicines.

How should I take TRUVADA?

• Take TRUVADA exactly as your healthcare provider tells you to take it.
• If you take TRUVADA to treat HIV-1 infection, you need to take other HIV-1 medicines. Your healthcare provider will tell you what medicines to take and how to take them.
• Take TRUVADA 1 time each day with or without food.
• Children should swallow the TRUVADA tablet. Tell your healthcare provider if your child cannot swallow the tablet, because they may need a different HIV-1 medicine.
• 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. Do not miss a dose of TRUVADA.
• If you take too much TRUVADA, call your healthcare provider or go to the nearest hospital emergency room right away.
• When your TRUVADA supply starts to run low, get more from your healthcare provider or pharmacy.
  • If you are taking TRUVADA for treatment of HIV-1, 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.
  • If you are taking TRUVADA for HIV-1 PrEP, missing doses increases your risk of getting HIV-1 infection.

What are the possible side effects of TRUVADA?

TRUVADA may cause serious side effects, including:

• See "What is the most important information I should know about TRUVADA?"
• New or worse kidney problems, including kidney failure. Your healthcare provider should do blood and urine tests to check your kidneys before you start and during treatment with TRUVADA. Your healthcare provider may tell you to take TRUVADA less often, or to stop taking TRUVADA if you get new or worse kidney problems.
• Changes in your immune system (Immune Reconstitution Syndrome) can happen when taking medicines to treat HIV-1 infection. Your immune system may get stronger and begin to fight infections that have been hidden in your body for a long time. Tell your healthcare provider right away if you start having any new symptoms after starting your HIV-1 medicine.
• Bone problems can happen in some people who take TRUVADA. Bone problems include bone pain, or softening or thinning of bones, which may lead to fractures. Your healthcare provider may need to do tests to check your bones.
• Too much lactic acid in your blood (lactic acidosis). Too much lactic acid is a serious but rare medical emergency that can lead to death. Tell your healthcare provider right away if you get these symptoms: weakness or being more tired than usual, unusual muscle pain, being short of breath or fast breathing, stomach pain with nausea and vomiting, cold or blue hands and feet, feel dizzy or lightheaded, or a fast or abnormal heartbeat.
• Severe liver problems. In rare cases, severe liver problems can happen that can lead to death. Tell your healthcare provider right away if you get these symptoms: skin or the white part of your eyes turns yellow, dark "tea-colored" urine, light-colored stools, loss of appetite for several days or longer, nausea, or stomach-area pain.

The most common side effects of TRUVADA for treatment of HIV-1 include:

diarrhea nausea tiredness headache dizziness

depression problems sleeping abnormal dreams rash

Common side effects in people who take TRUVADA for HIV-1 PrEP include:

headache

stomach-area (abdomen) pain

decreased weight

These are not all the possible side effects of TRUVADA.

Call your doctor for medical advice about side effects.

To report SUSPECTED ADVERSE REACTIONS, contact Gilead Sciences, Inc. at safety_fc@gilead.com or the US FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

How should I store TRUVADA?

• Store TRUVADA below 30°C (86°F).
• Keep TRUVADA in its original container.
• Keep the container tightly closed.
• Do not use TRUVADA if seal over bottle opening is broken or missing.

Keep TRUVADA and all other medicines out of reach of children.

General information about TRUVADA.

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. 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. You can ask your healthcare provider or pharmacist for information about TRUVADA that is written for health professionals.

What are the ingredients in 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 Light Blue Y-30-10671-A which contains FD&C Blue #2 aluminum lake, hydroxypropyl methylcellulose 2910, lactose monohydrate, titanium dioxide, and triacetin.

Manufactured and distributed for:

Gilead Sciences, Inc.

Foster City, CA 94404

TRUVADA is a trademark of Gilead Sciences, Inc., or its related companies.

For more information go to www.TRUVADA.com.
© 2020 Gilead Sciences, Inc. All rights reserved.

21752-GS-033A

Revised June 2020

This Medication Guide has been approved by the U.S Food and Drug Administration.