TRUVADA- emtricitabine and tenofovir disoproxil fumarate tablet, film coated 
Gilead Sciences, Inc

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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 Medication Guide section "What is TRUVADA?" for important information about how TRUVADA may be used):

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

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

TRUVADA can cause serious side effects, including:

 
1. Too much lactic acid in your blood (lactic acidosis). Your body normally makes lactic acid, but too much lactic acid is a serious medical emergency. It can be treated, but it can also lead to death.
 
Call 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
  • nausea, vomiting, and stomach-area pain
  • cold or blue hands and feet
  • feel dizzy or lightheaded
  • fast or abnormal heartbeats

 
 
2. Severe liver problems. Severe liver problems can happen in people who take TRUVADA. In some cases these liver problems can lead to death. Your liver may become large and tender. You may develop fat in your liver when you take TRUVADA.
Call your healthcare provider right away if you get the following symptoms:
  • your 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
  • stomach-area pain
 
You may be more likely to get lactic acidosis or severe liver problems if you are female, if you are very overweight (obese), or if you have been taking TRUVADA for a long time.

 
 
3. If you also have hepatitis B virus (HBV) infection and take TRUVADA, your hepatitis B may become worse if you stop taking TRUVADA.
  • Do not stop taking TRUVADA without first talking to your healthcare provider.
  • Do not run out of TRUVADA. Refill your prescription or talk to your healthcare provider before your TRUVADA is all gone.
  • If your healthcare provider stops TRUVADA, your healthcare provider will need to watch you closely for several months to check your hepatitis B infection, or give you a medication 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?" in this Medication Guide.

Other important information for people who take TRUVADA to help reduce their risk of getting HIV-1 infection:

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

While you are taking TRUVADA to reduce your risk of getting HIV-1:

See the section "What should I avoid while taking TRUVADA?" and talk to your healthcare provider for more information about how to prevent HIV-1 infection.

What is TRUVADA?

TRUVADA contains the prescription medicines emtricitabine (EMTRIVA®) and tenofovir disoproxil fumarate (VIREAD®). TRUVADA is used:

Use of TRUVADA to treat HIV-1 infection:

Use of TRUVADA to reduce the risk of HIV-1 infection:

Who should not take TRUVADA?

For people using TRUVADA to reduce the risk of getting HIV-1 infection:

TRUVADA can only help reduce your risk of getting HIV-1 before you are infected. Do not take TRUVADA to help reduce your risk of getting HIV-1 if:

What should I tell my healthcare provider before taking TRUVADA?

Tell your healthcare provider if you:

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

Do not take TRUVADA if you also take any of the medicines listed below:

TRUVADA may interact with other medicines. Especially tell your healthcare provider if you take:

  • didanosine (Videx EC)
  • atazanavir (Reyataz)
  • darunavir (Prezista)
  • lopinavir with ritonavir (Kaletra)

Your doctor may need to check you more often or change your dose if you take any of these medicines and TRUVADA.

Know the medicines you take. Keep a list of them to show your healthcare provider or pharmacist when you get a new medicine.

How should I take TRUVADA?

What should I avoid while taking TRUVADA?

While taking TRUVADA, avoid doing things that increase your risk of getting HIV-1 or spreading HIV-1 to other people.

Ask your healthcare provider if you have any questions about how to prevent getting HIV-1 or spreading HIV-1 to other people.

What are the possible side effects of TRUVADA?

TRUVADA may cause serious side effects, including:

The most common side effects of TRUVADA in people taking TRUVADA to treat HIV-1 infection include:

  • diarrhea
  • nausea
  • tiredness
  • headache
  • dizziness
  • depression
  • problems sleeping
  • abnormal dreams
  • rash

Common side effects in people who take TRUVADA to reduce the risk of getting HIV-1 infection include:

Tell your healthcare 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. For more information, ask your healthcare provider or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store TRUVADA?

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.

This Medication Guide 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, call 1-800-445-3235 or go to www.TRUVADA.com.

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 Blue Y-30-10701 which contains FD&C Blue #2 aluminum lake, hydroxypropyl methylcellulose 2910, lactose monohydrate, titanium dioxide, and triacetin.

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

Revised: 12/2013
 
Gilead Sciences, Inc