Patient information: uses, side effects, how to take - Emtricitabine, Rilpivirine, and Tenofovir Disoproxil

What is the most important information I should know about emtricitabine, rilpivirine and tenofovir disoproxil fumarate tablets?

Emtricitabine, rilpivirine and tenofovir disoproxil fumarate tablets can cause serious side effects, including:

Worsening of Hepatitis B virus (HBV) infection. Your healthcare provider will test you for HBV before starting treatment with emtricitabine, rilpivirine and tenofovir disoproxil fumarate tablets. If you have HBV infection and take emtricitabine, rilpivirine and tenofovir disoproxil fumarate tablets, your HBV may get worse (flare-up) if you stop taking emtricitabine, rilpivirine and tenofovir disoproxil fumarate tablets. A “flare-up” is when your HBV infection suddenly returns in a worse way than before.

Do not stop taking emtricitabine, rilpivirine and tenofovir disoproxil fumarate tablets without first talking to your healthcare provider.
Do not run out of emtricitabine, rilpivirine and tenofovir disoproxil fumarate tablets. Refill your prescription or talk to your healthcare provider before your emtricitabine, rilpivirine and tenofovir disoproxil fumarate tablets are all gone.
If you stop taking emtricitabine, rilpivirine and tenofovir disoproxil fumarate tablets, your healthcare provider will need to check your health often and do blood tests regularly for several months to check your HBV infection. Tell your healthcare provider about any new or unusual symptoms you may have after you stop taking emtricitabine, rilpivirine and tenofovir disoproxil fumarate tablets.

For more information about side effects, see the section “What are the possible side effects of emtricitabine, rilpivirine and tenofovir disoproxil fumarate tablets?”.

What are emtricitabine, rilpivirine and tenofovir disoproxil fumarate tablets?

Emtricitabine, rilpivirine and tenofovir disoproxil fumarate tablets are a prescription medicine that is used to treat Human Immunodeficiency Virus-1 (HIV-1) in people weighing at least 77 lb (35 kg) who:

have never taken HIV-1 medicines before, and who have an amount of HIV-1 in their blood (this is called ‘viral load’) that is no more than 100,000 copies/mL before they start taking emtricitabine, rilpivirine and tenofovir disoproxil fumarate tablets,

in certain people who have a viral load that is less than 50 copies/mL when they start taking emtricitabine, rilpivirine and tenofovir disoproxil fumarate tablets, to replace their current HIV-1 medicines.

HIV-1 is the virus that causes AIDS (Acquired Immune Deficiency Syndrome). Emtricitabine, rilpivirine and tenofovir disoproxil fumarate tablets do not cure HIV-1 or AIDS.

Emtricitabine, rilpivirine and tenofovir disoproxil fumarate tablets contain 3 medicines (emtricitabine, rilpivirine, tenofovir disoproxil fumarate) combined in one tablet.

Emtricitabine (EMTRIVA^®) and tenofovir disoproxil fumarate (VIREAD^®) are HIV-1 nucleoside analog reverse transcriptase inhibitors (NRTIs). Rilpivirine (Edurant^®) is an HIV-1 non-nucleoside analog reverse transcriptase inhibitor (NNRTI).

It is not known if emtricitabine, rilpivirine and tenofovir disoproxil fumarate tablets are safe and effective in children less than 12 years of age or who weigh less than 77 lb (35 kg).

Who should not take emtricitabine, rilpivirine and tenofovir disoproxil fumarate tablets?

Do not take emtricitabine, rilpivirine and tenofovir disoproxil fumarate tablets if you also take:

anti-seizure medicines:
carbamazepine
oxcarbazepine
phenobarbital
phenytoin
anti-tuberculosis (anti-TB) medicines:
rifampin
rifapentine
proton pump inhibitor (PPI) medicine for certain stomach or intestinal problems:
dexlansoprazole
esomeprazole
lansoprazole
omeprazole
pantoprazole sodium
rabeprazole
more than 1 dose of the steroid medicine dexamethasone or dexamethasone sodium phosphate
St. John’s wort (Hypericum perforatum)

What should I tell my healthcare provider before taking emtricitabine, rilpivirine and tenofovir disoproxil fumarate tablets?

Before taking emtricitabine, rilpivirine and tenofovir disoproxil fumarate tablets, tell your healthcare provider about all your medical conditions, including if you:

have liver problems, including hepatitis B or C virus infection
have kidney problems
have a history of depression or suicidal thoughts
have bone problems
are pregnant or plan to become pregnant. It is not known if emtricitabine, rilpivirine and tenofovir disoproxil fumarate tablets can harm your unborn child. Tell your healthcare provider if you become pregnant during treatment with emtricitabine, rilpivirine and tenofovir disoproxil fumarate tablets.

Pregnancy Registry. There is a pregnancy registry for those who take emtricitabine, rilpivirine and tenofovir disoproxil fumarate tablets 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. Do not breastfeed if you are taking emtricitabine, rilpivirine and tenofovir disoproxil fumarate tablets.
You should not breastfeed if you have HIV-1 because of the risk of passing HIV-1 to your baby.
At least two of the medicines contained in emtricitabine, rilpivirine and tenofovir disoproxil fumarate tablets can be passed to your baby in your breast milk.
Talk with your healthcare provider about the best way to feed your baby during treatment with emtricitabine, rilpivirine and tenofovir disoproxil fumarate tablets.

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

Some medicines interact with emtricitabine, rilpivirine and tenofovir disoproxil fumarate tablets. Keep a list of your medicines to show 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 can interact with emtricitabine, rilpivirine and tenofovir disoproxil fumarate tablets.
Do not start taking a new medicine without telling your healthcare provider. Your healthcare provider can tell you if it is safe to take emtricitabine, rilpivirine and tenofovir disoproxil fumarate tablets with other medicines.

How should I take emtricitabine, rilpivirine and tenofovir disoproxil fumarate tablets?

Take emtricitabine, rilpivirine and tenofovir disoproxil fumarate tablets exactly as your healthcare provider tells you to take it.
Take emtricitabine, rilpivirine and tenofovir disoproxil fumarate tablets with food. Taking emtricitabine, rilpivirine and tenofovir disoproxil fumarate tablets with food is important to help get the right amount of medicine in your body. A protein drink does not replace food. If your healthcare provider decides to stop emtricitabine, rilpivirine and tenofovir disoproxil fumarate tablets and you are switched to new medicines to treat HIV-1 that include rilpivirine tablets, the rilpivirine tablets should be taken only with a meal.
Do not change your dose or stop taking emtricitabine, rilpivirine and tenofovir disoproxil fumarate tablets without first talking with your healthcare provider. Stay under the care of your healthcare provider during treatment with emtricitabine, rilpivirine and tenofovir disoproxil fumarate tablets.
If you miss a dose of emtricitabine, rilpivirine and tenofovir disoproxil fumarate tablets within 12 hours of the time you usually take it, take your dose of emtricitabine, rilpivirine and tenofovir disoproxil fumarate tablets with food as soon as possible. Then, take your next dose of emtricitabine, rilpivirine and tenofovir disoproxil fumarate tablets at the regularly scheduled time. If you miss a dose of emtricitabine, rilpivirine and tenofovir disoproxil fumarate tablets by more than 12 hours of the time you usually take it, wait and then take the next dose of emtricitabine, rilpivirine and tenofovir disoproxil fumarate tablets at the regularly scheduled time.
Do not take more than your prescribed dose to make up for a missed dose.
If you take too many emtricitabine, rilpivirine and tenofovir disoproxil fumarate tablets, contact your local poison control center or go to the nearest hospital emergency room right away.
When your emtricitabine, rilpivirine and tenofovir disoproxil fumarate tablets supply starts to run low, get more from your healthcare provider or pharmacy. It is very important not to run out of emtricitabine, rilpivirine and tenofovir disoproxil fumarate tablets. The amount of virus in your blood may increase if the medicine is stopped for even a short time.

What are the possible side effects of emtricitabine, rilpivirine and tenofovir disoproxil fumarate tablets?

Emtricitabine, rilpivirine and tenofovir disoproxil fumarate tablets can cause serious side effects, including:

See “What is the most important information I should know about emtricitabine, rilpivirine and tenofovir disoproxil fumarate tablets?”

Severe skin rash and allergic reactions. Skin rash is a common side effect of emtricitabine, rilpivirine and tenofovir disoproxil fumarate tablets. Rash can be serious. Call your healthcare provider right away if you get a rash. In some cases, rash and allergic reaction may need to be treated in a hospital. If you get a rash with any of the following symptoms, stop taking emtricitabine, rilpivirine and tenofovir disoproxil fumarate tablets and call your healthcare provider or get medical help right away:

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.
Change in liver enzymes. People with a history of hepatitis B or C virus infection or who have certain liver enzyme changes may have an increased risk of developing new or worsening liver problems during treatment with emtricitabine, rilpivirine and tenofovir disoproxil fumarate tablets. Liver problems can also happen during treatment with emtricitabine, rilpivirine and tenofovir disoproxil fumarate tablets in people without a history of liver disease. Your healthcare provider may need to do tests to check your liver enzymes before and during treatment with emtricitabine, rilpivirine and tenofovir disoproxil fumarate tablets.
Depression or mood changes. Tell your healthcare provider right away if you have any of the following symptoms:
feel sad or hopeless
feel anxious or restless
have thoughts of hurting yourself (suicide) or have tried to hurt yourself
New or worse kidney problems, including kidney failure, can happen in some people who take emtricitabine, rilpivirine and tenofovir disoproxil fumarate tablets. Your healthcare provider should do blood tests to check your kidneys before starting treatment with emtricitabine, rilpivirine and tenofovir disoproxil fumarate tablets. If you have had kidney problems in the past or need to take another medicine that can cause kidney problems, your healthcare provider may need to do blood tests to check your kidneys during your treatment with emtricitabine, rilpivirine and tenofovir disoproxil fumarate tablets.
Bone problems can happen in some people who take emtricitabine, rilpivirine and tenofovir disoproxil fumarate tablets. Bone problems include bone pain, softening, or thinning (which may lead to fractures). Your healthcare provider may need to do additional 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.
Changes in your immune system (Immune Reconstitution Syndrome) can happen when you start taking HIV-1 medicines. 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 new symptoms after starting your HIV-1 medicine.

The most common side effects of rilpivirine, one of the medicines in emtricitabine, rilpivirine and tenofovir disoproxil fumarate tablets, include:

depression
trouble sleeping
headache

The most common side effects of emtricitabine and tenofovir disoproxil fumarate, two of the medicines in emtricitabine, rilpivirine and tenofovir disoproxil fumarate tablets, include:

These are not all the possible side effects of emtricitabine, rilpivirine and tenofovir disoproxil fumarate tablets.

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

How should I store emtricitabine, rilpivirine and tenofovir disoproxil fumarate tablets?

Store emtricitabine, rilpivirine and tenofovir disoproxil fumarate tablets at room temperature between 68°F to 77°F (20°C to 25°C).
Keep emtricitabine, rilpivirine and tenofovir disoproxil fumarate tablets in its original container and keep the container tightly closed.
Do not use emtricitabine, rilpivirine and tenofovir disoproxil fumarate tablets if the seal over the bottle opening is broken or missing.

Keep emtricitabine, rilpivirine and tenofovir disoproxil fumarate tablets and all other medicines out of reach of children.

General information about safe and effective use of emtricitabine, rilpivirine and tenofovir disoproxil fumarate tablets

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use emtricitabine, rilpivirine and tenofovir disoproxil fumarate tablets for a condition for which it was not prescribed. Do not give emtricitabine, rilpivirine and tenofovir disoproxil fumarate tablets 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 emtricitabine, rilpivirine and tenofovir disoproxil fumarate tablets that is written for health professionals.

What are the ingredients of emtricitabine, rilpivirine and tenofovir disoproxil fumarate tablets?

Active ingredients: emtricitabine, USP, rilpivirine hydrochloride, and tenofovir disoproxil fumarate.

Inactive ingredients: croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polysorbate 20, povidone K30. The tablet film coating contains polyethylene glycol 3350, polyvinyl alcohol, talc and titanium dioxide.

For more information, call Laurus Generics Inc. at 1-833-3-LAURUS (1-833-352-8787).

The brands listed are trademarks of their respective owners and are not trademarks of Laurus Labs Limited.

This Patient Information has been approved by the U.S. Food and Drug Administration.

Manufactured for:

Laurus Generics Inc.

400 Connell Drive

Suite 5200

Berkeley Heights, NJ 07922

Manufactured by:

Laurus Labs Limited

Anakapalli-531011

India

Revised: 9/2025

Emtricitabine, Rilpivirine, and Tenofovir Disoproxil: Uses, Side Effects and Dosage