WHAT IS EMTRICITABINE?

Emtricitabine, also known as FTC (brand name Emtriva), is a drug used as part of antiretroviral therapy (ART). The FDA approved emtricitabine in 2003 as an antiretroviral drug (ARV) for people with HIV infection. Generic versions have been approved under PEPFAR. Emtricitabine is manufactured by Gilead Sciences.

Emtricitabine is a type of drug called a non-nucleoside reverse transcriptase inhibitor (NNRTI). NNRTIs bind to and block reverse transcriptase (an HIV enzyme). HIV uses reverse transcriptase to convert its RNA into DNA (reverse transcription). Blocking reverse transcriptase and reverse transcription prevents HIV from replicating.

When used in combination with other ARVs to treat HIV infection, emtricitabine may help:

    • Reduce the amount of HIV in your blood. This is called viral load.
    • Increase the number of CD4 cells in your blood that help fight off other infections.

Reducing the amount of HIV and increasing the CD4 cells in your blood may help improve your immune system. This may reduce your risk of death or getting opportunistic infections (OIs) that can happen when your immune system is weak. Read more about viral suppression.

Emtricitabine does not cure HIV infection or AIDS. You must keep taking HIV medicines to control HIV infection and decrease HIV-related illnesses.

WHO SHOULD TAKE EMTRICITABINE?

Emtricitabine is a prescription HIV medicine used in combination with other ARVs to treat HIV infection in adults and children 3 months old and older. The safety and effectiveness of emtricitabine has not been established in children under 3 months of age. Emtricitabine has not been carefully studied in the elderly (65 years of age and older).

All people living with HIV should be on ART to keep healthy AND not transmit the virus to others. You and your healthcare provider should consider your CD4 cell count, your viral load, any symptoms you are having, and your preferences when deciding which HIV medications are right for you. Read more about U.S. ART guidelines.

WHO SHOULD NOT TAKE EMTRICITABINE?

Do not take emtricitabine if you are allergic to emtricitabine or any of the ingredients in this drug.

WHAT SHOULD I TELL MY HEALTHCARE PROVIDER BEFORE TAKING EMTRICITABINE?

Before you take emtricitabine, tell your healthcare provider about all of your medical conditions, and in particular if you:

Talk to your healthcare provider if you are pregnant or plan to become pregnant during treatment with emtricitabine. It is not known if emtricitabine can harm your unborn baby. There is a pregnancy registry for people who take ARVs during pregnancy. The purpose of this registry is to collect information about the health of you and your baby and monitor outcomes in people exposed to ARVs during pregnancy. Talk to your healthcare provider about how you can take part in this registry. Read more about pregnancy and HIV.

Talk to your healthcare provider if you are breastfeeding or plan to breastfeed during treatment with emtricitabine. Emtricitabine can pass to your baby in breast milk. Do not breastfeed if you have HIV because of the risk of passing HIV to your baby. Talk with your healthcare provider about the best way to feed your baby.

WHAT ABOUT DRUG RESISTANCE?

Many new copies of HIV are mutations. These new copies are slightly different from the original virus. Some mutations can keep multiplying even when you are taking an ARV. When this happens, the drug will stop working. This is called developing resistance to the drug. Sometimes, if your virus develops resistance to one ARV, it will also have resistance to other ARVs. This is called cross-resistance. Read more about HIV drug resistance.

Resistance can develop quickly. It is very important to take ARVs according
to instructions, on schedule, and not to skip or reduce doses.

HOW IS EMTRICITABINE TAKEN?

Emtricitabine is taken by mouth as a capsule, tablet, combination tablet/capsule or oral solution. The recommended dosage of emtricitabine for adults is 200 mg daily once daily, in combination with other ARVs. The recommended dosage of emtricitabine for children varies based on the child’s weight and age. Your healthcare provider will determine the correct dosage.

Emtricitabine can be taken with or without food.

You need to take emtricitabine in combination with other ARVs. Your healthcare provider will tell you what medicines to take and how to take them.

Emtricitabine is also available in several combination medications. Combination HIV medicines contain two or more HIV medicines from one or more drug classes.

    • bictegravir/emtricitabine/tenofovir alafenamide (Biktarvy)
    • darunavir/cobicistat/emtricitabine/ tenofovir alafenamide (Symtuza)
    • efavirenz/emtricitabine/tenofovir (Atripla)
    • elvitegravir/cobicistat/emtricitabine/ tenofovir alafenamide (Genvoya)
    • elvitegravir/cobicistat/emtricitabine/ tenofovir disoproxil fumarate (Stribild)
    • emtricitabine/rilpivirine/tenofovir (Complera)
    • emtricitabine/tenofovir alafenamide (Descovy)
    • emtricitabine/tenofovir disoproxil fumarate (Truvada)
    • rilpivirine/emtricitabine/tenofovir alafenamide (Odefsey)

WHAT ARE THE SIDE EFFECTS?

When you start any ARV, you may have temporary side effects such as headaches, nausea, indigestion, or a general sense of feeling ill. These side effects usually get better or disappear over time.

The most common side effects of emtricitabine are headaches, diarrhea, nausea, fatigue, dizziness, depression, bad dreams or sleep problems, rash, abdominal pain, weakness, cough, and runny nose. Skin discoloration in children may also happen with emtricitabine.

Emtricitabine can cause serious side effects including:

Worsening of HBV infection. Severe acute exacerbations of HBV have been reported in people who have both HIV and HBV and have stopped taking emtricitabine. Your healthcare provider will test you for HBV infection before you start taking emtricitabine to treat HIV. If you have HBV infection and take emtricitabine, your HBV infection may get worse (flare­up) if you stop taking emtricitabine. A “flare-up” is when your HBV infection suddenly returns in a worse way than before. Do not run out of emtricitabine. Refill your prescription or talk to your healthcare provider before your emtricitabine is all gone. Do not stop taking emtricitabine without first talking to your healthcare provider. If you stop taking emtricitabine, your healthcare provider will need to check your health often and do blood tests regularly to check your HBV infection. Tell your healthcare provider about any new or unusual symptoms you may have after you stop taking emtricitabine.

Immune Reconstitution Inflammatory Syndrome (IRIS). IRIS is a side effect that can happen when you start taking HIV medications. Your immune system might get stronger and begin to fight infections that have been hidden in your body for a long time. This may result in an inflammatory response which may require further evaluation and treatment. Tell your healthcare provider right away if you experience any new symptoms after starting emtricitabine.

Too much lactic acid in your blood (lactic acidosis). Lactic acidosis is a serious but rare medical emergency that can cause death. Tell your healthcare provider right away if you develop any of these symptoms:

    • Feel very weak or tired
    • Unusual (not normal) muscle pain
    • Trouble breathing
    • Stomach pain with nausea and vomiting
    • Feel cold, especially in your arms and legs
    • Feel dizzy or light-headed
    • Have a fast or irregular heartbeat

Severe liver problems. Serious liver problems can happen in people who take emtricitabine. In some cases, these serious liver problems can lead to death. Your liver may become large (hepatomegaly) and you may develop fat in your liver (steatosis). Tell your healthcare provider right away if you develop any of these symptoms:

    • Your skin or the white part of your eyes turns yellow (jaundice)
    • Dark or “tea-colored” urine
    • Light-colored stools (bowel movements)
    • Loss of appetite for several days or longer
    • Nausea
    • Pain, aching, or tenderness on the right side of your stomach area

You may be more likely to get lactic acidosis or serious liver problems if you are assigned female at birth (AFAB) or are very overweight (obese).

These are not all the possible side effects of emtricitabine. For more information, ask your healthcare provider or pharmacist. Call your healthcare provider for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

HOW DOES EMTRICITABINE REACT WITH OTHER DRUGS?

All ARVs can interact with other drugs or supplements you are taking. These interactions can change the amount of each drug or substance in your bloodstream and cause an under- or overdose. New interactions are constantly being identified. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Your healthcare provider can tell you if it is safe to take emtricitabine with other medicines.

MORE INFORMATION

Download the full Prescribing Information

Download the Patient Information leaflet

Apply for the Gilead Advancing Access Program

Reviewed June 2024

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