Truvada (Emtricitabine/Tenofovir Disoproxil Fumarate)

    Truvada (Emtricitabine/Tenofovir Disoproxil Fumarate) Dosage and Side Effects

    TRUVADA is a prescription medicine containing the drugs emtricitabine and tenofovir. It's used along with other therapies to treat human immunodeficiency virus (HIV), and to prevent infection among people at high risk for the virus.

    Warnings and Precautions

    Serious Warnings and Precautions

    • The most serious possible side effect is harm to the kidneys, including damage to kidney cells, kidney tissue inflammation and kidney failure. Your doctor may monitor your kidney function before beginning and while receiving TRUVADA. Some patients treated with tenofovir disoproxil fumarate (a component of TRUVADA) have had kidney problems. Your doctor may need to perform additional blood tests if you have had kidney problems in the past or need to take another drug that can cause kidney problems.
    • If you are also infected with the Hepatitis B Virus, “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. Do not stop taking TRUVADA without your doctor's advice. If you stop taking TRUVADA, tell your doctor immediately about any new, unusual or worsening symptoms that you notice after stopping treatment. After you stop taking TRUVADA, your doctor will still need to check your health and take blood tests to check your liver for several months. TRUVADA is not approved for the treatment of Hepatitis B Virus infection.
    • The class of medicines to which TRUVADA belong (NRTIs) can cause a condition called lactic acidosis, together with an enlarged liver. Non-specific symptoms such as nausea, vomiting and stomach pain might indicate the development of lactic acidosis. This rare but serious side effect has occasionally been fatal. Lactic acidosis occurs more often in women, particularly if they are very overweight. You should consult your doctor immediately if such symptoms occur while you are receiving TRUVADA. The symptoms that may indicate lactic acidosis include: feeling very weak, tired or uncomfortable; unusual or unexpected stomach discomfort; feeling cold; feeling dizzy or lightheaded; suddenly developing a slow or irregular heartbeat. If you notice these symptoms, stop taking TRUVADA and consult a doctor immediately.
    • Tenofovir disoproxil fumarate caused harm to the bones of animals. Tenofovir disoproxil fumarate reduced bone density in humans. If you notice bone pain, suffer a bone fracture, or other bone problem, consult your doctor. If you have bone problems, you may wish to discuss calcium and/or vitamin D supplements with your doctors.
    • Changes in body fat have been seen in some patients taking antiretroviral therapy. These changes may include increased amounts of fat in the upper back and neck (“buffalo hump”), breast, and around the trunk. Loss of fat from the legs, arms and face may also happen. The cause and long term health effects of these conditions are not known at this time.
    • TRUVADA should only be used for the PrEP indication if you are HIV negative before and during treatment. Discuss with your doctor if you have had a recent flu-like illness. Your doctor will run tests to confirm that you are HIV negative before and during TRUVADA treatment.

    Do NOT take TRUVADA if:

    • you are on other medications that may affect your kidneys and have not discussed this with your doctor
    • you have or are at known risk for any type of bone disease or bone related problems and have not discussed this with your doctor
    • you are allergic to TRUVADA or any of its ingredients. The medicinal ingredients are emtricitabine and tenofovir DF.
    • you are already taking 3TC, ATRIPLA, Combivir, COMPLERA, EMTRIVA, Heptovir, Kivexa, STRIBILD, Triumeq, Trizivir, or VIREAD because these medicines contain the same or similar active ingredients
    • you are also taking HEPSERA to treat your HBV infection

    Changes in your immune system (Immune Reconstitution Syndrome) can happen when an HIV-1 infected person starts taking HIV medicines. Your immune system may get stronger and begin to fight infections that have been hidden in your body for a long time, or you could develop an autoimmune disease in which your immune system reacts against your own body (e.g. Graves’ disease (which affects the thyroid gland), Guillain-Barré syndrome (which affects the nervous system) or polymyositis (which affects the muscles) and it may develop at any time, sometimes months later after the start of HIV therapy). Sometimes symptoms can be severe, so if you develop high temperature (fever), joint or muscle pain, redness, rash, swelling or fatigue, or any new symptoms, contact your doctor right away.

    Before taking TRUVADA to reduce your risk of getting HIV-1 infection (PrEP indication):

    • You must get tested to be sure you are HIV-negative. It is important that you also get tested at least every 3 months as recommended by your healthcare provider while taking TRUVADA. Do not take TRUVADA to reduce the risk of getting HIV (PrEP) unless you are confirmed to be HIV-negative.
    • Tell your healthcare provider if you have any of the following symptoms within the last month before you start taking TRUVADA or at any time while taking TRUVADA:
      • tiredness
      • fever
      • sweating a lot (especially at night)
      • rash
      • vomiting or diarrhea
      • joint or muscle aches
      • headache
      • sore throat
      • enlarged lymph nodes in the neck or groin

    These may be signs of HIV infection and you may need to have a different kind of test to diagnose HIV. If you are already taking TRUVADA to prevent HIV-1 infection (PrEP), your healthcare provider may tell you to stop taking TRUVADA until an HIV test confirms that you do not have HIV-1 infection.

    Just taking TRUVADA may not keep you from getting HIV. TRUVADA does NOT always prevent HIV.

    You must still practice safer sex at all times. Do not have any kind of sex without protection. Always practice safer sex by using a latex or polyurethane condom to lower the chance of sexual contact with semen, vaginal secretions, or blood.

    You must also use other prevention methods to keep from getting HIV.

    • Know your HIV-1 status and the HIV-1 status of your partners.
    • While taking TRUVADA, get tested at least every 3 months for HIV, as recommended by your healthcare provider. Ask your partners to get tested.
    • 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-negative.
    • Get tested for other sexually transmitted infections such as syphilis and gonorrhea. These infections make it easier for HIV to infect you.
    • Get information and support to help reduce risky sexual behavior.
    • Have fewer sex partners.
    • Do not miss any doses of TRUVADA. Missing doses may increase your risk of getting HIV-1 infection.

    BEFORE you use TRUVADA (emtricitabine/tenofovir disoproxil fumarate) talk to your doctor or pharmacist:

    If you are pregnant or planning to become pregnant: Pregnant mothers should not take TRUVADA unless specifically directed by the doctor.

    If you are a female who is taking TRUVADA to prevent HIV infection (PrEP) and you become pregnant while taking TRUVADA, talk to your healthcare provider about whether you should continue taking TRUVADA.

    Pregnancy Registry: There is a pregnancy registry for women who take antiviral medicines during pregnancy. The purpose of this registry is to collect information about the health of you and your baby. Talk to your healthcare provider about how you can take part in this Antiretroviral Pregnancy Registry.

    If you are breast-feeding or planning to breast-feed: Do not breast-feed if you are taking TRUVADA or have HIV. Emtricitabine and tenofovir DF, the two components of TRUVADA, pass to your baby in your breast milk. You should not breast-feed because of the risk of passing HIV to your baby. Talk to your doctor about the best way to feed your baby.

    If you have other medical conditions: Let your doctor know if you have other medical conditions, especially liver, bone and kidney problems.

    If you are taking other medicines: Some medicines can interact when taken together, including prescription and non-prescription medicines and dietary supplements.

    It is a good idea to 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 every time you visit your doctor or fill a prescription.

    Side Effects

    The most common side effects of TRUVADA are:

    • Diarrhea
    • Nausea
    • Vomiting
    • Dizziness
    • Headache

    Other side effects include:

    • Stomach pain
    • Indigestion
    • Inflammation of the pancreas
    • Sleeping problems
    • Abnormal dreams
    • Weakness
    • Pain
    • Shortness of breath
    • Allergic reaction (including swelling of the face, lips, tongue or throat)
    • Rash
    • Flatulence (intestinal gas)
    • Skin discoloration (small spots or freckles) may also happen with TRUVADA

    Interactions with this medication

    Let your doctor know if you are taking these or any other medications:

    • Drugs that contain didanosine (Videx, Videx EC). Tenofovir disoproxil fumarate (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), Kaletra (lopinavir/ritonavir), Prezista (darunavir) or HARVONI (ledipasvir/sofosbuvir). 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 together with Reyataz, Kaletra, Prezista or HARVONI. 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).
    • Non-steroidal anti-inflammatory drugs.

    Proper Use of this medication

    Stay under a doctor's care when taking TRUVADA. Do not change your treatment or stop treatment without first talking with your doctor.

    Take TRUVADA exactly as your doctor prescribed it. Follow the directions from your doctor, exactly as written on the label. Set up a dosing schedule and follow it carefully.

    When used to treat HIV-1 infection, TRUVADA is always used with other HIV-1 medicines.

    If you take TRUVADA to reduce your risk of getting HIV-1:

    • you must also use other methods to reduce your risk of getting HIV.
    • take TRUVADA every day, not just when you think you have been exposed to HIV-1.

    Avoid doing things that can increase your risk of getting HIV infection or spreading HIV infection to other people:

    • Do not re-use or share needles or other injection equipment.
    • Do not share personal items that can have blood or body fluids on them, like toothbrushes and razor blades.
    • Do not have any kind of sex without protection. Always practice safer sex by using a latex or polyurethane condom to lower the chance of sexual contact with semen, vagina secretions, or blood.

    Ask your healthcare provider if you have any questions on how to prevent getting HIV infection or spreading HIV infection to other people.

    When your TRUVADA supply starts to run low, get more from your doctor 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.

    Only take medicine that has been prescribed specifically for you. Do not give TRUVADA to others or take medicine prescribed for someone else.

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

    Usual adult dose:

    For the treatment of HIV-1 infection:

    • The usual dose of TRUVADA is one tablet orally (by mouth) once a day, in combination with other anti-HIV medicines.
    • TRUVADA may be taken with or without a meal.

    For prevention of HIV-1 infection (PrEP):

    • The usual dose of TRUVADA is one tablet orally (by mouth) once a day.
    • TRUVADA may be taken with or without a meal.

    Overdose:

    In case of drug overdose, contact a healthcare practitioner, hospital emergency department or regional poison control centre, even if there are no symptoms.

    Missed dose:

    It is important that you do not miss any doses. If you miss a dose of TRUVADA and it is less than 12 hours from the time you usually take TRUVADA, then take the dose. If more than 12 hours has passed from the time you usually take TRUVADA, then wait until the next scheduled daily dose. Do not take more than 1 dose of TRUVADA in a day.Do not take 2 doses at the same time. Call your doctor or pharmacist if you are not sure what to do.

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    The above information is an educational aid only. It is not intended as medical advice for individual conditions or treatments. Talk to your doctor, nurse or pharmacist before following any medical regimen to see if it is safe and effective for you.