Consumer Information for: TRUVADA
Consumer Information
Information about the product including what the product is used for, dosage, warnings, proper use and side effects. This summary will not tell you everything about the product. Contact your healthcare professional if you have any questions about the product.
What the medication is used for
TRUVADA is a type of medicine called an HIV (human immunodeficiency virus) nucleoside analog reverse transcriptase inhibitor (NRTI). TRUVADA contains 2 medicines, EMTRIVA® (emtricitabine) and VIREAD® (tenofovir disoproxil fumarate, or tenofovir DF) combined in one pill.
TRUVADA is used:
- To treat HIV-1 Infection when used with other anti-HIV medicines in adults.
OR
- To help reduce the risk of getting HIV-1 infection when used with safer sex practices in:
- HIV-1 negative men who have sex with men, who are at high risk of getting infected with HIV-1 through sex.
- Male-female sex partners when one partner has HIV-1infection and the other does not.
This is sometimes called Pre-Exposure Prophylaxis or PrEP.
- TRUVADA is for adults age 18 and older. TRUVADA is not indicated in children under age 18 or adults over age 65.
What it does
- Use of TRUVADA to treat HIV-1 infection:
When used with other HIV-1 medicines to treat HIV-1 infection, TRUVADA helps block HIV reverse transcriptase, a chemical in your body (enzyme) that is needed for HIV to multiply. TRUVADA lowers the amount of HIV in the blood (viral load). Lowering the amount of HIV in the blood lowers the chance of infections that happen when your immune system is weak (opportunistic infections).
HIV infection destroys CD4+ (T) cells, which are important to the immune system. The immune system helps fight infection. After a large number of T cells are destroyed, acquired immune deficiency syndrome (AIDS) develops. TRUVADA may also help to increase the number of T cells (CD4+ cells).
TRUVADA does not cure HIV-1 infection or AIDS. If you have HIV-1 infection, you must stay on continuous HIV therapy to control HIV infection and decrease HIV-related illnesses. People taking TRUVADA may still get opportunistic infections or other conditions that happen with HIV infection. Opportunistic infections are infections that develop because the immune system is weak. Some of these conditions are pneumonia, herpes virus infections, and Mycobacterium avium complex (MAC) infections.
- Use of TRUVADA to reduce the risk of HIV-1 infection (PrEP indication):
When used with safer sex practices, TRUVADA may help to reduce the risk of getting HIV-1 infection:
- TRUVADA works better to reduce the risk of getting HIV-1 when the medicines are in your bloodstream before you are exposed to HIV-1
It is very important that you see your doctor regularly while taking TRUVADA.
Considerations when TRUVADA is used for PrEP
- Together with your doctor, you need to decide whether TRUVADA is right for you.
- 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:
- 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.
- Your doctor will run tests to determine that you are HIV negative before PrEP treatment.
When it should not be used
Do not use TRUVADA if:
- You are allergic (hypersensitive) to any of the ingredients in this formulation (See What the medicinal ingredients are, What the nonmedicinal ingredients are)
- Do not use TRUVADA to reduce the risk of getting HIV if you already have HIV or do not know your HIV status.
What the medicinal ingredient is
emtricitabine
tenofovir disoproxil fumarate (tenofovir DF)
What the non-medicinal ingredients are
croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch, FD&C blue #2, hypromellose, titanium dioxide and triacetin.
What dosage form it comes in
TRUVADA is available as tablets. Each tablet contains 200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate (which is equivalent to 245 mg of tenofovir disoproxil), as active ingredients. The tablets are blue, capsule-shaped, film-coated, debossed with “GILEAD” on one side and with “701” on the other side. Each bottle contains 30 tablets and a desiccant (silica gel canister or sachet) and is closed with a child-resistant closure.
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 (See What the important nonmedicinal ingredients in TRUVADA are).
- 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. Grave's disease (which affects the thyroid gland), Guillain-Barre 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 DF) talk to your healthcare professional:
If you are pregnant or planning to become pregnant: Pregnant mothers should not take TRUVADA unless specifically directed by the healthcare professional.
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 breastfeeding or planning to breastfeed: Do not breastfeed 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 breastfeed because of the risk of passing HIV to your baby. Talk to your healthcare professional about the best way to feed your baby.
If you have other medical conditions: Let your healthcare professional 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 (see INTERACTIONS WITH THIS MEDICATION).
If you are taking didanosine: Taking didanosine and Truvada may cause serious reactions including lactic acidosis (too much acid in the blood), pancreatitis (inflamed pancreas) and nerve damage (neuropathy) (see INTERACTIONS WITH THIS MEDICATION and SIDE EFFECTS AND WHAT TO DO ABOUT THEM).
Truvada should not be used with or soon after cidofovir, acyclovir, valacyclovir, ganciclovir, valganciclovir, aminoglycosides, or nonsteroidal anti-inflammatory drugs (NSAIDS), due to potential harm to the kidneys.
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 healthcare professional or fill a prescription.
Other Special Warnings:
Your blood sugar levels (glucose) or levels of fats (lipids) in your blood may increase with HIV treatment. Your doctor may order blood tests for you.
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 DF (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), HARVONI® (ledipasvir/sofosbuvir) or EPCLUSA™ (sofosbuvir/velpatasvir). 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, HARVONI or EPCLUSA. 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.
Overdosage
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.
Side effects and what to do about them
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
| Symptom / effect | Talk with your doctor, nurse, or pharmacist only if severe | Talk with your doctor, nurse, or pharmacist in all cases | Stop taking drug and call your healthcare professional |
|---|---|---|---|
| Rare | |||
| Effect: Kidney problems Symptoms
|
✔ ✔ ✔ |
||
| Effect: Lactic acidosis Symptoms
|
✔ ✔ ✔ ✔ ✔ ✔ |
||
| Very Rare | |||
| Effect: Hepatotoxicity (severe liver problems) with hepatomegaly (liver enlargement) and steatosis (fat in the liver)
Symptoms
|
✔ ✔ ✔ ✔ ✔ |
||
| Effect: Flare-ups of hepatitis B virus infection following drug discontinuation
Symptoms
|
✔ ✔ ✔ ✔ ✔ ✔ |
||
Lactic acidosis is a medical emergency and must be treated in the hospital. You may be more likely to get lactic acidosis or serious liver problems if you are very overweight (obese) or have been taking nucleoside analog medicines, like TRUVADA, for a long time.
Muscle pain, muscle weakness, bone pain and softening of the bone (infrequently contributing to fractures) have also been reported.
There have been other side effects in patients taking EMTRIVA or VIREAD. This is not a complete list of side effects. If you have questions about side effects, ask your doctor, nurse, or pharmacist. You should report any new or continuing symptoms to your doctor right away. Your doctor may be able to help you manage these side effects.
How to store
- Keep TRUVADA and all other medications out of reach and sight of children.
- TRUVADA should be stored at 15–30 °C (59-86 °F). It should remain stable until the expiration date printed on the label.
- Do not keep your medicine in places that are too hot or cold.
- Do not keep medicine that is out of date or that you no longer need. If you throw any medicines away make sure that children will not find them.
- Keep TRUVADA in its original container and keep the container tightly closed.
Reporting side effects
You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following 3 ways:
- Report online at www.healthcanada.gc.ca/medeffect
- Call toll-free at 1-866-234-2345
- Complete a Canada Vigilance Reporting Form and:
- Fax toll-free to 1-866-678-6789, or
- Mail to: Canada Vigilance Program
Health Canada
Postal Locator 1908C
Ottawa, ON K1A 0K9
Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the Medeffect Canada Web site at www.healthcanada.gc.ca/medeffect.
NOTE: Should you require information related to the management of side effects, contact your health professional. The Canada Vigilance Program does not provide medical advice.
More information
This document plus the full Product Monograph, prepared for healthcare professionals, can be found at: www.gilead.ca
or by contacting the sponsor, Gilead Sciences Canada, Inc., at:
1- 866-207- 4267
This leaflet was prepared by Gilead Sciences Canada, Inc.
Last revised: July 5, 2018
Gilead Sciences, Inc.
Foster City, CA 94404
USA
Gilead Sciences Canada, Inc.
Mississauga, ON
L5N 2W3
COMPLERA®, DESCOVY®, EMTRIVA®, GENVOYA®, HARVONI®, EPCLUSA™, HEPSERA®, SOVALDI®, STRIBILD®, TRUVADA® and VIREAD® are trademarks of Gilead Sciences, Inc. or its related companies.
ATRIPLA® is a trademark of Bristol-Myers Squibb & Gilead Sciences, LLC.
All other trademarks referenced herein are the property of their owners.
© 2017 Gilead Sciences, Inc. All rights reserved.
e133222-GS-016
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