Consumer Drug Information

Emtricitabine/
Tenofovir

Generic Name: Emtricitabine/Tenofovir (EM-trye-SYE-ta-been/ten-OH-foe-vir)
Brand Name: Truvada

Lactic acidosis (buildup of an acid in the blood), a severe and sometimes fatal side effect, has been reported with this type of medicine. Tell your doctor right away if you experience extreme weakness or tiredness; unusual muscle pain; difficulty breathing; stomach pain with nausea and vomiting; feeling cold, especially in the arms and legs; dizziness or lightheadedness; or fast or irregular heartbeat. Severe and sometimes fatal liver problems have been reported with this type of medicine. Tell your doctor right away if you experience yellowing of the skin or eyes; dark urine; light-colored bowel movements (stools); not feeling like eating for several days; nausea; or stomach pain.

Emtricitabine/Tenofovir has not been approved to treat hepatitis B virus (HBV) infection. The safety and effectiveness of Emtricitabine/Tenofovir in patients who have both HBV and HIV infection have not been confirmed. Some patients with both HBV and HIV infection who took Emtricitabine/Tenofovir experienced severe worsening of HBV infection after they stopped it. Patients who have both HBV and HIV infection need close medical follow-up to check for worsening liver problems for at least several months after they stop Emtricitabine/Tenofovir . Keep all doctor and lab appointments. Do not stop taking Emtricitabine/Tenofovir without checking with your doctor.

Emtricitabine/Tenofovir is used for:

Treating HIV infection in combination with other medicines. Emtricitabine/Tenofovir is not a cure for HIV or AIDS. It may also be used for other conditions as determined by your doctor.

Emtricitabine/Tenofovir is an antiviral combination of 2 reverse transcriptase inhibitors. It works by blocking an enzyme, which slows the growth of HIV.

Do NOT use Emtricitabine/Tenofovir if:

you are allergic to any ingredient in Emtricitabine/Tenofovir
you have a history of abnormal liver function tests, severe liver problems, severe kidney problems, or lactic acidosis

Contact your doctor or health care provider right away if any of these apply to you.

Before using Emtricitabine/Tenofovir :

Some medical conditions may interact with Emtricitabine/Tenofovir . Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

if you are pregnant, planning to become pregnant, or are breast-feeding
if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
if you have allergies to medicines, foods, or other substances
if you have bone problems or kidney problems, including dialysis treatment
if you have liver problems, including HBV infection

Some MEDICINES MAY INTERACT with Emtricitabine/Tenofovir . Tell your health care provider if you are taking any other medicines, especially any of the following:

HIV protease inhibitors (eg, indinavir) because they may increase the risk of Emtricitabine/Tenofovir 's side effects
Didanosine because the risk of its side effects may be increased by Emtricitabine/Tenofovir

This may not be a complete list of all interactions that may occur. Ask your health care provider if Emtricitabine/Tenofovir may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Emtricitabine/Tenofovir :

Use Emtricitabine/Tenofovir as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Take Emtricitabine/Tenofovir by mouth with or without food.
It is important to not miss any doses of Emtricitabine/Tenofovir . Taking Emtricitabine/Tenofovir at the same time each day will help you remember to take it.
Continue to take Emtricitabine/Tenofovir even if you feel well. Do not miss any doses.
If you miss a dose of Emtricitabine/Tenofovir , take it as soon as possible. If you do not remember until the next day, skip the missed dose and go back to your regular dosing schedule. Do NOT take more than 1 dose in the same day.

Ask your health care provider any questions you may have about how to use Emtricitabine/Tenofovir .

Important safety information:

Emtricitabine/Tenofovir may cause dizziness or lightheadedness. These effects may be worse if you take it with alcohol or certain medicines. Use Emtricitabine/Tenofovir with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
Certain medicines should not be used with Emtricitabine/Tenofovir . Keep a 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 health care providers and your pharmacist every time you visit your health care provider or fill a prescription.
When your medicine supply is low, get more from your doctor or pharmacist as soon as you can. Do not stop taking Emtricitabine/Tenofovir , even for a short period of time. If you do, the virus may grow resistant to the medicine and become harder to treat.
Emtricitabine/Tenofovir is not a cure for HIV infection. Patients may still get illnesses and infections associated with HIV. Remain under the care of your doctor.
Emtricitabine/Tenofovir does not stop the spread of HIV to others through blood or sexual contact. Use barrier methods of birth control (eg, condoms) if you have HIV infection. Do not share needles, injection supplies, or items like toothbrushes or razors.
Emtricitabine/Tenofovir is not for the treatment of HBV. If you have HBV and HIV, you will need close medical follow-up for several months after stopping treatment with Emtricitabine/Tenofovir . Follow-up includes medical exams and blood tests to check for HBV infection that could be getting worse.
Ask your doctor if you should take a calcium and vitamin D supplement while you are taking Emtricitabine/Tenofovir .
Lab tests, including liver and kidney function tests and bone mineral density tests, may be performed while you use Emtricitabine/Tenofovir . These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
Emtricitabine/Tenofovir should not be used in CHILDREN; safety and effectiveness in children have not been confirmed.
PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Emtricitabine/Tenofovir while you are pregnant. It is not known if Emtricitabine/Tenofovir is found in breast milk. Mothers infected with HIV should not breast-feed. There is a risk of passing the HIV infection or Emtricitabine/Tenofovir to the baby. Do not breast-feed while taking Emtricitabine/Tenofovir .

Possible side effects of Emtricitabine/Tenofovir :

All medicines may cause side effects, but many people have no, or minor side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Abnormal skin sensations; back pain; changes in body fat (eg, increased fat in the upper back and stomach areas, decreased fat in the face, arms, and legs); cough; diarrhea; gas; headache; indigestion; lightening of the skin color on the palms of hands or soles of feet; loss of appetite; nausea; sinus drainage; skin discoloration (small spots or freckles); sleeplessness; strange dreams; sweating; vomiting; weakness; weight loss.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); bone pain; chest pain; chills; dark urine; decreased urination or difficulty urinating; dizziness; extreme weakness or tiredness; fast or irregular heartbeat; feeling cold, especially in the arms and legs; fever; increased thirst; increased urination; light-colored bowel movements (stools); lightheadedness; mental or mood changes (eg, depression); muscle aches; not feeling like eating for several days; numbness, burning, pain, or tingling in the hands or feet; pneumonia; rapid breathing; sore throat; stomach pain with nausea and vomiting; unusual muscle pain; unusual tiredness; yellowing of the skin or eyes.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org), or emergency room immediately.

Proper storage of Emtricitabine/Tenofovir :

Store at 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Do not use Emtricitabine/Tenofovir if the seal over the bottle opening is broken or missing. Keep Emtricitabine/Tenofovir in its original container and keep the container tightly closed. 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 or pets cannot find them. Keep Emtricitabine/Tenofovir out of the reach of children and away from pets.

General information:

If you have any questions about Emtricitabine/Tenofovir , please talk with your doctor, pharmacist, or other health care provider.
Emtricitabine/Tenofovir is to be used only by the patient for whom it is prescribed. Do not share it with other people.
If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Emtricitabine/Tenofovir . If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: September 3, 2008

Database Edition 08.3.1.003