Generic Name: emtricitabine/tenofovir (EM-trye-SYE-ta-been/ten-OF-oh-vir)
Brand Name: Truvada
Severe and sometimes fatal lactic acidosis (a buildup of lactic acid in the blood) and liver problems have occurred with this type of medicine. The risk may be greater in women, patients who are very overweight, or patients who have been taking nucleoside medicines (eg, emtricitabine, tenofovir) for a long time.
Tell your doctor right away if you develop symptoms of lactic acidosis (eg, unusual weakness or tiredness; unusual muscle pain or cramps; fast or difficult breathing; stomach pain with nausea and vomiting; feeling cold, especially in the arms and legs; dizziness or light-headedness; fast or irregular heartbeat). Tell your doctor right away if you develop symptoms of liver problems (eg, yellowing of the skin or eyes, dark urine, pale stools, persistent loss of appetite, nausea, 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 taking it. Patients who have HBV 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.
If you are taking emtricitabine/tenofovir to reduce the risk of getting HIV, you must have a negative HIV test before you start emtricitabine/tenofovir and at least every 3 months during use. Tell your doctor if you think you have been exposed to HIV. Contact your doctor right away if you develop fever, headache, tiredness, joint or muscle aches, vomiting, diarrhea, sore throat, rash, night sweats, or swollen glands or lymph nodes, or if you have had any of these symptoms within 1 month before starting emtricitabine/tenofovir.
Emtricitabine/ tenofovir is used for:
Treating HIV infection in combination with other medicines. Emtricitabine/tenofovir is also used in combination with safer sex practices to reduce the risk of getting HIV in patients who are at high risk of getting infected with HIV through sex. 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 to treat HIV by reducing the amount of HIV in the body by blocking its ability to multiply. Exactly how it works to reduce the risk of getting HIV is not known.
Do NOT use emtricitabine/ tenofovir if:
- you are allergic to any ingredient in emtricitabine/tenofovir
- you are taking adefovir, medicines that contain lamivudine, or another medicine that contains emtricitabine or tenofovir
- you take a medicine that may harm your kidneys (eg, an aminoglycoside antibiotic [eg, gentamicin], amphotericin B, cyclosporine, a nonsteroidal anti-inflammatory drug [NSAID] [eg, ibuprofen], tacrolimus, vancomycin). Ask you doctor if you are not sure if any of your medicines might harm your kidneys
- you are taking emtricitabine/tenofovir to treat HIV and you also have severe kidney problems or you are on dialysis
- you are taking emtricitabine/tenofovir to reduce the risk of getting HIV and you have kidney problems or have not had an HIV test
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 a history of kidney problems, lactic acidosis, or abnormal liver function tests or liver problems (eg, HBV infection)
- if you have osteoporosis (weak bones), a family history of osteoporosis, or other risk factors of osteoporosis (eg, smoking, poor nutrition), or if you have a history of bone problems (eg, fracture)
Some MEDICINES MAY INTERACT with emtricitabine/tenofovir. Tell your health care provider if you are taking any other medicines, especially any of the following:
- Acyclovir, cidofovir, ganciclovir, valacyclovir, valganciclovir, or medicines that may harm your kidneys (eg, an aminoglycoside antibiotic [eg, gentamicin], amphotericin B, cyclosporine, an NSAID eg, [ibuprofen], tacrolimus, vancomycin) because they may increase the risk of emtricitabine/tenofovir's side effects. Ask your doctor or pharmacist if you are not sure if any of your medicines may affect your kidneys
- Adefovir, other medicines that contain emtricitabine or tenofovir, lamivudine, or certain protease inhibitors (eg, atazanavir, lopinavir/ritonavir, tipranavir) 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.
- Emtricitabine/tenofovir comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get emtricitabine/tenofovir refilled.
- Take emtricitabine/tenofovir by mouth with or without food.
- Continue to take emtricitabine/tenofovir even if you feel well. Do not miss any doses.
- Do not suddenly stop taking emtricitabine/tenofovir without checking with your doctor. Some conditions (eg, hepatitis B) could become worse if you suddenly stop taking emtricitabine/tenofovir.
- Taking emtricitabine/tenofovir at the same time each day will help you remember to take it.
- 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 2 doses at once. 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. This effect 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.
- Keep a list of all the medicines that you take. Make a new list each time medicines are added or stopped. Find out about medicines that should not be taken while you are using emtricitabine/tenofovir. Be sure that each of your health care providers knows all the medicines that you are taking.
- You must always practice safer sex at all times. Do not have any kind of sex without protection (eg, latex or polyurethane condoms). Do not share needles, injection supplies, or items like toothbrushes or razors.
- Emtricitabine/tenofovir is not for the treatment of HBV. You should be tested for HBV infection before you start to take emtricitabine/tenofovir. If you have HBV, 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.
- The risk of severe side effects (eg, lactic acidosis, severe liver problems) may be greater in women, patients who are very overweight (obese), and patients who have taken nucleoside medicines (eg, emtricitabine, tenofovir) for a long time. Talk with your doctor if you have questions about your risk for severe side effects from emtricitabine/tenofovir.
- Changes in body fat (eg, an increased amount of fat in the upper back, neck, breast, and trunk, and loss of fat from the legs, arms, and face) may occur in some patients taking emtricitabine/tenofovir. The cause and long-term effects of these changes are unknown. Discuss any concerns with your doctor.
- Ask your doctor if you should take a calcium and vitamin D supplement while you are taking emtricitabine/tenofovir.
- If you are taking emtricitabine/tenofovir to treat HIV:
- 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 or AIDS. 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 the HIV virus from HIV-infected patients to others through blood or sexual contact. Talk with your health care provider about ways to prevent the spread of HIV to others.
- Emtricitabine/tenofovir may improve immune system function. This may reveal hidden infections in some patients. Tell your doctor right away if you notice symptoms of infection (eg, fever, sore throat, weakness, cough, shortness of breath) after you start emtricitabine/tenofovir.
- If you are taking emtricitabine/tenofovir to reduce the risk of getting HIV:
- Do not stop taking emtricitabine/tenofovir without checking with your doctor. If you do, you may be at greater risk of getting HIV. Discuss any questions or concerns with your doctor.
- Emtricitabine/tenofovir does not always prevent HIV. It should be used as a part of a prevention program that includes other measures (eg, safer sex practices, testing for other sexually transmitted infections). Discuss any questions or concerns with your doctor.
- Lab tests, including liver function, kidney function, and bone mineral density, 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 be used with extreme caution in CHILDREN younger than 12 years old, in children weighing less than 77 lb (35 kg), and in ELDERLY patients older than 65 years old; safety and effectiveness in these patients 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. Emtricitabine/tenofovir is found in breast milk. Do not breast-feed while taking emtricitabine/tenofovir. Mothers infected with HIV should not breast-feed. There is a risk of passing the HIV infection to the baby.
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:
Seek medical attention right away if any of these SEVERE side effects occur:
Abnormal skin sensations; back pain; darkened skin color on the palms of hands or soles of feet; diarrhea; dizziness; headache; indigestion; joint pain; mild stomach pain; nausea; sinus pain or drainage; strange dreams; tiredness; trouble sleeping; vomiting; weakness; weight loss.
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, throat, or tongue; unusual hoarseness); bone pain; fever; mental or mood changes (eg, depression); muscle pain, weakness, or cramping; numbness, burning, pain, or tingling in the hands or feet; severe or persistent dizziness; severe or persistent nausea or vomiting; shortness of breath; stomach pain; symptoms of kidney problems (eg, increased or decreased urination, increased thirst); symptoms of lactic acidosis (eg, unusual weakness or tiredness; unusual muscle pain or cramps; fast or difficult breathing; stomach pain with nausea and vomiting; feeling cold, especially in the arms and legs; dizziness or light-headedness; fast or irregular heartbeat); symptoms of liver problems (eg, yellowing of the skin or eyes; dark urine; pale stools; persistent loss of appetite).
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. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.
If OVERDOSE is suspected:
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.Proper storage of emtricitabine/tenofovir:
Store emtricitabine/tenofovir at room temperature, between 68 and 77 degrees F (20 and 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.
- 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.
- Check with your pharmacist about how to dispose of unused medicine.
This information should not be used to decide whether or not to take emtricitabine/tenofovir or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about emtricitabine/tenofovir. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to emtricitabine/tenofovir. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using emtricitabine/tenofovir.
Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.