Truvada

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EMTRICITABINE AND TENOFOVIR (Systemic)

Some commonly used brand names are:

In the U.S.—

  • Truvada

Not commercially available in Canada.

Category

  • Antiviral, systemic

Description

Emtricitabine (em-trye-SYE-ta-been) and tenofovir (te-NOE-foe-veer) combination is used with other anti-HIV medicines in the treatment of human immunodeficiency virus (HIV) infection. HIV is the virus that causes acquired immune deficiency syndrome (AIDS).

Emtricitabine and tenofovir combination will not cure or prevent HIV infection or the symptoms of AIDS; however, it helps keep HIV from reproducing, and appears to slow down the destruction of the immune system. This may help delay the development of serious health problems usually related to AIDS or HIV infection. Emtricitabine and tenofovir combination will not keep you from spreading HIV to other people. People who receive this medicine may continue to have other problems usually related to AIDS or HIV infection.

This medicine is available only with your doctor"s prescription, in the following dosage form(s):

  • Oral
  • Tablets (U.S.)

Before Using This Medicine

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For emtricitabine and tenofovir combination, the following should be considered:

Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to emtricitabine or tenofovir. Also tell your doctor and pharmacist if you are allergic to any other substances, such as foods, preservatives, or dyes.

Pregnancy—Studies in pregnant women have not been done. However, emtricitabine and tenofovir combination has not been shown to cause birth defects or other problems in animal studies. Also, it is not known whether emtricitabine and tenofovir combination reduces the chances that a baby born to an HIV-infected mother will also be infected. Before taking this medicine, make sure your doctor knows if you are pregnant or if you may become pregnant. Ask your doctor to register you with the Pregnancy Registry, to monitor the effect of treatment on you and your baby.

Breast-feeding—It is not known whether emtricitabine and tenofovir combination passes into human breast milk. However, if your baby does not already have the AIDS virus, there is a chance that you could pass it to your baby by breast-feeding. Talk to your doctor first if you are thinking about breast-feeding your baby.

Children—Studies on this medicine have been done only in adult patients, and there is no specific information comparing use of emtricitabine and tenofovir combination in children with use in other age groups.

Older adults—Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults or if they cause different side effects or problems in older people. Elderly patients are more likely to have other medical problems and they may need to take a lower dose than some younger adults.

Other medicines—Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking emtricitabine and tenofovir combination, it is especially important that your health care professional knows if you are taking any of the following:

  • Atazanavir (e.g., Reyataz) and/or
  • Lopinavir and ritonavir combination (e.g., Kaletra)—May increase the amount of tenofovir in your blood and could result in more unwanted adverse effects
  • Didanosine (e.g., Videx, Videx EC)—May increase the amount of didanosine in your blood and your doctor may want to adjust your dose and watch you more carefully
  • Emtricitabine (e.g., Emtriva) or
  • Tenofovir (e.g., Truvada)—Using additional emtricitabine or tenofovir with the combination medicine may increase the chance of side effects
  • Lamivudine (e.g., 3TC) or
  • Products containing lamivudine (e.g., Combivir, Epivir, Epivir-HBV, Epzicom, Trizivir)—Should not be used with emtricitabine and tenofovir combination

Other medical problems—The presence of other medical problems may affect the use of emtricitabine. Make sure you tell your doctor if you have any other medical problems, especially:

  • Hepatitis B virus (HBV) infection—Emtricitabine and tenofovir combination is not used to treat patients with hepatitis B virus infection. You may receive emtricitabine and tenofovir combination to treat your HIV infection even if you also have hepatitis B virus infection. Your doctor will want to follow you closely for several months and do regular medical exams once you stop taking emtricitabine and tenofovir combination.
  • Kidney problems or
  • Risk factors for kidney disease—Your doctor may want to lower your dose if you have kidney problems or are at risk for having kidney problems.
  • Liver disease or
  • Risk factors for liver disease or
  • Obesity (being overweight)—This medicine may make liver disease worse in patients with liver disease, obesity and other HIV medicine use.

Proper Use of This Medicine

Dosing—The dose of emtricitabine and tenofovir combination will be different for different patients. Follow your doctor"s orders or the directions on the label . The following information includes only the average doses of emtricitabine and tenofovir combination. If your dose is different, do not change it unless your doctor tells you to do so. Do not share your medicine with others.

It is important to take this medicine in combination with another anti-HIV medicine and to take it exactly as your doctor tells you to. You should take your medicine at the same time every day to avoid missing doses. It is very important that you do not miss any doses of this medicine or of your other anti-HIV medicines.

Do not take other medicines unless they have been discussed with your doctor. Tell your healthcare professional about all of the medicines and dietary supplements that you take. Keep a complete list of all the medications that you take. Make a new list when medications are added or stopped. Make sure you show this list to your doctor or pharmacist each time you have a visit or refill a prescription.

When your emtricitabine and tenofovir combination supply runs low, get more from your pharmacy or from your healthcare provider. This is very important because the amount of virus in your blood may increase if the medicine is stopped, even for a short time. The virus may develop resistance to emtricitabine or tenofovir and be harder to treat.

  • For oral dosage form (capsules):
    • For treatment of HIV infection
      • Adults—Oral, one tablet (200 milligrams [mg] of emtricitabine and 300 mg of tenofovir) taken once a day. This medicine can be taken with or without food. Your doctor may want to change the dose if you have certain medical problems.
      • Children—Use and dose must be determined by your doctor.

Missed dose—If you forget to take emtricitabine and tenofovir combination take it as soon as you remember that day. Do not take more than 1 dose of emtricitabine in a day. Do not take 2 doses at the same time. Call your healthcare provider or pharmacy if you are not sure what to do.

Storage—To store this medicine:

  • Keep out of the reach of children.
  • Do not keep your medicine in places that are too hot or too cold.
  • Do not store in the bathroom, near the kitchen sink, or in other damp places. Heat or moisture may cause the medicine to break down.
  • Do not keep outdated medicine or medicine no longer needed. Ask your health care professional how you should dispose of any medicine you do not use. Be sure that any discarded medicine is out of the reach of children.

Precautions While Using This Medicine

It is very important that you read the patient information when you start taking this medicine and each time you get a refill. There may be new information for you.

It is very important that your doctor check you at regular visits to be sure this medicine is working properly. You should remain under the care of a doctor while taking emtricitabine.

This medicine may cause serious problems with your liver or cause too much acid in your blood. If untreated, it can lead to severe low blood pressure and even death. Check with your doctor immediately if you notice abdominal discomfort; decreased appetite; diarrhea; fast, shallow breathing; general feeling of discomfort; muscle pain or cramping; nausea; shortness of breath; sleepiness; or unusual tiredness or weakness.

This medicine is not for the treatment of hepatitis B virus infection. Patients infected with both HBV and HIV who take emtricitabine and tenofovir combination need close medical follow-up for several months after stopping treatment to make sure their hepatitis B does not get worse.

Emtricitabine and tenofovir combination does not decrease the risk of transmitting the HIV infection to others through sexual contact or by contamination through blood. HIV may be acquired from or spread to others through infected body fluids, including blood, vaginal fluid, or semen. If you are infected, it is best to avoid any sexual activity involving an exchange of body fluids with other people. If you do have sex, always wear (or have your partner wear) a condom (“rubber”). Only use condoms made of latex or polyurethane and use them every time you have contact with semen, vaginal secretions, or blood. Also, do not share needles or equipment with anyone or use dirty needles. If you have any questions about this, check with your health care professional.

Side Effects of This Medicine

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Less common

Blisters under the skin; hives or welts; itching skin; rash with flat lesions or small raised lesions on the skin; redness of skin; spots on your skin resembling a blister or pimple; skin rash

Rare

Blindness or vision changes; burning of face or mouth; burning, crawling, itching, numbness, painful, prickling, "pins and needles", or tingling feelings in the hands, arms, feet, or legs; chest pain; clumsiness or unsteadiness; sensation of pins and needles; sneezing; sore throat; stabbing pain; weakness in hands or feet

Incidence not known

Abdominal discomfort; agitation; bloating; bloody or cloudy urine; bone pain; chills; coma; confusion; constipation; convulsions or seizures; cough; darkened urine; decreased appetite; decreased frequency or amount of urine; depression; difficult or labored breathing; difficult or painful urination; difficulty swallowing; diarrhea; dizziness; fast heartbeat; fast, shallow breathing; fever; general feeling of discomfort; headache; hostility; increase in amount of urine; increased blood pressure; increased thirst; indigestion; irritability; lethargy; loss of appetite; lower back or side pain; muscle pain or cramping; muscle twitching; nausea; pains in stomach, side, or abdomen, possibly radiating to the back; puffiness or swelling of the eyelids or around the eyes, face, lips or tongue; rapid weight gain; sleepiness; shortness of breath; stupor; sudden decrease in amount of urine; swelling of face, fingers, hands, lower legs, or ankles; tightness in chest; troubled breathing; unusual tiredness or weakness; vomiting; weight gain; wheezing; yellow eyes or skin

Other side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. However, check with your doctor if any of the following side effects continue or are bothersome.

Less common

Lack or loss of strength; passing of gas; weight loss

Rare

Acid or sour stomach; back pain; belching; difficulty in moving; discouragement; feeling sad or empty; heartburn; increased cough; joint pain; lack of appetite; loss of interest or pleasure; muscle aching or cramping; muscle pain or stiffness; pain; pain in joints; runny nose; shortness of breath; sleeplessness; stomach discomfort, upset, or pain; stuffy nose; sweating; swollen joints; tiredness; trouble concentrating; trouble sleeping; unable to sleep

Other side effects not listed above may also occur in some patients. If you notice any other effects, check with your doctor.

Developed: 02/23/2005

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