emtricitabine and tenofovir

What is the most important information I should know about emtricitabine and tenofovir?

Truvada PrEP is used to reduce the risk of becoming infected with HIV in adults who are HIV-negative. This medicine alone will not protect you from infection with HIV. You must also use safer sex practices and get tested for HIV at least every 3 months.

If you've ever had hepatitis B, it may become active or get worse after you stop using emtricitabine and tenofovir. You may need frequent liver function tests for several months.

What is emtricitabine and tenofovir?

Emtricitabine and tenofovir are antiviral medicines that prevent human immunodeficiency virus (HIV) from multiplying in your body.

Emtricitabine and tenofovir is a combination medicine used to treat HIV, the virus that can cause acquired immunodeficiency syndrome (AIDS). This medicine is not a cure for HIV or AIDS, but it can be used to treat HIV in adults and children who are at least 12 years old and weigh at least 17 kilograms (37 pounds).

Emtricitabine and tenofovir is also used in children who weigh between 55 and 77 pounds (25 to 35 kilograms) and who take certain other HIV medications.

Truvada PrEP is used together with safer-sex practices to reduce the risk of becoming infected with HIV. You must be HIV-negative and an adult to use Truvada PrEP for this purpose.

Emtricitabine and tenofovir may also be used for purposes not listed in this medication guide.

What should I discuss with my healthcare provider before taking emtricitabine and tenofovir?

If you take Truvada PrEP to reduce your risk of HIV infection: You must have a negative HIV test immediately before you start taking the medicine.

Tell your doctor if you have ever had:

• liver disease (you may be tested for hepatitis B before you can use this medicine);
• osteopenia (low bone mineral density); or
• kidney disease.

Tell your doctor if you are pregnant, and use your medications properly to control your infection. HIV can be passed to your baby if the virus is not controlled during pregnancy. Your name may be listed on a registry to track any effects of antiviral medicine on the baby.

How should I take emtricitabine and tenofovir?

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

You may take this medicine with or without food.

Use all HIV medications as directed and read all medication guides you receive. Do not change your dose or dosing schedule without your doctor's advice. Every person with HIV should remain under the care of a doctor.

You will need frequent medical tests to check your kidney and liver function, or your bone mineral density.

Truvada PrEP alone will not protect you from infection with HIV. You must also use safer sex practices and get tested for HIV at least every 3 months.

If you've ever had hepatitis B, this virus may become active or get worse in the months after you stop using emtricitabine and tenofovir. You may need frequent liver function tests while using this medicine and for several months after your last dose.

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skipping doses may increase the risk of your virus becoming resistant to antiviral medicine. Try not to miss any doses.

Get your prescription refilled before you run out of medicine completely.

What happens if I overdose?

What should I avoid while taking emtricitabine and tenofovir?

Using this medicine will not prevent your disease from spreading. Do not have unprotected sex or share razors or toothbrushes. Talk with your doctor about safe ways to prevent HIV transmission during sex. Sharing drug or medicine needles is never safe, even for a healthy person.

What are the possible side effects of emtricitabine and tenofovir?

• symptoms of new HIV infection --fever, night sweats, tiredness, muscle or joint pain, sore throat, vomiting, diarrhea, rash, swollen glands in your neck or groin;
• sudden or unusual bone pain;
• kidney problems --little or no urination, swelling in your feet or ankles, feeling tired or short of breath; or
• liver problems --nausea, swelling around your midsection, upper stomach pain, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Emtricitabine and tenofovir affects your immune system, which may cause certain side effects (even weeks or months after you've taken this medicine). Tell your doctor if you have:

• signs of a new infection --fever, sweats, swollen glands, cold sores, cough, wheezing, diarrhea, weight loss;
• trouble speaking or swallowing, problems with balance or eye movement, weakness or prickly feeling; or
• swelling in your neck or throat (enlarged thyroid), menstrual changes, impotence.

Common side effects may include:

• headache, dizziness, feeling depressed or tired;
• trouble sleeping, strange dreams;
• nausea, stomach pain;
• weight loss; or
• rash.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect emtricitabine and tenofovir?

Sometimes it is not safe to use certain medications at the same time. Some drugs can affect your blood levels of other drugs you take, which may increase side effects or make the medications less effective.

Emtricitabine and tenofovir can harm your kidneys, especially if you also use certain medicines for infections, cancer, osteoporosis, organ transplant rejection, bowel disorders, high blood pressure, or pain or arthritis (including Advil, Motrin, and Aleve).

Other drugs may affect emtricitabine and tenofovir, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.

Where can I get more information?

Your pharmacist can provide more information about emtricitabine and tenofovir.