Emtricitabine/tenofovir (By mouth)

When This Medicine Should Not Be Used

Drugs and Foods to Avoid

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• There are many other medicines that you should not use together with emtricitabine and tenofovir disoproxil fumarate. Make sure your doctor knows about all other medicines you are using.
• Make sure your doctor knows if you are also using acyclovir (Zovirax®), atazanavir (Reyataz®), cidofovir (Vistide®), didanosine (Videx®), ganciclovir (Cytovene®), lopinavir/ritonavir (Kaletra®), valacyclovir (Valtrex®), or valganciclovir (Valcyte?). Tell your doctor if you are using any medicines that may be hard on your kidneys. This medicine may interact with many other medicines.

Possible Side Effects While Using This Medicine

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Chest pain.
• Dark-colored urine or pale stools.
• Decrease in how much or how often you urinate.
• Extreme weakness, tiredness, or confusion.
• Lightheadedness or fainting.
• Nausea, vomiting, loss of appetite, or pain in your upper stomach.
• Numbness, tingling, or burning pain in your hands, arms, legs, or feet.
• Rapid breathing or trouble breathing.
• Yellowing of your skin or the whites of your eyes.

If you notice these less serious side effects, talk with your doctor:

• Changes in skin color of your hands or feet.
• Cough, stuffy or runny nose, or sore throat.
• Depression or trouble sleeping
• Gaining weight around your neck, upper back, breast, face, or waist.
• Headache or dizziness.
• Joint or muscle pain.
• Mild nausea, vomiting, diarrhea, or stomach pain.
• Mild skin rash.
• Weight loss.

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088

How to Use This Medicine

Tablet

• Your doctor will tell you how much of this medicine to use and how often. Do not use more medicine or use it more often than your doctor tells you to.
• You may take this medicine with or without food.
• Try to take your medicine at the same time each day.
• This medicine works best when there is a constant amount in the blood. To help keep the amount constant, do not miss any doses.
• When your supply of this medicine is running low, contact your doctor or pharmacy ahead of time. Do not allow yourself to run out of this medicine.
• This medicine is used with other medicines to treat HIV infection. Take all other medicines your doctor has prescribed as part of your combination treatment.
• Keep using this medicine for the full treatment time, even if you feel better after the first few doses. Your infection may not clear up if you stop using the medicine too soon.
• This medicine comes with patient instructions. Read and follow these instructions carefully. Ask your doctor or pharmacist if you have any questions.

If a dose is missed:

• If you miss a dose or forget to use your medicine, use it as soon as you can. If it is almost time for your next dose, wait until then to use the medicine and skip the missed dose. Do not use extra medicine to make up for a missed dose.

How to Store and Dispose of This Medicine

• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep your medicine bottle tightly closed.
• Ask your pharmacist, doctor, or health caregiver about the best way to dispose of any outdated medicine or medicine no longer needed.
• Keep all medicine away from children and never share your medicine with anyone.

Introduction

Emtricitabine (em-trye-SYE-ta-been), Tenofovir Disoproxil Fumarate (ten-OF-oh-vir dye-soe-PROX-il FUE-ma-rate)

Treats human immunodeficiency virus (HIV) infection. HIV causes acquired immune deficiency syndrome (AIDS). This medicine does not cure HIV or AIDS, but combinations of drugs may slow the progress of the disease.

Brand Name(s)

Truvada

Warnings While Using This Medicine

• Make sure your doctor knows if you are pregnant or breastfeeding, or if you have kidney problems, liver disease (especially hepatitis B), or bone problems (such as osteomalacia, osteopenia, or osteoporosis). Tell your doctor if you are on dialysis.
• This medicine is not for treating chronic hepatitis B virus (HBV) infection.
• Two rare but serious reactions to this medicine are lactic acidosis (build-up of acid in the blood) and an enlarged liver. Call your doctor right away if you or your child feel very tired, weak, or nauseated, if you vomit or have trouble breathing, or if your skin or eyes have turned yellow.
• This medicine may also increase your risk of developing fractures (broken bones). Ask your doctor about this if you or your child have any concerns.
• When you start taking HIV medicines, your immune system may get stronger. If you have infections that are hidden in your body, such as pneumonia or tuberculosis, you or your child may notice new symptoms when your body tries to fight them. If this occurs, be sure to tell your doctor.
• This medicine may cause you to have excess body fat. Tell your doctor if you or your child notice changes in your body shape, such as an increased amount of fat in the upper back and neck, or around the chest and stomach area. You might also lose fat from the legs, arms, and face.
• You should not breast feed if you have HIV or AIDS, because you may give the infection to your baby through your breast milk.
• This medicine will not keep you from giving HIV to your partner during sex. Make sure you understand and practice safe sex, even if your partner also has HIV. Do not share needles with anyone.
• Do not change your dose or stop taking this medicine, even for a short time, without checking first with your doctor.
• Make sure any doctor or dentist who treats you knows that you are using this medicine. This medicine may affect the results of certain medical tests.
• Your doctor will need to check your blood or urine at regular visits while you are using this medicine. Be sure to keep all appointments. Your doctor may also want to check you or your child for several months after you stop using this medicine.