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

Treats and prevents HIV infection. HIV causes AIDS. This medicine does not cure HIV or AIDS, but combinations of drugs may slow the progress of the disease.

Brand Name(s):

Truvada

When This Medicine Should Not Be Used:

How to Use This Medicine:

Tablet

• Your doctor will tell you how much medicine to use. Do not use more than directed.
• 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.
• Do not stop using this medicine without checking first with your doctor. If you stop the medicine even briefly, the virus may become harder to treat. Contact your doctor or pharmacist when your supply is running low so you do not run out.
• This medicine should come with a Medication Guide. Ask your pharmacist for a copy if you do not have one.
• Missed dose: Take a dose as soon as you remember. If it is almost time for your next dose, wait until then and take a regular dose. Do not take extra medicine to make up for a missed dose.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep the medicine in the original bottle.

Drugs and Foods to Avoid:

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

• Some medicines can affect how emtricitabine and tenofovir combination works. Tell your doctor if you are using:
  • Acyclovir, adefovir dipivoxil, atazanavir, cidofovir, darunavir/ritonavir, didanosine, ganciclovir, gentamicin, ledipasvir/sofosbuvir, lopinavir/ritonavir, sofosbuvir/velpatasvir, valacyclovir, valganciclovir
  • NSAID pain or arthritis medicine (including aspirin, ibuprofen, naproxen)

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant, or if you have kidney disease, liver disease (including hepatitis B), or bone problems (including osteoporosis).
• Do not breastfeed. You can spread HIV or AIDS to your baby through your breast milk.
• This medicine may cause the following problems:
  • Worsening of hepatitis B infection
  • Kidney problems
  • Lower bone mineral density
  • Lactic acidosis (too much acid in your blood)
  • Liver problems
• Your immune system may get stronger when you start taking HIV medicines. This could cause a hidden infection in your body to become active. Tell your doctor right away if you notice any changes in your health.
• Always practice safe sex, even if your partner also has HIV. If you stop taking this medicine or do not take it as prescribed, you may spread HIV to others. Do not reuse or share needles, or other items, that may have blood or body fluids on them.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments. If you are using this medicine to prevent HIV (HIV-1 PrEP), your doctor may also check you for HIV and other sexually transmitted infections before starting this medicine and for at least once every 3 months during treatment. You must stay HIV-negative to keep taking this medicine for HIV-1 PrEP.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

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
• Bone pain
• Change in how much or how often you urinate, cloudy urine
• Dark urine or pale stools, loss of appetite, stomach pain, yellow skin or eyes
• Fast or troubled breathing, nausea, vomiting, lightheadedness, severe weakness or tiredness, confusion

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

• Cough, runny or stuffy nose, sore throat
• Feeling depressed, trouble sleeping, unusual dreams
• Headache, dizziness
• Mild nausea, diarrhea

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