Emtricitabine; Tenofovir Disoproxil Fumarate Tablets

What is this medication?

EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE (em trye SYE ta been; ten OF oh vir dye soe PROX il FUE ma rate) helps manage the symptoms of HIV infection. It may also be used for PrEP (pre-exposure prophylaxis), which lowers the risk of getting HIV through sex. It works by limiting the spread of HIV in the body. It is a combination of two antiretroviral medications. This medication is not a cure for HIV or AIDS and it may still be possible to spread HIV to others while taking it. It does not prevent other sexually transmitted infections (STIs).

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): Truvada

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• Bone problems
• Kidney disease
• Liver disease
• An unusual or allergic reaction to emtricitabine, tenofovir, other medications, foods, dyes, or preservatives
• Pregnant or trying to get pregnant
• Breast-feeding

How should I use this medication?

Take this medication by mouth. Do not cut, crush or chew this medication. Swallow the tablets whole. You can take it with or without food. If it upsets your stomach, take it with food. For your therapy to work as well as possible, take each dose exactly as prescribed on the prescription label. Do not skip doses. Skipping doses can make the HIV virus resistant to this and other medications. Keep taking this therapy unless your care team tells you to stop.

A special MedGuide will be given to you by the pharmacist with each prescription and refill. Be sure to read this information carefully each time.

Talk to your care team about the use of this medication in children. While it may be given to children for selected conditions, precautions do apply.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

What may interact with this medication?

Do not take this medication with any of the following:

• Adefovir
• Any medication that contains emtricitabine or tenofovir
• Any medication that contains lamivudine

This medication may also interact with the following:

• Atazanavir
• Didanosine, ddI
• Lopinavir; ritonavir
• Medications for viral infections like cidofovir, acyclovir, valacyclovir, ganciclovir, valganciclovir
• Saquinavir

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Visit your care team for regular check-ups. Discuss any new symptoms with your care team. You will need to have important blood work done while on this medication.

HIV is spread to others through sexual or blood contact. Talk to your care team about how to stop the spread of HIV.

If you have hepatitis B, talk to your care team if you plan to stop this medication. The symptoms of hepatitis B may get worse if you stop this medication.

What side effects may I notice from receiving this medication?

Side effects that you should report to your care team as soon as possible:

• Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
• Bone pain
• High lactic acid level—muscle pain or cramps, stomach pain, trouble breathing, general discomfort and fatigue
• Infection—fever, chills, cough, or sore throat
• Kidney injury—decrease in the amount of urine, swelling of the ankles, hands, or feet
• Liver injury—right upper belly pain, loss of appetite, nausea, light-colored stool, dark yellow or brown urine, yellowing skin or eyes, unusual weakness or fatigue

Side effects that usually do not require medical attention (report to your care team if they continue or are bothersome):

• Diarrhea
• Dizziness
• Fatigue
• Headache
• Nausea
• Trouble sleeping

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medication?

Keep out of the reach of children.

Store at room temperature between 15 and 30 degrees C (59 and 86 degrees F). Throw away any unused medication after the expiration date.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.