Emtricitabine/Tenofovir Disoproxil Fumarate, Oral

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KEY POINTS

• This medicine is taken by mouth to prevent or treat HIV infection. It is not a cure for HIV infection. Take it exactly as directed. Do not stop taking this medicine or change your dosage unless directed to do so by your healthcare provider.
• This medicine may cause a buildup of lactic acid in the blood that can be dangerous. This medicine may also cause severe or life-threatening liver problems. It may cause other unwanted side effects. Tell your healthcare provider if you have any side effects that are serious, continue, or get worse.
• Keep all appointments for tests to see how this medicine affects you.
• Tell all healthcare providers who treat you about all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take.

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What are other names for this medicine?

Type of medicine: antiretroviral (anti-HIV)

Generic and brand names: emtricitabine/tenofovir disoproxil fumarate, oral; Truvada

What is this medicine used for?

This medicine is a combination of 2 medicines in each tablet. This medicine is taken by mouth to help prevent HIV or treat infection. It will not cure HIV or AIDS but may slow the progression of the disease. It is used with other antiretroviral medicines.

This medicine may be used to treat other conditions as determined by your healthcare provider.

What should my healthcare provider know before I take this medicine?

Tell your healthcare provider if you have ever had:

• An allergic reaction to any medicine
• Bone problems such as osteoporosis
• Hepatitis B or other liver disease
• Kidney disease

Tell your provider if you also take adefovir (Hepsera). You should not take this medicine if you also take Hepsera to treat hepatitis B.

If you are taking this medicine to help prevent HIV infection, you must be HIV-negative before taking this medicine and at least every 3 months while you are taking it. You must get tested to make sure that you do not already have HIV infection. You should not take this medicine to prevent HIV infection if:

• You are HIV-positive.
• You have been exposed to HIV within the past month.
• You have symptoms of new HIV infection such as fever, night sweats, swollen glands in the neck or groin, diarrhea, joint or muscle pain.

Females of childbearing age: Tell your healthcare provider if you are pregnant or plan to become pregnant. Do not breast-feed while taking this medicine.

How do I take it?

Read the Medication Guide that comes in the medicine package when you start taking this medicine and each time you get a refill.

Check the label on the medicine for directions about your specific dose. Take this medicine exactly as your healthcare provider prescribes. Do not take more or less or take it longer than prescribed. Do not stop taking this medicine without your healthcare provider's approval. Your symptoms may get worse if you stop taking this medicine too soon.

Do not let your medicine run out. The amount of virus in your blood may increase if you stop the medicine, even for a short time.

Check with your healthcare provider before using this medicine in children who weigh less than 37 pounds.

You may take this medicine with or without food. Taking it with meals may lessen the chance the drug will upset your stomach.

What if I miss a dose?

If you miss a dose, take it as soon as you remember unless it is time for your next dose (the next day). Do not double the dose the next day. If you are not sure of what to do if you miss a dose, or if you miss more than one dose, contact your healthcare provider.

What if I overdose?

Symptoms of an acute overdose have not been reported.

What should I watch out for?

You need to have urine and blood tests regularly to see how this medicine affects you. Keep all appointments.

You may need bone scans or X-rays to see if the medicine is affecting your bones. Your healthcare provider may prescribe calcium and vitamin D supplements while you are taking this medicine. Follow your healthcare provider's instructions about exercise, diet, and taking vitamin supplements.

Lactic acidosis is a rare but serious complication that can happen with use of this medicine. This condition is caused by a buildup of lactic acid in the blood. This happens more often in people with kidney problems. Most people with kidney problems should not take this medicine. The symptoms of lactic acidosis are:

• Feeling very tired or weak
• Unusual muscle pain
• Trouble breathing
• Feeling cold, especially in hands or feet
• Stomach pain with nausea and vomiting
• Feeling dizzy or lightheaded
• Fast or irregular heartbeat

This medicine is not approved for treatment of hepatitis B. Your healthcare provider may test you for hepatitis B. If you are also infected with hepatitis B, you need blood tests and checkups for several months after you stop taking this medicine. This medicine may cause flare-ups of hepatitis B.

This medicine may cause severe or life-threatening liver problems. Contact your healthcare provider right away if you have yellowing of your skin or eyes, dark urine, light-colored bowel movements, and loss of appetite.

Your immune system may get stronger and start to fight infections that have been hidden in your body for a long time. Call your healthcare provider right away if you start having new symptoms after starting this medicine.

Alcohol may increase the risk of side effects of this medicine. Do not drink alcohol without your healthcare provider's approval.

This medicine does not reduce the risk of passing HIV to others through sexual contact or blood contamination. Continue to practice safe sex and do not share needles.

Treatment with this medicine may cause a change in the location of fat in your body. Talk with your healthcare provider about this.

If you need emergency care, surgery, lab tests, or dental work, tell the healthcare provider or dentist you are taking this medicine.

What are the possible side effects?

Along with its needed effects, your medicine may cause some unwanted side effects. Some side effects may be very serious. Some side effects may go away as your body adjusts to the medicine. Tell your healthcare provider if you have any side effects that continue or get worse.

Life-threatening (Report these to your healthcare provider right away. If you cannot reach your healthcare provider right away, get emergency medical care or call 911 for help.): Allergic reaction (hives; itching; rash; trouble breathing; tightness in your chest; swelling of your lips, tongue, and throat).

Serious (Report these to your healthcare provider right away.): Fast, slow, or irregular heartbeat; decreased urination; pain when urinating; dark urine, yellowing of your eyes or skin; light-colored bowel movements; unexplained fever; muscle or joint pain; unusual muscle weakness, severe dizziness or fainting; unusual tiredness or weakness; trouble breathing; feeling cold; severe nausea or vomiting; severe stomach or back pain; tingling or numbness; enlarged lymph nodes in your neck or groin; depression or other mood changes.

Other: Mild nausea or vomiting, diarrhea, gas, mild stomach pain, loss of appetite, weight loss, changes in body fat, headache, mild rash, mild dizziness, trouble sleeping, abnormal dreams, runny nose.

What products might interact with this medicine?

When you take this medicine with other medicines, it can change the way this or any of the other medicines work. Nonprescription medicines, vitamins, natural remedies, and certain foods may also interact. Using these medicines together might cause harmful side effects. Talk to your healthcare provider if you are taking:

• Antibiotics such as amikacin, azithromycin (Zithromax, Zmax), clarithromycin (Biaxin), erythromycin (E.E.S., Ery-Tab, Erythrocin), gentamicin, rifabutin (Mycobutin), rifampin (Rifadin), rifapentine (Priftin), telithromycin (Ketek), tobramycin, and vancomycin (Vancocin)
• Nonsteroidal anti-inflammatory medicines (NSAIDs) such as celecoxib (Celebrex), diclofenac (Cambia, Voltaren, Zipsor), diflunisal, etodolac, ibuprofen (Advil, Motrin), indomethacin (Indocin), ketoprofen, ketorolac, meloxicam (Mobic), nabumetone (Relafen), naproxen (Aleve, Anaprox, Naprelan), oxaprozin (Daypro), piroxicam (Feldene), and sulindac (Clinoril)
• Other antiviral medicines such as abacavir/lamivudine (Epzicom), abacavir/lamivudine/zidovudine (Trizivir), acyclovir (Zovirax), adefovir (Hepsera), atazanavir (Reyataz), cidofovir (Vistide), darunavir (Prezista), delavirdine (Rescriptor), didanosine (Videx), efavirenz (Sustiva), efavirenz/emtricitabine/tenofovir (Atripla), elvitegravir/cobicistat/emtricitabine/tenofovir (Stribild), emtricitabine (Emtriva), emtricitabine/rilpivirine/tenofovir (Complera, Odefsey), etravirine (Intelence), fosamprenavir (Lexiva), ganciclovir (Cytovene), indinavir (Crixivan), lamivudine (Epivir, Epivir-HBV), ledipasvir/sofosbuvir (Harvoni), lopinavir/ritonavir (Kaletra), maraviroc (Selzentry), nelfinavir (Viracept), nevirapine (Viramune), rilpivirine (Edurant), ritonavir (Norvir), saquinavir (Invirase), stavudine (Zerit), tenofovir (Viread), tipranavir (Aptivus), valacyclovir (Valtrex), valganciclovir (Valcyte), and zidovudine/lamivudine (Combivir)
• Tacrolimus (Astagraf, Prograf, Protopic)
• Trospium

If you are not sure if your medicines might interact, ask your pharmacist or healthcare provider. Keep a list of all your medicines with you. List all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take. Be sure that you tell all healthcare providers who treat you about all the products you are taking.

How should I store this medicine?

Store this medicine at room temperature. Keep the container tightly closed. Protect it from heat, high humidity, and bright light.

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This advisory includes selected information only and may not include all side effects of this medicine or interactions with other medicines. Ask your healthcare provider or pharmacist for more information or if you have any questions.

Ask your pharmacist for the best way to dispose of outdated medicine or medicine you have not used. Do not throw medicine in the trash.

Keep all medicines out of the reach of children.

Do not share medicines with other people.