Tenofovir Disoproxil Fumarate, Oral

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KEY POINTS

• This medicine is taken by mouth to treat HIV infection. Take it exactly as directed.
• Keep all appointments for checkups and tests to see how this medicine affects you.
• This medicine may cause a buildup of lactic acid in the blood that can be dangerous. This is more likely if you have kidney problems.
• This medicine may also cause liver damage in some people, or other unwanted side effects. Tell your healthcare provider if you have any side effects that are serious, continue, or get worse.
• 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: nucleotide reverse transcriptase inhibitor; antiretroviral (anti-HIV)

Generic and brand names: tenofovir disoproxil fumarate, oral; Viread

What is this medicine used for?

This medicine is taken by mouth to treat HIV 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 is also used to treat chronic hepatitis B infection. It will not cure or prevent hepatitis B infection.

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

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 without your healthcare provider's approval.

How do I take it?

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.

For chronic hepatitis B infection: Check with your healthcare provider before using this medicine in children under age 12.

For HIV infection: Check with your healthcare provider before using this medicine in children under age 2.

This medicine comes in a tablet and a powder form. You may take the tablet form of this medicine with or without food. Taking it with meals may lessen the chance the drug will upset your stomach. Take this medicine with a full glass of water.

If you have the powder, follow the instructions in the medicine package for how to prepare and use it. Only use the dosing scoop that comes with the medicine. Do not use a kitchen spoon because the dose may not be correct. If you have any questions, ask your healthcare provider or pharmacist.

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 urine tests, blood tests, and checkups regularly to see how this medicine affects you. Your healthcare provider will continue to check your health for several months after you stop taking this medicine. Keep all appointments for tests.

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 weak or tired
• Unusual muscle pain
• Having trouble breathing
• Severe stomach pain with nausea and vomiting
• Feeling cold
• Feeling dizzy or lightheaded
• Suddenly developing a fast or irregular heartbeat

This medicine may also cause liver damage in some people. Contact your provider right away if you have symptoms of liver damage such as dark urine, yellowing of the skin and eyes, unexplained tiredness, pain in the upper right part of the stomach, loss of appetite, nausea, or vomiting.

After you stop taking this medicine, tell your healthcare provider about any new, unusual, or worsening symptoms.

This medicine may affect your bones. 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 supplements.

This medicine may cause immune reconstitution syndrome (IRS). As the immune system gets stronger, the body's responses to diseases such as Graves’ disease, polymyositis, and Guillain-Barré syndrome may also get stronger. Talk with your provider about this.

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

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.

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; chest pain or tightness in your chest; swelling of your lips, tongue, and throat).

Serious (Report these to your healthcare provider right away.): Decreased urination, pain when urinating, dark urine, yellowing of your eyes or skin, light-colored bowel movements, loss of appetite, unexplained fever, unusual tiredness or weakness, trouble breathing, severe dizziness or fainting, stomach pain, severe nausea or vomiting, fast or irregular heartbeat, unexplained muscle or joint pain, unexplained swelling.

Other: Nausea, vomiting, diarrhea, gas, headache, changes in body fat, dizziness, trouble sleeping, itching, nervousness.

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, clarithromycin (Biaxin), erythromycin (E.E.S., Ery-Tab, Erythrocin), gentamicin, rifabutin (Mycobutin), rifampin (Rifadin), rifapentine (Priftin), tobramycin, and vancomycin (Vancocin)
• Antiviral medicines such as acyclovir (Zovirax), adefovir (Hepsera), cidofovir (Vistide), ganciclovir (Cytovene), ledipsavir/Sofosbuvir (Harvoni), maraviroc (Selzentry), ombitasvir/paritaprevir/ritonavir/dasabuvir (Viekira), simeprevir (Olysio), valacyclovir (Valtrex), and valganciclovir (Valcyte)
• Cancer medicines such as bosutinib (Bosulif), cisplatin, doxorubicin (Doxil), imatinib (Gleevec), lapatinib (Tykerb), and vemurafenib (Zelboraf)
• Cholesterol-lowering medicines such as atorvastatin (Lipitor), lovastatin (Altoprev), and pravastatin (Pravachol)
• Heart medicines such as amiodarone (Cordarone, Pacerone), digoxin (Lanoxin), diltiazem (Cardizem, Cartia, Tiazac), and verapamil (Calan, Covera, Verelan)
• Immunosuppressants such as cyclosporine (Gengraf, Neoral, Sandimmune), sirolimus (Rapamune), and tacrolimus (Astagraf, Prograf, Protopic)
• Medicines to treat or prevent blood clots such as apixaban (Eliquis), dabigatran (Pradaxa), and rivaroxaban (Xarelto)
• 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 HIV medicines such as atazanavir (Reyataz), darunavir (Prezista), delavirdine (Rescriptor), didanosine (Videx), efavirenz (Sustiva), efavirenz/emtricitabine/tenofovir (Atripla), elvitegravir/cobicistat/emtricitabine/tenofovir (Stribild), emtricitabine/rilpivirine/tenofovir (Complera, Odefsey), emtricitabine/tenofovir (Truvada), etravirine (Intelence), fosamprenavir (Lexiva), indinavir (Crixivan), lopinavir/ritonavir (Kaletra), nelfinavir (Viracept), nevirapine (Viramune), ritonavir (Norvir), saquinavir (Invirase), stavudine (Zerit), and tipranavir (Aptivus)

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.