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AIDSinfo Drug Database

AIDSinfo Drug Database

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FDA-approved

Investigational

Tenofovir Disoproxil Fumarate  Audio icon

Brand Name: Viread
Other Names: TDF, tenofovir DF
Drug Class: Nucleoside Reverse Transcriptase Inhibitors
Approved Use: Treatment of HIV Infection; Treatment of Chronic Hepatitis B Virus Infection
Drug Images:
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Tenofovir
Tenofovir 150 mg tablet
Tenofovir 250 mg tablet
Tenofovir 200 mg tablet
Tenofovir 40 mg oral powder
Chemical Image:
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tenofovir disoproxil fumarate
tenofovir disoproxil fumarate
Molecular Weight: 635.5166

WARNING:

Tenofovir disoproxil fumarate (tenofovir DF) can cause serious, life-threatening side effects. These include lactic acidosis (buildup of acid in your blood) and severe liver problems.

Contact your health care provider right away if you have any of the following symptoms that could be signs of lactic acidosis:

  • Feeling very weak or tired.
  • Unusual muscle pain.
  • Trouble breathing.
  • Stomach pain with either nausea or vomiting.
  • Feeling cold, especially in your arms and legs.
  • Feeling dizzy or lightheaded.
  • Fast or irregular heartbeat.
Contact your health care provider right away if you have any of the following symptoms that could be signs of severe liver problems:
 
  • Yellowing of your skin or the whites of your eyes (jaundice).
  • Dark-colored urine.
  • Light-colored bowel movements.
  • Loss of appetite for several days or longer.
  • Nausea.
  • Stomach pain.

If you have hepatitis B virus (HBV) infection and take tenofovir DF and then stop using it, you may have worsening of your HBV infection. Tell your health care provider about any new or unusual symptoms after you stop taking tenofovir DF.

While taking tenofovir DF, it is important to keep all of your appointments with your health care provider.

What is tenofovir disoproxil fumarate?

Tenofovir DF is a prescription medicine approved by the U.S. Food and Drug Administration (FDA) for the treatment of HIV infection in adults and children 2 years of age and older. Tenofovir DF is always used in combination with other anti-HIV medicines.

Tenofovir DF belongs to a class (group) of HIV drugs called nucleoside reverse transcriptase inhibitors (NRTIs). NRTIs block an HIV enzyme called reverse transcriptase. (An enzyme is a protein that starts or increases the speed of a chemical reaction.) By blocking reverse transcriptase, NRTIs prevent HIV from multiplying and can reduce the amount of HIV in the body.

HIV medicines can’t cure HIV/AIDS, but taking a combination of HIV medicines (called an HIV treatment regimen) every day helps people with HIV live longer, healthier lives. HIV medicines also reduce the risk of HIV transmission. If you are taking HIV medicines, including tenofovir DF, don’t cut down on, skip, or stop taking them unless your health care provider tells you to.

Tenofovir DF is also an HBV reverse transcriptase inhibitor, approved by FDA for the treatment of chronic HBV in adults and children 12 years of age and older. HBV is an opportunistic infection. An opportunistic infection is an infection that occurs more frequently or is more severe in people with weakened immune systems—such as those infected with HIV—than in people with healthy immune systems.

The Guidelines for the Prevention and Treatment of Opportunistic Infections in HIV-Infected Adults and Adolescents, prepared by the Centers for Disease Control and Prevention (CDC), the National Institutes of Health (NIH), and the HIV Medicine Association of the Infectious Diseases Society of America (IDSA-HIVMA), includes recommendations on the use of tenofovir DF to treat HBV infection in people who are also receiving combination antiretroviral therapy (ART) for HIV infection.

What should I tell my health care provider before taking tenofovir disoproxil fumarate?

Before taking tenofovir DF, tell your health care provider:

  • If you are allergic to tenofovir DF or any other medicines.
  • If you have liver problems, including HBV infection.
  • If you have kidney problems.
  • If you have bone problems.
  • If you have any other medical conditions.
  • If you are pregnant or plan to become pregnant. Whether tenofovir DF can harm an unborn baby is unknown. Tenofovir DF should be used during pregnancy only if clearly needed.
  • If you are breastfeeding or plan to breastfeed. Do not breastfeed if you are infected with HIV or are taking tenofovir DF.
  • About other prescription and nonprescription medicines, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Tenofovir DF may affect the way other medicines or products work, and other medicines or products may affect how tenofovir DF works. Taking tenofovir DF together with certain medicines or products may cause serious and/or life-threatening side effects.

How should I take tenofovir disoproxil fumarate?

Tenofovir DF comes in the following forms and strengths, under the brand name Viread:

  • 150-mg tablets.
  • 200-mg tablets.
  • 250-mg tablets.
  • 300-mg tablets.
  • 40-mg/1 g oral powder.

Take tenofovir DF according to your health care provider’s instructions.

Tenofovir DF tablets should be swallowed whole and can be taken with or without food. People who are unable to swallow the tablets whole may take the oral powder. Use the provided dosing scoop to measure the oral powder. Mix the oral powder with soft foods that can be swallowed without chewing, such as applesauce, baby food, or yogurt. Take the dose of oral powder right after mixing it. Do not mix the oral powder with liquid.

Always take tenofovir DF in combination with other HIV medicines.

If you take too much tenofovir DF, contact your health care provider or local poison control center (1-800-222-1222) right away or go to the nearest hospital emergency room.

For more information on how to take tenofovir DF, see the FDA drug label from DailyMed. (DailyMed is a federal website that includes the most recent drug labels submitted to FDA.)

What should I do if I forget a dose?

If you miss a dose of tenofovir DF, take the missed dose as soon as you remember it. But if it is almost time for your next dose, skip the missed dose and just take your next dose at the regular time. Do not take two doses at the same time to make up for a missed dose.

What side effects can tenofovir disoproxil fumarate cause?

Tenofovir DF can cause severe side effects. These include lactic acidosis (buildup of acid in your blood) and severe liver problems. (See the WARNING above.)

Other possible side effects of tenofovir DF include:

  • New or worsening kidney problems.
  • Bone problems, including bone pain, softening, or thinning (osteopenia), which may lead to fractures.
  • Changes in body fat (lipodystrophy).
  • Immune reconstitution inflammatory syndrome (IRIS), a condition that sometimes occurs when the immune system begins to recover after treatment with an HIV medicine. As the immune system gets stronger, it may have an increased response to a previously hidden infection. Tell your health care provider if you start having new symptoms after starting your HIV medicine.

Tell your health care provider if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of tenofovir DF. To learn more about possible side effects of tenofovir DF, read the drug label or package insert or talk to your health care provider or pharmacist.

The AIDSinfo fact sheet on HIV Medicines and Side Effects also includes information that may apply to tenofovir DF.

You can also report side effects to FDA at 1-800-FDA-1088 (1-800-332-1088) or online at https://www.accessdata.fda.gov/scripts/medwatch/.

How should tenofovir disoproxil fumarate be stored?

  •  Store tenofovir DF at room temperature, 6859°F to 7786°F (2015°C to 2530°C).
  • Do not use tenofovir DF[drug] if the original seal over the bottle opening is broken or missing.
  • Keep tenofovir DF in the original container.
  • Keep the original container tightly closed.
  • Throw away tenofovir DF that is no longer needed or expired (out of date). Follow FDA guidelines on how to safely dispose of unused medicine.
  • Keep tenofovir DF and all medicines out of reach of children.

Where can I find more information about tenofovir disoproxil fumarate?

More information about tenofovir DF is available:

Manufacturer Information

Gilead Sciences, Inc.
800-445-3235

The above Patient Version drug summary is based on the following FDA label(s): Powder, tablet (coated).

Last Reviewed: May 21, 2015

Last Updated: May 21, 2015


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