Tenofovir

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What is the most important information I should know about tenofovir?

Do not take other medicines that also contain tenofovir (such as Truvada).

Some people have developed a life-threatening condition called lactic acidosis while taking tenofovir. Early signs of lactic acidosis generally get worse over time and this condition can be fatal. Get emergency medical help if you have even mild symptoms of lactic acidosis, such as: muscle pain or weakness, numb or cold feeling in your arms and legs, trouble breathing, stomach pain, nausea with vomiting, slow or uneven heart rate, dizziness, or feeling very weak or tired.

Tenofovir can also cause severe or fatal liver problems. Symptoms include nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, or jaundice (yellowing of the skin or eyes). Call your doctor at once if you have any of these symptoms.

If you have hepatitis B you may develop liver symptoms after you stop taking tenofovir, even months after stopping. Your doctor may want to check your liver function on a regular basis for several months after you stop using this medication. Do not miss any scheduled visits.

HIV/AIDS is usually treated with a combination of different drugs. To best treat your condition, use all of your medications as directed by your doctor. Do not change your doses or medication schedule without advice from your doctor. Every person with HIV or AIDS should remain under the care of a doctor.

Warning

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

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What is tenofovir?

Tenofovir is an antiviral medication that prevents human immunodeficiency virus (HIV) cells from multiplying in your body.

Tenofovir is used to treat HIV, which causes the acquired immunodeficiency syndrome (AIDS). Tenofovir is not a cure for HIV or AIDS. Tenofovir is also used to treat chronic hepatitis B.

Tenofovir may also be used for other purposes not listed in this medication guide.

Precautions

Do not use this medication if you have ever had an allergic reaction to a medicine containing tenofovir, including Truvada.

You should not take tenofovir if you are also taking Truvada (emtricitabine/tenofovir) or adefovir (Hepsera).

If you have certain conditions, you may need a dose adjustment or special tests to safely use this medication. Before taking tenofovir, tell your doctor if you are allergic to any drugs, or if you have:

liver disease (including hepatitis B);
kidney disease; or
bone problems (such as osteopenia).

Some people have developed a life-threatening condition called lactic acidosis while taking tenofovir. You may be more likely to develop lactic acidosis if you have liver or kidney disease, congestive heart failure, or if you drink large amounts of alcohol. Talk with your doctor about your individual risk.

FDA pregnancy category B. This medication is not expected to be harmful to an unborn baby, but HIV can be passed to the baby if the mother is not properly treated during pregnancy. Tell your doctor if you are pregnant or plan to become pregnant during treatment. Take all of your HIV medicines as directed to control your infection while you are pregnant.

Your name may need to be listed on an antiviral pregnancy registry when you start using tenofovir. The purpose of this registry is to track the outcome of the pregnancy and delivery to evaluate whether tenofovir had any effect on the baby.

You should not breast-feed while you are using tenofovir. Women with HIV or AIDS should not breast-feed at all. Even if your baby is born without HIV, you may still pass the virus to the baby in your breast milk.

Tenofovir should not be given to a child unless your doctor has told you otherwise.

Avoid drinking alcohol while taking tenofovir. Alcohol may increase the risk of damage to the liver.

Avoid having unprotected sex or sharing needles, razors, or toothbrushes. Taking this medication will not prevent you from passing HIV to other people. Talk with your doctor about safe methods of preventing HIV transmission during sex. Sharing drug or medicine needles is never safe, even for a healthy person.

Instructions

Seek emergency medical attention if you think you have used too much of this medicine. Symptoms of an tenofovir overdose are not known.

Take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the medicine at the next regularly scheduled time. Do not take extra medicine to make up the missed dose.

Side Effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

liver damage - nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
lactic acidosis - muscle pain or weakness, numb or cold feeling in your arms and legs, dizziness, trouble breathing, stomach pain, nausea with vomiting, slow or uneven heart rate, dizziness, or feeling very weak or tired;
kidney problems - increased thirst and urination, loss of appetite, weakness, constipation, urinating less than usual or not at all;
fever, chills, body aches, flu symptoms; or
any other signs of new infection.

Less serious side effects may include:

sleep problems (insomnia), strange dreams;
depression, headache, dizziness;
diarrhea, bloating, gas;
muscle or joint pain;
skin rash; or
changes in the shape or location of body fat (especially in your arms, legs, face, neck, breasts, and trunk).

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Interactions

Before taking tenofovir, tell your doctor if you are using any of the following drugs:

amphotericin B (Fungizone, AmBisome, Amphotec, Abelcet);
pentamidine (Nebupent, Pentam);
tacrolimus (Prograf);
antibiotics such as capreomycin (Capastat), rifampin (Rifadin, Rimactane, Rifater), vancomycin (Vancocin, Vancoled);
antiviral medicines such as acyclovir (Zovirax), cidofovir (Vistide), foscarnet (Foscavir), ganciclovir (Cytovene), valacyclovir (Valtrex), or valganciclovir (Valcyte);
aspirin or other NSAIDs (non-steroidal anti-inflammatory drugs) such as ibuprofen (Motrin, Advil), diclofenac (Voltaren), indomethacin, naproxen (Aleve, Naprosyn), piroxicam (Feldene), nabumetone (Relafen), etodolac (Lodine), and others;
cancer medicine such as aldesleukin (Proleukin), carmustine (BiCNU, Gliadel), cisplatin (Platinol), ifosfamide (Ifex), oxaliplatin (Eloxatin), plicamycin (Mithracin), streptozocin (Zanosar), or tretinoin (Vesanoid); or
other HIV or AIDS medications such as atazanavir (Reyataz), didanosine (Videx), lopinavir and ritonavir (Kaletra).

This list is not complete and there are many other medicines that can interact with tenofovir. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor. Keep a list with you of all the medicines you use and show this list to any doctor or other healthcare provider who treats you.

Disclaimer

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.