Generic Name: emtricitabine and tenofovir (EM trye SYE ta been and ten OF oh vir )
Brand Names: AccessPak for HIV PEP Basic, Truvada

What is Truvada?

Truvada contains a combination of emtricitabine and tenofovir. Emtricitabine and tenofovir are antiviral drugs that work by preventing HIV (human immunodeficiency virus) cells from multiplying in the body.

Truvada is used to treat HIV, which causes acquired immunodeficiency syndrome (AIDS). This medicine is not a cure for HIV or AIDS.

Truvada is also used together with safer-sex practices to reduce the risk of becoming infected with HIV. You must be HIV-negative to use Truvada for this purpose. This medication may not provide protection from disease in every person.

Important information

Do not take Truvada if you also take other medicines that contain emtricitabine, tenofovir, lamivudine, or adefovir (this includes Atripla, Combivir, Complera, Emtriva, Epivir, Epzicom, Hepsera, Stribild, Trizivir, and Viread).

Slideshow: Flashback: FDA Drug Approvals 2013

Truvada is sometimes used to reduce the risk of becoming infected with HIV. You must be HIV-negative to use Truvada for this purpose.

This medicine may cause a serious condition called lactic acidosis. Get emergency medical help if you have even mild symptoms such as: muscle pain or weakness, numb or cold feeling in your arms and legs, trouble breathing, stomach pain, nausea with vomiting, fast or uneven heart rate, dizziness, or feeling very weak or tired.

If you have hepatitis B you may develop liver symptoms after you stop taking this medication, even months after stopping.

Before taking this medicine

You should not take Truvada if you are allergic to emtricitabine or tenofovir. Do not take Truvada if you also take other medicines that contain emtricitabine, tenofovir, lamivudine, or adefovir (this includes Atripla, Combivir, Complera, Emtriva, Epivir, Epzicom, Hepsera, Stribild, Trizivir, and Viread).

If you use Truvada to reduce your risk of HIV infection: You must have a negative HIV test immediately before you start taking the medicine. An HIV test is also required every 3 months during treatment.

Do not take Truvada to reduce infection risk if you are HIV-positive, if have been exposed to HIV within the past month, or if you had any symptoms (such as fever, night sweats, swollen glands, diarrhea, body aches).

To make sure Truvada is safe for you, tell your doctor if you have:

  • liver or kidney disease;

  • osteopenia (low bone mineral density); or

  • if you also have hepatitis B infection.

Some people taking this medicine develop a serious condition called lactic acidosis. This may be more likely in women, in people who are overweight or have liver disease, and in people who have taken HIV/AIDS medication for a long time. Talk with your doctor about your risk.

FDA pregnancy category B. Truvada is not expected to harm an unborn baby. However, HIV can be passed to your baby if you are not properly treated during pregnancy. Take all of your HIV medicines as directed to control your infection.

See also: Pregnancy and breastfeeding warnings (in more detail)

You should not breast-feed while you are using this medication to treat or prevent HIV. Women with HIV or AIDS should not breast-feed a baby. Even if your baby is born without HIV, the virus may be passed to the baby in your breast milk.

This medication should not be given to a child younger than 12 years old, or weighing less than 77 pounds.

How should I take Truvada?

Take Truvada exactly as prescribed by your doctor. Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended.

While using this medicine, you may need frequent blood tests. Your kidney and liver function, or bone mineral density may also need to be checked.

Use Truvada regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.

If you have hepatitis B you may develop liver symptoms after you stop taking this medication, even months after stopping. Your doctor may want to check your liver function for several months after you stop using Truvada.

HIV/AIDS is usually treated with a combination of drugs. Use all medications as directed by your doctor. Read the medication guide or patient instructions provided with each medication. Do not change your doses or medication schedule without your doctor's advice. Every person with HIV or AIDS should remain under the care of a doctor.

Store in the original container at room temperature, away from moisture and heat.

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid?

Taking this medication will not prevent you from passing HIV to other people. Do not have unprotected sex or share razors or toothbrushes. Talk with your doctor about safe ways to prevent HIV transmission during sex. Sharing drug or medicine needles is never safe, even for a healthy person.

Truvada side effects

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

Early symptoms of lactic acidosis may get worse over time and this condition can be fatal. Get emergency medical help if you have even mild symptoms: muscle pain or weakness, numb or cold feeling in your arms and legs, trouble breathing, stomach pain, nausea with vomiting, fast or uneven heart rate, dizziness, or feeling very weak or tired.

Call your doctor at once if you have swelling, rapid weight gain, and little or no urinating.

Truvada may increase your risk of certain infections or autoimmune disorders by changing the way your immune system works. Symptoms may occur weeks or months after you start treatment with Truvada. Tell your doctor if you have:

  • signs of a new infection--fever, night sweats, swollen glands, mouth sores, diarrhea, stomach pain, weight loss;

  • chest pain (especially when you breathe), dry cough, wheezing, feeling short of breath;

  • cold sores, sores on your genital or anal area;

  • rapid heart rate, feeling anxious or irritable, weakness or prickly feeling, problems with balance or eye movement;

  • trouble speaking or swallowing, severe lower back pain, loss of bladder or bowel control; or

  • swelling in your neck or throat (enlarged thyroid), menstrual changes, impotence, loss of interest in sex.

Common Truvada side effects may include:

  • headache, mild dizziness, depressed mood;

  • strange dreams;

  • mild itching or skin rash; or

  • changes in the shape or location of body fat (especially in your arms, legs, face, neck, breasts, and waist).

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.

See also: Side effects (in more detail)

What other drugs will affect Truvada?

Truvada can harm your kidneys. This effect is increased when you also use certain other medicines, including: antivirals, chemotherapy, injected antibiotics, medicine for bowel disorders, medicine to prevent organ transplant rejection, injectable osteoporosis medications, and some pain or arthritis medicines (including aspirin, Tylenol, Advil, and Aleve).

Other drugs may interact with emtricitabine and tenofovir, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.

Where can I get more information?

  • Your pharmacist can provide more information about Truvada.
  • Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use Truvada only for the indication prescribed.
  • 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.

Copyright 1996-2014 Cerner Multum, Inc. Version: 9.01. Revision Date: 2013-07-16, 2:32:57 PM.

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