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emtricitabine and tenofovir

Pronunciation: em trye SYE ta been and ten OF oh vir

Brand: AccessPak for HIV PEP Basic, Truvada

Truvada

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

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You should not take this medication if you are allergic to emtricitabine (Emtriva) or tenofovir (Viread). Do not take emtricitabine and tenofovir if you also take Atripla, Combivir, Complera, Emtriva, Epivir, Epzicom, Hepsera, Trizivir, or Viread.

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Some people develop lactic acidosis while taking emtricitabine and tenofovir. Early symptoms may get worse over time and this condition can be fatal. 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, vomiting, fast or uneven heart rate, or feeling very weak or tired.

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Emtricitabine and tenofovir can cause severe or fatal liver problems. Call your doctor at once if you have symptoms such as nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

What is emtricitabine and tenofovir?

Emtricitabine and tenofovir are antiviral drugs that work by preventing HIV (human immunodeficiency virus) cells from multiplying in the body.

The combination of emtricitabine and tenofovir is used to treat HIV, which causes acquired immunodeficiency syndrome (AIDS). Emtricitabine and tenofovir is not a cure for HIV or AIDS.

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

Emtricitabine and tenofovir may also be used for purposes not listed in this medication guide.

What should I discuss with my healthcare provider before taking emtricitabine and tenofovir?

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

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

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Do not take emtricitabine and tenofovir 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 you can safely take emtricitabine and tenofovir, tell your doctor if you have other medical conditions, especially:

  • liver or kidney disease;
  • osteopenia (low bone mineral density); or
  • if you also have hepatitis B infection.
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Some people develop a life-threatening condition called lactic acidosis while taking emtricitabine and tenofovir. You may be more likely to develop lactic acidosis if you are overweight or have liver disease, if you are a woman, or if you have taken HIV or AIDS medications for a long time. Talk with your doctor about your individual risk.

FDA pregnancy category B. Emtricitabine and tenofovir is not expected to be harmful to 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. Tell your doctor if you are pregnant or plan to become pregnant during treatment.

If you are pregnant, your name may be listed on a pregnancy registry. This is to track the outcome of the pregnancy and to evaluate any effects of emtricitabine and tenofovir on the baby.

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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.

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

How should I take emtricitabine and tenofovir?

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

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

To be sure this medication is helping your condition and not causing harmful effects, your blood will need to be tested often. Your kidney and liver function or bone density may also need to be tested. Visit your doctor regularly.

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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 emtricitabine and tenofovir. Visit your doctor regularly.

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.

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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?

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

What should I avoid while taking emtricitabine and tenofovir?

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Taking this medication will not prevent you from passing HIV to other people. Avoid having unprotected sex or sharing 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.

What are the possible side effects of emtricitabine and tenofovir?

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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.

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This medication may cause lactic acidosis (a build-up of lactic acid in the body, which can be fatal). Lactic acidosis can start slowly and get worse over time. 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, vomiting, fast or uneven heart rate, or feeling very weak or tired.

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

  • rapid heart rate, increased sweating, tremors, sleep problems (insomnia), feeling anxious or irritable;
  • severe diarrhea, unexplained weight loss, menstrual changes, impotence, loss of interest in sex;
  • swelling in your neck or throat (enlarged thyroid), feeling short of breath;
  • weakness or prickly feeling in your fingers or toes, joint pain;
  • problems with balance or eye movement, trouble speaking or swallowing;
  • severe lower back pain, loss of bladder or bowel control;
  • signs of new infection such as fever, chills, skin lesions, or cough with yellow or green mucus; or
  • signs of liver damage - nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Less serious side effects may include:

  • mild diarrhea. mild nausea or stomach pain;
  • headache, 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.

What other drugs will affect emtricitabine and tenofovir?

Emtricitabine and tenofovir can harm your kidneys. This effect is increased when you also use other medicines harmful to the kidneys. You may need dose adjustments or special tests if you have recently used:

  • medicines to treat a bowel disorder;
  • medication to prevent organ transplant rejection;
  • antiviral medications;
  • chemotherapy;
  • pain or arthritis medicines; or
  • any injected antibiotics.

Other medications that can affect emtricitabine and tenofovir include:

  • the herpes medications acyclovir (Zovirax) or valacyclovir (Valtrex);
  • medications to treat cytomegalovirus (CMV) such as cidofovir (Vistide), ganciclovir (Cytovene) or valganciclovir (Valcyte); or
  • certain other HIV medicines such as atazanavir (Reyataz), didanosine (Videx), or ritonavir (Kaletra, Norvir).

This list is not complete and other drugs may interact with emtricitabine and tenofovir. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

Where can I get more information?

Your pharmacist can provide more information about emtricitabine and tenofovir.


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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