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

Some people have developed a life-threatening condition called lactic acidosis while taking entricitabine. 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.

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

Treatment of HIV/AIDS almost always requires using many medicines together. 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.

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.

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 emtricitabine?

Emtricitabine is an antiviral medication. It is in a category of HIV medicines called reverse transcriptase inhibitors. Emtricitabine works by preventing HIV cells from multiplying in the body.

Emtricitabine is used to treat the human immunodeficiency virus (HIV), which causes the acquired immunodeficiency syndrome (AIDS). Emtricitabine is not a cure for HIV or AIDS.

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

Precautions

Do not use this medication if you are allergic to emtricitabine, or if you are also using:

  • emtricitabine and tenofovir (Truvada);
  • efavirenz, emtricitabine, and tenofovir (Atripla); or
  • any medication containing lamivudine (Combivir, Epivir, Epivir-HBV, Epzicom, or Trizivir).

If you have any of these other conditions, you may need a dose adjustment or special tests to safely use emtricitabine:

  • kidney disease;
  • hepatitis B (HBV) infection;
  • tuberculosis;
  • pneumonia; or
  • cytomegalovirus.

Some people have developed a life-threatening condition called lactic acidosis while taking emtricitabine. You may be more likely to develop lactic acidosis if you are overweight or have liver disease, or if you have taken certain HIV or AIDS medications for a long time. Talk with your doctor about your individual risk.

FDA pregnancy category B. This medication is not expected to be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment.

Your name may need to be listed on an antiviral pregnancy registry when you start using this medication.

You should not breast-feed while you are using emtricitabine. 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.

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.

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Instructions

Seek emergency medical attention if you think you have used too much of this medicine.

Symptoms of an emtricitabine overdose are not known.

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

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Side Effects

Stop using emtricitabine and 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.

Emtricitabine 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;
  • feeling dizzy, light-headed, tired, or very weak;
  • stomach pain, nausea with vomiting; or
  • slow or uneven heart rate.

Emtricitabine may also cause severe liver damage, which can be fatal. Call your doctor at once if you have any of these symptoms of liver problems:

  • nausea, stomach pain;
  • loss of appetite;
  • low fever;
  • dark urine;
  • clay-colored stools; or
  • jaundice (yellowing of the skin or eyes).

Early in your treatment with emtricitabine, you may have a flare-up of other infections such as tuberculosis, pneumonia, or cytomegalovirus. Contact your doctor if you develop any possible symptoms of other infections, such as fever, chills, sore throat, cough, flu symptoms, or problems with breathing or vision.

Less serious side effects may include:

  • headache;
  • diarrhea, mild nausea or stomach pain;
  • darkened patches of skin on your palms and/or soles;
  • sleep problems (insomnia);
  • cough, runny nose;
  • skin rash; or
  • change in the shape or location of body fat (especially in the 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.

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Interactions

There may be other drugs that can affect emtricitabine, making it less effective or making side effects more likely to occur. 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.

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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 1996-2004 Cerner Multum, Inc. Version 2.05. Revision date 8/23/04