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

There are many other medicines that can cause interactions or serious medical problems if you take them together with efavirenz, emtricitabine, and 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.

Do not use this medication if you are taking astemizole (Hismanal), cisapride (Propulsid), midazolam (Versed) or triazolam (Halcion), voriconazole (Vfend), or an ergot medicine such as methysergide (Sansert), ergotamine (Ergostat, Medihaler, Cafergot, Ercaf, Wigraine), dihydroergotamine mesylate (D.H.E., Migranal Nasal Spray). Do not take other medicines that also contain efavirenz, emtricitabine, or tenofovir (such as Sustiva, Emtriva, Truvada, or Viread). Do not take other medicines that contain lamivudine (such as Combivir, Epivir, Epzicom, or Trizivir). This medication may cause lactic acidosis (the build-up of lactic acid in the body). Symptoms include unusual muscle pain and weakness, trouble breathing, fast or uneven heartbeat, nausea, vomiting, stomach pain, and numbness or cold feeling in your arms or legs. Contact your doctor at once if you have any of these symptoms, even if they are only mild. Early signs of lactic acidosis generally get worse over time and this condition can be fatal. Efavirenz, emtricitabine, and tenofovir can cause severe or fatal liver problems. Symptoms include nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes). Call your doctor at once if you have any of these symptoms.

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.

What is efavirenz, emtricitabine, and tenofovir?

Efavirenz, emtricitabine, and tenofovir is an antiviral medication that prevents human immunodeficiency virus (HIV) from reproducing in your body.

Efavirenz, emtricitabine, and tenofovir treats HIV, which causes acquired immunodeficiency syndrome (AIDS). Efavirenz, emtricitabine, and tenofovir is not a cure for HIV or AIDS.

Efavirenz, emtricitabine, and tenofovir may also be used for purposes other than those listed in this medication guide.

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

Do not use this medication if you are taking any of the following drugs:

• astemizole (Hismanal);

• cisapride (Propulsid);

• lamivudine (Combivir, Epivir, Epzicom, or Trizivir);

• midazolam (Versed) or triazolam (Halcion);

• voriconazole (Vfend); or

• an ergot medicine such as methysergide (Sansert), ergotamine (Ergostat, Medihaler, Cafergot, Ercaf, Wigraine), dihydroergotamine mesylate (D.H.E., Migranal Nasal Spray); or

• any other medicines that also contain efavirenz, emtricitabine, or tenofovir (such as Sustiva, Emtriva, Truvada, or Viread).

Some of these medicines can cause life-threatening interactions if you take them with efavirenz, emtricitabine, and tenofovir.

Before taking this medication, tell your doctor if you have:

• liver disease;
• kidney disease;

• a history of mental illness, use of antipsychotic medication, or injection drug use;

• epilepsy or other seizure disorder;

• bone problems; or

• hepatitis B (HBV) infection.

If you have any of these conditions, you may not be able to use efavirenz, emtricitabine, and tenofovir, or you may need a dosage adjustment or special tests during treatment.

FDA pregnancy category D. This medication can cause harm to an unborn baby. Do not use the medication without your doctor's consent if you are pregnant. 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 a pregnancy patient registry when you start using this medication.

You should not breast-feed while you are using efavirenz, emtricitabine, and 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. This medication may cause lactic acidosis (the build up of lactic acid in the body). Lactic acidosis symptoms can start slowly and gradually get worse. Symptoms include unusual muscle pain and weakness, trouble breathing, fast or uneven heart rate, nausea, vomiting, stomach pain, and numbness or cold feeling in your arms or legs. Contact your doctor at once if you have any of these symptoms, even if they are only mild. Early signs of lactic acidosis generally get worse over time and this condition can be fatal.