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What is efavirenz/emtricitabine/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.

Precautions

Instructions

Side-effects

Interactions

Precautions

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.

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).

Avoid drinking alcohol, which can increase some of the side effects of this medication.

Avoid using other medicines that make you sleepy (such as cold medicine, pain medication, muscle relaxers, and medicine for seizures, depression or anxiety). They can add to sleepiness caused by efavirenz, emtricitabine, and tenofovir.

This medication can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert.

Taking this medication will not prevent you from passing HIV to other people through unprotected sex or sharing of needles. Talk with your doctor about safe methods of preventing HIV transmission during sex, such as using a condom and spermicide. 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 efavirenz, emtricitabine, and 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.

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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:

• unusual muscle pain and weakness, trouble breathing, fast or uneven heartbeat, vomiting, and numbness or cold feeling in your arms or legs;
• nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
• urinating less than usual or not at all;
• increased thirst and urination, loss of appetite, weakness, constipation;
• fever, chills, body aches, flu symptoms;
• unusual thoughts or behavior, severe depression, extreme fear, thoughts of hurting yourself or others, hallucinations;
• a red, blistering, peeling skin rash; or
• seizure (convulsions).

Other, less serious side effects are more likely to occur, such as:

• dizziness, drowsiness, anxiety, weakness, ringing in your ears, vision problems;
• sleep problems (insomnia), confusion, strange dreams, forgetfulness;
• mild nausea, vomiting, diarrhea, or constipation;
• darkened skin on the palms of your hands or the soles of your feet;
• joint or muscle pain;
• numbness or tingly feeling;
• runny or stuffy nose, cough; or
• changes in the shape or location of body fat (especially in your arms, legs, face, neck, breasts, and waist).

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.

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Interactions

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

Drugs that can interact with efavirenz, emtricitabine, and tenofovir include:

• acyclovir (Zovirax), ganciclovir (Cytovene), valacyclovir (Valtrex), or valganciclovir (Valcyte);
• St. John's wort;
• sertraline (Zoloft);
• methadone (Methadose);
• birth control pills;
• adefovir (Hepsera) or cidofovir (Vistide);
• a blood thinner such as warfarin (Coumadin);
• cholesterol medications such as atorvastatin (Lipitor), pravastain (Pravachol), or simvastatin (Zocor);
• antibiotics such as clarithromycin (Biaxin), itraconazole (Sporanox), ketoconazole (Nizoral), rifabutin (Mycobutin), rifampin (Rifater, Rifamate);
• seizure medicines such as carbamazepine (Tegretrol, Carbatrol), phenytoin (Dilantin), phenobarbital (Luminal, Solfoton); or
• certain other HIV medicines such as amprenavir (Agenerase), didanosine (Videx), indinavir (Crixivan), saquinavir (Invirase), lopinavir/ritonavir (Kaletra), fosamprenavir (Lexiva), ritonavir (Norvir), atazanavir (Reyataz), or nelfinavir (Viracept).

If you are using any of these drugs, you may not be able to take efavirenz, emtricitabine, and tenofovir, or you may need dosage adjustments or special tests during treatment.

There may be other drugs not listed that can affect 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.

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