Efavirenz-Emtricitabine-Tenofovir Treatment Report

Precautions

Instructions

Side Effects

Interactions

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

• cisapride (Propulsid);
• midazolam (Versed) or triazolam (Halcion);
• St. John's wort;
• voriconazole (Vfend);
• an ergot medicine such as dihydroergotamine (D.H.E. 45, Migranal), ergonovine (Ergotrate), ergotamine (Ergomar), or methylergonovine (Methergine); or
• lamivudine (Combivir, Epivir, Epzicom, or Trizivir); or
• any other medicines that also contain efavirenz, emtricitabine, or tenofovir (such as Sustiva, Emtriva, Truvada, or Viread).

If you have certain conditions, you may need a dose adjustment or special tests to safely use this medication. Before you take efavirenz, emtricitabine, and tenofovir, tell your doctor if you have:

• liver or kidney disease;
• a history of mental illness, use of antipsychotic medication, or injection drug use;
• epilepsy or other seizure disorder;
• osteopenia (low bone mineral density); or
• hepatitis B or C infection.

FDA pregnancy category D. Do not use efavirenz, emtricitabine, and tenofovir if you are pregnant. It could harm the unborn baby. Tell your doctor right away if you become pregnant during treatment.

Use two forms of birth control, including an effective barrier form (such as a condom or diaphragm with spermicide gel or inserts) while taking this medication. Keep using birth control to prevent pregnancy for at least 12 weeks after you stop taking efavirenz, emtricitabine, and tenofovir. It may take that long for the medication to completely clear from your body.

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.

Some people have developed a life-threatening condition called lactic acidosis while taking this medication. 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 certain HIV or AIDS medications for a long time. Talk with your doctor about your individual risk.

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

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.

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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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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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.

Efavirenz, emtricitabine, and tenofovir 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, nausea with vomiting, fast or uneven heart rate, dizziness, or feeling very weak or tired.

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

• signs of liver damage - 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;
• fever, chills, body aches, flu symptoms;
• unusual thoughts or behavior, severe depression, extreme fear, thoughts of hurting yourself or others, hallucinations;
• severe blistering, peeling, and red skin rash; or
• seizure (convulsions).

Less serious side effects may include:

• dizziness, drowsiness, anxiety, depressed mood;
• headache, tired feeling, ringing in your ears, vision problems;
• sleep problems (insomnia), confusion, strange dreams, forgetfulness;
• mild nausea, vomiting, diarrhea, loss of appetite, upset stomach;
• darkened skin on the palms of your hands or the soles of your feet;
• joint pain, back 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).

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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Before using efavirenz, emtricitabine, and tenofovir, tell your doctor if you regularly use other medicines that make you sleepy (such as cold or allergy medicine, sedatives, narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for seizures, depression, or anxiety). They can add to sleepiness caused by 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 if you use any of the following:

• acyclovir (Zovirax), ganciclovir (Cytovene), valacyclovir (Valtrex), or valganciclovir (Valcyte);
• sertraline (Zoloft);
• methadone (Methadose);
• adefovir (Hepsera) or cidofovir (Vistide);
• a blood thinner such as warfarin (Coumadin);
• cholesterol medications such as atorvastatin (Lipitor), pravastatin (Pravachol), or simvastatin (Zocor);
• antibiotics such as clarithromycin (Biaxin), itraconazole (Sporanox), ketoconazole (Nizoral), rifabutin (Mycobutin), rifampin (Rifater, Rifamate);
• a calcium channel blocker such as amlodipine (Norvasc), diltiazem (Tiazac, Cartia, Cardizem), felodipine (Plendil), nifedipine (Procardia, Adalat), verapamil (Calan, Covera, Isoptin, Verelan), and others;
• seizure medicines such as carbamazepine (Tegretol, Carbatrol), phenytoin (Dilantin), phenobarbital (Luminal, Solfoton); or
• certain other HIV medicines such as atazanavir (Reyataz), didanosine (Videx), indinavir (Crixivan), saquinavir (Invirase), lopinavir/ritonavir (Kaletra), fosamprenavir (Lexiva), or ritonavir (Norvir).

This list is not complete and there may be other drugs that can interact 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.

Atripla and efavirenz/emtricitabine/tenofovir

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