Efavirenz/emtricitabine/tenofovir (By mouth)

Brand Name(s)

Atripla

There may be other brand names for this medicine.

Introduction

Efavirenz (ef-a-VYE-renz), Emtricitabine (em-trye-SYE-ta-been), Tenofovir Disoproxil Fumarate (ten-OF-oh-vir dye-soe-PROX-il FUE-ma-rate)

Used alone or with other medicines to treat human immunodeficiency virus (HIV) infection. HIV causes acquired immune deficiency syndrome (AIDS). This medicine does not cure HIV or AIDS, but it may slow the worsening of the disease.

When This Medicine Should Not Be Used

You should not use this medicine if you have had an allergic reaction to efavirenz, emtricitabine, tenofovir, Complera?, Emtriva®, Sustiva®, Truvada®, or Viread®. You should not use this medicine if you are pregnant or if you are also using any medicine that contains lamivudine (such as Combivir®, Epivir®, Epivir-HBV®, Epzicom?, or Trizivir®). You should not use this medicine if you are using adefovir (Hepsera®), bepridil (Vascor®), cisapride (Propulsid®), midazolam (Versed®), pimozide (Orap®), triazolam (Halcion®), voriconazole (Vfend®), St. John's wort, or ergotamine medicines (such as dihydroergotamine, ergonovine, ergotamine, methylergonovine, Cafergot®, Ergomar®, or Wigraine®).

How to Use This Medicine

Tablet

• Your doctor will tell you how much of this medicine to use and how often. Do not use more medicine or use it more often than your doctor tells you to.
• It is best to take this medicine on an empty stomach.
• Take this medicine at the same time each day, preferably at bedtime.
• Keep taking this medicine for the full time of treatment, even if you begin to feel better. Do not change or stop using this medicine without checking first with your doctor. When your supply of this medicine is running low, contact your doctor or pharmacist ahead of time. Do not allow yourself to run out of this medicine.
• This medicine comes with patient instructions. Read and follow these instructions carefully. Ask your doctor or pharmacist if you have any questions.

If a dose is missed:

• If you miss a dose or forget to use your medicine, use it as soon as you can. If it is almost time for your next dose, wait until then to use the medicine and skip the missed dose. Do not use extra medicine to make up for a missed dose.

Warnings While Using This Medicine

• Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant. You should not become pregnant while you are taking this medicine and for 12 weeks after stopping it. Some birth control pills may not work as well while you are using this medicine. Use birth control pills together with another form of birth control, such as a condom, diaphragm, or contraceptive foam or jelly. If you think you have become pregnant while using the medicine, tell your doctor right away.
• You should not breast feed if you have HIV or AIDS, because you may give the infection to your baby through your breast milk.
• Make sure your doctor knows if you have liver disease (especially hepatitis B or C infection), kidney disease, bone problems, or any history of seizures, mental illness, emotional problems, or drug abuse. Tell your doctor if you are currently using alcohol or any illegal ("street") drugs.
• Two rare but serious reactions to this medicine are lactic acidosis (too much acid in the blood) and liver toxicity, including an enlarged liver. These are more common if you are female, very overweight (obese), or have been taking anti-HIV medicines for a long time. Call your doctor right away if you have abdominal or stomach discomfort; cramping, nausea, vomiting, diarrhea, or a decreased appetite; muscle cramping or pain; unusual tiredness or weakness; trouble with breathing; or yellow skin or eyes.
• This medicine may increase your risk of having serious mental or behavioral problems. Tell your doctor if you develop any mood changes, strange thoughts, or any unusual behavior while you are using this medicine.
• This medicine may also increase your risk of developing fractures (broken bones). Ask your doctor about this if you have any concerns.
• Some people who have used this medicine developed serious skin problems. Stop using this medicine and tell your doctor right away if you notice a severe skin rash; blistering, peeling, or loosening of the skin; red skin lesions; sores or ulcers on the skin; or fever or chills while you are using this medicine.
• When you start taking HIV medicines, your immune system may get stronger. If you already have infections that are hidden in your body, such as pneumonia or tuberculosis, you may notice new symptoms when your body tries to fight them. If this occurs, be sure to tell your doctor.
• This medicine may cause you to have excess body fat. Tell your doctor if you notice changes in your body shape, such as an increased amount of fat in the upper back and neck, or around the chest and stomach area. You might also lose fat from the legs, arms, and face.
• Make sure any doctor or dentist who treats you knows that you are using this medicine. This medicine may affect the results of certain medical tests.
• This medicine will not keep you from giving HIV to your partner during sex. Make sure you understand and practice safe sex, even if your partner also has HIV. Do not share needles with anyone.
• Your doctor will need to check your blood at regular visits while you are using this medicine. Be sure to keep all appointments.
• This medicine may make you dizzy, lightheaded, or drowsy. Avoid driving, using machines, or doing anything else that could be dangerous if you are not alert.

Possible Side Effects While Using This Medicine

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Blistering, peeling, or red skin rash.
• Change in how much or how often you urinate.
• Dark-colored urine or pale stools.
• Extreme weakness, tiredness, or confusion.
• Fast or pounding heartbeat.
• Fever, chills, cough, runny or stuffy nose, sore throat, and body aches.
• Lightheadedness, dizziness, or drowsiness.
• Numbness, tingling, or burning pain in your hands, arms, legs, or feet.
• Seizures or tremors.
• Severe depression, confusion, anger, or thoughts of hurting yourself or others.
• Sudden and severe stomach pain, nausea, or vomiting.
• Trouble breathing.
• Unusual tiredness or weakness.
• Yellowing of your skin or the whites of your eyes.

If you notice these less serious side effects, talk with your doctor:

• Bone, joint, or muscle pain.
• Gaining weight around your neck, upper back, breast, face, or waist.
• Headache.
• Loss of appetite.
• Mild nausea, vomiting, diarrhea, constipation, or upset stomach.
• Mild skin rash, itching, or change in skin color.
• Mood changes, anxiety, nervousness, or memory problems.
• Trouble sleeping or unusual dreams.

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088

How to Store and Dispose of This Medicine

• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.
• Ask your pharmacist, doctor, or health caregiver about the best way to dispose of any outdated medicine or medicine no longer needed.
• Keep all medicine away from children and never share your medicine with anyone.

Drugs and Foods to Avoid

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• There are many other medicines that you should not use together with efavirenz, emtricitabine, or tenofovir combination. Make sure your doctor knows about all other medicines you are using.
• Make sure your doctor knows if you are using other medicines to treat HIV/AIDS (such as acyclovir, amprenavir, atazanavir, cidofovir, didanosine, fosamprenavir, ganciclovir, indinavir, lopinavir, maraviroc, nelfinavir, ritonavir, saquinavir, valacyclovir, valganciclovir, Agenerase®, Crixivan®, Cytovene®, Fortovase®, Invirase®, Kaletra®, Reyataz®, Selzentry®, Valcyte?, Valtrex®, Videx®, Videx® EC, Viracept®, Vistide®, or Zovirax®). Tell your doctor if you are using clarithromycin (Biaxin®), methadone (Dolophine®), rifabutin (Mycobutin®), rifampin (Rifadin®), sertraline (Zoloft®), or a blood thinner (such as warfarin, Coumadin®).
• Tell your doctor if you are also using cyclosporine (Gengraf®, Neoral®, Sandimmune®), sirolimus (Rapamune®), tacrolimus (Prograf®), medicine to treat seizures (such as carbamazepine, phenobarbital, phenytoin, Dilantin®, or Tegretol®), medicine to lower cholesterol (such as atorvastatin, pravastatin, simvastatin, Lipitor®, Pravachol®, or Zocor®), or medicine to treat a fungal infection (such as itraconazole, ketoconazole, posaconazole, Nizoral®, Noxafil®, or Sporanox®). Make sure your doctor knows if you are also using certain blood pressure medicines (such as diltiazem, felodipine, nicardipine, nifedipine, verapamil, Adalat®, Calan®, Cardene®, Cardizem®, Covera HS®, Isoptin®, Plendil®, Procardia®, Tiazac®, or Verelan®), an estrogen hormone replacement or birth control pill (such as ethinyl estradiol, norgestimate, Estinyl®, Ortho-Cyclen®, or Ortho Tri-Cyclen®), or birth control implant (such as etonogestrel, Implanon?).
• Do not drink alcohol while you are using this medicine.