efavirenz, emtricitabine, and tenofovir

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Pronunciation: ef AV ir enz, em trye SYE ta been, and ten OF oh vir

Brand: Atripla

What is the most important information I should know about this medicine?

Do not take Atripla together with adefovir, atazanavir, voriconazole, or any medications that contain emtricitabine, lamivudine, or tenofovir.

Many drugs can interact with Atripla, and some drugs should not be used together. Tell your doctor about all your current medicines and any you start or stop using while you are taking Atripla.

Atripla may cause a serious condition called lactic acidosis. Get emergency medical help if you have even mild symptoms 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.

This medication can also cause severe or fatal liver problems. Call your doctor at once if you have symptoms such as nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

What is efavirenz, emtricitabine, and tenofovir (Atripla)?

Atripla is a combination antiviral medication that prevents human immunodeficiency virus (HIV) from reproducing in your body.

Atripla is used to treat HIV, the virus that can cause acquired immunodeficiency syndrome (AIDS). Atripla is not a cure for HIV or AIDS. Atripla is for use in adults and children who are at least 12 years old.

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

What should I discuss with my healthcare provider before taking Atripla?

You should not take this medicine if you are allergic to efavirenz (Sustiva), emtricitabine (Emtriva), or tenofovir (Viread).

Do not take Atripla together with adefovir (Hepsera), atazanavir (Reyataz), voriconazole (Vfend), or a combination medicine that contains emtricitabine, lamivudine, or tenofovir (Combivir, Complera, Descovy, Epivir, Epzicom, Genvoya, Odefsey, Stribild, Trizivir, Truvada, Vemlidy).

This medication should not be used in children weighing less than 88 pounds.

To make sure Atripla is safe for you, tell your doctor if you have:

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

Some people taking Atripla develop a serious condition called lactic acidosis. This may be more likely in women, in people who are overweight or have liver disease, and in people who have taken HIV/AIDS medication for a long time. Talk with your doctor about your risk.

Atripla can cause birth defects. Do not use if you are pregnant, and do not get pregnant for at least 12 weeks after you stop taking Atripla. Use two barrier forms of birth control (condom or diaphragm with spermicide) to prevent pregnancy. Hormonal contraception (birth control pills, injections, implants, skin patches, and vaginal rings) may not be effective enough to prevent pregnancy while you are taking Atripla. Keep using barrier birth control during treatment and for at least 12 weeks after you stop taking Atripla.

HIV can be passed to your baby if you are not properly treated during pregnancy. Take all of your HIV medicines as directed to control your infection.

Women with HIV or AIDS should not breast-feed a baby. Even if your baby is born without HIV, the virus may be passed to the baby in your breast milk.

How should I take Atripla?

Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended.

Take this medication on an empty stomach at bedtime.

While using Atripla, you may need frequent blood tests. Your liver function may also need to be tested.

This medication can cause you to have a false positive drug screening test. If you provide a urine sample for drug screening, tell the laboratory staff that you are taking Atripla.

Store in the original container at room temperature, away from moisture, heat, and light. Keep the bottle tightly closed when not in use.

If you have hepatitis B you may develop liver symptoms after you stop taking Atripla, even months after stopping. Your doctor may want to check your liver function for several months after you stop using Atripla.

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. Overdose symptoms may include uncontrolled muscle movements.

What should I avoid while taking Atripla?

This medication may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

Taking this medication will not prevent you from passing HIV to other people. Do not have unprotected sex or share razors or toothbrushes. Talk with your doctor about safe ways to prevent HIV transmission during sex. Sharing drug or medicine needles is never safe, even for a healthy person.

What are the possible side effects of Atripla?

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Early symptoms of lactic acidosis may get worse over time and this condition can be fatal. Get emergency medical help if you have even mild symptoms: 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:

  • unusual thoughts or behavior, anger, severe depression, thoughts of hurting yourself or others, hallucinations;
  • a seizure (convulsions);
  • kidney problems --increased thirst and urination, muscle pain or weakness;
  • liver problems --nausea, upper stomach pain, itching, tiredness, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes); or
  • severe skin reaction --fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.

Atripla may increase your risk of certain infections or autoimmune disorders by changing the way your immune system works. Symptoms may occur weeks or months after you start treatment with Atripla. Tell your doctor if you have:

  • signs of a new infection--fever, night sweats, swollen glands, mouth sores, cold sores, sores on your genital or anal area, diarrhea, stomach pain, weight loss;
  • chest pain (especially when you breathe), dry cough, wheezing, feeling short of breath;
  • rapid heart rate, feeling anxious or irritable, weakness or prickly feeling, problems with balance or eye movement;
  • trouble speaking or swallowing, severe lower back pain, loss of bladder or bowel control; or
  • swelling in your neck or throat (enlarged thyroid), menstrual changes, impotence, loss of interest in sex.

Common side effects may include:

  • dizziness, drowsiness, tired feeling;
  • nausea, diarrhea;
  • headache, depressed mood, trouble concentrating;
  • sleep problems (insomnia), strange dreams;
  • rash; 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.

What other drugs will affect efavirenz, emtricitabine, and tenofovir?

This medicine can harm your kidneys. This effect is increased when you also use certain other medicines, including: antivirals, chemotherapy, injected antibiotics, medicine for bowel disorders, medicine to prevent organ transplant rejection, and some pain or arthritis medicines (including aspirin, Tylenol, Advil, and Aleve).

Many drugs can interact with Atripla, and some drugs should not be used together. Your doctor may need to change your treatment plan if you are taking any of the following drugs:

  • clarithromycin (Biaxin), methadone, St. John's wort;
  • an antidepressant --bupropion (Wellbutrin, Zyban), sertraline (Zoloft);
  • antifungal medicine --itraconazole, posaconazole, voriconazole;
  • any other HIV medicines --darunavir, didanosine, efavirenz, indinavir, lopinavir, maraviroc, ritonavir, saquinavir;
  • cholesterol medication --atorvastatin (Lipitor), pravastatin, simvastatin (Zocor);
  • heart or blood pressure medication --diltiazem, verapamil;
  • medicine to prevent organ transplant rejection --cyclosporine, sirolimus, tacrolimus;
  • medicine to treat hepatitis --boceprevir (Victrelis), ledipasvir/sofosbuvir (Harvoni), simeprevir (Olysio), sofosbuvir/velpatasvir (Epclusa);
  • seizure medicine --carbamazepine, phenobarbital, phenytoin; or
  • tuberculosis medications --rifabutin, rifampin.

This list is not complete and many other drugs can interact with Atripla. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide. Tell your doctor about all medicines you use, and those you start or stop using during your treatment with Atripla. Give a list of all your medicines to any healthcare provider who treats you.

Where can I get more information?

Your pharmacist can provide more information about efavirenz, emtricitabine, and tenofovir (Atripla).

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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