efavirenz, emtricitabine, and tenofovir

Generic Name: efavirenz, emtricitabine, and tenofovir (ef AV ir enz, em trye SYE ta been, and ten OF oh vir)
Brand Name: Atripla

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 treats HIV in adults and children who are at least 12 years old. HIV causes acquired immunodeficiency syndrome (AIDS). This medication is not a cure for HIV or AIDS.

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

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

Do not take Atripla together with adefovir (Hepsera), or with medications that contain emtricitabine, lamivudine, or tenofovir (Combivir, Complera, Emtriva, Epivir, Epzicom, Stribild, Trizivir, Truvada, Viread).

Some other medicines can cause unwanted or dangerous effects when used with Atripla. Your doctor may need to change your treatment plan if you also use: midazolam, pimozide, St. John's wort, triazolam, voriconazole, or an ergot medicine (dihydroergotamine, ergonovine, ergotamine, methylergonovine).

Slideshow: Debunking The Myths - HIV/Aids Unravelled

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 should I discuss with my healthcare provider before taking Atripla?

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

Do not take Atripla together with adefovir (Hepsera), or with medications that contain emtricitabine, lamivudine, or tenofovir (Combivir, Complera, Emtriva, Epivir, Epzicom, Stribild, Trizivir, Truvada, Viread).

Some medicines can cause unwanted or dangerous effects when used with Atripla. Your doctor may need to change your treatment plan if you are taking any of the following drugs:

  • midazolam or triazolam;

  • pimozide;

  • St. John's wort;

  • voriconazole; or

  • an ergot medicine--dihydroergotamine, ergonovine, ergotamine, methylergonovine.

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;

  • 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.

FDA pregnancy category D. Do not use this medication if you are pregnant. It could harm the unborn baby. Use two forms of birth control, including a barrier form (such as a condom or diaphragm with spermicide) while you are using this medication and for at least 12 weeks after your treatment ends.

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.

Use this medication regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.

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 this medication, 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.

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.

Atripla side effects

Get emergency medical help if you have any of these 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.

Stop using Atripla and call your doctor at once if you have:

  • kidney problems--increased thirst and urination, loss of appetite, constipation, little or no urinating; or

  • sore throat, flu symptoms, easy bruising or unusual bleeding;

  • liver problems--nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

  • unusual thoughts or behavior, anger, severe depression, thoughts of hurting yourself or others, hallucinations, seizure (convulsions); 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, diarrhea, stomach pain, weight loss;

  • chest pain (especially when you breathe), dry cough, wheezing, feeling short of breath;

  • cold sores, sores on your genital or anal area;

  • 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:

  • mild nausea;

  • mild depression;;

  • headache, dizziness, tired feeling, strange dreams; 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.

See also: Side effects (in more detail)

Efavirenz, emtricitabine, and tenofovir dosing information

Usual Adult Dose for HIV Infection:

1 tablet orally once a day

Approved indication: As a complete regimen or in combination with other antiretroviral agents for the treatment of HIV-1 infection

Usual Pediatric Dose for HIV Infection:

12 years or older weighing at least 40 kg: 1 tablet orally once a day

Approved indication: As a complete regimen or in combination with other antiretroviral agents for the treatment of HIV-1 infection

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. Not all possible interactions are listed here. Tell your doctor about all your medications and any you start or stop using during treatment with Atripla, especially:

  • a blood thinner--clopidogrel; any other HIV medicines--especially atazanavir, didanosine, efavirenz, lopinavir with ritonavir, or tenofovir.

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. 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.
  • Disclaimer: Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2012 Cerner Multum, Inc. Version: 8.02. Revision Date: 2013-06-16, 11:54:04 PM.

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