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This site is intended for US
residents 18 years of age or older.

For Healthcare Professionals

How to Take ATRIPLA

ATRIPLA® (efavirenz/emtricitabine/tenofovir disoproxil fumarate) combines 3 HIV-1 medicines into one pill. Most people may only need to take ATRIPLA as their complete daily HIV-1 regimen. Some people may also need to take other HIV-1 medicines along with ATRIPLA.

One pill once daily
Note: Pill shown is not actual size

On an empty stomach,
with water

Preferably at bedtime, which may make
some side effects less bothersome

How can I remember to take ATRIPLA?

You must be ready to take your HIV medicines as your doctor directs. If you miss doses, you could become resistant to the medicines you are taking. This means your medicines could stop working for you.

Take the exact amount of ATRIPLA your healthcare provider prescribes. Never change the dose on your own. To take ATRIPLA, swallow it with a glass of water. Do not stop this medicine unless your healthcare provider tells you to stop.

When your ATRIPLA supply starts to run low, get more from your healthcare provider or pharmacy. This is very important because the amount of virus in your blood may increase if the medicine is stopped for even a short time. The virus may develop resistance to ATRIPLA and become harder to treat.

In order to help you remember to take your medicine, it helps to establish a reminder that’s part of your routine. This reminder can be something like watching a TV show, opening a book to read before bed, or brushing your teeth.

What if I miss a dose of ATRIPLA?

If you are taking ATRIPLA, you should try to take your medicine at the same time every day. Do not miss a dose of ATRIPLA. However, if you do forget to take ATRIPLA, you should take the missed dose as soon as possible, unless it’s almost time for your next dose. Remember that if you miss a dose of ATRIPLA you should not double the next dose. Instead, carry on with your regular dosing schedule.

What if I take too much ATRIPLA?

If you believe you took more than the prescribed amount of ATRIPLA, contact your local poison control center or emergency room right away.

What if I start new medicine while I take ATRIPLA?

Tell your healthcare provider if you start any new medicine or change how you take old ones. Your doses may need adjustment.

Will my doctor monitor for side effects while I take ATRIPLA?

Your healthcare provider will monitor you for any symptoms you may experience and may want to do blood tests to check for certain side effects while you take ATRIPLA.

Drug Interactions

More Important Safety Information 

IMPORTANT SAFETY INFORMATION

What is the most important information I should know about ATRIPLA?

ATRIPLA can cause serious side effects:

  • Some people who have taken medicines like ATRIPLA (which contains nucleoside analogs) have developed lactic acidosis (build up of an acid in the blood). Lactic acidosis can be a serious medical emergency that can lead to death.

    Call your healthcare provider right away if you get the following signs or symptoms of lactic acidosis:

    • feel very weak or tired
    • have unusual (not normal) muscle pain
    • have trouble breathing
    • have stomach pain with nausea and vomiting
    • feel cold, especially in your arms and legs
    • feel dizzy or lightheaded
    • have a fast or irregular heartbeat
  • Some people who have taken medicines like ATRIPLA have developed serious liver problems (hepatotoxicity), with liver enlargement (hepatomegaly) and fat in the liver (steatosis). In some cases, these liver problems can lead to death.

    Call your healthcare provider right away if you get the following signs or symptoms of liver problems:

    • skin or the white part of your eyes turns yellow (jaundice)
    • urine turns dark
    • bowel movements (stools) turn light in color
    • don’t feel like eating food for several days or longer
    • feel sick to your stomach (nausea)
    • have lower stomach area (abdominal) pain
  • You may be more likely to get lactic acidosis or liver problems if you are female, very overweight (obese), or have been taking nucleoside analog-containing medicines, like ATRIPLA (efavirenz/emtricitabine/tenofovir disoproxil fumarate), for a long time.
  • If you also have hepatitis B virus (HBV) infection and you stop taking ATRIPLA, you may get a “flare-up” of your hepatitis. A “flare-up” is when the disease suddenly returns in a worse way than before. Patients with HBV who stop taking ATRIPLA need close medical follow-up for several months to check for hepatitis that could be getting worse. ATRIPLA is not approved for the treatment of HBV, so you need to discuss your HBV therapy with your healthcare provider.

Who should not take ATRIPLA?

You and your healthcare provider should decide if ATRIPLA is right for you. Do not take ATRIPLA if you are allergic to ATRIPLA or any of its ingredients.

What should I tell my healthcare provider before taking ATRIPLA?

Tell your healthcare provider if you:

  • Are pregnant or planning to become pregnant: Women should not become pregnant while taking ATRIPLA and for 12 weeks after stopping ATRIPLA. Serious birth defects have been seen in children of women treated during pregnancy with efavirenz, one of the medicines in ATRIPLA. Women must use a reliable form of barrier contraception, such as a condom or diaphragm, even if they also use other methods of birth control, while on ATRIPLA and for 12 weeks after stopping ATRIPLA. Women should not rely only on hormone-based birth control, such as pills, injections, or implants, because ATRIPLA may make these contraceptives ineffective.
  • Are breastfeeding: Women with HIV should not breastfeed because they can pass HIV and some of the medicines in ATRIPLA through their milk to the baby. It is not known if ATRIPLA could harm your baby.
  • Have kidney problems or are undergoing kidney dialysis treatment.
  • Have bone problems.
  • Have liver problems, including hepatitis B or C virus infection. Your healthcare provider may want to do tests to check your liver while you take ATRIPLA or may switch you to another medicine.
  • Have ever had mental illness or are using drugs or alcohol.
  • Have ever had seizures or are taking medicine for seizures. Seizures have occurred in patients taking efavirenz, a component of ATRIPLA, generally in those with a history of seizures. If you have ever had seizures, or take medicine for seizures, your healthcare provider may want to switch you to another medicine or monitor you.

What important information should I know about taking other medicines with ATRIPLA?

ATRIPLA may change the effect of other medicines, including the ones for HIV-1, and may cause serious side effects. Your healthcare provider may change your other medicines or change their doses.

MEDICINES YOU SHOULD NOT TAKE WITH ATRIPLA

  • ATRIPLA should not be taken with: Combivir® (lamivudine/zidovudine), COMPLERA® (emtricitabine/rilpivirine/tenofovir disoproxil fumarate), EMTRIVA® (emtricitabine), Epivir® or Epivir-HBV® (lamivudine), Epzicom® (abacavir sulfate/lamivudine), STRIBILD® (elvitegravir/cobicistat/emtricitabine/tenofovir DF), Trizivir® (abacavir sulfate/lamivudine/zidovudine), TRUVADA® (emtricitabine/tenofovir DF), or VIREAD® (tenofovir DF), because they contain the same or similar active ingredients as ATRIPLA. ATRIPLA should not be used with SUSTIVA® (efavirenz) unless recommended by your healthcare provider.
  • Vfend® (voriconazole) should not be taken with ATRIPLA since it may lose its effect or may increase the chance of having side effects from ATRIPLA.
  • ATRIPLA should not be used with HEPSERA® (adefovir dipivoxil).

These are not all the medicines that may cause problems if you take ATRIPLA. Tell your healthcare provider about all prescription and nonprescription medicines, vitamins, or herbal supplements you are taking or plan to take.

What are the possible side effects of ATRIPLA?

ATRIPLA may cause the following additional serious side effects:

  • Serious psychiatric problems. Severe depression, strange thoughts, or angry behavior have been reported by a small number of patients. Some patients have had thoughts of suicide, and a few have actually committed suicide. These problems may occur more often in patients who have had mental illness.
  • Kidney problems (including decline or failure of kidney function). If you have had kidney problems, or take other medicines that may cause kidney problems, your healthcare provider should do regular blood tests. Symptoms that may be related to kidney problems include a high volume of urine, thirst, muscle pain, and muscle weakness.
  • Other serious liver problems. Some patients have experienced serious liver problems, including liver failure resulting in transplantation or death. Most of these serious side effects occurred in patients with a chronic liver disease such as hepatitis infection, but there have also been a few reports in patients without any existing liver disease.
  • Changes in bone mineral density (thinning bones). Lab tests show changes in the bones of patients treated with tenofovir DF, a component of ATRIPLA. Some HIV patients treated with tenofovir DF developed thinning of the bones (osteopenia), which could lead to fractures. Also, bone pain and softening of the bone (which may lead to fractures) may occur as a consequence of kidney problems. If you have had bone problems in the past, your healthcare provider may want to do tests to check your bones or may prescribe medicines to help your bones.

Common side effects:

  • Patients may have dizziness, headache, trouble sleeping, drowsiness, trouble concentrating, and/or unusual dreams during treatment with ATRIPLA (efavirenz/emtricitabine/tenofovir disoproxil fumarate). These side effects may be reduced if you take ATRIPLA at bedtime on an empty stomach; they tend to go away after taking ATRIPLA for a few weeks. Tell your healthcare provider right away if any of these side effects continue or if they bother you. These symptoms may be more severe if ATRIPLA is used with alcohol and/or mood-altering (street) drugs.
  • If you are dizzy, have trouble concentrating, and/or are drowsy, avoid activities that may be dangerous, such as driving or operating machinery.
  • Rash is a common side effect with ATRIPLA that usually goes away without any change in treatment. Rash may be serious in a small number of patients. Rash occurs more commonly in children and may be a serious problem. If a rash develops, call your healthcare provider right away.
  • Other common side effects include: tiredness, upset stomach, vomiting, gas, and diarrhea.

Other possible side effects:

  • Changes in body fat have been seen in some people taking anti-HIV-1 medicines. Increase of fat in the upper back and neck, breasts, and around the trunk may happen. Loss of fat from the legs, arms, and face may also happen. The cause and long-term health effects of these changes in body fat are not known.
  • Skin discoloration (small spots or freckles) may also happen.
  • In some patients with advanced HIV infection (AIDS), signs and symptoms of inflammation from previous infections may occur soon after anti-HIV treatment is started. If you notice any symptoms of infection, contact your healthcare provider right away.
  • Additional side effects are inflammation of the pancreas, allergic reaction (including swelling of the face, lips, tongue, or throat), shortness of breath, pain, stomach pain, weakness, and indigestion.

This is not a complete list of side effects. Tell your healthcare provider or pharmacist if you notice any side effects while taking ATRIPLA.

You should take ATRIPLA once daily on an empty stomach. Taking ATRIPLA at bedtime may make some side effects less bothersome.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

Please see Full Prescribing Information, including “What is the most important information I should know about ATRIPLA” in the Patient Information section.

More Important Safety Information  

SELECTED IMPORTANT SAFETY INFORMATION

What is the most important information I should know about ATRIPLA?

ATRIPLA can cause serious side effects:

  • Some people who have taken medicines like ATRIPLA (which contains nucleoside analogs) have developed lactic acidosis (build up of an acid in the blood). Lactic acidosis can be a serious medical emergency that can lead to death.

    Call your healthcare provider right away if you get the following signs or symptoms of lactic acidosis:

    • feel very weak or tired
    • have unusual (not normal) muscle pain
    • have trouble breathing
    • have stomach pain with nausea and vomiting
    • feel cold, especially in your arms and legs
    • feel dizzy or lightheaded
    • have a fast or irregular heartbeat
  • Some people who have taken medicines like ATRIPLA have developed serious liver problems (hepatotoxicity), with liver enlargement (hepatomegaly) and fat in the liver (steatosis). In some cases, these liver problems can lead to death.

    Call your healthcare provider right away if you get the following signs or symptoms of liver problems:

    • skin or the white part of your eyes turns yellow (jaundice)
    • urine turns dark
    • bowel movements (stools) turn light in color
    • don’t feel like eating food for several days or longer
    • feel sick to your stomach (nausea)
    • have lower stomach area (abdominal) pain
  • You may be more likely to get lactic acidosis or liver problems if you are female, very overweight (obese), or have been taking nucleoside analog-containing medicines, like ATRIPLA (efavirenz/emtricitabine/tenofovir disoproxil fumarate), for a long time.
  • If you also have hepatitis B virus (HBV) infection and you stop taking ATRIPLA, you may get a “flare-up” of your hepatitis. A “flare-up” is when the disease suddenly returns in a worse way than before. Patients with HBV who stop taking ATRIPLA need close medical follow-up for several months to check for hepatitis that could be getting worse. ATRIPLA is not approved for the treatment of HBV, so you need to discuss your HBV therapy with your healthcare provider.