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

For Healthcare Professionals

Sticking to HIV-1 therapy

Beginning HIV therapy requires a strong commitment. You must be ready to take your HIV-1 medications exactly as your doctor prescribes. If you miss doses, HIV could become resistant to the medicines you are taking. This means your medicines could stop working for you.

How important is it to stick to your medication?

Taking your medicines as your healthcare provider has prescribed is very important to HIV therapy and can help you reach your treatment goals. Because medications usually work on controlling the HIV for the time between dosings, it’s important to take them on time, every time.

What are some tips to help me remember to take my medication?

  • take medication at the same time everydayTake medication at the same time every day
  • refill presriptions in advanceRefill your prescription in advance
  • keep medications organized Keep your medications organized
  • use reminders to stay on trackKeep reminder notes near everyday activities

Here are some ideas for setting a routine:

  • Set a timer or alarm clock
  • Keep your meds in the same place so
    you don’t have to search for them
  • Tape a note to your bathroom mirror
    as a reminder
  • When traveling, carry medications in
    your carry-on luggage
  • Refill your prescription in advance
  • Take medication at the same time every day
  • Keep your medications organized
  • Keep reminder notes near everyday activities

When you miss a dose, even for a short time, the medication cannot fight against HIV as well. This may lead to an increase in viral load and a decrease in CD4+ cells.

When you skip doses, your HIV may develop drug resistance, which can make it harder to treat. This means you could develop strains of HIV that are resistant to the medications you are currently taking, and possibly even medications that you aren’t currently taking. This could leave you with fewer treatment options in the future.

At every visit, speak to your healthcare team about how you’re doing. If you find you are having difficulty sticking with your medications, talk to your healthcare team right away.

What happens if I miss a dose?

You should not miss a dose of ATRIPLA (efavirenz/
emtricitabine/tenofovir disoproxil fumarate). However, if you do forget to take ATRIPLA, you should take the missed dose right away, unless it is almost time for your next dose. If you miss a dose of ATRIPLA, you should not double the next dose. Instead, just carry on with your regular dosing schedule. If you need help in planning the best times to take your medicine, ask your healthcare provider, case manager, or pharmacist.

Medication Management

More Important Safety Information 

IMPORTANT SAFETY INFORMATION

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

  • 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), DESCOVY® (emtricitabine/
    tenofovir alafenamide), EMTRIVA® (emtricitabine), Epivir® or Epivir-HBV® (lamivudine),
    Epzicom® (abacavir sulfate/
    lamivudine), GENVOYA® (elvitegravir/cobicistat/
    emtricitabine/tenofovir alafenamide), ODEFSEY® (emtricitabine/rilpivirine
    /tenofovir alafenamide), STRIBILD® (elvitegravir/cobicistat/
    emtricitabine/tenofovir DF), Trizivir® (abacavir sulfate/lamivudine/zidovudine), TRUVADA® (emtricitabine/tenofovir DF), VEMLIDY® (tenofovir alafenamide), or
    VIREAD® (tenofovir DF). 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:

  • Too much lactic acid in your blood (lactic acidosis). This is a serious but rare medical emergency. Tell your healthcare provider right away if you get these symptoms: weakness or being more tired than usual, unusual muscle pain, being short of breath or fast breathing, stomach pain with nausea and vomiting, cold or blue hands and feet, feel dizzy or lightheaded, or a fast or abnormal heartbeat.
  • Severe liver problems. In rare cases, severe liver problems can happen that can lead to death. Tell your healthcare provider right away if you get these symptoms: skin or the white part of your eyes turns yellow, dark “tea-colored” urine, light-colored stools, loss of appetite for several days or longer, nausea, or stomach-area pain.
  • 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.
  • 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. 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 may be a serious problem in some children. 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.

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

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.

More Important Safety Information  

SELECTED IMPORTANT SAFETY INFORMATION

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

  • 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.