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ATRIPLA- efavirenz, emtricitabine, and tenofovir disoproxil fumarate tablet, film coated


  1. Patients Should Be Advised That:
  2. Patient Information
  3. Who Should Not Take Atripla?do Not Take Atripla If You:
  4. Before Taking Atripla, Tell Your Healthcare Provider About All Of Your Medical Conditions, Including If You:
  5. Pregnancy Registry:
  6. What Should I Avoid While Taking Atripla?
  7. Atripla May Cause Serious Side Effects, Including:
  8. What Are The Ingredients Of Atripla?active Ingredients:
  9. Inactive Ingredients:
  10. What Is The Most Important Information I Should Know About Atripla?
  11. What Is Atripla?
  12. Does Atripla Cure Hiv-1 Or Aids?
  13. Who Should Not Take Atripla?
  14. Tell Your Healthcare Provider If You:
  15. It Is Also Important To Tell Your Healthcare Provider If You Are Taking Any Of The Following:
  16. How Should I Take Atripla?
  17. Atripla May Cause The Following Serious Side Effects:
  18. General Information About Atripla:
  19. Active Ingredients:
  20. Manufactured And Distributed By:

Patients Should Be Advised That: 

  • ATRIPLA is not a cure for HIV-1 infection and that they may continue to experience illnesses associated with HIV-1 infection, including opportunistic infections. Patients should remain under the care of a physician when using ATRIPLA.
  • The use of ATRIPLA has not been shown to reduce the risk of transmission of HIV-1 to others through sexual contact or blood contamination. Patients should be advised to continue to practice safer sex and to use latex or polyurethane condoms to lower the chance of sexual contact with any body fluids such as semen, vaginal secretions or blood. Patients should be advised never to re-use or share needles.
  • The long term effects of ATRIPLA are unknown.
  • Redistribution or accumulation of body fat may occur in patients receiving antiretroviral therapy and that the cause and long-term health effects of these conditions are not known.
  • ATRIPLA should not be coadministered with SUSTIVA, EMTRIVA, VIREAD, or TRUVADA, or drugs containing lamivudine, including Combivir, Epivir, Epivir-HBV, Epzicom, or Trizivir.
  • ATRIPLA should not be administered with HEPSERA[SeeWarnings and Precautions (5.2)].

17.3 Lactic Acidosis/Severe Hepatomegaly with Steatosis

Patients should be informed that lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported. Treatment will be suspended in any patients who develop clinical symptoms suggestive of lactic acidosis or pronounced hepatotoxicity (including nausea, vomiting, unusual or unexpected stomach discomfort, and weakness)[SeeWarnings and Precautions (5.1)].

17.4 Patients Coinfected with HIV-1 and HBV

Patients with HIV-1 should be tested for hepatitis B virus (HBV) before initiating antiretroviral therapy.

Patients should be advised that severe acute exacerbations of hepatitis B have been reported in patients who are coinfected with HBV and HIV-1 and have discontinued EMTRIVA (emtricitabine) or VIREAD (tenofovir DF), which are components of ATRIPLA.

17.5 New Onset or Worsening Renal Impairment

Renal impairment, including cases of acute renal failure and Fanconi syndrome, has been reported. ATRIPLA should be avoided with concurrent or recent use of a nephrotoxic agent[SeeWarnings and Precautions (5.7)].

17.6 Decreases in Bone Mineral Density

Patients should be informed that decreases in bone mineral density have been observed with the use of tenofovir DF. Bone mineral density monitoring may be performed in patients who have a history of pathologic bone fracture or are at risk for osteopenia[SeeWarnings and Precautions (5.11)].

17.7 Dosing Instructions

Patients should be advised to take ATRIPLA orally on an empty stomach and that it is important to take ATRIPLA on a regular dosing schedule to avoid missing doses.

17.8 Nervous System Symptoms

Patients should be informed that central nervous system symptoms (NSS) including dizziness, insomnia, impaired concentration, drowsiness, and abnormal dreams are commonly reported during the first weeks of therapy with efavirenz. Dosing at bedtime may improve the tolerability of these symptoms, which are likely to improve with continued therapy. Patients should be alerted to the potential for additive effects when ATRIPLA is used concomitantly with alcohol or psychoactive drugs. Patients should be instructed that if they experience NSS they should avoid potentially hazardous tasks such as driving or operating machinery[SeeWarnings and Precautions (5.6), andDosage and Administration (2)].

17.9 Psychiatric Symptoms

Patients should be informed that serious psychiatric symptoms including severe depression, suicide attempts, aggressive behavior, delusions, paranoia, and psychosis-like symptoms have been reported in patients receiving efavirenz. If they experience severe psychiatric adverse experiences they should seek immediate medical evaluation. Patients should be advised to inform their physician of any history of mental illness or substance abuse[SeeWarnings and Precautions (5.5)].

17.10 Rash

Patients should be informed that a common side effect is rash. Rashes usually go away without any change in treatment. However, since rash may be serious, patients should be advised to contact their physician promptly if rash occurs.

17.11 Reproductive Risk Potential

Women receiving ATRIPLA should be instructed to avoid pregnancy[SeeWarnings and Precautions (5.8)]. A reliable form of barrier contraception must always be used in combination with other methods of contraception, including oral or other hormonal contraception. Because of the long half-life of efavirenz, use of adequate contraceptive measures for 12 weeks after discontinuation of ATRIPLA is recommended. Women should be advised to notify their physician if they become pregnant or plan to become pregnant while taking ATRIPLA. If this drug is used during the first trimester of pregnancy, or if the patient becomes pregnant while taking this drug, she should be apprised of the potential harm to the fetus.

Patient Information 

Advise the patient to read the FDA-approved patient labeling (Patient Information).

Severe Acute Exacerbation of Hepatitis B in Patients Coinfected with HIV-1 and HBV

Inform patients that severe acute exacerbations of hepatitis B have been reported in patients who are coinfected with HBV and HIV-1 and have discontinued FTC or TDF, and may occur with discontinuation of ATRIPLA.Advise patients not to discontinue ATRIPLA without first informing their healthcare provider. All patients should be tested for HBV infection before or when starting ATRIPLA and those who are infected with HBV need close medical follow-up for several months after stopping ATRIPLA to monitor for exacerbations of hepatitis[
ATRIPLA is a prescription medicine that contains efavirenz, emtricitabine, and tenofovir disoproxil fumarate combined in 1 tablet. ATRIPLA is used alone as a complete regimen, or in combination with other anti-HIV-1 medicines to treat people with HIV-1 infection who weigh at least 88 lbs (40 kg).
It is not known if ATRIPLA is safe and effective for use in children with HIV-1 infection who weigh less than 88 lbs (40 kg).

Who Should Not Take Atripla?do Not Take Atripla If You: 

  • are allergic to efavirenz
  • take the medicine called voriconazole, elbasvir or grazoprevir
Ask your healthcare provider if you are not sure if you take any of these medicines.

Before Taking Atripla, Tell Your Healthcare Provider About All Of Your Medical Conditions, Including If You: 

  • have liver problems, including hepatitis B or C virus infection
  • have heart problems
  • have or have had mental problems
  • have a history of drug or alcohol abuse
  • have nervous system problems
  • have kidney problems or receive kidney dialysis treatment
  • have bone problems
  • have had seizures or take medicines used to treat seizures
  • are pregnant or plan to become pregnant. ATRIPLA can harm your unborn baby. If you are able to become pregnant, your healthcare provider should do a pregnancy test before you start treatment with ATRIPLA.You should not become pregnant during treatment with ATRIPLA and for 12 weeks after stopping treatment.Tell your healthcare provider if you become pregnant or think you may be pregnant during treatment with ATRIPLA.
    • Females who are able to become pregnant,should use 2 effective forms of birth control (contraception) during treatment with ATRIPLA and for 12 weeks after stopping treatment.
    • A barrier form of birth control should always be used along with another type of birth control. Barrier forms of birth control may include condoms, contraceptive sponges, diaphragm with spermicide, and cervical cap.
    • Birth control methods that contain the hormone progesterone such as birth control pills, injections, vaginal rings, or implants, may not work as well while taking ATRIPLA.
    • Talk to your healthcare provider about birth control methods that may be right for you during treatment with ATRIPLA.

Pregnancy Registry: 

There is a pregnancy registry for women who take ATRIPLA during pregnancy. The purpose of this registry is to collect information about the health of you and your baby. Talk to your healthcare provider about how you can take part in this registry.
  • are breastfeeding or plan to breastfeed. ATRIPLA can pass into your breast milk. Do not breastfeed because of the risk of passing HIV-1 to your baby.
  • Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins and herbal supplements.
    Keep a list of your medicines and show it to your healthcare provider and pharmacist when you get a new medicine.
    ATRIPLA and some medicines may interact with each other causing serious side effects.
    You can ask your healthcare provider or pharmacist for a list of medicines that interact with ATRIPLA. Do not start a new medicine without telling your healthcare provider. Your healthcare provider can tell you if it is safe to take ATRIPLA with other medicines.

    What Should I Avoid While Taking Atripla? 

    • ATRIPLA can cause dizziness, impaired concentration and drowsiness. If you have these symptoms, do not drive a car, use heavy machinery, or do anything that requires you to be alert.
    What are the possible side effects of ATRIPLA?

    Atripla May Cause Serious Side Effects, Including: 

      • Store ATRIPLA at room temperature between 68 F to 77 F (20 C to 25 C).
      • Keep ATRIPLA in its original container and keep the container tightly closed.
      Keep ATRIPLA and all other medicines out of reach of children.General information about the safe and effective use of ATRIPLA.
      Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use ATRIPLA for a condition for which it was not prescribed. Do not give ATRIPLA to other people, even if they have the same symptoms that you have. It may harm them. You can ask your healthcare provider or pharmacist for information about ATRIPLA that is written for health professionals.

    What Are The Ingredients Of Atripla?active Ingredients: 

    efavirenz, emtricitabine, and tenofovir disoproxil fumarate

    Inactive Ingredients: 

    croscarmellose sodium, hydroxypropyl cellulose, magnesium sterate, microcrystalline cellulose, and sodium lauryl sulfate. The film coating contains black iron oxide, polyethylene glycol, polyvinyl alcohol, red iron oxide, talc, and titanium dioxide.
    Manufactured and distributed by: Gilead Sciences, Inc. Foster City, CA 94404
    For more information go to www.ATRIPLA.com or call 1-800-445-3235.
    ATRIPLA, EMTRIVA, TRUVADA, and VIREAD are trademarks of Gilead Sciences, Inc., or its related companies. All other trademarks referenced herein are the property of their respective owners.
    2018 Gilead Sciences, LLC. All rights reserved.
    21937-GS-019

    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, including medical exams and blood tests to check for hepatitis that could be getting worse. ATRIPLA is not approved for the treatment of HBV, so you must discuss your HBV therapy with your healthcare provider.

    What Is Atripla? 

    ATRIPLA contains 3 medicines, SUSTIVA(efavirenz), EMTRIVA(emtricitabine), and VIREAD(tenofovir disoproxil fumarate also called tenofovir DF) combined in one pill. EMTRIVA and VIREAD are HIV-1 (human immunodeficiency virus) nucleoside analog reverse transcriptase inhibitors (NRTIs) and SUSTIVA is an HIV-1 non-nucleoside analog reverse transcriptase inhibitor (NNRTI). VIREAD and EMTRIVA are the components of TRUVADA. ATRIPLA can be used alone as a complete regimen, or in combination with other anti-HIV-1 medicines to treat people with HIV-1 infection. ATRIPLA is for adults and children 12 years of age and older who weigh at least 40 kg (at least 88 lbs). ATRIPLA is not recommended for children younger than 12 years of age. ATRIPLA has not been studied in adults over 65 years of age.

    HIV infection destroys CD4+ T cells, which are important to the immune system. The immune system helps fight infection. After a large number of T cells are destroyed, acquired immune deficiency syndrome (AIDS) develops.

    ATRIPLA helps block HIV-1 reverse transcriptase, a viral chemical in your body (enzyme) that is needed for HIV-1 to multiply. ATRIPLA lowers the amount of HIV-1 in the blood (viral load). ATRIPLA may also help to increase the number of T cells (CD4+ cells), allowing your immune system to improve. Lowering the amount of HIV-1 in the blood lowers the chance of death or infections that happen when your immune system is weak (opportunistic infections).

    Does Atripla Cure Hiv-1 Or Aids? 

    ATRIPLA does not cure HIV-1 infection or AIDSand you may continue to experience illnesses associated with HIV-1 infection, including opportunistic infections. You should remain under the care of a doctor when using ATRIPLA.

    Who Should Not Take Atripla? 

    Together with your healthcare provider, you need to decide whether ATRIPLA is right for you.

    Do not take ATRIPLA if you are allergic to ATRIPLA or any of its ingredients. The active ingredients of ATRIPLA are efavirenz, emtricitabine, and tenofovir DF.

    Tell Your Healthcare Provider If You: 

    • Are pregnant or planning to become pregnant(

      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. Other medicines, including herbal products, may affect ATRIPLA. For this reason,it is very important tolet all your healthcare providers and pharmacists know what medications, herbal supplements, or vitamins you are taking.

      MEDICINES YOU SHOULD NOT TAKE WITH ATRIPLA

      • ATRIPLA also should not be used with Combivir (lamivudine/zidovudine), COMPLERA, DESCOVY, EMTRIVA, Epivir, Epivir-HBV (lamivudine), Epzicom (abacavir sulfate/lamivudine), GENVOYA, ODEFSEY, STRIBILD, Trizivir (abacavir sulfate/lamivudine/zidovudine), TRUVADA, VEMLIDY, or VIREAD. ATRIPLA also should not be used with SUSTIVA 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).

    It Is Also Important To Tell Your Healthcare Provider If You Are Taking Any Of The Following: 

    • Fortovase, Invirase (saquinavir), Biaxin (clarithromycin), Noxafil (posaconazole), Sporanox (itraconazole), Victrelis (boceprevir), Olysio (simeprevir), or EPCLUSA (sofosbuvir/velpatasvir);these medicines may need to be replaced with another medicine when taken with ATRIPLA.
    • Calcium channel blockers such as Cardizem or Tiazac (diltiazem), Covera HS or Isoptin (verapamil) and others; Crixivan (indinavir), Selzentry (maraviroc); the immunosuppressant medicines cyclosporine (Gengraf, Neoral, Sandimmune, and others), Prograf (tacrolimus), or Rapamune (sirolimus); Methadone; Mycobutin (rifabutin); Rifampin; cholesterol-lowering medicines such as Lipitor (atorvastatin), Pravachol (pravastatin sodium), and Zocor (simvastatin); or the anti-depressant medications bupropion (Wellbutrin, Wellbutrin SR, Wellbutrin XL, and Zyban) or Zoloft (sertraline);dose changes may be needed when these drugs are taken with ATRIPLA.
    • Videx, Videx EC (didanosine); tenofovir DF (a component of ATRIPLA) may increase the amount of didanosine in your blood, which could result in more side effects.You may need to be monitored more carefullyif you are taking ATRIPLA and didanosine together. Also, the dose of didanosine may need to be changed.
    • Reyataz (atazanavir sulfate), Prezista (darunavir) with Norvir (ritonavir), Kaletra (lopinavir/ritonavir), EPCLUSA(sofosbuvir/velpatasvir) or HARVONI(ledipasvir/sofosbuvir); these medicines may increase the amount of tenofovir DF (a component of ATRIPLA) in your blood, which could result in more side effects. EPCLUSA and Reyataz are not recommended with ATRIPLA.You may need to be monitored more carefullyif you are taking ATRIPLA, Prezista, and Norvir together, or if you are taking ATRIPLA and Kaletra together. The dose of Kaletra should be increased when taken with efavirenz.
    • Medicine for seizures [for example, Dilantin (phenytoin), Tegretol (carbamazepine), or phenobarbital]; your healthcare provider may want to switch you to another medicine or check drug levels in your blood from time to time.

    These are not all the medicines that may cause problems if you take ATRIPLA. Be sure to tell your healthcare provider about all medicines that you take.

    Keep a complete list of all the prescription and nonprescription medicines as well as any herbal remedies that you are taking, how much you take, and how often you take them. Make a new list when medicines or herbal remedies are added or stopped, or if the dose changes. Give copies of this list to all of your healthcare providers and pharmacistseverytime you visit your healthcare provider or fill a prescription. This will give your healthcare provider a complete picture of the medicines you use. Then he or she can decide the best approach for your situation.

    How Should I Take Atripla? 

    • Take the exact amount of ATRIPLA your healthcare provider prescribes. Never change the dose on your own. Do not stop this medicine unless your healthcare provider tells you to stop.
    • You should take ATRIPLA on an empty stomach.
    • Swallow ATRIPLA with water.
    • Taking ATRIPLA at bedtime may make some side effects less bothersome.
    • Do not miss a dose of ATRIPLA. If you forget to take ATRIPLA, take the missed dose right away, unless it is almost time for your next dose. Do not double the next dose. Carry on with your regular dosing schedule. If you need help in planning the best times to take your medicine, ask your healthcare provider or pharmacist.
    • If you believe you took more than the prescribed amount of ATRIPLA, contact your local poison control center or emergency room right away.
    • Tell your healthcare provider if you start any new medicine or change how you take old ones. Your doses may need adjustment.
    • 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.
    • Your healthcare provider may want to do blood tests to check for certain side effects while you take ATRIPLA.

    Atripla May Cause The Following Serious Side Effects: 

    • "Flare-ups" of hepatitis B virus (HBV) infection, in which the disease suddenly returns in a worse way than before, can occur if you have HBV and you stop taking ATRIPLA. Your healthcare provider will monitor your condition for several months after stopping ATRIPLA if you have both HIV-1 and HBV infection and may recommend treatment for your HBV. ATRIPLA is not approved for the treatment of hepatitis B virus infection. If you have advanced liver disease and stop treatment with ATRIPLA, the "flare-up" of hepatitis B may cause your liver function to decline. (

      • Keep ATRIPLA and all other medicines out of reach of children.
      • Store ATRIPLA at room temperature 77 F (25 C).
      • Keep ATRIPLA in its original container and keep the container tightly closed.
      • Do not keep medicine that is out of date or that you no longer need. If you throw any medicines away make sure that children will not find them.

    General Information About Atripla: 

    Medicines are sometimes prescribed for conditions that are not mentioned in patient information leaflets. Do not use ATRIPLA for a condition for which it was not prescribed. Do not give ATRIPLA to other people, even if they have the same symptoms you have. It may harm them.

    This leaflet summarizes the most important information about ATRIPLA. If you would like more information, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about ATRIPLA that is written for health professionals.

    Do not use ATRIPLA if the seal over bottle opening is broken or missing.

    Active Ingredients: 

    efavirenz, emtricitabine, and tenofovir disoproxil fumarate

    Manufactured And Distributed By: 

    Gilead Sciences, Inc.

    Foster City, CA 94404

    ATRIPLA is a trademark of Bristol-Myers Squibb & Gilead Sciences, LLC. COMPLERA, DESCOVY, EMTRIVA, EPCLUSA, GENVOYA, HARVONI, HEPSERA, ODEFSEY, STRIBILD, TRUVADA, VEMLIDY, and VIREAD are trademarks of Gilead Sciences, Inc., or its related companies. SUSTIVA is a trademark of Bristol-Myers Squibb Pharma Company. Reyataz and Videx are trademarks of Bristol-Myers Squibb Company. Pravachol is a trademark of ER Squibb & Sons, LLC. All other trademarks referenced herein are the property of their respective owners.

    2017 Gilead Sciences, Inc. All rights reserved.

    21937-GS-017



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