Atripla

Name: Atripla

Atripla Interactions

Tell your doctor about all prescription, non-prescription, illegal, recreational, herbal, nutritional, or dietary drugs you're taking, especially those listed in the Atripla Warnings section above, and any of the following:

  • A blood thinner such as Plavix (clopidogrel)
  • Antivirals
  • Birth control pills
  • Chemotherapy
  • Injected antibiotics
  • Medicines for bowel disorders
  • Medicines to prevent organ transplant rejection
  • Muscle relaxants
  • Other HIV medicines
  • Pain or arthritis drugs such as Advil (ibuprofen), Aleve (naproxen), aspirin, or Tylenol (acetaminophen)

Atripla and Other Interactions

Atripla may make you dizzy or drowsy.

Don't drive or perform any activity that requires alertness until you know how this medicine affects you.

Atripla and Alcohol

Alcohol can worsen certain side effects of Atripla.

Avoid drinking alcohol while taking this drug.

Atripla Overview

Atripla is a prescription medication used to treat HIV and AIDS in adults. This medication comes as a single tablet containing three different medications; efavirenz, emtricitabine, and tenofovir. Efavirenz belongs to a group of drugs called non-nucleoside reverse transcriptase inhibitors, while emtricitabine and tenofovir belong to a group of drugs called nucleoside reverse transcriptase inhibitors. Both classes of drugs decrease the presence of HIV in the blood. 

This medication comes in tablet form and is taken once a day on an empty stomach at bedtime. Some of the common side effects of Atripla include dizziness, headache, difficulty sleeping, and drowsiness.

Manufacturer

  • Gilead Sciences, Inc.

Atripla Food Interactions

Medicines can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Atripla there are no specific foods that you must exclude from your diet when receiving this medication.

Atripla FDA Warning

WARNINGS: LACTIC ACIDOSIS/SEVERE HEPATOMEGALY WITH STEATOSIS and POST-TREATMENT EXACERBATION OF HEPATITIS B

Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogs, including tenofovir disoproxil fumarate, a component of Atripla, in combination with other antiretrovirals. Atripla is not approved for the treatment of chronic hepatitis B virus (HBV) infection and the safety and efficacy of Atripla have not been established in patients coinfected with HBV and HIV-1. Severe acute exacerbations of hepatitis B have been reported in patients who have discontinued Emtriva or Viread, which are components of Atripla. Hepatic function should be monitored closely with both clinical and laboratory follow-up for at least several months in patients who are coinfected with HIV-1 and HBV and discontinue Atripla. If appropriate, initiation of anti-hepatitis B therapy may be warranted.

 

 

Atripla side effects

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.

Proper Use of Atripla

Take this medicine exactly as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.

This medicine comes with a patient information insert. Read and follow the instructions in the insert carefully. Ask your doctor if you have any questions.

Do not change the dose or stop using this medicine without checking first with your doctor. When your supply of this medicine is running low, contact your doctor or pharmacist ahead of time. Do not allow yourself to run out of this medicine.

Take this medicine on an empty stomach, at the same time each day, preferably at bedtime.

Keep taking this medicine for the full time of treatment even if you begin to feel better. It is also important that you continue taking all of the medicines that your doctor has given you for HIV infection.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

  • For oral dosage form (tablets):
    • For treatment of HIV infection:
      • Adults and children 12 years of age and older and weighs at least 40 kilograms (kg)—One tablet once a day.
      • Children younger than 12 years of age—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep the bottle tightly closed. Keep the medicine in the original bottle that you were given at the pharmacy.

Indications and Usage for Atripla

Atripla® is indicated for use alone as a complete regimen or in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and pediatric patients 12 years of age and older.

Nonclinical Toxicology

Carcinogenesis, Mutagenesis, Impairment of Fertility

Efavirenz: Long-term carcinogenicity studies in mice and rats were carried out with efavirenz. Mice were dosed with 0, 25, 75, 150, or 300 mg/kg/day for 2 years. Incidences of hepatocellular adenomas and carcinomas and pulmonary alveolar/bronchiolar adenomas were increased above background in females. No increases in tumor incidence above background were seen in males. In studies in which rats were administered efavirenz at doses of 0, 25, 50, or 100 mg/kg/day for 2 years, no increases in tumor incidence above background were observed. The systemic exposure (based on AUCs) in mice was approximately 1.7-fold that in humans receiving the 600-mg/day dose. The exposure in rats was lower than that in humans. The mechanism of the carcinogenic potential is unknown. However, in genetic toxicology assays, efavirenz showed no evidence of mutagenic or clastogenic activity in a battery of in vitro and in vivo studies. These included bacterial mutation assays in S. typhimurium and E. coli, mammalian mutation assays in Chinese hamster ovary cells, chromosome aberration assays in human peripheral blood lymphocytes or Chinese hamster ovary cells, and an in vivo mouse bone marrow micronucleus assay. Given the lack of genotoxic activity of efavirenz, the relevance to humans of neoplasms in efavirenz-treated mice is not known.

Efavirenz did not impair mating or fertility of male or female rats, and did not affect sperm of treated male rats. The reproductive performance of offspring born to female rats given efavirenz was not affected. As a result of the rapid clearance of efavirenz in rats, systemic drug exposures achieved in these studies were equivalent to or below those achieved in humans given therapeutic doses of efavirenz.

Emtricitabine: In long-term carcinogenicity studies of emtricitabine, no drug-related increases in tumor incidence were found in mice at doses up to 750 mg/kg/day (26 times the human systemic exposure at the therapeutic dose of 200 mg/day) or in rats at doses up to 600 mg/day (31 times the human systemic exposure at the therapeutic dose).

Emtricitabine was not genotoxic in the reverse mutation bacterial test (Ames test), or the mouse lymphoma or mouse micronucleus assays.

Emtricitabine did not affect fertility in male rats at approximately 140-fold or in male and female mice at approximately 60-fold higher exposures (AUC) than in humans given the recommended 200 mg daily dose. Fertility was normal in the offspring of mice exposed daily from before birth (in utero) through sexual maturity at daily exposures (AUC) of approximately 60-fold higher than human exposures at the recommended 200 mg daily dose.

Tenofovir DF: Long-term oral carcinogenicity studies of tenofovir DF in mice and rats were carried out at exposures up to approximately 16 times (mice) and 5 times (rats) those observed in humans at the therapeutic dose for HIV-1 infection. At the high dose in female mice, liver adenomas were increased at exposures 16 times that in humans. In rats, the study was negative for carcinogenic findings at exposures up to 5 times that observed in humans at the therapeutic dose.

Tenofovir DF was mutagenic in the in vitro mouse lymphoma assay and negative in an in vitro bacterial mutagenicity test (Ames test). In an in vivo mouse micronucleus assay, tenofovir DF was negative when administered to male mice.

There were no effects on fertility, mating performance, or early embryonic development when tenofovir DF was administered to male rats at a dose equivalent to 10 times the human dose based on body surface area comparisons for 28 days prior to mating and to female rats for 15 days prior to mating through Day 7 of gestation. There was, however, an alteration of the estrous cycle in female rats.

Animal Toxicology and/or Pharmacology

Efavirenz: Nonsustained convulsions were observed in 6 of 20 monkeys receiving efavirenz at doses yielding plasma AUC values 4- to 13-fold greater than those in humans given the recommended dose.

Tenofovir DF: Tenofovir and tenofovir DF administered in toxicology studies to rats, dogs, and monkeys at exposures (based on AUCs) greater than or equal to 6-fold those observed in humans caused bone toxicity. In monkeys the bone toxicity was diagnosed as osteomalacia. Osteomalacia observed in monkeys appeared to be reversible upon dose reduction or discontinuation of tenofovir. In rats and dogs, the bone toxicity manifested as reduced bone mineral density. The mechanism(s) underlying bone toxicity is unknown.

Evidence of renal toxicity was noted in 4 animal species administered tenofovir and tenofovir DF. Increases in serum creatinine, BUN, glycosuria, proteinuria, phosphaturia and/or calciuria and decreases in serum phosphate were observed to varying degrees in these animals. These toxicities were noted at exposures (based on AUCs) 2- to 20-times higher than those observed in humans. The relationship of the renal abnormalities, particularly the phosphaturia, to the bone toxicity is not known.

Patient Information

Atripla® (uh TRIP luh) Tablets

ALERT: Find out about medicines that should NOT be taken with Atripla.

Please also read the section "MEDICINES YOU SHOULD NOT TAKE WITH Atripla."

Generic name: efavirenz, emtricitabine, and tenofovir disoproxil fumarate (eh FAH vih renz, em tri SIT uh bean and te NOE' fo veer dye soe PROX il FYOU mar ate)

Read the Patient Information that comes with Atripla before you start taking it and each time you get a refill since there may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or treatment. You should stay under a healthcare provider's care when taking Atripla. Do not change or stop your medicine without first talking with your healthcare provider. Talk to your healthcare provider or pharmacist if you have any questions about Atripla.

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 AIDS and 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. See the end of this leaflet for a complete list of ingredients.

What should I tell my healthcare provider before taking Atripla?

Tell your healthcare provider if you:

  • Are pregnant or planning to become pregnant (see "What should I avoid while taking Atripla?").
  • Are breastfeeding (see "What should I avoid while taking Atripla?").
  • Have kidney problems or are undergoing kidney dialysis treatment.
  • Have bone problems.
  • Have liver problems, including hepatitis B 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.

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. Other medicines, including herbal products, may affect Atripla. For this reason, it is very important to let 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 carefully if 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 carefully if 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 pharmacists every time 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.

What should I avoid while taking Atripla?

  • Women should not become pregnant while taking Atripla and for 12 weeks after stopping it. Serious birth defects have been seen in the babies of animals and women treated with efavirenz (a component of Atripla) during pregnancy. It is not known whether efavirenz caused these defects. Tell your healthcare provider right away if you are pregnant. Also talk with your healthcare provider if you want to become pregnant.
  • Women should not rely only on hormone-based birth control, such as pills, injections, or implants, because Atripla may make these contraceptives ineffective. 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. Efavirenz, a component of Atripla, may remain in your blood for a time after therapy is stopped. Therefore, you should continue to use contraceptive measures for 12 weeks after you stop taking Atripla.
  • Do not breastfeed if you are taking Atripla. Some of the medicines in Atripla can be passed to your baby in your breast milk. We do not know whether it could harm your baby. Also, mothers with HIV-1 should not breastfeed because HIV-1 can be passed to the baby in the breast milk. Talk with your healthcare provider if you are breastfeeding. You should stop breastfeeding or may need to use a different medicine.
  • Taking Atripla with alcohol or other medicines causing similar side effects as Atripla, such as drowsiness, may increase those side effects.
  • Do not take any other medicines, including prescription and nonprescription medicines and herbal products, without checking with your healthcare provider.
  • Avoid doing things that can spread HIV-1 to others.
    • Do not share needles or other injection equipment.
    • Do not share personal items that can have blood or body fluids on them, like toothbrushes and razor blades.
    • Do not have any kind of sex without protection. Always practice safe sex by using a latex or polyurethane condom to lower the chance of sexual contact with semen, vaginal secretions, or blood.

What are the possible side effects of 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. (See "What is the most important information I should know about Atripla?")
  • Too much lactic acid in your blood (lactic acidosis). Too much lactic acid is a serious but rare medical emergency that can lead to death. 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. A small number of patients may experience severe depression, strange thoughts, or angry behavior while taking Atripla. Some patients have thoughts of suicide and a few have actually committed suicide. These problems may occur more often in patients who have had mental illness. Contact your healthcare provider right away if you think you are having these psychiatric symptoms, so your healthcare provider can decide if you should continue to take Atripla.
  • Kidney problems (including decline or failure of kidney function). If you have had kidney problems in the past or take other medicines that can cause kidney problems, your healthcare provider should do regular blood tests to check your kidneys. 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). Laboratory 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. If you have had bone problems in the past, your healthcare provider may need to do tests to check your bone mineral density or may prescribe medicines to help your bone mineral density. Additionally, bone pain and softening of the bone (which may contribute to fractures) may occur as a consequence of kidney problems.

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 also tend to go away after you have taken the medicine for a few weeks. If you have these common side effects, such as dizziness, it does not mean that you will also have serious psychiatric problems, such as severe depression, strange thoughts, or angry behavior. Tell your healthcare provider right away if any of these side effects continue or if they bother you. It is possible that these symptoms may be more severe if Atripla is used with alcohol or mood altering (street) drugs.

If you are dizzy, have trouble concentrating, or are drowsy, avoid activities that may be dangerous, such as driving or operating machinery.

Rash may be common. Rashes usually go away without any change in treatment. In a small number of patients, rash may be serious. If you develop a rash, call your healthcare provider right away. Rash may be a serious problem in some children. Tell your child's healthcare provider right away if you notice rash or any other side effects while your child is taking Atripla.

Other common side effects include tiredness, upset stomach, vomiting, gas, and diarrhea.

Other possible side effects with Atripla:

  • Changes in body fat. Changes in body fat develop in some patients taking anti HIV-1 medicine. These changes may include an increased amount of fat in the upper back and neck ("buffalo hump"), in the breasts, and around the trunk. Loss of fat from the legs, arms, and face may also happen. The cause and long-term health effects of these fat changes are not known.
  • Skin discoloration (small spots or freckles) may also happen with Atripla.
  • 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. It is believed that these symptoms are due to an improvement in the body's immune response, enabling the body to fight infections that may have been present with no obvious symptoms. If you notice any symptoms of infection, please inform your doctor immediately.
  • 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.

Tell your healthcare provider or pharmacist if you notice any side effects while taking Atripla.

Contact your healthcare provider before stopping Atripla because of side effects or for any other reason.

This is not a complete list of side effects possible with Atripla. Ask your healthcare provider or pharmacist for a more complete list of side effects of Atripla and all the medicines you will take.

How do I store Atripla?

  • 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.

What are the ingredients of Atripla?

Active Ingredients: efavirenz, emtricitabine, and tenofovir disoproxil fumarate

Inactive Ingredients: croscarmellose sodium, hydroxypropyl cellulose, microcrystalline cellulose, magnesium stearate, and sodium lauryl sulfate. The film coating contains black iron oxide, polyethylene glycol, polyvinyl alcohol, red iron oxide, talc, and titanium dioxide.

Revised: April 2017

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

PRINCIPAL DISPLAY PANEL - Representative Label - 30 Tablet Bottle Label

NDC 15584-0101-1

Atripla®

(efavirenz 600 mg/emtricitabine 200 mg/
tenofovir disoproxil fumarate 300 mg)
Tablets

30 tablets

Note to pharmacist: Do not cover ALERT box with pharmacy label.

ALERT: Find out about medicines that
should NOT be taken with Atripla®

Atripla 
efavirenz, emtricitabine, and tenofovir disoproxil fumarate tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:15584-0101
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
EFAVIRENZ (EFAVIRENZ) EFAVIRENZ 600 mg
EMTRICITABINE (EMTRICITABINE) EMTRICITABINE 200 mg
TENOFOVIR DISOPROXIL FUMARATE (TENOFOVIR ANHYDROUS) TENOFOVIR DISOPROXIL FUMARATE 300 mg
Inactive Ingredients
Ingredient Name Strength
CROSCARMELLOSE SODIUM  
HYDROXYPROPYL CELLULOSE (1200000 MW)  
MAGNESIUM STEARATE  
MICROCRYSTALLINE CELLULOSE  
SODIUM LAURYL SULFATE  
FERROSOFERRIC OXIDE  
POLYETHYLENE GLYCOL 3350  
POLYVINYL ALCOHOL, UNSPECIFIED  
FERRIC OXIDE RED  
TALC  
TITANIUM DIOXIDE  
Product Characteristics
Color PINK Score no score
Shape OVAL Size 20mm
Flavor Imprint Code 123
Contains     
Packaging
# Item Code Package Description
1 NDC:15584-0101-1 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021937 07/20/2006
Labeler - Bristol Myers Squibb & Gilead Sciences, LLC (780297904)
Revised: 04/2017   Bristol Myers Squibb & Gilead Sciences, LLC

Important information

Do not take Atripla together with adefovir, atazanavir, voriconazole, or any medications that contain emtricitabine, lamivudine, or tenofovir (Combivir, Complera, Descovy, Epivir, Epzicom, Genvoya, Odefsey, Stribild, Trizivir, Truvada, Vemlidy).

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).

Atripla dosing information

Usual Adult Dose for HIV Infection:

1 tablet orally once a day

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

Usual Adult Dose for Nonoccupational Exposure:

US CDC recommendations: 1 tablet orally once a day
Duration of therapy: 28 days

Comments:
-The components of this drug are recommended as a preferred NNRTI-based regimen for nonoccupational postexposure prophylaxis of HIV infection.
-Prophylaxis should be started as soon as possible, within 72 hours of exposure.
-Current guidelines should be consulted for additional information.

Usual Adult Dose for Occupational Exposure:

US Public Health Service working group recommendations: 1 tablet orally once a day
Duration of therapy: 28 days, if tolerated

Comments:
-Only with expert consultation, an alternative regimen for use as HIV postexposure prophylaxis
-Prophylaxis should be started as soon as possible, preferably within hours after exposure.
-The optimal duration of prophylaxis is unknown and may differ based on institution protocol.
-Current guidelines should be consulted for additional information.

Usual Pediatric Dose for HIV Infection:

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

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

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.

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