Efavirenz/ emtricitabine/ tenofovir

Generic Name: efavirenz/emtricitabine/tenofovir (EF-a-VIR-enz/EM-trye-SYE-ta-been/ten-OF-oh-vir)
Brand Name: Atripla

Severe and sometimes fatal lactic acidosis (a buildup of lactic acid in the blood) and liver problems have occurred with tenofovir, which is part of efavirenz/emtricitabine/tenofovir. The risk may be greater in women, patients who are very overweight, or patients who have been taking nucleoside medicines (eg, emtricitabine, tenofovir) for a long time.

Tell your doctor right away if you develop symptoms of lactic acidosis (eg, unusual weakness or tiredness; unusual muscle pain; fast or difficult breathing; stomach pain with nausea and vomiting; feeling cold, especially in the arms and legs; dizziness or light-headedness; fast or irregular heartbeat). Tell your doctor right away if you develop symptoms of liver problems (eg, yellowing of the skin or eyes, dark urine, pale stools, persistent loss of appetite, nausea, stomach pain).

Efavirenz/emtricitabine/tenofovir is not approved to treat hepatitis B virus (HBV) infection. Safety and effectiveness have not been confirmed in patients who have both HIV and HBV infection. Some patients with HBV infection who took emtricitabine or tenofovir have had severe worsening of HBV infection after they stopped taking them. Patients with both HIV and HBV who take efavirenz/emtricitabine/tenofovir should have medical exams and liver function tests performed for at least several months after they stop taking efavirenz/emtricitabine/tenofovir. Keep all doctor and lab appointments. Do not stop taking efavirenz/emtricitabine/tenofovir without checking with your doctor.


Efavirenz/ emtricitabine/ tenofovir is used for:

Treating HIV infection alone or along with other medicines.

Efavirenz/emtricitabine/tenofovir is an antiviral combination of 3 reverse transcriptase inhibitors. It works by slowing the growth of HIV, the virus that causes AIDS. Efavirenz/emtricitabine/tenofovir is not a cure for HIV or AIDS.

Do NOT use efavirenz/ emtricitabine/ tenofovir if:

  • you are allergic to any ingredient in efavirenz/emtricitabine/tenofovir
  • you have developed red, swollen, blistered, or peeling skin after taking efavirenz, a component of efavirenz/emtricitabine/tenofovir
  • you have moderate to severe kidney problems
  • you have moderate to severe liver problems or lactic acidosis
  • you are taking adefovir, artemether-lumefantrine, atazanavir, bepridil, boceprevir, bortezomib, bosutinib, cabazitaxel, cisapride, an ergot derivative (eg, dihydroergotamine, ergotamine), lurasidone, midazolam, nevirapine, pimozide, St. John's wort, ticagrelor, triazolam, vandetanib, or voriconazole
  • you are taking a medicine that contains lamivudine, or another medicine that contains emtricitabine or tenofovir
  • you take a medicine that may harm your kidneys (eg, an aminoglycoside antibiotic [eg, gentamicin], amphotericin B, cyclosporine, a nonsteroidal anti-inflammatory drug [NSAID] [eg, ibuprofen], tacrolimus, vancomycin). Ask your doctor if you are not sure if any of your medicines might harm your kidneys

Contact your doctor or health care provider right away if any of these apply to you.

Slideshow: Flashback: FDA Drug Approvals 2013

Before using efavirenz/ emtricitabine/ tenofovir:

Some medical conditions may interact with efavirenz/emtricitabine/tenofovir. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

  • if you are pregnant, planning to become pregnant, or are breast-feeding
  • if you are able to become pregnant
  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
  • if you have allergies to medicines, foods, or other substances
  • if you have a history of bone problems (eg, fracture, osteoporosis), seizures, high cholesterol, kidney problems (including dialysis treatment), lactic acidosis, inflammation of the pancreas (pancreatitis), or liver problems (eg, hepatitis, abnormal liver function tests)
  • if you have a history of mental or mood problems (eg, depression), suicidal thoughts or actions, injection drug use, or alcohol or other substance abuse or dependence
  • if you are very overweight
  • if you take a medicine that may harm the liver (eg, acetaminophen, methotrexate, ketoconazole, isoniazid, certain medicines for HIV infection) because the risk of liver side effects may be increased. Ask your doctor if you are unsure if any of your medicines might harm the liver

Some MEDICINES MAY INTERACT with efavirenz/emtricitabine/tenofovir. Tell your health care provider if you are taking any other medicines, especially any of the following:

  • Many prescription and nonprescription medicines (eg, used for aches and pains, anxiety, birth control, blood thinning, cancer, depression or other mental or mood problems, emergency contraception, hepatitis C, high blood pressure, high cholesterol, HIV, immune system suppression, infections, inflammation, irregular heartbeat or other heart problems, narcotic or other substance abuse or dependence, pain, seizures, sleep, stomach problems), multivitamin products, or herbal or dietary supplements (eg, herbal teas, coenzyme Q10, garlic, ginseng, ginkgo) because they may interact with efavirenz/emtricitabine/tenofovir. Ask your doctor or pharmacist if you are unsure if any of your medicines might interact with efavirenz/emtricitabine/tenofovir

This may not be a complete list of all interactions that may occur. Ask your health care provider if efavirenz/emtricitabine/tenofovir may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use efavirenz/ emtricitabine/ tenofovir:

Use efavirenz/emtricitabine/tenofovir as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • An extra patient leaflet is available with efavirenz/emtricitabine/tenofovir. Talk to your pharmacist if you have questions about this information.
  • Take efavirenz/emtricitabine/tenofovir by mouth on an empty stomach at least 1 hour before or 2 hours after eating.
  • Take efavirenz/emtricitabine/tenofovir with a full glass of water (8 oz [240 mL]).
  • Do not take efavirenz/emtricitabine/tenofovir if the seal over the bottle opening is broken or missing.
  • Continue to take efavirenz/emtricitabine/tenofovir even if you feel well. Do not miss any doses.
  • Take efavirenz/emtricitabine/tenofovir at the same time each day, preferably at bedtime, unless otherwise directed by your doctor.
  • If you miss a dose of efavirenz/emtricitabine/tenofovir, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use efavirenz/emtricitabine/tenofovir.

Important safety information:

  • Efavirenz/emtricitabine/tenofovir may cause drowsiness, dizziness, or trouble concentrating. These effects may be worse if you take it with alcohol or certain medicines. Use efavirenz/emtricitabine/tenofovir with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
  • Check with your doctor before you drink alcohol or use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using efavirenz/emtricitabine/tenofovir; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.
  • Efavirenz/emtricitabine/tenofovir may cause dizziness, drowsiness, trouble sleeping, trouble concentrating, or unusual dreams. These effects usually go away after you have taken efavirenz/emtricitabine/tenofovir for about 2 to 4 weeks. Taking it at bedtime may help make these effects less bothersome. Check with your doctor if they continue or are severe.
  • Do NOT take more than the recommended dose, change your dose, or stop taking efavirenz/emtricitabine/tenofovir without checking with your doctor. Taking more than the recommended dose may not provide additional benefits and may increase the risk of side effects.
  • You should be tested for HBV infection before you start to take efavirenz/emtricitabine/tenofovir.
  • Tell your doctor or dentist that you take efavirenz/emtricitabine/tenofovir before you receive any medical or dental care, emergency care, or surgery.
  • Keep a list of all the medicines that you take. Make a new list each time medicines are added or stopped. Find out about medicines that should not be taken while you are using efavirenz/emtricitabine/tenofovir. Be sure that each of your health care providers knows all the medicines that you are taking.
  • Efavirenz/emtricitabine/tenofovir is not a cure for HIV infection. Patients may still get illnesses and infections associated with HIV. Remain under the care of your doctor.
  • Efavirenz/emtricitabine/tenofovir does not stop the spread of HIV to others through blood or sexual contact. Do not have any kind of sex without protection (eg, latex or polyurethane condoms) if you have HIV infection. Do not share needles, injection supplies, or items such as toothbrushes or razors. Talk with your health care provider about ways to prevent the spread of HIV to others.
  • When your medicine supply is low, get more from your doctor or pharmacist as soon as you can. Do not stop taking efavirenz/emtricitabine/tenofovir, even for a short period of time. If you do, the virus may grow resistant to the medicine and become harder to treat.
  • Changes in body fat (eg, an increased amount of fat in the upper back, neck, breast, and trunk, and loss of fat from the legs, arms, and face) may occur in some patients taking efavirenz/emtricitabine/tenofovir. The cause and long-term effects of these changes are unknown. Discuss any concerns with your doctor.
  • Efavirenz/emtricitabine/tenofovir may improve immune system function. This may reveal hidden infections in some patients. Tell your doctor right away if you notice symptoms of infection (eg, fever, sore throat, weakness, cough, shortness of breath) after you start efavirenz/emtricitabine/tenofovir.
  • Check with your doctor to see if you should take a calcium and vitamin D supplement while you are taking efavirenz/emtricitabine/tenofovir.
  • Women who may become pregnant should have a negative pregnancy test before they start to take efavirenz/emtricitabine/tenofovir. Discuss any questions or concerns with your doctor.
  • If you may become pregnant, you must use an effective form of birth control while you take efavirenz/emtricitabine/tenofovir and for 12 weeks after you stop taking it. Hormonal birth control (eg, birth control pills) may not work as well while you are using efavirenz/emtricitabine/tenofovir. You should always use a barrier form of birth control (eg, condoms), even if you already use another method of birth control (eg, hormonal birth control). If you have questions about effective birth control, talk with your doctor.
  • Efavirenz/emtricitabine/tenofovir may affect certain lab tests, including drug tests. Be sure your doctor and lab personnel know you are taking efavirenz/emtricitabine/tenofovir.
  • Lab tests, including liver and kidney function, cholesterol and triglyceride levels, and bone density, may be performed while you use efavirenz/emtricitabine/tenofovir. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
  • Efavirenz/emtricitabine/tenofovir should not be used in CHILDREN younger than 12 years old; the doses needed for these children cannot be made with efavirenz/emtricitabine/tenofovir.
  • PREGNANCY and BREAST-FEEDING: Efavirenz/emtricitabine/tenofovir may cause harm to the fetus. Do not become pregnant while you take efavirenz/emtricitabine/tenofovir and for 12 weeks after you stop taking it. If you think you may be pregnant, contact your doctor right away. Efavirenz/emtricitabine/tenofovir is found in breast milk. Do not breast-feed while taking efavirenz/emtricitabine/tenofovir. Mothers infected with HIV should not breast-feed. There is a risk of passing the HIV infection or efavirenz/emtricitabine/tenofovir to the baby.

Possible side effects of efavirenz/ emtricitabine/ tenofovir:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Back pain; cough; darkened skin color on the palms of hands or soles of feet; diarrhea; dizziness; drowsiness; gas or indigestion; headache; loss of appetite; mild sore throat; mild stomach pain; muscle or joint aches; nausea; skin discoloration (small spots or freckles); stomach upset; strange dreams; stuffy or runny nose; tiredness; trouble concentrating; trouble sleeping; vomiting.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, throat, or tongue); bone pain; change in personality; chest pain; confusion; decreased coordination; delusions; fever, chills, or persistent sore throat; hallucinations; memory problems; mental, mood, or behavior changes (eg, abnormal thoughts, agitation, aggression, anxiety, depression, nervousness, paranoia); muscle pain or weakness; numbness, burning, pain, or tingling of the hands, feet, or skin; red, swollen, blistered, or peeling skin; seizures; severe or persistent stomach pain, nausea, or vomiting; shortness of breath; suicidal thoughts or actions; symptoms of kidney problems (eg, increased or decreased urination, increased thirst); symptoms of lactic acidosis (eg, dizziness or light-headedness; fast or difficult breathing; fast or irregular heartbeat; feeling cold, especially in the arms and legs; stomach pain with nausea and vomiting; unusual muscle pain; unusual weakness or tiredness); symptoms of liver problems (eg, dark urine, pale stools, persistent loss of appetite, yellowing of the skin or eyes).

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include hallucinations; muscle twitching; severe dizziness, drowsiness, or coordination problems; trouble concentrating; trouble sleeping.

Proper storage of efavirenz/emtricitabine/tenofovir:

Store efavirenz/emtricitabine/tenofovir at 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Store only in original container and keep it tightly closed. Do not store in the bathroom. Do not use efavirenz/emtricitabine/tenofovir if it is past the expiration date on the bottle. Keep efavirenz/emtricitabine/tenofovir out of the reach of children and away from pets.

General information:

  • If you have any questions about efavirenz/emtricitabine/tenofovir, please talk with your doctor, pharmacist, or other health care provider.
  • Efavirenz/emtricitabine/tenofovir is to be used only by the patient for whom it is prescribed. Do not share it with other people.
  • If your symptoms do not improve or if they become worse, check with your doctor.
  • Check with your pharmacist about how to dispose of unused medicine.

This information should not be used to decide whether or not to take efavirenz/emtricitabine/tenofovir or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about efavirenz/emtricitabine/tenofovir. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to efavirenz/emtricitabine/tenofovir. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using efavirenz/emtricitabine/tenofovir.

Issue Date: September 3, 2014
Database Edition 14.3.1.003
Copyright © 2014 Wolters Kluwer Health, Inc.

Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.

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