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 Atripla. 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).
Atripla 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 Atripla should have medical exams and liver function tests performed for at least several months after they stop taking Atripla. Keep all doctor and lab appointments. Do not stop taking Atripla without checking with your doctor.
Atripla is used for:
Treating HIV infection alone or along with other medicines.
Atripla is an antiviral combination of 3 reverse transcriptase inhibitors. It works by slowing the growth of HIV, the virus that causes AIDS. Atripla is not a cure for HIV or AIDS.
Do NOT use Atripla if:
- you are allergic to any ingredient in Atripla
- you have developed red, swollen, blistered, or peeling skin after taking efavirenz, a component of Atripla
- 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.
Before using Atripla:
Some medical conditions may interact with Atripla. 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 Atripla. 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 Atripla. Ask your doctor or pharmacist if you are unsure if any of your medicines might interact with Atripla
This may not be a complete list of all interactions that may occur. Ask your health care provider if Atripla 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 Atripla:
Use Atripla as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- An extra patient leaflet is available with Atripla. Talk to your pharmacist if you have questions about this information.
- Take Atripla by mouth on an empty stomach at least 1 hour before or 2 hours after eating.
- Take Atripla with a full glass of water (8 oz [240 mL]).
- Do not take Atripla if the seal over the bottle opening is broken or missing.
- Continue to take Atripla even if you feel well. Do not miss any doses.
- Take Atripla at the same time each day, preferably at bedtime, unless otherwise directed by your doctor.
- If you miss a dose of Atripla, 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 Atripla.
Important safety information:
- Atripla may cause drowsiness, dizziness, or trouble concentrating. These effects may be worse if you take it with alcohol or certain medicines. Use Atripla 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 Atripla; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.
- Atripla may cause dizziness, drowsiness, trouble sleeping, trouble concentrating, or unusual dreams. These effects usually go away after you have taken Atripla 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 Atripla 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 Atripla.
- Tell your doctor or dentist that you take Atripla 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 Atripla. Be sure that each of your health care providers knows all the medicines that you are taking.
- Atripla is not a cure for HIV infection. Patients may still get illnesses and infections associated with HIV. Remain under the care of your doctor.
- Atripla 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 Atripla, 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 Atripla. The cause and long-term effects of these changes are unknown. Discuss any concerns with your doctor.
- Atripla 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 Atripla.
- Check with your doctor to see if you should take a calcium and vitamin D supplement while you are taking Atripla.
- Women who may become pregnant should have a negative pregnancy test before they start to take Atripla. 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 Atripla 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 Atripla. 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.
- Atripla may affect certain lab tests, including drug tests. Be sure your doctor and lab personnel know you are taking Atripla.
- Lab tests, including liver and kidney function, cholesterol and triglyceride levels, and bone density, may be performed while you use Atripla. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
- Atripla should not be used in CHILDREN younger than 12 years old; the doses needed for these children cannot be made with Atripla.
- PREGNANCY and BREAST-FEEDING: Atripla may cause harm to the fetus. Do not become pregnant while you take Atripla and for 12 weeks after you stop taking it. If you think you may be pregnant, contact your doctor right away. Atripla is found in breast milk. Do not breast-feed while taking Atripla. Mothers infected with HIV should not breast-feed. There is a risk of passing the HIV infection or Atripla to the baby.
Possible side effects of Atripla:
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:
Seek medical attention right away if any of these SEVERE side effects occur:
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.
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 Atripla:
Store Atripla 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 Atripla if it is past the expiration date on the bottle. Keep Atripla out of the reach of children and away from pets.
- If you have any questions about Atripla, please talk with your doctor, pharmacist, or other health care provider.
- Atripla 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 Atripla 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 Atripla. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Atripla. 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 Atripla.
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.