What is Atripla?
Atripla (efavirenz, emtricitabine, and tenofovir) is an antiviral medication that prevents human immunodeficiency virus (HIV) from reproducing in your body.
Atripla treats HIV in adults and children who are at least 12 years old. HIV causes acquired immunodeficiency syndrome (AIDS). This medication is not a cure for HIV or AIDS.
Atripla may also be used for purposes not listed in this medication guide.
Important information
Do not take Atripla together with adefovir (Hepsera), or with medications that contain emtricitabine, lamivudine, or tenofovir (Combivir, Complera, Emtriva, Epivir, Epzicom, Stribild, Trizivir, Truvada, Viread).
Some other medicines can cause unwanted or dangerous effects when used with Atripla. Your doctor may need to change your treatment plan if you also use: midazolam, pimozide, St. John’s wort, triazolam, voriconazole, or an ergot medicine (dihydroergotamine, ergonovine, ergotamine, methylergonovine).
Slideshow: Flashback: FDA Drug Approvals 2013
Flashback: FDA Drug Approvals 2013
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.
Atripla 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).
Before taking this medicine
You should not take Atripla if you are allergic to efavirenz (Sustiva), emtricitabine (Emtriva), or tenofovir (Viread).
Do not take Atripla together with adefovir (Hepsera), or with medications that contain emtricitabine, lamivudine, or tenofovir (Combivir, Complera, Emtriva, Epivir, Epzicom, Stribild, Trizivir, Truvada, Viread).
Some medicines can cause unwanted or dangerous effects when used with Atripla. Your doctor may need to change your treatment plan if you are taking any of the following drugs:
midazolam or triazolam;
pimozide;
St. John’s wort;
voriconazole; or
an ergot medicine–dihydroergotamine, ergonovine, ergotamine, methylergonovine.
This medication should not be used in children weighing less than 88 pounds.
To make sure Atripla is safe for you, tell your doctor if you have:
liver or kidney disease;
a history of mental illness, use of antipsychotic medication, or injection drug use;
epilepsy or other seizure disorder;
low bone mineral density; or
hepatitis B or C infection.
Some people taking Atripla develop a serious condition called lactic acidosis. This may be more likely in women, in people who are overweight or have liver disease, and in people who have taken HIV/AIDS medication for a long time. Talk with your doctor about your risk.
FDA pregnancy category D. Do not use Atripla if you are pregnant. It could harm the unborn baby. Use two forms of birth control, including a barrier form (such as a condom or diaphragm with spermicide) while you are using this medication and for at least 12 weeks after your treatment ends.
See also: Pregnancy and breastfeeding warnings (in more detail)
HIV can be passed to your baby if you are not properly treated during pregnancy. Take all of your HIV medicines as directed to control your infection.
Women with HIV or AIDS should not breast-feed a baby. Even if your baby is born without HIV, the virus may be passed to the baby in your breast milk.
How should I take Atripla?
Take Atripla exactly as prescribed by your doctor. Follow all directions on your prescription label. Do not take Atripla in larger or smaller amounts or for longer than recommended.
Take this medication on an empty stomach at bedtime.
While using Atripla, you may need frequent blood tests. Your liver function may also need to be tested.
This medication can cause you to have a false positive drug screening test. If you provide a urine sample for drug screening, tell the laboratory staff that you are taking Atripla.
Use Atripla regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.
Store Atripla in the original container at room temperature, away from moisture, heat, and light. Keep the bottle tightly closed when not in use.
If you have hepatitis B you may develop liver symptoms after you stop taking this medication, even months after stopping. Your doctor may want to check your liver function for several months after you stop using Atripla.
What happens if I miss a dose?
Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.
What happens if I overdose?
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.
What should I avoid?
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.
Atripla side effects
Get emergency medical help if you have any of these 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.
Stop using Atripla and call your doctor at once if you have:
kidney problems–increased thirst and urination, loss of appetite, constipation, little or no urinating; or
sore throat, flu symptoms, easy bruising or unusual bleeding;
liver problems–nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).
unusual thoughts or behavior, anger, severe depression, thoughts of hurting yourself or others, hallucinations, seizure (convulsions); 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, diarrhea, stomach pain, weight loss;
chest pain (especially when you breathe), dry cough, wheezing, feeling short of breath;
cold sores, sores on your genital or anal area;
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
mild nausea;
mild depression;;
headache, dizziness, tired feeling, strange dreams; 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.
See also: Side effects (in more detail)
What other drugs will affect Atripla?
Atripla can harm your kidneys. This effect is increased when you also use certain other medicines, including: antivirals, chemotherapy, injected antibiotics, medicine for bowel disorders, medicine to prevent organ transplant rejection, and some pain or arthritis medicines (including aspirin, Tylenol, Advil, and Aleve).
Many drugs can interact with Atripla. Not all possible interactions are listed here. Tell your doctor about all your medications and any you start or stop using during treatment with Atripla, especially:
a blood thinner–clopidogrel; any other HIV medicines–especially atazanavir, didanosine, efavirenz, lopinavir with ritonavir, or tenofovir.
This list is not complete and many other drugs can interact with Atripla. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Give a list of all your medicines to any healthcare provider who treats you.
Efavirenz / emtricitabine / tenofovir Pregnancy and Breastfeeding Warnings
Efavirenz / emtricitabine / tenofovir is also known as: Atripla
Overview
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Dosage
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Pregnancy
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Efavirenz / emtricitabine / tenofovir Pregnancy Warnings
Animal studies have revealed evidence of fetal harm with efavirenz. Efavirenz crosses the placenta in animals and produces fetal blood levels similar to maternal blood levels. Efavirenz may cause fetal harm when used during the first trimester. There are no controlled data in human pregnancy. To monitor maternal-fetal outcomes of pregnant women exposed to antiretroviral therapy, an Antiretroviral Pregnancy Registry (APR) has been established. Healthcare providers are encouraged to prospectively register patients. Information is available at www.apregistry.com. As of July 2010, the APR had received reports of 792 pregnancies exposed to efavirenz-containing regimens, 718 of which were first trimester exposures. Birth defects were observed in 17 of 604 live births with first trimester exposure and 2 of 69 live births with second or third trimester exposure. One of these prospective reports with first trimester exposure was a neural tube defect. Also, a single case of anophthalmia has been prospectively reported with first trimester efavirenz exposure; however, this case included severe oblique facial clefts and amniotic banding, a known association with anophthalmia. There have been 6 cases of findings consistent with neural tube defects (including meningomyelocele) retrospectively reported in infants of mothers with first trimester efavirenz exposure. Multiple defects (Dandy-Walker syndrome) in a fetus from a spontaneous abortion and neural tube defects in a fetus from a pregnancy terminated during the second trimester have also been reported. Both mothers had first trimester exposure to efavirenz-containing regimens. Causality could not be clearly established in any of these cases. The manufacturer recommends avoiding pregnancy during efavirenz/emtricitabine/tenofovir therapy. Barrier contraception must always be used in combination with other methods of contraception (e.g., hormonal) during use of this drug. Use of adequate contraception for 12 weeks after discontinuing the drug is recommended. Women of childbearing age should undergo pregnancy testing before starting efavirenz/emtricitabine/tenofovir and should be advised to notify their physician if they become pregnant during therapy. Patients should be advised of the potential harm to the fetus if they become pregnant while taking efavirenz/emtricitabine/tenofovir or if it is used during the first trimester. FDA pregnancy category D: There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.
FDA pregnancy category: D Efavirenz/emtricitabine/tenofovir should not be used during pregnancy unless there are no alternatives and the benefit outweighs the risk to the fetus. Comments: Effective contraception is recommended during therapy and for 12 weeks after the drug is stopped.
Efavirenz / emtricitabine / tenofovir Breastfeeding Warnings
Breast milk samples from 5 HIV-1 infected women showed emtricitabine is secreted in human milk. Infants breastfed by mothers treated with emtricitabine may be at risk for developing viral resistance to emtricitabine. Other emtricitabine-associated risks in such infants are unknown. Breast milk samples from 5 HIV-1 infected mothers showed tenofovir is secreted in human milk. The impact of this exposure in infants breastfed by mothers treated with tenofovir is unknown. Since the risks of infant exposure to emtricitabine and tenofovir are unknown and due to the potential for HIV-1 transmission, the manufacturer states that mothers should not breastfeed if they are taking efavirenz/emtricitabine/tenofovir.
Breastfeeding is not recommended during use of efavirenz/emtricitabine/tenofovir. Excreted into human milk: Unknown (efavirenz); Yes (emtricitabine and tenofovir) Excreted into animal milk: Yes (efavirenz and tenofovir); Unknown (emtricitabine) The effects in the nursing infant are unknown. The US Centers for Disease Control and Prevention and the American Academy of Pediatrics advise HIV-infected women not to breastfeed to avoid postnatal transmission of HIV to a child who may not yet be infected.
Atripla Side Effects
Generic Name: efavirenz / emtricitabine / tenofovir
Overview
Side Effects
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For Professionals
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Note: This page contains information about the side effects of efavirenz / emtricitabine / tenofovir. Some of the dosage forms included on this document may not apply to the brand name Atripla.
Not all side effects for Atripla may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.
For the Consumer
Applies to efavirenz / emtricitabine / tenofovir: oral tablet
Along with its needed effects, efavirenz / emtricitabine / tenofovir may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur while taking efavirenz / emtricitabine / tenofovir:
Less common
Abdominal or stomach pain or tenderness
blistering, peeling, or loosening of the skin
body aches or pain
clay-colored stools
cough
dark urine
ear congestion
fever or chills
headache
itching
loss of voice
muscle aches
nausea and vomiting
severe skin rash
sore throat
swelling of the feet or lower legs
tightness of the chest
trouble concentrating
yellow eyes or skin
Some side effects of efavirenz / emtricitabine / tenofovir may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
More common
Diarrhea
dizziness
unusual tiredness or weakness
decreased appetite
discouragement
feeling sad or empty
irritability
loss of appetite
loss of interest or pleasure
mild rash
pain or tenderness around the eyes and cheekbones
sleepiness
trouble sleeping
unusual drowsiness
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Atripla
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