Atripla (efavirenz/emtricitabine/tenofovir) Dosage and Side Effects
ATRIPLA contains 3 medicines, SUSTIVA (efavirenz), EMTRIVA (emtricitabine) and VIREAD (tenofovir DF), combined in one pill. ATRIPLA can be used alone as a complete regimen, or in combination with other medications to treat people with HIV infection.
Warnings and Precautions
Tenofovir DF, a component of ATRIPLA, caused harm to the bones of animals. If you notice bone pain, suffer a bone fracture, or other bone problem, consult your doctor. If you have bone problems, you may wish to discuss calcium and/or vitamin D supplementation with your doctor. The effect of supplementation with calcium and/or vitamin D is unknown.
Patients who experience dizziness, trouble concentrating or drowsiness should avoid driving or operating machinery.
Women should not become pregnant while taking ATRIPLA and for 12 weeks after stopping it. Serious birth defects have been seen in animals and women treated with efavirenz (a component of ATRIPLA) during pregnancy. It is not known whether efavirenz caused these defects. A reliable form of barrier contraception must always be used even if you or your partner is using other methods of contraception such as the pill or other hormonal therapy (e.g. implants, injections). ATRIPLA may remain in your blood for a time after therapy is stopped. Therefore, you should continue use of a reliable form of contraception for 12 weeks after stopping treatment with ATRIPLA. If you are pregnant or become pregnant while taking ATRIPLA, your doctor may register you in the Antiretroviral Pregnancy Registry. The Registry monitors fetal outcomes in pregnant women using antiretroviral medicines.
A small number of patients taking efavirenz, one of the components of ATRIPLA, have had severe depression, strange thoughts, or angry behavior. Some patients have had thoughts of suicide and a few patients have actually committed suicide. These problems tend to occur more often in patients with a history of mental illness. You should contact your doctor immediately if you think you are having these symptoms, so your doctor can decide whether you should continue to take ATRIPLA.
Consult your doctor if you have a rash since some rashes may be serious.
BEFORE you use ATRIPLA (efavirenz/emtricitabine/tenofovir DF) talk to your doctor or pharmacist:
If you have ever had a previous life threatening skin reaction (e.g. Stevens-Johnson syndrome).
If you are breast-feeding or plan to breast-feed:
Do not breast-feed if you have HIV or are taking ATRIPLA. HIV can be passed to your baby in your breast milk. All components of ATRIPLA, efavirenz, emtricitabine and tenofovir DF, can be passed to your baby in your breast milk and may cause harm to your baby. Talk to your doctor about the best way to feed your baby.
If you have other medical conditions:
Let your doctor know if you have other medical conditions, especially liver, kidney problems, pancreatitis (inflammation of the pancreas), seizures or mental illness, or have or are at risk for bone disease or bone-related problems.
The most common side effects of SUSTIVA, EMTRIVA and VIREAD are:
Nervous system symptoms such as dizziness, trouble sleeping, drowsiness, trouble concentrating, unusual dreams
Flatulence (intestinal gas)
Allergic reaction (including swelling of the face, lips, tongue or throat)
Other side effects may include pancreatitis (inflammation of the pancreas) and shortness of breath.
Skin discoloration (small spots or freckles) may also happen with ATRIPLA.
A small number of patients taking efavirenz, one of the components of ATRIPLA, have had severe depression, strange thoughts, or angry behavior. Some patients have had thoughts of suicide and a few patients have actually committed suicide. These problems tend to occur more often in patients with a history of mental illness. Contact your doctor immediately if you think you are having these symptoms so your doctor can decide whether you should continue to take ATRIPLA.
Changes in body fat have been seen in some patients taking antiretroviral therapy. These changes may include increased amounts of fat in the upper back and neck (“buffalo hump”), breast, 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 conditions are not known at this time.
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 a hepatitis infection, but there have also been a few reports in patients without any existing liver disease.
Changes in your immune system (Immune Reconstitution Inflammatory Syndrome) can happen when you start taking HIV medicines. Your immune system may get stronger and begin to fight infections that have been hidden in your body for a long time, or you could develop an autoimmune disease in which your immune system reacts against your own body [e.g. Grave's disease (which affects the thyroid gland), Guillain-Barré syndrome (which affects the nervous system) or polymyositis (which affects the muscles)] and it may develop at any time, sometimes months later after the start of HIV therapy. Sometimes symptoms can be severe, so if you develop high temperature (fever), joint or muscle pain, redness, rash, swelling or fatigue, or any new symptoms, contact your doctor right away.
Lactic acidosis is a medical emergency and must be treated in the hospital. You may be more likely to get lactic acidosis or serious liver problems if you are very overweight (obese) or have been taking nucleoside analog medicines, like ATRIPLA, for a long time.
Muscle pain, muscle weakness, bone pain and softening of the bone (infrequently contributing to fractures) have also been reported due to tenofovir DF (a component of ATRIPLA).
There have been other side effects in patients taking SUSTIVA, EMTRIVA or VIREAD. This is not a complete list of side effects. If you have questions about side effects, ask your doctor, nurse, or pharmacist. You should report any new or continuing symptoms to your doctor right away. Your doctor may be able to help you manage these side effects.
Interactions with this medication
No drug interaction studies have been done with ATRIPLA.
Drugs that must not be taken with ATRIPLA:
Propulsid (cisapride)†, Versed (midazolam), Halcion (triazolam), ergot medications (for example Wigraine and Cafergot), Hismanal (astemizole)†, Seldane (terfenadine)†, Vascor (bepridil)† or Orap (pimozide). Taking these medications with ATRIPLA could create the potential for serious or life-threatening side effects.
Vfend (voriconazole) since it may lose its effect or may increase the chance of having side effects from ATRIPLA.
Do not take ATRIPLA if you are taking St. John's wort (Hypericum perforatum), or products containing St. John's wort. St. John's wort is an herbal product sold as a dietary supplement. Taking St. John's wort may decrease ATRIPLA levels and may lead to increased viral load and possible resistance to efavirenz or resistance to the class of non-nucleoside reverse transcriptase inhibitors (NNRTIs).
It is also important to tell your doctor if you are taking any of the following:
ATRIPLA should not be used with Combivir, COMPLERA, EMTRIVA, 3TC, Heptovir, HEPSERA, Kivexa, Triumeq, Trizivir, TRUVADA, STRIBILD or VIREAD. ATRIPLA also should not be used with SUSTIVA unless your doctor decides a dose adjustment is needed (e.g. with rifampin).
Do not take ATRIPLA if you are on other medications that may affect your kidneys and have not discussed this with your doctor.
Reyataz (atazanavir sulfate), Fortovase or Invirase (saquinavir), or Biaxin (clarithromycin); these medicines need to be replaced with another medicine when taken with ATRIPLA. If your doctor does prescribe Reyataz and ATRIPLA together, you may need to be monitored more carefully for side effects.
Crixivan (indinavir), methadone, Mycobutin (rifabutin), Zoloft (sertraline), Wellbutrin SR, Wellbutrin XL, or Zyban (bupropion); these medicines may need to have their dose changed when taken with ATRIPLA.
Videx or 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.
Kaletra (lopinavir/ritonavir) or HARVONI (ledipasvir/sofosbuvir) may increase the amount of tenofovir DF (a component of ATRIPLA) in your blood, which could result in more side effects. You may need to be monitored more carefully if you are taking ATRIPLA and Kaletra together or ATRIPLA and HARVONI together. Also, the dose of Kaletra may need to be changed.
Medicines for seizures [for example, Dilantin (phenytoin), Tegretol (carbamazepine), or phenobarbital]; your doctor may want to switch you to another medicine or check drug levels in your blood from time to time.
Sporanox (itraconazole) and Posanol (posaconazole) may need to be replaced by another medicine when taken with ATRIPLA.
The cholesterol-lowering medicines Lipitor (atorvastatin), Pravachol (pravastatin sodium), and Zocor (simvastatin).
Rifadin (rifampin) or the rifampin-containing medicines Rofact and Rifater.
Calcium channel blockers such as Cardizem, or Tiazac (diltiazem), Covera HS, Isoptin SR or Tarka (verapamil), and others.
Immunosuppressants such as Neoral (cyclosporine), Advagraf or Prograf (tacrolimus), Rapamune or Torisel (sirolimus).
Hepatitis C antiviral agents such as Victrelis (boceprevir), Galexos (simeprevir) and Incivek (telaprevir).
The effect of combining alcohol or recreational (street, illicit) drugs with efavirenz has not been studied. Because they may interact with each other, speak with your doctor before you combine ATRIPLA with these drugs.
These are not all the medicines that may cause problems if you take ATRIPLA. Be sure to tell your doctor about all the medicines you take.
Keep a complete list of all the prescription and nonprescription medicines as well as any herbal medicines that you are taking, how much you take and how often you take them. Make a new list when medicines or herbal medicines are added or stopped, or if the dose changes. Give copies of this list to all your doctors and pharmacists every time you visit them or fill a prescription. This will give your doctor a complete picture of the medicines you use. Then he or she can decide the best approach for the situation.
Proper Use of this medication
Stay under a doctor's care when taking ATRIPLA. Do not change your treatment or stop treatment without first talking with your doctor.
Take ATRIPLA every day exactly as your doctor prescribed it. Follow the directions from your doctor, exactly as written on the label. Set up a dosing schedule and follow it carefully.
When your ATRIPLA supply starts to run low, get more from your doctor 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.
Only take medicine that has been prescribed specifically for you. Do not give ATRIPLA to others or take medicine prescribed for someone else. Do not use if seal over bottle opening is broken or missing.
Usual Adult Dose
The usual dose of ATRIPLA is one tablet orally (by mouth) once a day.
ATRIPLA should be taken on an empty stomach. Taking ATRIPLA at bedtime may make some side effects less bothersome.
It is important that you do not miss any doses. If you miss a dose of ATRIPLA, take it as soon as you remember that day. Do not take more than 1 dose of ATRIPLA in a day. Do not take 2 doses at the same time. Call your doctor or pharmacist if you are not sure what to do.
Other related products
The above information is an educational aid only. It is not intended as medical advice for individual conditions or treatments. Talk to your doctor, nurse or pharmacist before following any medical regimen to see if it is safe and effective for you.