Atripla (Efavirenz, Emtricitabine, and Tenofovir)

Gilead Sciences, Inc.

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(NNRTIs)

HIV

This product contains 3 different medications: efavirenz, emtricitabine, and tenofovir. It is used alone or with other HIV medications to help control HIV infection. It helps to decrease the amount of HIV in your body so your immune system can work better. This lowers your chance of getting HIV complications (such as new infections, cancer) and improves your quality of life. Efavirenz belongs to a class of drugs known as non-nucleoside reverse transcriptase inhibitors (NNRTIs). Emtricitabine and tenofovir belong to a class of drugs known as nucleoside reverse transcriptase inhibitors (NRTIs). OTHER USES: This section contains uses of this drug that are not listed in the approved professional labeling for the drug but that may be prescribed by your health care professional. Use this drug for a condition that is listed in this section only if it has been so prescribed by your health care professional. This product may also be used to lessen the risk of HIV infection after contact with the virus (for example, due to a needle stick). Ask your doctor for more details.

Take this medication by mouth on an empty stomach, without food, usually once daily at bedtime or as directed by your doctor. Taking this medication at bedtime helps to decrease some of the side effects. See Side Effects section. Because this combination product has fixed doses of efavirenz, emtricitabine, and tenofovir, you should only use it if your doctor has determined that the doses of all 3 medications in this product are right for you. It is very important to continue taking this medication (and other HIV medications) exactly as prescribed by your doctor. Do not skip any doses. Do not increase your dose, take this drug more often than prescribed, or stop taking it (or other HIV medicines) even for a short time unless directed to do so by your doctor. Skipping or changing your dose without approval from your doctor may cause the amount of virus to increase, make the infection more difficult to treat (resistant), or worsen side effects. This medication works best when the amount of drug in your body is kept at a constant level. Therefore, take this drug at evenly spaced intervals. To help you remember, take it at the same time each day. Efavirenz/emtricitabine/tenofovir can commonly cause a rash that is usually not serious. However, you may not be able to tell it apart from a rare rash that could be a sign of a severe reaction. Therefore, seek immediate medical attention if you develop any rash.

Dizziness, trouble sleeping, drowsiness, unusual dreams, and trouble concentrating may frequently occur. These side effects may begin 1-2 days after starting this medication and usually go away in 2-4 weeks. They are also reduced by taking this medication on an empty stomach at bedtime. Tiredness, headache, nausea, vomiting, diarrhea, and skin discoloration (such as small spots/freckles, darkening of the palms of the hands/soles of the feet) may also occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly. Some people may experience worsening of a previous medical condition (such as an old infection) as their immune systems improve, or develop new conditions because their immune systems have become overactive. This reaction may occur at any time (soon after starting HIV treatment or many months later). Tell your doctor right away if you have any serious side effects, including: unexplained weight loss, persistent muscle aches/weakness, joint pain, numbness/tingling of the hands/feet/arms/legs, severe tiredness, vision changes, severe/persistent headaches, signs of infection (such as fever, chills, trouble breathing, cough, non-healing skin sores), signs of an overactive thyroid (such as irritability, nervousness, heat intolerance, fast/pounding/irregular heartbeat, bulging eyes, unusual growth in the neck/thyroid known as a goiter), signs of a certain nerve problem known as Guillain-Barre Syndrome (such as difficulty breathing/swallowing/moving your eyes, drooping face, paralysis, slurred speech). Infrequently, serious psychiatric symptoms may occur during efavirenz/emtricitabine/tenofovir treatment. These effects may be seen especially in people who have mental/mood conditions. Tell your doctor right away if any of these unlikely but serious side effects occur: mental/mood changes (such as depression, rare thoughts of suicide, strange thoughts, anxiety, angry behavior, hallucinations, confusion). Tell your doctor right away if any of these rare but serious side effects occur: signs of kidney problems (such as a change in the amount of urine), unusual thirst, signs of pancreatitis (such as nausea, vomiting, stomach/abdominal/back pain, fever). Changes in body fat may occur while you are taking this medication (such as increased fat in the upper back and stomach areas, decreased fat in the arms and legs). The cause and long-term effects of these changes are unknown. Discuss the risks and benefits of treatment with your doctor, as well as the possible use of exercise to reduce this side effect. Tenofovir may increase the risk of bone loss. Discuss the risks and benefits of treatment with your doctor, as well as the possible use of calcium and vitamin D to reduce this side effect. If you are at risk for bone loss, your doctor may monitor your bone mineral density. Tell your doctor right away if any of the following serious side effects occur: bone pain, easily broken bones. Efavirenz/emtricitabine/tenofovir can commonly cause a rash that is usually not serious. However, you may not be able to tell it apart from a rare rash that could be a sign of a severe reaction. Therefore, seek immediate medical attention if you develop any rash. A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, blisters, peeling skin, fever, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval. Some products that may interact with this drug include: other drugs that may affect the kidneys (including adefovir, cidofovir, aminoglycosides such as amikacin/gentamicin), a certain combination product used to treat chronic hepatitic C (ombitasvir/paritaprevir/ritonavir/dasabuvir). Do not take this medication with other products that contain emtricitabine or tenofovir. Do not take this medication with another efavirenz product unless specifically directed by your doctor. Also, lamivudine is similar to emtricitabine and should not be taken with this medication. Other medications can affect the removal of efavirenz/emtricitabine/tenofovir from your body, which may affect how this product works. Examples include some drugs used to treat seizures (such as carbamazepine), among others. Efavirenz/emtricitabine/tenofovir can speed up the removal of many other medications from your body, which may affect how they work. Examples of affected drugs include atovaquone/proguanil, azole antifungals (such as voriconazole), bedaquiline, cobicistat, elvitegravir, certain protease inhibitors (boceprevir, simeprevir), macrolide antibiotics (such as clarithromycin), among others. This medication may decrease the effectiveness of hormonal birth control such as pills, patch, or ring. This could cause pregnancy. Talk to your doctor about additional or alternative reliable forms of birth control, and always use an effective barrier method (latex or polyurethane condoms/dental dams) during all sexual activity to decrease the risk of spreading HIV to others. Tell your doctor if you have any new spotting or breakthrough bleeding, because these may be signs that your hormonal birth control is not working well. (See also Precautions section.) Tell your doctor or pharmacist if you are taking other products that cause drowsiness including alcohol, antihistamines (such as cetirizine, diphenhydramine), drugs for sleep or anxiety (such as diazepam, zolpidem), muscle relaxants, and narcotic pain relievers (such as codeine). Check the labels on all your medicines (such as allergy or cough-and-cold products) because they may contain ingredients that cause drowsiness. Ask your pharmacist about using those products safely. This medication may interfere with certain laboratory tests (including urine cannabinoid tests), possibly causing false test results. Make sure laboratory personnel and all your doctors know you use this drug.

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222.

If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.