Efavirenz, emtricitabine, and tenofovir

Atripla is a combination antiviral medication that stops human immunodeficiency virus (HIV) from multiplying in your body.

Atripla is used to treat HIV, the virus that can lead to acquired immunodeficiency syndrome (AIDS). Atripla is not a cure for HIV or AIDS. Atripla is for adults and children who are at least 12 years old and weigh at least 88 pounds (40 kilograms).

Atripla may also be used for reasons not mentioned in this medication guide.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Take this medicine on an empty stomach with a full glass of water.

You will need frequent medical tests.

This medicine may affect a drug-screening urine test and you may get false results. Tell the laboratory staff that you use Atripla.

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've ever had hepatitis B, this virus may become active or get worse in the months after you stop using Atripla. You may need frequent liver function tests while using this medicine and for several months after your last dose.

Do not take Atripla with adefovir, atazanavir, voriconazole, or any medications that contain emtricitabine, lamivudine, or tenofovir.

Tell your doctor about all the medicines you are currently taking and any that you start or stop. Many drugs can interact, and some should not be used together.

Atripla can cause severe or fatal liver problems. Call your doctor immediately if you have symptoms like stomach pain or swelling, loss of appetite, dark urine, or yellowing of your skin or eyes.

You may develop lactic acidosis, which is a dangerous build-up of lactic acid in your blood. Call your doctor or get emergency medical help if you experience unusual muscle pain, trouble breathing, stomach pain, dizziness, feeling cold, or feeling very weak or tired.

If you have ever had hepatitis B, it may become active or worsen after you stop taking Atripla. You may need to have liver function tests done frequently for several months.

You should not take efavirenz, emtricitabine, and tenofovir if you are allergic to efavirenz (Sustiva), emtricitabine (Emtriva), or tenofovir (Viread).

Do not take Atripla together with adefovir, atazanavir, voriconazole, or any medications that contain emtricitabine, lamivudine, or tenofovir (such as Combivir, Complera, Descovy, Epivir, Epzicom, Genvoya, Odefsey, Stribild, Trizivir, Truvada, Vemlidy).

Tell your doctor if you have ever had:

• liver or kidney disease;
• long QT syndrome;
• 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.

You may develop lactic acidosis, a dangerous build-up of lactic acid in your blood. This may be more likely if you have other medical conditions, if you've taken HIV medication for a long time, or if you are a woman. Ask your doctor about your risk.

Atripla can cause birth defects. Do not use if you are pregnant, and do not get pregnant for at least 12 weeks after you stop taking Atripla.

Atripla can make hormonal birth control less effective, including birth control pills, injections, implants, skin patches, and vaginal rings. To prevent pregnancy while using Atripla, use a barrier form of birth control: condom, diaphragm, cervical cap, or contraceptive sponge.

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.

Get emergency medical help if you notice signs of an allergic reaction (hives, difficulty breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling).

Mild symptoms of lactic acidosis can get worse over time, and this condition can be fatal. Get emergency medical help if you experience: unusual muscle pain, trouble breathing, stomach pain, vomiting, irregular heart rate, dizziness, feeling cold, or feeling very weak or tired.

Efavirenz, emtricitabine, and tenofovir can cause serious side effects. Call your doctor right away if you experience:

• unusual thoughts or behavior, anger, severe depression, thoughts of harming yourself or others, hallucinations;
• a seizure (convulsions);
• kidney problems—such as increased thirst and urination, muscle pain or weakness; or
• liver problems—such as swelling around your midsection, right-sided upper stomach pain, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Atripla can affect your immune system, which may lead to certain side effects (even weeks or months after taking efavirenz, emtricitabine, and tenofovir). Inform your doctor if you have:

• signs of a new infection—fever, night sweats, swollen glands, cold sores, cough, wheezing, diarrhea, weight loss;
• trouble speaking or swallowing, issues with balance or eye movement, weakness or tingling; or
• swelling in your neck or throat (enlarged thyroid), changes in your menstrual cycle, impotence.

Common side effects of efavirenz, emtricitabine, and tenofovir may include:

• dizziness, drowsiness, feeling tired;
• nausea, diarrhea;
• headache, feeling depressed, trouble concentrating;
• sleep issues (insomnia), unusual dreams;
• rash; 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 happen. Contact your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Usual Adult Dose for HIV Infection:

1 tablet orally once a dayUse: As a complete regimen or in combination with other antiretroviral agents for the treatment of HIV-1 infection

Usual Adult Dose for Nonoccupational Exposure:

US CDC Recommendations: 1 tablet orally once a dayDuration of therapy: 28 daysComments:-Only with expert consultation, an alternative regimen for HIV nonoccupational postexposure prophylaxis (nPEP)-Efavirenz is contraindicated as nPEP in pregnant women; it should be avoided in nPEP regimens during the first trimester and should not be used for women of childbearing potential who might become pregnant during antiretroviral prophylaxis.-Prophylaxis should be started as soon as possible, within 72 hours of exposure.-Current guidelines should be consulted for additional information.

Usual Adult Dose for Occupational Exposure:

US Public Health Service working group recommendations: 1 tablet orally once a dayDuration of therapy: 28 days, if toleratedComments:-Only with expert consultation, an alternative regimen for use as HIV postexposure prophylaxis-Prophylaxis should be started as soon as possible, preferably within hours after exposure.-The optimal duration of prophylaxis is unknown and may differ based on institution protocol.-Current guidelines should be consulted for additional information.

Usual Pediatric Dose for HIV Infection:

At least 40 kg: 1 tablet orally once a dayUse: As a complete regimen or in combination with other antiretroviral agents for the treatment of HIV-1 infection

Take the medicine as soon as you can, but if it is almost time for your next dose, skip the missed dose. Do not take two doses at once.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. Overdose symptoms may include uncontrolled muscle movements.

Avoid driving or doing anything dangerous until you know how efavirenz, emtricitabine, and tenofovir will affect you. Your reactions could be affected.

Using this medicine will not stop your disease from spreading. 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.

Sometimes it is not safe to use certain medications together. Some drugs can change the levels of other drugs in your blood, which may increase side effects or reduce how well the medications work.

Atripla can harm your kidneys, especially if you also take certain medicines for infections, cancer, osteoporosis, preventing organ transplant rejection, bowel disorders, high blood pressure, or pain or arthritis (including Advil, Motrin, and Aleve).

Tell your doctor about all the medicines you are currently taking. Many drugs can affect Atripla, especially:

• St. John's wort;
• an antibiotic or antifungal medicine;
• an antidepressant;
• any other HIV medicines;
• cholesterol medication;
• heart or blood pressure medication;
• medicine to prevent organ transplant rejection;
• medicine to treat hepatitis;
• seizure medicine; or
• tuberculosis medication.

This list is not complete. Many drugs can affect Atripla, and some drugs should not be used together. Tell your doctor about all your current medicines and any medicine you start or stop using. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here.