Efavirenz (ef-a-VYE-renz), Emtricitabine (em-trye-SYE-ta-been), Tenofovir Disoproxil Fumarate (ten-OF-oh-vir dye-soe-PROX-il FUE-ma-rate)

Treats HIV infection. HIV causes AIDS. This medicine does not cure HIV or AIDS, but combinations of drugs may slow the progress of the disease.

Brand Name(s):

Atripla

When This Medicine Should Not Be Used:

How to Use This Medicine:

Tablet

• Your doctor will tell you how much medicine to use. Do not use more than directed.
• Take this medicine at the same time each day, preferably at bedtime.
• Do not stop using this medicine without checking first with your doctor. If you stop the medicine even briefly, the virus may become harder to treat. Contact your doctor or pharmacist when your supply is running low so you do not run out.
• It is best to take this medicine on an empty stomach.
• Read and follow the patient instructions that come with this medicine. Talk to your doctor or pharmacist if you have any questions.
• Missed dose: Take a dose as soon as you remember. If it is almost time for your next dose, wait until then and take a regular dose. Do not take extra medicine to make up for a missed dose.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep the bottle tightly closed. Keep the medicine in the original bottle that you were given at the pharmacy.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Do not use this medicine together with elbasvir/grazoprevir or voriconazole.
• There are many drugs that can interact with this medicine. Make sure your doctor knows about all other medicines you are using, especially the following:
  • Acyclovir, adefovir, atazanavir, artemether/lumefantrine, atovaquone/proguanil, boceprevir, bupropion, carbamazepine, cidofovir, clarithromycin, cyclosporine, darunavir/ritonavir, didanosine, fosamprenavir/ritonavir, ganciclovir, itraconazole, ketoconazole, ledipasvir/sofosbuvir, lopinavir/ritonavir, maraviroc, methadone, phenobarbital, phenytoin, posaconazole, rifabutin, rifampin, ritonavir, saquinavir, sertraline, simeprevir, sirolimus, sofosbuvir/velpatasvir, tacrolimus, valacyclovir, valganciclovir
  • Aminoglycoside antibiotic (including gentamicin)
  • Birth control pills
  • Blood pressure medicine
  • Blood thinner (including warfarin)
  • NSAID pain or arthritis medicine (including aspirin, celecoxib, diclofenac, ibuprofen, naproxen)
  • Statin medicine

Warnings While Using This Medicine:

• It is not safe to take this medicine during pregnancy. It could harm an unborn baby. Tell your doctor right away if you become pregnant. Birth control pills may not work as well to prevent pregnancy when used with this medicine. Use 2 effective forms of birth control (including condoms or spermicide) along with your pills during treatment with this medicine and for at least 12 weeks after your last dose.
• Do not breastfeed. You can spread HIV or AIDS to your baby through your breast milk.
• Tell your doctor if you have kidney disease, liver disease (including hepatitis B or C), bone problems (including osteoporosis), heart rhythm problems, mental health problems, or a history of seizures or drug or alcohol use. Tell your doctor if you drink alcohol.
• This medicine may cause the following problems:
  • Worsening of hepatitis B infection (if the medicine is stopped)
  • Serious skin reactions
  • Liver problems
  • QT prolongation (heart rhythm problem)
  • Changes in mood or behavior
  • Kidney problems
  • Lower bone mineral density
  • Seizures
  • Lactic acidosis (too much acid in the blood)
• Your immune system may get stronger when you start taking HIV medicines. This could cause a hidden infection in your body to become active. Tell your doctor right away if you notice any changes in your health.
• This medicine may make you dizzy or drowsy. Do not drive or do anything else that could be dangerous until you know how this medicine affects you.
• Always practice safe sex, even if your partner also has HIV. If you stop taking this medicine or do not take it as prescribed, you may spread HIV to others. Do not reuse or share needles, or other items, that may have blood or body fluids on them.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
• Tell any doctor or dentist who treats you that you are using this medicine. This medicine may affect certain medical test results.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Anxiety, anger, aggression, severe depression, seeing or hearing things that are not there, or thoughts of hurting yourself or others
• Behavior or mood changes , paranoid or manic behavior
• Blistering, peeling, red skin rash
• Bone, joint, or muscle pain
• Change in how much or how often you urinate
• Dark urine or pale stools, nausea, vomiting, loss of appetite, stomach pain, yellow skin or eyes
• Fast breathing, trouble breathing, lightheadedness, severe weakness, tiredness, or confusion
• Fast, pounding, or uneven heartbeat
• Seizures
• Severe sleepiness, decreased awareness or responsiveness

If you notice these less serious side effects, talk with your doctor:

• Cough, runny or stuffy nose, sore throat
• Diarrhea
• Headache, dizziness
• Mild skin rash, change in skin color
• Weight gain around your neck, upper back, breast, or waist

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088