Important Safety Information

What is the most important information I should know about ATRIPLA®?

ATRIPLA may cause serious side effects:

• Worsening of hepatitis B (HBV) infection. ATRIPLA is not approved to treat HBV. If you have both HIV-1 and HBV and stop taking ATRIPLA, your HBV may suddenly get worse. Do not stop taking ATRIPLA without first talking to your healthcare provider, as they will need to monitor your health.

Who should not take ATRIPLA?

Do not take ATRIPLA if you:

• Are allergic to ATRIPLA or any of its ingredients.
• Take certain prescription medicines for other conditions. It is important to ask your healthcare provider or pharmacist about medicines that should not be taken with ATRIPLA. Do not start a new medicine without telling your healthcare provider.
• Are taking the medicines lamivudine (Epivir-HBV^®), adefovir dipivoxil (Hepsera^®), tenofovir alafenamide (Vemlidy^®) or voriconazole (Vfend^®).
• Are prescribed other HIV-1 medicines unless recommended by your healthcare provider.

What are the other possible side effects of ATRIPLA?

Serious side effects of ATRIPLA may include:

• Too much lactic acid in your blood (lactic acidosis), which is a serious but rare medical emergency that can lead to death. Tell your healthcare provider right away if you get these symptoms: weakness or being more tired than usual, unusual muscle pain, shortness of breath or fast breathing, stomach pain with nausea and vomiting, cold or blue hands and feet, feeling dizzy or lightheaded, or a fast or abnormal heartbeat.
• Severe liver problems, which in rare cases can lead to death. Tell your healthcare provider right away if you get these symptoms: skin or the white part of your eyes turns yellow, dark "tea-colored" urine, light-colored stools, loss of appetite for several days or longer, nausea, or stomach-area pain.
• Serious psychiatric problems. Severe depression, strange thoughts, or angry behavior have been reported by a small number of patients. Some patients have had thoughts of suicide, and a few have actually committed suicide. These problems may occur more often in patients who have had mental illness.
• New or worse kidney problems, including kidney failure. Your healthcare provider should do blood tests to check your kidneys before starting treatment with ATRIPLA. If you have had kidney problems or take other medicines that may cause kidney problems, your healthcare provider may also check your kidneys during treatment with ATRIPLA.
• Serious liver problems. Some patients have experienced serious liver problems, including liver failure that resulted in transplantation or death. Most of these serious side effects occurred in patients with a chronic liver disease such as hepatitis infection, but there have also been a few reports in patients without any existing liver disease.
• Changes in bone mineral density. Some patients have experienced bone problems, including bone pain or bones getting soft or thin, which may lead to fractures. Your healthcare provider may do tests to check your bones.

Other possible side effects:

• Changes in body fat, which can happen in people taking HIV-1 medicines.
• Skin discoloration (small spots or freckles) may also happen.
• Changes in your immune system. Your immune system may get stronger and begin to fight infections. Tell your healthcare provider if you have any new symptoms after you start taking ATRIPLA.
• Additional side effects are inflammation of the pancreas, allergic reaction (including swelling of the face, lips, tongue, or throat), shortness of breath, pain, stomach pain, weakness, and indigestion.

What are the common side effects of ATRIPLA?

• The most common side effects of ATRIPLA include dizziness, headache, trouble sleeping, drowsiness, trouble concentrating, and/or unusual dreams. These side effects may be reduced if you take ATRIPLA at bedtime on an empty stomach; they tend to go away after taking ATRIPLA for a few weeks. These symptoms may be more severe if ATRIPLA is used with alcohol and/or mood-altering (street) drugs. Other common side effects include tiredness, upset stomach, vomiting, gas, and diarrhea.
• If you are dizzy, have trouble concentrating, and/or are drowsy, avoid activities that may be dangerous, such as driving or operating machinery.
• Rash. Rash is a common side effect that may go away without any change in treatment. Rash may be serious in a small number of patients. Rash may be a serious problem in some children. If a rash develops, call your healthcare provider right away.

Tell your healthcare provider if you have any side effects that bother you or do not go away.

What should I tell my healthcare provider before taking ATRIPLA?

• If you are pregnant. Women should not become pregnant while taking ATRIPLA and for 12 weeks after stopping ATRIPLA. Serious birth defects have been seen in children of women treated during pregnancy with efavirenz, one of the medicines in ATRIPLA. Women must use a reliable form of barrier contraception, such as a condom or diaphragm, even if they also use other methods of birth control. Women should not rely on hormone-based birth control, such as pills, injections, or implants, because ATRIPLA may make these contraceptives ineffective.
• If you are breastfeeding (nursing) or plan to breastfeed. Do not breastfeed. HIV-1 can be passed to the baby in breast milk.
• All your health problems. Be sure to tell your healthcare provider if you have or have had any kidney, bone, or liver problems, including hepatitis virus infection.
• If you have ever had mental illness or are using drugs or alcohol.
• If you have ever had seizures or are taking medicine for seizures. Seizures have occurred in patients taking efavirenz, a component of ATRIPLA, generally in those with a history of seizures.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-10881-800-FDA-1088.

WHAT IS ATRIPLA?

ATRIPLA is a prescription medication that can be used alone as a complete regimen, or in combination with other anti-HIV-1 medicines, to treat HIV-1 in patients who weigh at least 40 kg (88 lbs).

ATRIPLA does not cure HIV-1 infection or AIDS, and you may continue to experience illnesses associated with HIV-1 infection, including opportunistic infections. You should remain under the care of a doctor when using ATRIPLA.

Please click here for full Prescribing Information, including Patient Information with important warnings.