Important Information

INDICATION
ATRIPLA^® (efavirenz 600 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate [DF] 300 mg) is a prescription medication used alone as a complete regimen or with other medicines to treat HIV-1 infection in adults.

ATRIPLA does not cure HIV-1 and has not been shown to prevent passing HIV-1 to others.

Do not stop taking ATRIPLA unless directed by your healthcare provider. See your healthcare provider regularly.

IMPORTANT SAFETY INFORMATION
Contact your healthcare provider right away if you get the following side effects or conditions associated with ATRIPLA:

• Nausea, vomiting, unusual muscle pain, and/or weakness. These may be signs of a buildup of acid in the blood (lactic acidosis), which is a serious medical condition.
• Light-colored stools, dark-colored urine, and/or if your skin or the whites of your eyes turn yellow. These may be signs of serious liver problems.
• If you have HIV-1 and hepatitis B virus (HBV), your liver disease may suddenly get worse if you stop taking ATRIPLA.

Vfend^® (voriconazole) or REYATAZ^® (atazanavir sulfate), with or without Norvir^® (ritonavir), should not be taken with ATRIPLA since they may lose their effect and may also increase the chance of having side effects from ATRIPLA. Fortovase^® or Invirase^® (saquinavir) should not be used as the only protease inhibitor in combination with ATRIPLA.

Taking ATRIPLA with St. John's wort or products containing St. John's wort is not recommended as it may cause decreased levels of ATRIPLA, increased viral load, and possible resistance to ATRIPLA or cross-resistance to other anti-HIV drugs.

This list of medicines is not complete. Discuss with your healthcare provider all prescription and non-prescription medicines, vitamins, or herbal supplements you are taking or plan to take.

Tell your healthcare provider 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 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 while on ATRIPLA and for 12 weeks after stopping ATRIPLA.
• Are breastfeeding: Women with HIV should not breastfeed because they can pass HIV through their milk to the baby. Also, ATRIPLA may pass through breast milk and cause serious harm to the baby.
• Have liver problems, including hepatitis B or C virus infection.
• Have ever had seizures: Seizures have occurred in patients taking a component of ATRIPLA, usually in those with a history of seizures. If you have ever had seizures, or take medicine for seizures, your healthcare provider may want to switch you to another medicine or monitor you.
• Have ever had mental illness or use drugs or alcohol.

Contact your healthcare provider right away if you experience any of the following serious or common side effects:

Serious side effects associated with ATRIPLA:

• 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.
• Kidney problems (including decline or failure of kidney function). If you have had kidney problems, or take other medicines that may cause kidney problems, your healthcare provider should do regular blood tests. Symptoms that may be related to kidney problems include a high volume of urine, thirst, muscle pain, and muscle weakness.
• Bone changes. Lab tests show changes in the bones of patients treated with tenofovir DF, a component of ATRIPLA. Some HIV patients treated with tenofovir DF developed thinning of the bones (osteopenia) which could lead to fractures. Also, bone pain and softening of the bone (which may lead to fractures) may occur as a consequence of kidney problems. If you have had bone problems in the past, your healthcare provider may want to check your bones.

Common side effects:

• Dizziness, headache, trouble sleeping, drowsiness, trouble concentrating, and/or unusual dreams.These side effects tend to go away after taking ATRIPLA for a few weeks. These symptoms may be more severe with the use of alcohol and/or mood-altering (street) drugs. If you are dizzy, have trouble concentrating, and/or are drowsy, avoid activities that may be dangerous, such as driving or operating machinery.
• Rash is a common side effect that usually goes away without any change in treatment, but may be serious in a small number of patients.
• Other common side effects include: tiredness, upset stomach, vomiting, gas, and diarrhea.

Other possible side effects:

• Changes in body fat have been seen in some people taking anti-HIV-1 medicines. The cause and long-term health effects are not known.
• Skin discoloration (small spots or freckles) may also happen.
• If you notice any symptoms of infection, contact your healthcare provider right away.
• 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.

You should take ATRIPLA once daily on an empty stomach. Taking ATRIPLA at bedtime may make some side effects less bothersome.

Please click here for Full Prescribing Information on this Web site, including "What is the most important information I should know about ATRIPLA?" in the Patient Information section.

Distance to search:

5 mi 10 mi 25 mi 50 mi 100 mi

Enter your ZIP code: