What is BIKTARVY®?

BIKTARVY is a complete, 1-pill, once-a-day prescription medicine used to treat HIV-1 in adults. It can either be used in people who have never taken HIV-1 medicines before, or people who are replacing their current HIV-1 medicines and whose healthcare provider determines they meet certain requirements.

BIKTARVY does not cure HIV-1 or AIDS.

To control HIV-1 infection and decrease HIV-related illnesses, you must keep taking BIKTARVY. Ask your healthcare provider if you have questions about how to reduce the risk of passing HIV-1 to others. Always practice safer sex and use condoms to lower the chance of sexual contact with body fluids. Never reuse or share needles or other items that have body fluids on them.

Important Safety Information

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

BIKTARVY may cause serious side effects:

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

Who should not take BIKTARVY?

Do not take BIKTARVY if you take:

  • dofetilide
  • rifampin
  • any other medicines to treat HIV-1

What are the other possible side effects of BIKTARVY?

Serious side effects of BIKTARVY may also include:

  • 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 BIKTARVY.
  • Kidney problems, including kidney failure. Your healthcare provider should do blood and urine tests to check your kidneys. If you develop new or worse kidney problems, they may tell you to stop taking BIKTARVY.
  • 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, being short of breath or fast breathing, stomach pain with nausea and vomiting, cold or blue hands and feet, feel 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.

The most common side effects of BIKTARVY in clinical studies were diarrhea (6%), nausea (5%), and headache (5%). Tell your healthcare provider if you have any side effects that bother you or don’t go away.

What should I tell my healthcare provider before taking BIKTARVY?

  • All your health problems. Be sure to tell your healthcare provider if you have or have had any kidney or liver problems, including hepatitis virus infection.
  • All the medicines you take, including prescription and over-the-counter medicines, antacids, laxatives, vitamins, and herbal supplements. BIKTARVY and other medicines may affect each other. Keep a list of all your medicines and show it to your healthcare provider and pharmacist, and ask if it is safe to take BIKTARVY with all of your other medicines.
  • If you are pregnant or plan to become pregnant. It is not known if BIKTARVY can harm your unborn baby. Tell your healthcare provider if you become pregnant while taking BIKTARVY.
  • If you are breastfeeding (nursing) or plan to breastfeed. Do not breastfeed. HIV-1 can be passed to the baby in breast milk.

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

Please click here for full Prescribing Information for BIKTARVY and DESCOVY®, including Patient Information with important warnings.

What is ODEFSEY®?

ODEFSEY is a 1-pill, once-a-day prescription medicine used to treat HIV-1 in people 12 years and older. It can either be used in people who are starting HIV-1 treatment, have never taken HIV-1 medicines before, and have an amount of HIV-1 in their blood ("viral load") that is no more than 100,000 copies/mL; or in people who are replacing their current HIV-1 medicines and whose healthcare provider determines they meet certain requirements. These include having an undetectable viral load (less than 50 copies/mL) for 6 months or more on their current HIV-1 treatment. ODEFSEY combines 3 medicines into 1 pill taken once a day with a meal. ODEFSEY is a complete HIV-1 treatment and should not be used with other HIV-1 medicines.

ODEFSEY does not cure HIV-1 infection or AIDS.

To control HIV-1 infection and decrease HIV-related illnesses, you must keep taking ODEFSEY. Ask your healthcare provider if you have questions about how to reduce the risk of passing HIV-1 to others. Always practice safer sex and use condoms to lower the chance of sexual contact with body fluids. Never reuse or share needles or other items that have body fluids on them.

Important Safety Information

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

ODEFSEY may cause serious side effects:

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

Who should not take ODEFSEY?

Do not take ODEFSEY if you take:

  • Certain medicines for other conditions. It is important to ask your healthcare provider or pharmacist about medicines that should not be taken with ODEFSEY. Do not start a new medicine without telling your healthcare provider.
  • The herbal supplement St. John's wort.
  • Any other medicines to treat HIV-1 infection.

What are the other possible side effects of ODEFSEY?

Serious side effects of ODEFSEY may also include:

  • Severe skin rash and allergic reactions. Skin rash is a common side effect of ODEFSEY. Call your healthcare provider right away if you get a rash, as some rashes and allergic reactions may need to be treated in a hospital. Stop taking ODEFSEY and get medical help right away if you get a rash with any of the following symptoms: fever, skin blisters, mouth sores, redness or swelling of the eyes (conjunctivitis), swelling of the face, lips, mouth, or throat, trouble breathing or swallowing, pain on the right side of the stomach (abdominal) area, and/or dark "tea-colored" urine.
  • Depression or mood changes. Tell your healthcare provider right away if you: feel sad or hopeless, feel anxious or restless, have thoughts of hurting yourself (suicide) or have tried to hurt yourself.
  • Changes in liver enzymes. People who have had hepatitis B or C or who have certain liver enzyme changes may have a higher risk for new or worse liver problems while taking ODEFSEY. Liver problems can also happen in people who have not had liver disease. Your healthcare provider may do tests to check your liver enzymes before and during treatment with ODEFSEY.
  • 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 ODEFSEY.
  • Kidney problems, including kidney failure. Your healthcare provider should do blood and urine tests to check your kidneys. Your healthcare provider may tell you to stop taking ODEFSEY if you develop new or worse kidney problems.
  • 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, being short of breath or fast breathing, stomach pain with nausea and vomiting, cold or blue hands and feet, feel 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.

The most common side effects of ODEFSEY are headache and problems sleeping. 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 ODEFSEY?

  • All your health problems. Be sure to tell your healthcare provider if you have or have had any kidney, mental health (depression or suicidal thoughts), or liver problems, including hepatitis virus infection.
  • All the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Other medicines may affect how ODEFSEY works. Keep a list of all your medicines and show it to your healthcare provider and pharmacist. Ask your healthcare provider if it is safe to take ODEFSEY with all of your other medicines.
  • If you are pregnant or plan to become pregnant. It is not known if ODEFSEY can harm your unborn baby. Tell your healthcare provider if you become pregnant while taking ODEFSEY.
  • If you are breastfeeding (nursing) or plan to breastfeed. Do not breastfeed. HIV-1 can be passed to the baby in breast milk.

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

Please click here for full Prescribing Information for ODEFSEY and DESCOVY®, including Patient Information with important warnings.

What is GENVOYA®?

GENVOYA is a 1-pill, once-a-day prescription medicine used to treat HIV-1 in people 12 years and older who weigh at least 77 pounds. It can either be used in people who are starting HIV-1 treatment and have never taken HIV-1 medicines before, or people who are replacing their current HIV-1 medicines and whose healthcare provider determines they meet certain requirements. These include having an undetectable viral load (less than 50 copies/mL) for 6 months or more on their current HIV-1 treatment. GENVOYA combines 4 medicines into 1 pill taken once a day with food. GENVOYA is a complete HIV-1 treatment and should not be used with other HIV-1 medicines.

GENVOYA does not cure HIV-1 infection or AIDS.

To control HIV-1 infection and decrease HIV-related illnesses, you must keep taking GENVOYA. Ask your healthcare provider if you have questions about how to reduce the risk of passing HIV-1 to others. Always practice safer sex and use condoms to lower the chance of sexual contact with body fluids. Never reuse or share needles or other items that have body fluids on them.

IMPORTANT SAFETY INFORMATION

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

GENVOYA may cause serious side effects:

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

Who should not take GENVOYA?

Do not take GENVOYA if you 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 GENVOYA. Do not start a new medicine without telling your healthcare provider.
  • The herbal supplement St. John's wort.
  • Any other medicines to treat HIV-1 infection.

What are the other possible side effects of GENVOYA?

Serious side effects of GENVOYA may also include:

  • 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 GENVOYA.
  • Kidney problems, including kidney failure. Your healthcare provider should do blood and urine tests to check your kidneys. If you develop new or worse kidney problems, they may tell you to stop taking GENVOYA.
  • 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, being short of breath or fast breathing, stomach pain with nausea and vomiting, cold or blue hands and feet, feel 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.

The most common side effect of GENVOYA is nausea. Tell your healthcare provider if you have any side effects that bother you or don't go away.

What should I tell my healthcare provider before taking GENVOYA?

  • All your health problems. Be sure to tell your healthcare provider if you have or have had any kidney or liver problems, including hepatitis virus infection.
  • All the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Other medicines may affect how GENVOYA works. Keep a list of all your medicines and show it to your healthcare provider and pharmacist. Ask your healthcare provider if it is safe to take GENVOYA with all of your other medicines.
  • If you take antacids. Take antacids at least 2 hours before or after you take GENVOYA.
  • If you are pregnant or plan to become pregnant. It is not known if GENVOYA can harm your unborn baby. Tell your healthcare provider if you become pregnant while taking GENVOYA.
  • If you are breastfeeding (nursing) or plan to breastfeed. Do not breastfeed. HIV-1 can be passed to the baby in breast milk.

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

Please click here for full Prescribing Information for GENVOYA and DESCOVY®, including Patient Information with important warnings.

What is STRIBILD®?

STRIBILD is a prescription medicine used to treat HIV-1 in people 12 years and older who weigh at least 77 pounds. It can either be used in people who are starting HIV-1 treatment and have never taken HIV-1 medicines before, or in people who are replacing their current HIV-1 medicines and whose healthcare provider determines that they meet certain requirements. These include having an undetectable viral load (less than 50 copies/mL of virus in their blood) for 6 months or more on their current HIV-1 treatment. STRIBILD combines 4 medicines into 1 pill to be taken once a day with food. STRIBILD is a complete single tablet regimen and should not be used with other HIV-1 medicines.

STRIBILD does not cure HIV-1 infection or AIDS.

To control HIV-1 infection and decrease HIV-related illnesses you must keep taking STRIBILD. Ask your healthcare provider if you have questions about how to reduce the risk of passing HIV-1 to others. Always practice safer sex and use condoms to lower the chance of sexual contact with body fluids. Never reuse or share needles or other items that have body fluids on them.

Important Safety Information

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

STRIBILD can cause serious side effects:

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

Who should not take STRIBILD?

Do not take STRIBILD if you 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 STRIBILD. Do not start a new medicine without telling your healthcare provider.
  • The herbal supplement St. John's wort.
  • Any other medicines to treat HIV-1 infection, or the medicine adefovir (Hepsera®).

What are the other possible side effects of STRIBILD?

Serious side effects of STRIBILD may also include:

  • New or worse kidney problems, including kidney failure. Your healthcare provider should do regular blood and urine tests to check your kidneys before and during treatment with STRIBILD. If you develop kidney problems, your healthcare provider may tell you to stop taking STRIBILD.
  • 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, being short of breath or fast breathing, stomach pain with nausea and vomiting, cold or blue hands and feet, feel 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.
  • 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.
  • 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 STRIBILD.

The most common side effects of STRIBILD include nausea and diarrhea. Tell your healthcare provider if you have any side effects that bother you or don't go away.

What should I tell my healthcare provider before taking STRIBILD?

  • 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.
  • All the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements. STRIBILD may affect the way other medicines work, and other medicines may affect how STRIBILD works. Keep a list of all your medicines and show it to your healthcare provider and pharmacist. Do not start any new medicines while taking STRIBILD without first talking with your healthcare provider.
  • If you take antacids. Take antacids at least 2 hours before or after you take STRIBILD.
  • If you are pregnant or plan to become pregnant. It is not known if STRIBILD can harm your unborn baby. Tell your healthcare provider if you become pregnant while taking STRIBILD.
  • If you are breastfeeding (nursing) or plan to breastfeed. Do not breastfeed. HIV-1 can be passed to the baby in breast milk.

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

Please click for full Prescribing Information for STRIBILD and TRUVADA®, including Patient Information with important warnings.

What is COMPLERA®?

COMPLERA is a prescription medicine used to treat HIV-1 in people 12 years and older. It can be used in people who have never taken HIV-1 medicines before, and who have an amount of HIV-1 in their blood ("viral load") that is no more than 100,000 copies/mL. It can also replace current HIV-1 medicines for some people who have an undetectable viral load (less than 50 copies/mL) and whose healthcare provider determines that they meet certain other requirements. COMPLERA combines 3 medicines into 1 pill taken once a day with food. COMPLERA is a complete HIV-1 treatment and should not be used with other HIV-1 medicines.

COMPLERA does not cure HIV-1 infection or AIDS.

To control HIV-1 infection and decrease HIV-related illnesses, you must keep taking COMPLERA. Ask your healthcare provider if you have questions about how to reduce the risk of passing HIV-1 to others. Always practice safer sex and use condoms to lower the chance of sexual contact with body fluids. Never reuse or share needles or other items that have body fluids on them.

Important Safety Information

What is the most important information I should know about COMPLERA?

COMPLERA can cause serious side effects:

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

Who should not take COMPLERA?

Do not take COMPLERA if you 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 COMPLERA. Do not start a new medicine without telling your healthcare provider.
  • The herbal supplement St. John's wort.
  • Other HIV-1 medicines unless recommended by your healthcare provider.

What are the other possible side effects of COMPLERA?

Serious side effects of COMPLERA may also include:

  • Severe skin rash and allergic reactions. Call your healthcare provider right away if you get a rash. Some rashes and allergic reactions may need to be treated in a hospital. Stop taking COMPLERA and get medical help right away if you get a rash with any of the following symptoms: fever, skin blisters, mouth sores, redness or swelling of the eyes (conjunctivitis), swelling of the face, lips, mouth, tongue or throat, trouble breathing or swallowing, pain on the right side of the stomach (abdominal) area, and/or dark or "tea-colored" urine.
  • New or worse kidney problems, including kidney failure. Your healthcare provider should do blood tests to check your kidneys before starting treatment with COMPLERA. 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 COMPLERA.
  • 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, being short of breath or fast breathing, stomach pain with nausea and vomiting, cold or blue hands and feet, feel 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.
  • Depression or mood changes. Tell your healthcare provider right away if you have any of the following symptoms: feeling sad or hopeless, feeling anxious or restless, have thoughts of hurting yourself (suicide) or have tried to hurt yourself.
  • Changes in liver enzymes. People who have had hepatitis B or C, or who have had changes in their liver function tests in the past may have an increased risk for liver problems while taking COMPLERA. Some people without prior liver disease may also be at risk. Your healthcare provider may do tests to check your liver enzymes before and during treatment with COMPLERA.
  • 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.
  • 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 COMPLERA.

The most common side effects of rilpivirine, one of the medicines in COMPLERA, include depression, trouble sleeping, and headache.

The most common side effects of emtricitabine and tenofovir disoproxil fumarate, two of the medicines in COMPLERA, include diarrhea, nausea, tiredness, headache, dizziness, depression, trouble sleeping, abnormal dreams, and rash. 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 COMPLERA?

  • All your health problems. Be sure to tell your healthcare provider if you have or have had any kidney, mental health, bone, or liver problems, including hepatitis virus infection.
  • All the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Other medicines may affect how COMPLERA works. Keep a list of all your medicines and show it to your healthcare provider and pharmacist. Ask your healthcare provider if it is safe to take COMPLERA with all of your other medicines
  • If you take antacids. Take antacids at least 2 hours before or at least 4 hours after you take COMPLERA.
  • If you take stomach acid blockers. Take acid blockers at least 12 hours before or at least 4 hours after you take COMPLERA. Ask your healthcare provider if your acid blocker is okay to take, as some acid blockers should never be taken with COMPLERA.
  • If you are pregnant or plan to become pregnant. It is not known if COMPLERA can harm your unborn baby. Tell your healthcare provider if you become pregnant while taking COMPLERA.
  • If you are breastfeeding (nursing) or plan to breastfeed. Do not breastfeed. HIV-1 can be passed to the baby in breast milk.

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

Please click for full Prescribing Information for COMPLERA and TRUVADA®, including Patient Information with important warnings.

What is ATRIPLA®?

ATRIPLA is a prescription medicine that is used alone as a complete regimen, or in combination with other anti-HIV-1 medicines to treat HIV-1 in people who weigh at least 88 lbs.

ATRIPLA does not cure HIV-1 infection or AIDS. HIV-1 is the virus that causes AIDS.

To control HIV-1 infection and decrease HIV-related illnesses, you must keep taking ATRIPLA. Ask your healthcare provider if you have questions about how to reduce the risk of passing HIV-1 to others. Always practice safer sex and use condoms to lower the chance of sexual contact with body fluids. Never reuse or share needles or other items that have body fluids on them.

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. 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 efavirenz, one of the ingredients in ATRIPLA.
  • Are taking the medicines voriconazole, elbasvir, or grazoprevir.

What are the other possible side effects of ATRIPLA?

Serious side effects of ATRIPLA may also include:

  • Rash. Rash is a serious side effect, but may also be common. Tell your healthcare provider right away if you develop a rash during treatment with ATRIPLA.
  • 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.
  • Mental problems. Severe depression, suicidal thoughts and actions, aggressive behavior, delusions, catatonia, and paranoid and manic reactions have happened in people who take ATRIPLA. These mental health problems may happen more often in people who have a history of mental problems or drug use, or who take medicines to treat mental problems. Tell your healthcare provider right away if you develop any mental problems during treatment with ATRIPLA.
  • Nervous system problems. Symptoms of nervous system problems may include dizziness, problems sleeping or concentrating, tiredness, abnormal dreams, seeing or hearing things that are not real (hallucinations), unusually happy mood, confusion, agitation, memory problems, or thought problems. These problems may become more severe if you drink alcohol or take mood altering (street) drugs while taking ATRIPLA.
  • Kidney problems, including kidney failure. Your healthcare provider should do blood and urine tests to check your kidneys. If you develop new or worse kidney problems, they may tell you to stop taking ATRIPLA.
  • Bone problems. 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.
  • Seizures. Your healthcare provider may do blood tests if you take certain medicines used to prevent seizures.
  • 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, being short 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.
  • 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.
  • Changes in body fat, which can happen in people taking HIV-1 medicines.

The most common side effects of ATRIPLA in clinical studies were diarrhea, nausea, tiredness, headache, dizziness, depression, problems sleeping, abnormal dreams, and rash. Tell your healthcare provider if you have any side effects that bother you or do not go away. Taking ATRIPLA at bedtime may make some side effects less bothersome.

What should I avoid while taking ATRIPLA?

  • ATRIPLA can cause dizziness, impaired concentration and drowsiness. If you have these symptoms, do not drive a car, use heavy machinery, or do anything that requires you to be alert.

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. If you are able to become pregnant, your healthcare provider should do a pregnancy test before you start treatment with ATRIPLA. A barrier form of birth control, including condoms or a diaphragm, should always be used along with another type 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, heart, or liver problems, including hepatitis virus infection.
  • All the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements. ATRIPLA and other medicines may affect each other. Keep a list of all your medicines and show it to your healthcare provider and pharmacist, and ask if it is safe to take ATRIPLA with all of your other medicines.
  • If you have ever had mental or nervous system problems.
  • If you are using drugs or alcohol.
  • If you have ever had seizures or take medicines for seizures.

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

Please click for full Prescribing Information for ATRIPLA and TRUVADA®, including Patient Information with important warnings.