Potential Side Effects with COMPLERA®

Serious Side Effects

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.

These are not all of the possible side effects. Tell your healthcare provider if you have any side effect that bothers you or does not go away.

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

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.

Common Side Effects

In clinical studies of people who were new to therapy, most patients were able to stay on treatment with COMPLERA.

The most common side effects of rilpivirine, one of the medicines in COMPLERA, include:

  • Depression
  • Trouble sleeping
  • 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
  • Rash

Most of these common side effects were mild in severity. Some patients reported moderate-to-severe side effects with COMPLERA.

Two out of every 100 patients stopped taking COMPLERA because of side effects.

These are not all of the possible side effects. Tell your healthcare provider if you have any side effect that bothers you or does not go away. You may also report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call .

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.

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.

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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.