Potential side effects with COMPLERA

Learning about HIV-1 treatment is an important part of taking care of your health. This includes being aware of the possible side effects of medicines.

COMPLERA can cause serious side effects:

  • Build-up of an acid in your blood (lactic acidosis), which is a serious medical emergency. Symptoms of lactic acidosis include feeling very weak or tired, unusual (not normal) muscle pain, trouble breathing, stomach pain with nausea or vomiting, feeling cold especially in your arms and legs, feeling dizzy or lightheaded, and/or a fast or irregular heartbeat
  • Serious liver problems. The liver may become large (hepatomegaly) and fatty (steatosis). Symptoms of liver problems include your skin or the white part of your eyes turns yellow (jaundice), dark “tea-colored” urine, light-colored bowel movements (stools), loss of appetite for several days or longer, nausea, and/or stomach pain
  • You may be more likely to get lactic acidosis or serious liver problems if you are female, very overweight (obese), or have been taking COMPLERA for a long time. In some cases, these serious conditions have led to death. Call your healthcare provider right away if you have any symptoms of these conditions
  • Worsening of hepatitis B (HBV) infection. If you also have HBV and stop taking COMPLERA, your hepatitis may suddenly get worse. Do not stop taking COMPLERA without first talking to your healthcare provider, as they will need to monitor your health. COMPLERA is not approved for the treatment of HBV

Serious side effects of COMPLERA may also include:

  • 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
  • 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, or if you have thoughts of hurting yourself (suicide) or have tried to hurt yourself
  • Changes in liver enzymes. If you have hepatitis B or C, or already have abnormal liver tests, or have had changes in your liver function tests, you may be at an increased risk for liver problems while taking COMPLERA. Some people without prior liver disease may also be at risk. Your healthcare provider may need to check your liver enzymes before starting and during treatment with COMPLERA
  • Bone problems. You may experience bone pain, softening, or thinning (which may lead to fractures). Your healthcare provider may need to do additional tests to check your bones
  • Changes in body fat can happen in people taking HIV-1 medicine
  • Changes in your immune system. Your immune system may get stronger and begin to fight infections that have been hidden in your body for a long time. Tell your healthcare provider if you start having new symptoms after starting COMPLERA

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 COMPLERA (occurring in at least 1 out of every 10 patients) include:

  • Trouble sleeping (insomnia)
  • Abnormal dreams
  • Headache
  • Dizziness
  • Diarrhea
  • Nausea
  • Rash
  • Tiredness
  • Depression

Additional common side effects included vomiting, stomach pain or discomfort, skin discoloration (small spots or freckles), and pain.

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

Learn about HIV and HIV treatment

Talk to your healthcare provider about what to expect when starting COMPLERA


Download a list of questions to ask your healthcare provider »

IMPORTANT SAFETY INFORMATION

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

COMPLERA can cause serious side effects:

  • Build-up of an acid in your blood (lactic acidosis), which is a serious medical emergency. Symptoms of lactic acidosis include feeling very weak or tired, unusual (not normal) muscle pain, trouble breathing, stomach pain with nausea or vomiting, feeling cold especially in your arms and legs, feeling dizzy or lightheaded, and/or a fast or irregular heartbeat.
  • Serious liver problems. The liver may become large (hepatomegaly) and fatty (steatosis). Symptoms of liver problems include your skin or the white part of your eyes turns yellow (jaundice), dark “tea-colored” urine, light-colored bowel movements (stools), loss of appetite for several days or longer, nausea, and/or stomach pain.
  • You may be more likely to get lactic acidosis or serious liver problems if you are female, very overweight (obese), or have been taking COMPLERA for a long time. In some cases, these serious conditions have led to death. Call your healthcare provider right away if you have any symptoms of these conditions.
  • Worsening of hepatitis B (HBV) infection. If you also have HBV and stop taking COMPLERA, your hepatitis may suddenly get worse. Do not stop taking COMPLERA without first talking to your healthcare provider, as they will need to monitor your health. COMPLERA is not approved for the treatment of HBV.

What is COMPLERA?

COMPLERA (emtricitabine 200 mg, rilpivirine 25 mg, tenofovir disoproxil fumarate 300 mg) is a prescription medicine used as a complete HIV-1 treatment in one pill a day. COMPLERA is for adults who have never taken HIV-1 medicines before and who have no more than 100,000 copies/mL of virus in their blood (this is called ‘viral load’). COMPLERA can also replace current HIV-1 medicines for some adults 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 to be taken once a day with food. COMPLERA is a complete single tablet regimen and should not be used with other HIV-1 medicines. It is not known if COMPLERA is safe and effective in children under the age of 18 years.

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.

Please click here to view additional Important Safety Information
for COMPLERA including important warnings »

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