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 or "tea-colored" urine; light-colored stools (bowel movements); loss of appetite; nausea; and/or pain, aching, or tenderness on the right side of your stomach area.
  • 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 or a similar medicine for a long time. In some cases, lactic acidosis and serious liver problems have led to death. Call your healthcare provider right away if you have any symptoms of these conditions.
  • Worsening of hepatitis B (HBV) infection. COMPLERA is not approved to treat HBV. If you have 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.

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.
  • 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 body fat can happen in people taking HIV-1 medicines.
  • 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.

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 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 or “tea-colored” urine; light-colored stools (bowel movements); loss of appetite; nausea; and/or pain, aching, or tenderness on the right side of your stomach area.
  • 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 or a similar medicine for a long time. In some cases, lactic acidosis and serious liver problems have led to death. Call your healthcare provider right away if you have any symptoms of these conditions.
  • Worsening of hepatitis B (HBV) infection. COMPLERA is not approved to treat HBV. If you have 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.

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

By following this link, you are now leaving www.complera.com. These sites are not controlled by Gilead Sciences, Inc. Gilead Sciences, Inc. is not responsible for their content or your use of them.

You are now leaving COMPLERA.com

You may be eligible for co-pay support for COMPLERA with the Gilead Advancing Access® co-pay coupon card.

To learn more and to find out if you are eligible to sign up for the Gilead Advancing Access Co-pay Coupon Card, we will now direct you to another site.

Would you like to continue?

Close

Get updates

Sign up to receive updates when new information on COMPLERA is made available.

I would like information:

Submit

Terms and Conditions

Gilead respects the privacy of your personal information. Gilead, and companies providing services to Gilead, may use the information that you provide to send you marketing or informational materials, analyze and use your information to improve or develop services and programs, and contact you about marketing programs or research and health topics that may be of interest to you.

Gilead, and companies providing services to Gilead, will not sell or rent your personally identifiable information. For more information regarding our Privacy Policy, click here.

Print

Thank you.

You will be notified as new information is made available on this Web site.