What are the most important things to know about Complera?
Complera can cause serious, life-threatening side effects. These include a buildup ofin the blood ( ), severe skin rash and allergic reactions, problems, or mood changes, and new or worsening problems, including kidney failure.
Contact your health care provider right away if you have any of the following symptoms that could be signs of lactic acidosis:
- Weakness or unusual tiredness
- Unusual muscle pain
- Shortness of breath or fast breathing
- Stomach pain with nausea and vomiting
- Cold or blue hands and feet
- Dizziness or lightheadedness
- Fast or abnormal heartbeat
Contact your health care provider right away if you develop a rash while taking Complera. Stop taking Complera and get medical help right away if you develop a rash with any of the following symptoms:
- General ill feeling
- Extreme tiredness
- Muscle or joint aches
- Blistering or peeling skin
- Blisters or sores in your mouth
- Redness or swelling of the eyes ( )
- Swelling of the face, lips, mouth, tongue, or throat
- Trouble breathing or swallowing
Some people taking Complera may develop liver problems. People with a history of(HBV) or (HCV) or who have elevated results on liver function tests may have an increased chance of developing new or worsening liver problems while taking Complera. Liver problems may also occur in people taking Complera who have no history of liver disease.
Contact your health care provider right away if you have any of the following symptoms that could be signs of liver problems:
- Yellowing of your skin or the whites of your eyes ( )
- Dark-colored urine
- Light-colored bowel movements
- Loss of appetite for several days or longer
- Nausea or vomiting
- Pain, aching or tenderness on the right side of your stomach/abdominal area
If you have both HIV and HBV and take Complera, your HBV infection may get much worse (flare-up) if you stop taking Complera. Do not stop taking Complera without first talking to your health care provider.
Contact your health care provider right away or get medical help if you have any of the following symptoms that could be signs of depression or mood changes:
- Feeling sad or hopeless
- Feeling anxious or restless
- Harming yourself or having thoughts about harming yourself (including suicidal thoughts)
Contact your health care provider right away if you have any of the following symptoms that could be signs of a worsening kidney problem (called), which may be related to tenofovir-containing drugs:
- Bone pain that does not go away or gets worse
- Pain in your arms, hands, legs, or feet
- Broken bones
- Muscle pain or weakness
While taking Complera, it is important to keep all of your appointments with your health care provider.
What is Complera?
Complera is a prescription medicine approved by the U.S.(FDA) for the treatment of HIV in adults and children 12 years of age and older who weigh at least 77 lb (35 kg) and meet certain requirements, as determined by a health care provider.
Complera is a complete HIVand should not be used with other HIV medicines.
For more information on the use of Complera in people with HIV, please refer to the Guidelines for the Use of Antiretroviral Agents in Adults and Adolescents with HIV and the Guidelines for the Use of Antiretroviral Agents in Pediatric HIV Infection.HIV medicines cannot cure HIV/AIDS, but taking HIV medicines every day helps people with HIV live longer, healthier lives. HIV medicines also reduce the risk of HIV . If you are taking HIV medicines, do not cut down on, skip, or stop taking them unless your health care provider tells you to.
What should I tell my health care provider before taking Complera?
Before taking Complera, tell your health care provider:
- If you are allergic to any of the HIV medicines in Complera (emtricitabine, rilpivirine, or tenofovir disoproxil fumarate) or any other medicines.
- If you have liver problems, including
- If you have problems, including if you are on dialysis.
- If you have a history of or suicidal thoughts.
- If you have bone problems.
- If you have any other medical conditions.
- If you are pregnant or plan to become pregnant. Talk to your health care provider about the risks and benefits of taking Complera during pregnancy. For more information on the use of Complera during pregnancy, please refer to the Recommendations for the Use of Antiretroviral Drugs During Pregnancy and Interventions to Reduce Perinatal HIV Transmission in the United States.
- If you are breast/chestfeeding or plan to breast/chestfeed. For people with HIV in the United States, the Guideline recommends speaking with your health care provider to discuss options for feeding your baby. People with suppressed viral load have a less than 1% chance of transmitting HIV to their baby via their own milk.
- If you are using HIV and Birth Control infographic. -based birth control (such as pills, , or vaginal rings). For more information about using birth control and HIV medicines at the same time, view the HIVinfo
- About other prescription and nonprescription medicines, vitamins, nutritional supplements, and herbal products (including St. John's wort) you are taking or plan to take. Complera may affect the way other medicines or products work, and other medicines or products may affect how Complera works. Taking Complera together with certain medicines or products may cause serious side effects.
How should I take Complera?
Complera comes in tablet form. Each tablet contains:
Take Complera according to your health care provider’s instructions. Do not miss aof Complera, and do not change your dose or stop taking Complera without first talking with your health care provider.
Take Complera by mouth with food. (Adrink is not a substitute for food.) Do not take Complera with other HIV medicines.
If you are taking any other medicines or supplements, including, proton pump inhibitors, or H2 blockers (medicines for reducing stomach acid), carefully follow instructions on how to take them with Complera.
If you also take the medicine rifabutin during treatment with Complera, your health care provider will prescribe an additional dose of rilpivirine for you to take. Follow your health care provider's instructions about when to take rilpivirine and how much to take. This is usually one tablet of rilpivirine taken at the same time that you take Complera and with a meal.
If you have taken too much Complera, contact your health care provider or local poison control center (1-800-222-1222) right away, or go to the nearest hospital emergency room.
For more information on how to take Complera, see the FDA drug label.
What should I do if I forget a dose?
If you miss aof Complera within 12 hours of the time you usually take it, take your dose with food as soon as possible. Then take your next dose at the regularly scheduled time. If you miss a dose by more than 12 hours of the time you usually take it, wait and then take the next dose at the regularly scheduled time. Do not take more than your prescribed dose to make up for a missed dose.
What side effects can Complera cause?
Complera may cause side effects. Some side effects of Complera can be serious as noted above. Many side effects from HIV medicines, such as nausea or occasional dizziness, are manageable. See the HIVinfo fact sheet on HIV Medicines and Side Effects for more information.Other possible side effects of Complera include:
- Bone problems, including bone pain, or softening or thinning of the bones ( , which may lead to fractures.
- Changes in your (called or IRIS). IRIS is a condition that sometimes occurs when the immune system begins to recover after treatment with an HIV medicine. As the immune system gets stronger, it may have an increased response to a previously hidden .
Tell your health care provider if you have any side effect that bothers you or that does not go away.
These are not all the possible side effects of Complera. To learn more about possible side effects of Complera, read the d or or talk to your health care provider or pharmacist.
You can report side effects to FDA at 1-800-FDA-1088 (1-800-332-1088) or online.
How should Complera be stored?
- Store Complera at room temperature, 68°F to 77°F (20°C to 25°C).
- Keep Complera in the container that it came in and keep the container tightly closed. If the container has a small packet of drying agent (called a ), do not remove it. The desiccant protects the medicine from moisture.
- Do not use Complera if the original seal over the container opening is broken or missing.
- Throw away Complera that is no longer needed or expired (out of date). Follow FDA guidelines on how to safely dispose of unused medicine.
- Keep Complera and all medicines out of reach of children.
Where can I find more information about Complera?
- For more information on the use of Complera in people with HIV, please refer to the Guidelines for the Use of Antiretroviral Agents in Adults and Adolescents with HIV and the Guidelines for the Use of Antiretroviral Agents in Pediatric HIV Infection.
- This Patient Version drug summary is based on the following FDA label(s): Tablet (film coated). The Patient Package Insert includes information for people taking Complera.
- The American Hospital Formulary Service (AHFS) Patient Medication Information for emtricitabine, rilpivirine, and tenofovir available from MedlinePlus.
- Complera-related research studies, from ClinicalTrials.gov. (The ClinicalTrials.gov search can be modified so that you can get results that better match your interests. To learn more about the ClinicalTrials.gov search features, please see How to Search.)
- A list of FDA-approved HIV medicines, from HIVinfo.
Gilead Sciences, Inc.
Main number: 800-445-3235
Patient assistance: 800-226-2056
Last Reviewed: January 12, 2023