Drug Database: Emtricitabine / Rilpivirine / Tenofovir Disoproxil Fumarate

What is Complera?What is Complera?

What is Complera?

Complera is a prescription medicine approved by the U.S. Food and Drug Administration (FDA) for the treatment of HIV infection 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 HIV treatment regimen and should not be used with other HIV medicines.

Complera contains three different medicines: emtricitabine, rilpivirine, and tenofovir disoproxil fumarate.

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 transmission. 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?What should I tell my health care provider before taking Complera?

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 hepatitis B virus infection (HBV) or hepatitis C virus infection (HCV).
• If you have kidney problems, including if you are on dialysis.
• If you have a history of depression 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 hormone-based birth control (such as pills, implants, or vaginal rings). For more information about using birth control and HIV medicines at the same time, view the HIVinfo HIV and Birth Control infographic.
• 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?How should I take Complera?

How should I take Complera?

Complera comes in tablet form. Each tablet contains:

• 200 mg emtricitabine
• 25 mg rilpivirine
• 300 mg tenofovir disoproxil fumarate

Take Complera according to your health care provider’s instructions. Do not miss a dose of 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. (A protein drink is not a substitute for food.) Do not take Complera with other HIV medicines.

If you are taking any other medicines or supplements, including H2 blockers or antacids (medicines for reducing stomach acid) or other products containing aluminum, calcium carbonate, or magnesium hydroxide, carefully follow instructions on how to take them with Complera.

Proton pump inhibitors (medicines for reducing stomach acid) should NOT be taken 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 or online) 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?What should I do if I forget a dose?

What should I do if I forget a dose?

If you miss a dose of 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?What side effects can Complera cause?

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 (osteopenia), which may lead to fractures.
• Changes in your immune system (called immune reconstitution inflammatory syndrome 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 infection.

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 drug label or package insert 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?How should Complera be stored?

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 desiccant), 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?Where can I find more information about Complera?

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.)
• A list of FDA-approved HIV medicines, from HIVinfo.