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Emtricitabine / Rilpivirine / Tenofovir Disoproxil Fumarate

Emtricitabine / Rilpivirine / Tenofovir Disoproxil Fumarate

Brand Name: Complera Other Names: FTC / RPV / TDF, emtricitabine / rilpivirine / tenofovir, emtricitabine / rilpivirine hydrochloride / tenofovir disoproxil fumarate Drug Class: Combination Drugs

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What are the most important things to know about Complera?

What are the most important things to know about Complera?

Complera can cause serious, life-threatening side effects. These include a buildup of lactic acid in the blood (lactic acidosis), severe skin rash and allergic reactions, liver problems, and new or worsening kidney 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

Stop taking Complera and contact your health care provider 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 area
  • Dark-colored urine

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 (jaundice)
  • Dark-colored urine
  • Light-colored bowel movements
  • Loss of appetite for several days or longer
  • Nausea
  • Stomach-area pain

Complera is not approved for the treatment of chronic hepatitis B virus infection (HBV). If you have both HIV and HBV infection and take Complera, your HBV infection may get much worse (flare-up) if you stop taking Complera.

Some people taking Complera have developed new or worsening kidney problems, including kidney failure. Your health care provider may do blood and urine tests to check your kidneys before and during treatment with Complera.

While taking Complera, it is important to keep all of your appointments with your health care provider.

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 who weigh at least 77 lb (35 kg) and meet certain requirements, as determined by a health care provider.

Complera is a complete regimen for the treatment of HIV infection and should not be used with other HIV medicines.

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

HIV medicines can’t 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, don't 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?

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.
  • 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.
  • If you are breastfeeding or plan to breastfeed. Do not breastfeed if you have HIV or are taking Complera.
  • 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 AIDSinfo 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, life-threatening side effects.

How should I take Complera?

How should I take Complera?

Complera comes in tablet form. Each tablet contains:

Take Complera according to your health care provider’s instructions.

Take Complera with food (a protein drink is not a substitute for food). Do not take Complera with other HIV medicines. (Sometimes an additional tablet of rilpivirine is given with Complera.)

If you take 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?

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?

Complera may cause side effects. Many side effects from HIV medicines, such as nausea or occasional dizziness, are manageable. See the AIDSinfo fact sheet on HIV Medicines and Side Effects for more information.

Some side effects of Complera can be serious. Serious side effects of Complera include a buildup of lactic acid in the blood (lactic acidosis), severe skin rash and allergic reactions, liver problems, and new or worsening kidney problems, including kidney failure. (See section above: What are the most important things to know about Complera?)

Other possible side effects of Complera include:
  • Depression or mood changes. Tell your health care provider right away if you have any of the following symptoms: feeling sad or hopeless; feeling anxious or restless; or having thoughts of hurting yourself (suicide) or have tried to hurt yourself.
  • Bone problems (bone pain, softening, or thinning [osteopenia]).
  • 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?

  • 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?

More information about Complera is available:

Manufacturer Information

Gilead Sciences, Inc.
Main number: 800-445-3235
Patient assistance: 800-226-2056

The above Patient Version drug summary is based on the following FDA label(s): Tablet (film coated).

Last Reviewed: November 11, 2019