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An Overview of Complera (Rilpivirine/Tenofovir/Emtricitabine)

January 19, 2017

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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?

Complera may cause side effects. Most side effects from Complera are manageable, but a few can be serious. Serious side effects of Complera include lactic acidosis (buildup of lactic acid in the blood), severe skin reactions or rash, and liver problems. (See the WARNING above.)

Other possible side effects of Complera include:

  • New or worsening kidney problems, including kidney failure.
  • 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 body fat (lipodystrophy syndrome).
  • Changes in the immune system (immune reconstitution inflammatory syndrome [IRIS]), 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.

The AIDSinfo fact sheet on HIV Medicines and Side Effects also includes information that may apply to Complera.

You can also report side effects to FDA at 1-800-FDA-1088 (1-800-332-1088) or online at www.accessdata.fda.gov/scripts/medwatch/.


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?

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).

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This article was provided by AIDSinfo. Visit the AIDSinfo website to find out more about their activities and publications.
 
See Also
More on Complera (Rilpivirine/Tenofovir/FTC)

 

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