Contact your health care provider right away if you have any of the following symptoms that could be signs of lactic acidosis:
Stop taking Complera and contact your health care provider right away if you get a rash with any of the following symptoms:
Liver problems have occurred even in a few people who had no prior risk factors for liver problems. People taking Complera should be monitored for liver problems before starting treatment and during treatment. Contact your health care provider right away if you have any of the following symptoms that could be signs of liver problems:
Complera is not approved for the treatment of hepatitis B virus (HBV) infection. If you have both HIV and HBV infection and take Complera, your HBV infection may get worse (flare up) if you stop taking Complera.
Complera should not be taken with certain drugs, including the HBV drug adefovir dipivoxil (brand name: Hepsera) and any drugs that contain emtricitabine, rilpivirine, tenofovir disproxil fumarate, or lamivudine.
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 have never taken HIV medicines before and who have a viral load (number of HIV RNA copies per mL of blood) of 100,000 copies/mL or less. In certain people who have a viral load of less than 50 copies/mL and who are on a stable HIV medicine regimen, Complera may be used to replace their current HIV medicine regimen. Complera is a complete regimen for the treatment of HIV infection and should not be used with other HIV medicines.
Complera contains the following three different medicines combined in one pill:
Both NNRTIs and NRTIs block an HIV enzyme called reverse transcriptase. (An enzyme is a protein that starts or increases the speed of a chemical reaction.) By blocking reverse transcriptase, the three drugs in combination prevent HIV from multiplying and can reduce the amount of HIV in the body.
Before taking Complera, tell your health care provider:
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 from DailyMed. (DailyMed is a federal website that includes the most recent drug labels submitted to FDA.)
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.
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:
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 https://www.accessdata.fda.gov/scripts/medwatch/.
More information about Complera is available:
Gilead Sciences, Inc.
Last Reviewed: March 21, 2016