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An Overview of Complera (Rilpivirine/Tenofovir/Emtricitabine)

January 28, 2013

Complera

Brand Name: Complera
Other Names: FTC/RPV/TDF, emtricitabine/rilpivirine hydrochloride/tenofovir disoproxil fumarate
Drug Class: Combination Drugs
Approved Use: Treatment of HIV Infection

WARNING:

Complera can cause serious, life-threatening side effects. These include lactic acidosis (buildup of acid in the blood) and liver problems.

Contact your health care provider right away if you have any of the following symptoms that may signal lactic acidosis:

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 may signal liver problems:

Complera is not approved for the treatment of hepatitis B virus (HBV) infection. People co-infected with HIV and HBV who stopped taking emtricitabine or tenofovir disoproxil fumarate, which are two anti-HIV medicines included in Complera, have had severe worsening of their HBV infections.

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


What is Complera?

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

Complera contains the following three anti-HIV medicines combined in one pill: emtricitabine, rilpivirine, and tenofovir disoproxil fumarate. Emtricitabine and tenofovir disoproxil fumarate are types of anti-HIV medicines called nucleoside reverse transcriptase inhibitors (NRTIs). Rilpivirine is a type of anti-HIV medicine called a non-nucleoside reverse transcriptase inhibitor (NNRTI). The three drugs in combination help block HIV reverse transcriptase, an HIV enzyme. This prevents HIV from replicating and lowers the amount of HIV in the blood.

Complera does not cure HIV/AIDS. It is not known if Complera reduces the risk of passing HIV to other people.


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

Before taking Complera, tell your health care provider:


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 a meal (a protein drink does not replace a meal). Do not take Complera in combination with other anti-HIV medicines.

If you take too much Complera, contact your local poison control center (1-800-222-1222) or go to the nearest hospital emergency room right away.

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.)


What should I do if I forget a dose?

If you miss a dose within 12 hours of the time you usually take it, take your dose with a meal 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 can cause serious, life-threatening side effects. These include lactic acidosis (buildup of acid in the blood) 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. Ask your health care provider or pharmacist for more information on side effects of Complera.


How should Complera be stored?


Where can I find more information about Complera?

More information about Complera is available:


Manufacturer Information

Gilead Sciences
800-445-3235

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




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