Complera can cause serious, life-threatening side effects. These include lactic acidosis (buildup of lactic acid in the blood) and liver problems.
Contact your health care provider right away if you have any of the following symptoms that may be signs of lactic acidosis:
- Weakness or tiredness.
- Unusual (not normal) muscle pain.
- Trouble breathing.
- Stomach pain with nausea and vomiting.
- Feeling cold, especially in your arms and legs.
- Dizziness or lightheadedness.
- Fast or irregular heartbeat.
Stop taking Complera and contact your health care provider right away if you get a rash with any of the following symptoms:
- Severe allergic reactions causing a swollen face, lips, mouth, tongue or throat, which may lead to difficulty swallowing or breathing.
- Mouth sores or blisters on your body.
- Inflamed eyes (conjunctivitis).
- Fever, dark urine, or pain on the right side of the stomach area (abdominal pain).
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:
- 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.
- Pain in the stomach area (abdominal pain).
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 HPV drug adefovir dipivoxil (brand name: Hepsera) and any drugs that contain emtricitabine, rilpivirine, tenofovir disproxil fumarate, or lamivudine.
While taking Complera, it is important to keep all of your appointments with your health care provider.
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 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 adults 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 HIV medicines combined in one pill:
- Emtricitabine - an HIV medicine called a nucleoside reverse transcriptase inhibitor (NRTI).
- Rilpivirine – an HIV medicine called a non-nucleoside reverse transcriptase inhibitor (NNRTI).
- Tenofovir disoproxil fumarate - another HIV medicine (also an NRTI).
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 lower the amount of HIV in the body.
HIV medicines can’t cure HIV/AIDS, but taking a combination of HIV medicines (called an HIV treatment regimen) every day helps people with HIV live longer, healthier lives. HIV medicines also reduce the risk of HIV transmission.
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 HBV or hepatitis C virus (HCV) infection.
- If you have kidney problems.
- If you have ever had a mental health problem.
- If you have bone problems.
- If you are pregnant or plan to become pregnant. Whether Complera can harm an unborn baby is unknown. Complera should be used during pregnancy only if the potential benefit justifies the potential risk to the unborn baby. Talk to your health care provider about possible risks with taking Complera when pregnant.
- If you are breastfeeding or plan to breastfeed. Do not breastfeed if you are infected with HIV or are taking Complera.
- About other prescription and nonprescription medicines, vitamins, nutritional supplements, and herbal products 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?
Complera comes in tablet form. Each tablet contains:
- 200 mg emtricitabine (brand name: Emtriva).
- 25 mg rilpivirine (brand name: Edurant).
- 300 mg tenofovir disoproxil fumarate (brand name: Viread).
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.)
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 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 can cause serious, life-threatening side effects. These 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).
- 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 start having new symptoms after starting Complera.
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/.
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 bottle 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:
Gilead Sciences, Inc.
The above Patient Version drug summary is based on the following FDA label(s): Tablet (film coated)
Last Reviewed: July 20, 2014