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COMPLERA- emtricitabine, rilpivirine hydrochloride, and tenofovir disoproxil fumarate tablet, film coated

  1. Patient Information
  2. Complera Can Cause Serious Side Effects, Including:
  3. Complera Is Used To Treat Hiv-1 Infection In People 12 Years Of Age And Older Who:
  4. Complera May Help:
  5. Avoid Doing Things That Can Spread Hiv-1 Infection To Others:
  6. Do Not Take Complera If:
  7. Before You Take Complera, Tell Your Healthcare Provider If You:
  8. How Should I Take Complera?
  9. Active Ingredients:
  10. Inactive Ingredients:

Patient Information 

Advise the patient to read the FDA-approved patient labeling (Patient Information).

A statement to patients and healthcare providers is included on the product's bottle label:ALERT: Find out about medicines that should NOT be taken with COMPLERA.A Patient Package Insert for COMPLERA is available for patient information.

Information for Patients

Advise patients to remain under the care of a healthcare provider when using COMPLERA.

Inform patients that COMPLERA is not a cure for HIV infection. Patients should stay on continuous HIV therapy to control HIV infection and decrease HIV-related illnesses. Inform patients that sustained decreases in plasma HIV RNA have been associated with a reduced risk of progression to AIDS and death.

Advise patients to continue to practice safer sex, and to use latex or polyurethane condoms to lower the chance of sexual contact with any body fluids such as semen, vaginal secretions, or blood. Advise patients to never re-use or share needles.

Inform patients that there is a pregnancy exposure registry available that monitors outcomes in women exposed to COMPLERA during pregnancy[

Complera Can Cause Serious Side Effects, Including: 

Worsening of Hepatitis B infection.If you have both HIV-1 and hepatitis B virus (HBV) infections, your HBV may get worse (flare-up) if you stop taking COMPLERA. A "flare-up" is when your HBV infection suddenly returns in a worse way than before. COMPLERA is not approved for the treatment of HBV, so you must discuss your HBV therapy with your healthcare provider.
  • Do not run out of COMPLERA. Refill your prescription or talk to your healthcare provider before your COMPLERA is all gone.
  • Do not stop taking COMPLERA without first talking to your healthcare provider.
  • If you stop taking COMPLERA, your healthcare provider will need to check your health often and do blood tests regularly for several months to check your HBV infection. Tell your healthcare provider about any new or unusual symptoms you may have after you stop taking COMPLERA.

For more information about side effects,

COMPLERA is a prescription HIV-1 (Human Immunodeficiency Virus) medicine. HIV-1 is the virus that causes AIDS (Acquired Immunodeficiency Syndrome).

Complera Is Used To Treat Hiv-1 Infection In People 12 Years Of Age And Older Who: 

  • havenevertaken HIV-1 medicines before,andwho have an amount of HIV-1 in their blood (this is called 'viral load') that is no more than 100,000 copies/mL before they start taking COMPLERA,
  • in certain people who have a viral load that is less than 50 copies/mL when they start taking COMPLERA, to replace their current HIV-1 medicines.

Your healthcare provider will measure your viral load.

COMPLERA contains 3 medicines (emtricitabine, rilpivirine, tenofovir disoproxil fumarate) combined in one tablet. Emtricitabine (EMTRIVA) and tenofovir disoproxil fumarate (VIREAD) are HIV-1 nucleoside analog reverse transcriptase inhibitors (NRTIs). Rilpivirine (Edurant) is an HIV-1 non-nucleoside analog reverse transcriptase inhibitor (NNRTI).

It is not known if COMPLERA is safe and effective in children less than 12 years of age or who weigh less than 77 lb (35 kg).

Complera May Help: 

  • Reduce the amount of HIV-1 in your blood. This is called "viral load".
  • Increase the number of CD4+ (T) cells in your blood that help fight off other infections.

Reducing the amount of HIV-1 and increasing the CD4+ (T) cells in your blood may help improve your immune system. This may reduce your risk of death or getting infections that can happen when your immune system is weak (opportunistic infections).

COMPLERA does not cure HIV-1 infections or AIDS.You must keep taking HIV-1 medicines to control HIV-1 infection and decrease HIV-related illnesses.

Avoid Doing Things That Can Spread Hiv-1 Infection To Others: 

  • Do not share or re-use needles or other injection equipment.
  • Do not share personal items that can have blood or body fluids on them, like toothbrushes and razor blades.
  • Do not have any kind of sex without protection. Always practice safer sex by using a latex or polyurethane condom to lower the chance of sexual contact with any body fluids such as semen, vaginal secretions, or blood.

Ask your healthcare provider if you have any questions about how to prevent passing HIV-1 to other people.

Do Not Take Complera If: 

  • you are taking any of the following medicines:
    • anti-seizure medicines:
      • carbamazepine (Carbatrol, EpitolEquetro, Tegretol, Tegretol- XR, Teril)
      • oxcarbazepine (Oxtellar XR, Trileptal)
      • phenobarbital (Luminal)
      • phenytoin (Dilantin, Dilantin-125, Phenytek)
    • anti-tuberculosis (anti-TB) medicines:
      • rifampin (Rifater, Rifamate, Rimactane, Rifadin)
      • rifapentine (Priftin)
    • proton pump inhibitor (PPI) medicine for certain stomach or intestinal problems:
      • dexlansoprazole (Dexilant)
      • esomeprazole (Nexium, Vimovo)
      • lansoprazole (Prevacid, Prevpac)
      • omeprazole (Prilosec, Zegerid)
      • pantoprazole sodium (Protonix)
      • rabeprazole (Aciphex, Aciphex Sprinkle)
    • more than 1 dose of the steroid medicine dexamethasone or dexamethasone sodium phosphate
    • St. John's wort (Hypericum perforatum)

Before You Take Complera, Tell Your Healthcare Provider If You: 

  • have liver problems, including hepatitis B or C virus infection
  • have kidney problems
  • have ever had a mental health problem
  • have bone problems
  • are pregnant or plan to become pregnant. It is not known if COMPLERA can harm your unborn child.
    Pregnancy Registry.There is a pregnancy registry for women who take antiretroviral medicines during pregnancy. The purpose of this registry is to collect information about the health of you and your baby. Talk to your healthcare provider about how you can take part in this registry.
  • are breastfeeding or plan to breastfeed. You should not breastfeed if you have HIV-1 because of the risk of passing HIV-1 to your baby. Do not breastfeed if you are taking COMPLERA. At least two of the medicines contained in COMPLERA can be passed to your baby in your breast milk. We do not know whether this could harm your baby. Talk to your healthcare provider about the best way to feed your baby.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Some medicines interact with COMPLERA. Keep a list of your medicines to show your healthcare provider and pharmacist.

  • You can ask your healthcare provider or pharmacist for a list of medicines that can interact with COMPLERA.
  • Do not start taking a new medicine without telling your healthcare provider. Your healthcare provider can tell you if it is safe to take COMPLERA with other medicines.

How Should I Take Complera? 

  • Stay under the care of your healthcare provider during treatment with COMPLERA.
  • Take COMPLERA exactly as your healthcare provider tells you to take it.
  • Always take COMPLERA with food.Taking COMPLERA with food is important to help get the right amount of medicine in your body. A protein drink does not replace food. If your healthcare provider decides to stop COMPLERA and you are switched to new medicines to treat HIV-1 that include rilpivirine tablets, the rilpivirine tablets should be taken only with a meal.
  • Do not change your dose or stop taking COMPLERA without first talking with your healthcare provider.

    COMPLERA can cause serious side effects, including:

      • Store COMPLERA at room temperature between 68 F to 77 F (20 C to 25 C).
      • Keep COMPLERA in its original container and keep the container tightly closed.
      • Do not use COMPLERA if the seal over the bottle opening is broken or missing.

      Keep COMPLERA and all other medicines out of reach of children.

      General information about safe and effective use of COMPLERA
      Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use COMPLERA for a condition for which it was not prescribed. Do not give COMPLERA to other people, even if they have the same symptoms you have. It may harm them.
      If you would like more information, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about COMPLERA that is written for health professionals. For more information, call 1-800-445-3235 or go to

Active Ingredients: 

emtricitabine, rilpivirine hydrochloride, and tenofovir disoproxil fumarate.

Inactive Ingredients: 

pregelatinized starch, lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, magnesium stearate, povidone, polysorbate 20. The tablet film coating contains polyethylene glycol, hypromellose, lactose monohydrate, triacetin, titanium dioxide, iron oxide red, FD&C Blue #2 aluminum lake, FD&C Yellow #6 aluminum lake.
Manufactured and distributed by:
Gilead Sciences, Inc.
Foster City, CA 94404

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