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


  1. Patient Information
  2. Who Should Not Take Complera?do Not Take Complera If You Also Take:
  3. Before Taking Complera, Tell Your Healthcare Provider About All Your Medical Conditions, Including If You:
  4. How Should I Take Complera?
  5. What Are The Ingredients Of Complera?active Ingredients:
  6. Inactive Ingredients:

Patient Information 

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

Posttreatment Acute Exacerbation of Hepatitis B inPatients Coinfected with HIV-1 and HBV

Severe acute exacerbations of hepatitis B have been reported in patients who are coinfected with HBV and HIV-1 and who have discontinued products containing FTC or TDF[
COMPLERA is a prescription medicine that is used to treat Human Immunodeficiency Virus-1 (HIV-1) in people weighing at least 77 lb (35 kg) 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,
    or
  • 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.
HIV-1 is the virus that causes AIDS (Acquired Immune Deficiency Syndrome). COMPLERA does not cure HIV-1 or AIDS.
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).

Who Should Not Take Complera?do Not Take Complera If You Also Take: 

  • anti-seizure medicines:
    • carbamazepine
    • oxcarbazepine
    • phenobarbital
    • phenytoin
  • anti-tuberculosis (anti-TB) medicines:
    • rifampin
    • rifapentine
  • proton pump inhibitor (PPI) medicine for certain stomach or intestinal problems:
    • dexlansoprazole
    • esomeprazole
    • lansoprazole
    • omeprazole
    • pantoprazole sodium
    • rabeprazole
  • more than 1 dose of the steroid medicine dexamethasone or dexamethasone sodium phosphate
  • St. John's wort (Hypericum perforatum)
What should I tell my healthcare provider before taking COMPLERA?

Before Taking Complera, Tell Your Healthcare Provider About All Your Medical Conditions, Including If You: 

  • have liver problems, including hepatitis B or C virus infection
  • have kidney problems
  • have a history of depression or suicidal thoughts
  • have bone problems
  • are pregnant or plan to become pregnant. It is not known if COMPLERA can harm your unborn child. Tell your healthcare provider if you become pregnant during treatment with COMPLERA.
    Pregnancy Registry.There is a pregnancy registry for those who take COMPLERA during pregnancy. The purpose of this registry is to collect information about the health of you and your baby. Talk with your healthcare provider about how you can take part in this registry.
  • are breastfeeding or plan to breastfeed. Do not breastfeed if you are taking COMPLERA.
    • You should not breastfeed if you have HIV-1 because of the risk of passing HIV-1 to your baby.
    • At least two of the medicines contained in COMPLERA can be passed to your baby in your breast milk.
    • Talk with your healthcare provider about the best way to feed your baby during treatment with COMPLERA.
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 when you get a new medicine.
  • 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? 

  • Take COMPLERA exactly as your healthcare provider tells you to take it.
  • 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. Stay under the care of your healthcare provider during treatment with COMPLERA.
  • If you miss a dose of COMPLERA within 12 hours of the time you usually take it, take your dose of COMPLERAwith foodas soon as possible. Then, take your next dose of COMPLERA at the regularly scheduled time. If you miss a dose of COMPLERA by more than 12 hours of the time you usually take it, wait and then take the next dose of COMPLERA at the regularly scheduled time.
  • Do not take more than your prescribed dose to make up for a missed dose.
  • If you take too much COMPLERA, contact your local poison control center or go to the nearest hospital emergency room right away.
  • When your COMPLERA supply starts to run low, get more from your healthcare provider or pharmacy. It is very important not to run out of COMPLERA. The amount of virus in your blood may increase if the medicine is stopped for even a short time.
What are the possible side effects of COMPLERA?
COMPLERA can cause serious side effects, including
:
    • Store COMPLERA at room temperature below 30 C (86 F).
    • 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. You can ask your healthcare provider or pharmacist for information about COMPLERA that is written for health professionals.
    For more information, go to www.COMPLERA.com.

What Are The Ingredients Of Complera?active Ingredients: 

emtricitabine, rilpivirine hydrochloride, and tenofovir disoproxil fumarate.

Inactive Ingredients: 

croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polysorbate 20, povidone, pregelatinized starch. The tablet film coating contains hypromellose, lactose monohydrate, polyethylene glycol, titanium dioxide, triacetin.
Manufactured and distributed by: Gilead Sciences, Inc. Foster City, CA 94404
COMPLERA, EMTRIVA, and VIREAD are trademarks of Gilead Sciences, Inc., or its related companies. All other trademarks referenced herein are the property of their respective owners.
2018 Gilead Sciences, Inc. All rights reserved.
202123-GS-012A



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