Please click here for Important Safety Information, including Boxed WARNINGS about acid build-up in the blood (lactic acidosis),
severe liver problems (hepatotoxicity), and flare-ups of hepatitis B when COMPLERA is discontinued.

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IMPORTANT SAFETY INFORMATION

COMPLERA can cause serious side effects. Contact your healthcare provider right away if you experience any of the following:

  • Build-up of lactic acid in the blood (lactic acidosis), which is a serious medical condition that can lead to death. Watch for the following symptoms:
    • feeling very weak or tired
    • feeling cold, especially in your arms and legs
    • unusual (not normal) muscle pain
    • trouble breathing
    • stomach pain with nausea (feeling sick to your stomach) or vomiting
    • feeling dizzy or lightheaded
    • fast or irregular heartbeat
  • Severe liver problems (hepatotoxicity), with liver enlargement (hepatomegaly), and fat in the liver (steatosis), which in some cases can lead to death. Watch for the following symptoms:
    • your skin or the white part of your eyes turn yellow (jaundice)
    • dark “tea-colored” urine
    • light-colored bowel movements (stools)
    • loss of appetite for several days or longer
    • nausea
    • stomach pain

You may be more likely to get lactic acidosis or severe liver problems if you are female, very overweight (obese), or have been taking COMPLERA or a similar medicine containing nucleoside analogs for a long time.

Worsening of hepatitis B infection. If you have HIV-1 and hepatitis B virus (HBV), your liver disease may suddenly get worse if you stop taking COMPLERA. Do not stop taking COMPLERA without first talking to your healthcare provider. Your healthcare provider will monitor your condition. COMPLERA is not approved for the treatment of HBV

COMPLERA may affect the way other medicines work, and other medicines may affect how COMPLERA works, and may cause serious side effects.

Do not take COMPLERA if you are taking the following medicines:
  • other HIV medicines (COMPLERA provides a complete treatment for HIV infection)
  • the anti-seizure medicines carbamazepine (Carbatrol®, Equetro®, Tegretol®, Tegretol-XR®, Teril®, Epitol®), oxcarbazepine (Trileptal®), phenobarbital (Luminal®), phenytoin (Dilantin®, Dilantin-125®, Phenytek®)
  • the anti-tuberculosis medicines rifabutin (Mycobutin), rifampin (Rifater®, Rifamate®, Rimactane®, Rifadin®) and rifapentine (Priftin®)
  • a proton pump inhibitor medicine for certain stomach or intestinal problems, including esomeprazole (Nexium®, Vimovo®), lansoprazole (Prevacid®), omeprazole (Prilosec®), pantoprazole sodium (Protonix®), rabeprazole (Aciphex®)
  • more than 1 dose of the steroid medicine dexamethasone or dexamethasone sodium phosphate
  • St. John’s wort (Hypericum perforatum)
  • other medicines that contain tenofovir (VIREAD®, TRUVADA®, ATRIPLA®)
  • other medicines that contain emtricitabine or lamivudine (EMTRIVA®, Combivir®, Epivir® or Epivir-HBV®, Epzicom®, Trizivir®)
  • rilpivirine (EDURANT®)
  • adefovir (HEPSERA®)
In addition, also tell your healthcare provider if you take:
  • an antacid medicine that contains aluminum, magnesium hydroxide, or calcium carbonate. Take antacids at least 2 hours before or at least 4 hours after you take COMPLERA
  • a histamine-2 blocker medicine, including famotidine (Pepcid®), cimetidine (Tagamet®), nizatidine (Axid®), or ranitidine hydrochloride (Zantac®). Take these medicines at least 12 hours before or at least 4 hours after you take COMPLERA
  • the antibiotic medicines clarithromycin (Biaxin®), erythromycin (E-Mycin®, Eryc®, Ery-Tab®, PCE®, Pediazole®, Ilosone®), and troleandomycin (TAO®)
  • an antifungal medicine by mouth, including fluconazole (Diflucan®), itraconazole (Sporanox®), ketoconazole (Nizoral®), posaconazole (Noxafil®), voriconazole (Vfend®)
  • methadone (Dolophine®)

This list of medicines is not complete. Discuss with your healthcare provider all prescription and nonprescription medicines, vitamins, or herbal supplements you are taking or plan to take.

Before taking 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
  • are breastfeeding; women with HIV should not breast-feed because they can pass HIV through their milk to the baby

Contact your healthcare provider right away if you experience any of the following serious or common side effects:

Serious side effects associated with COMPLERA:
  • New or worse kidney problems can happen in some people who take COMPLERA. If you have had kidney problems in the past or take other medicines that can cause kidney problems, your healthcare provider may need to do blood tests to check your kidneys during your treatment with COMPLERA
  • Depression or mood changes can happen in some people who take COMPLERA. Tell your healthcare provider right away if you have any of the following symptoms: feeling sad or hopeless, feeling anxious or restless, or if you have thoughts of hurting yourself (suicide) or have tried to hurt yourself
  • Bone problems can happen in some people who take COMPLERA. Bone problems include bone pain, softening or thinning (which may lead to fractures). Your healthcare provider may need to do additional tests to check your bones
  • Changes in body fat can happen in people taking HIV medicine. These changes may include increased amount of fat in the upper back and neck (“buffalo hump”), breast, and around the main part of your body (trunk). Loss of fat from the legs, arms and face may also happen. The cause and long-term health effect of these conditions are not known
  • Changes in your immune system (Immune Reconstitution Syndrome) can happen when you start taking HIV medicines. Your immune system may get stronger and begin to fight infections that have been hidden in your body for a long time. Tell your healthcare provider if you start having new symptoms after starting your HIV medicine
Common side effects associated with COMPLERA:
  • trouble sleeping (insomnia), abnormal dreams, headache, dizziness, diarrhea, nausea, rash, tiredness, and depression
Other side effects associated with COMPLERA:
  • vomiting, stomach pain or discomfort, skin discoloration (small spots or freckles), and pain

Tell your healthcare 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. For more information, ask your healthcare provider or pharmacist. Call your healthcare provider for medical advice about side effects.

INDICATION

COMPLERA® (emtricitabine 200 mg/rilpivirine 25 mg/tenofovir disoproxil fumarate 300 mg) is a prescription HIV medicine that contains 3 medicines, EMTRIVA® (emtricitabine), EDURANT® (rilpivirine), and VIREAD® (tenofovir disoproxil fumarate) combined in one pill. COMPLERA is used as a complete single-tablet regimen to treat HIV-1 infection in adults (age 18 and older) who have never taken HIV medicines before.

COMPLERA does not cure HIV and has not been shown to prevent passing HIV to others. It is important to always practice safer sex, use latex or polyurethane condoms to lower the chance of sexual contact with any body fluids, and to never re-use or share needles. Do not stop taking COMPLERA unless directed by your healthcare provider. See your healthcare provider regularly.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

Take COMPLERA exactly as your healthcare provider tells you to take it
  • Always take COMPLERA with a meal. Taking COMPLERA with a meal is important to help get the right amount of medicine in your body. A protein drink does not replace a meal
  • Stay under the care of your healthcare provider during treatment with COMPLERA and see your healthcare provider regularly

Read full Prescribing Information

Read FDA-Approved Patient Labeling

The information on this site is intended for residents of the United States who are 18 years of age or older.

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