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Generic Name: emtricitabine, rilpivirine, and tenofovir (em trye SYE ta been, RIL pi VIR een, and ten OF oh vir)
Brand Names: Complera

What is Complera?

Complera contains a combination of emtricitabine, rilpivirine, and tenofovir. Emtricitabine, rilpivirine, and tenofovir are antiviral drugs that prevent HIV (human immunodeficiency virus) cells from multiplying in the body. HIV causes acquired immunodeficiency syndrome (AIDS).

Complera is used to treat HIV in adults who have never taken HIV medicines before. Emtricitabine, rilpivirine, and tenofovir is not a cure for HIV or AIDS.

Complera should not be taken together with other antiviral medications to treat HIV or AIDS.

Complera may also be used for purposes not listed in this medication guide.

Important information

Some medicines can interact with Complera and should not be used at the same time, including: dexamethasone, St. John's wort, tuberculosis medication (rifabutin, rifampin, rifapentine), seizure medicine (carbamazepine, oxcarbazepine, phenobarbital, phenytoin), or stomach acid reducers (dexlansoprazole, esomeprazole, lansoprazole, omeprazole, pantoprazole, rabeprazole).

Slideshow: Flashback: FDA Drug Approvals 2013

Some people develop lactic acidosis while taking tenofovir. Early symptoms may get worse over time and this condition can be fatal. Get emergency medical help if you have even mild symptoms such as: muscle pain or weakness, numb or cold feeling in your arms and legs, trouble breathing, stomach pain, nausea with vomiting, fast or uneven heart rate, dizziness, or feeling very weak or tired.

If you have hepatitis B you may develop liver symptoms after you stop taking Complera, even months after stopping. Your doctor may want to check your liver function for several months after you stop using Complera.

Before taking this medicine

You should not take Complera if you are allergic to emtricitabine, rilpivirine, or tenofovir.

Do not take Complera with other medicines that also contain emtricitabine, rilpivirine, or tenofovir (Atripla, Edurant, Emtriva, Stribild, Truvada, Viread), or adefovir or lamivudine (Combivir, Epivir, Epzicom, Hepsera, or Trizivir).

There are many other drugs that can make rilpivirine less effective. The following drugs should not be used together with Complera:

  • dexamethasone;

  • St. John's wort;

  • tuberculosis medication--rifabutin, rifampin, rifapentine;

  • seizure medicine--carbamazepine, oxcarbazepine, phenobarbital, phenytoin; or

  • stomach acid reducers--dexlansoprazole, esomeprazole, lansoprazole, omeprazole, pantoprazole, rabeprazole.

To make sure you can safely take Complera, tell your doctor if you have any of these other conditions:

  • kidney disease;

  • liver disease (including hepatitis B or C);

  • a history of mental illness;

  • a personal or family history of Long QT syndrome; or

  • osteopenia (low bone mineral density).

Some people taking tenofovir develop a serious condition called lactic acidosis. This may be more likely in women, in people who are overweight or have liver disease, and in people who have taken HIV/AIDS medication for a long time. Talk with your doctor about your risk.

HIV can be passed to your baby if you are not properly treated during pregnancy. Take all of your HIV medicines as directed to control your infection. Tell your doctor if you become pregnant during treatment.

Women with HIV or AIDS should not breast-feed a baby. Even if your baby is born without HIV, the virus may be passed to the baby in your breast milk.

Do not give Complera to anyone under 18 without the advice of a doctor.

How should I take Complera?

Take Complera exactly as prescribed by your doctor. Follow all directions on your prescription label. Do not take Complera in larger or smaller amounts or for longer than recommended.

Complera is usually taken once per day with a meal.

While using Complera, you may need frequent blood tests at your doctor's office. Your bone density may also need to be tested.

If you have hepatitis B you may develop liver symptoms after you stop taking this medication, even months after stopping. Your doctor may want to check your liver function for several months after you stop using Complera.

HIV/AIDS is usually treated with a combination of drugs. Use all medications as directed by your doctor. Read the medication guide or patient instructions provided with each medication. Do not change your doses or medication schedule without your doctor's advice. Every person with HIV or AIDS should remain under the care of a doctor.

Store Complera in original container at room temperature away from moisture and heat. Keep the bottle tightly closed when not in use.

What happens if I miss a dose?

If you are less than 12 hours late in taking your medicine, take the missed dose as soon as you remember. Be sure to take the medicine with a meal. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid?

If you also take an antacid, take it at least 2 hours before or 4 hours after taking Complera.

If you also take a heartburn or GERD medicine (such as Tagamet, Pepcid, Axid, or Zantac), take it at least 12 hours before or 4 hours after taking Complera.

Taking this medication will not prevent you from passing HIV to other people. Avoid having unprotected sex or sharing razors or toothbrushes. Talk with your doctor about safe ways to prevent HIV transmission during sex. Sharing drug or medicine needles is never safe, even for a healthy person.

Complera side effects

Get emergency medical help if you have any of these signs of an allergic reaction to Complera: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Some people develop lactic acidosis while taking Complera. Early symptoms may get worse over time and this condition can be fatal. Get emergency medical help if you have even mild symptoms such as: muscle pain or weakness, numb or cold feeling in your arms and legs, trouble breathing, stomach pain, nausea with vomiting, fast or uneven heart rate, dizziness, or feeling very weak or tired.

Call your doctor at once if you have:

  • upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);

  • confusion, severe depression, unusual thoughts or behavior, suicidal thoughts or actions;

  • swelling, rapid weight gain, little or no urinating; or

  • increased thirst and urination, weakness, constipation.

Complera may increase your risk of certain infections or autoimmune disorders by changing the way your immune system works. Symptoms may occur weeks or months after you start treatment with Complera. Tell your doctor if you have:

  • signs of a new infection--fever, night sweats, swollen glands, diarrhea, weight loss;

  • chest pain (especially when you breathe), dry cough, wheezing;

  • cold sores, sores on your genital or anal area;

  • feeling anxious or irritable, weakness or prickly feeling, problems with balance or eye movement;

  • trouble speaking or swallowing, severe lower back pain, loss of bladder or bowel control; or

  • swelling in your neck or throat (enlarged thyroid), menstrual changes, impotence, loss of interest in sex.

Common Complera side effects may include:

  • headache, mild tired feeling;

  • sleep problems (insomnia), strange dreams;

  • mild nausea; or

  • changes in the shape or location of body fat (especially in your arms, legs, face, neck, breasts, and waist).

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

See also: Side effects (in more detail)

What other drugs will affect Complera?

Complera can harm your kidneys. This effect is increased when you also use certain other medicines, including: antivirals, chemotherapy, injected antibiotics, medicine for bowel disorders, medicine to prevent organ transplant rejection, and some pain or arthritis medicines (including aspirin, Tylenol, Advil, and Aleve).

Many drugs can interact with Complera. Not all possible interactions are listed here. Tell your doctor about all your medications and any you start or stop using during treatment with Complera, especially:

  • antibiotics or antifungal medications;

  • an antidepressant;

  • anti-malaria medication;

  • heart or blood pressure medication;

  • medicines to treat narcolepsy;

  • medicine to prevent or treat nausea and vomiting;

  • medicines to treat psychiatric disorders;

  • many other HIV medicines;

  • migraine headache medication; or

  • narcotic medication.

This list is not complete and many other drugs can interact with Complera. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Give a list of all your medicines to any healthcare provider who treats you.

Where can I get more information?

  • Your pharmacist can provide more information about Complera.
  • Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use Complera only for the indication prescribed.
  • Disclaimer: Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2015 Cerner Multum, Inc. Version: 2.01. Revision Date: 2013-04-02, 11:23:55 AM.