emtricitabine, rilpivirine, and tenofovir

emtricitabine, rilpivirine, and tenofovir

Pronunciation: em trye SYE ta been, RIL pi VIR een, and ten OF oh vir

Brand: Complera

What is the most important information I should know about emtricitabine, rilpivirine, and tenofovir?

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You should not take this medication if you are allergic to emtricitabine (Emtriva), rilpivirine (Edurant), or tenofovir (Viread).

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

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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.

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Emtricitabine, rilpivirine, and tenofovir can cause severe or fatal liver problems. Call your doctor at once if you have symptoms such as nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, or jaundice (yellowing of the skin or eyes).

What is emtricitabine, rilpivirine, and tenofovir?

Emtricitabine, rilpivirine, and tenofovir are antiviral drugs that prevent preventing HIV (human immunodeficiency virus) cells from multiplying in the body.

The combination of emtricitabine, rilpivirine, and tenofovir is used to treat HIV, which causes acquired immunodeficiency syndrome (AIDS). Emtricitabine, rilpivirine, and tenofovir is not a cure for HIV or AIDS.

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This combination medicine should not be taken together with other antiviral medications to treat HIV or AIDS.

Emtricitabine, rilpivirine, and tenofovir may also be used for purposes not listed in this medication guide.

What should I discuss with my healthcare provider before taking emtricitabine, rilpivirine, and tenofovir?

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You should not take this medication if you are allergic to emtricitabine (Emtriva), rilpivirine (Edurant), or tenofovir (Viread).

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

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

  • dexamethasone (Cortastat, Dexasone, Solurex, DexPak);
  • St. John's wort;
  • rifabutin (Mycobutin), rifampin (Rifadin, Rifater, Rifamate), or rifapentine (Priftin);
  • the seizure medicines carbamazepine (Carbatrol, Equetro, Tegretol), oxcarbazepine (Trileptal), phenobarbital (Solfoton), or phenytoin (Dilantin); or
  • stomach acid reducers such as esomeprazole (Nexium, Vimovo), lansoprazole (Prevacid), omeprazole (Prilosec, Zegerid), pantoprazole (Protonix), or rabeprazole (AcipHex).

To make sure you can safely take emtricitabine, rilpivirine, and tenofovir, tell your doctor if you have any of these other conditions:

  • kidney disease;
  • osteopenia (low bone mineral density);
  • a personal or family history of Long QT syndrome; or
  • if you also have hepatitis B infection.
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Some people develop a life-threatening condition called lactic acidosis while taking tenofovir. You may be more likely to develop lactic acidosis if you are overweight or have liver disease, if you are a woman, or if you have taken HIV or AIDS medications for a long time. Talk with your doctor about your individual risk.

FDA pregnancy category B. Emtricitabine, rilpivirine, and tenofovir is not expected to be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment.

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.

If you are pregnant, your name may be listed on a pregnancy registry. This is to track the outcome of the pregnancy and to evaluate any effects of emtricitabine, rilpivirine, and tenofovir on the baby.

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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.

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

How should I take emtricitabine, rilpivirine, and tenofovir?

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

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Emtricitabine, rilpivirine, and tenofovir is usually taken once per day with a meal. Follow your doctor's instructions.

Use emtricitabine, rilpivirine, and tenofovir regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.

To be sure this medication is helping your condition and not causing harmful effects, your blood will need to be tested often. Your kidney and liver function or bone density may also need to be tested. Visit your doctor regularly.

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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 emtricitabine, rilpivirine, and tenofovir. Visit your doctor regularly.

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.

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Store 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?

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

What should I avoid while taking emtricitabine, rilpivirine, and tenofovir?

If you also take an antacid, take it at least 2 hours before or 4 hours after taking emtricitabine, rilpivirine, and tenofovir.

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 emtricitabine, rilpivirine, and tenofovir.

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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.

What are the possible side effects of emtricitabine, rilpivirine, and tenofovir?

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

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This medication may cause lactic acidosis (a build-up of lactic acid in the body, which can be fatal). Lactic acidosis can start slowly and get worse over time. Get emergency medical help if you have even mild symptoms of lactic acidosis, such as:

  • muscle pain or weakness;
  • numb or cold feeling in your arms and legs;
  • trouble breathing;
  • feeling dizzy, light-headed, tired, or very weak;
  • stomach pain, nausea with vomiting; or
  • fast or uneven heart rate.
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Call your doctor at once if you have any of these other serious side effects:

  • signs of liver damage - nausea, 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;
  • increased thirst and urination, weakness, constipation;
  • urinating less than usual or not at all;
  • swelling, rapid weight gain, feeling short of breath;
  • signs of infection such as fever, chills, skin lesions, or cough with yellow or green mucus.

Less serious side effects may include:

  • headache, mild tired feeling;
  • dizziness, depressed mood;
  • sleep problems (insomnia), strange dreams;
  • diarrhea, 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.

What other drugs will affect emtricitabine, rilpivirine, and tenofovir?

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This medication can harm your kidneys. This effect is increased when you also use other medicines harmful to the kidneys. You may need dose adjustments or special tests if you have recently used:

  • medicines to treat a bowel disorder;
  • medication to prevent organ transplant rejection;
  • chemotherapy;
  • other antiviral medications (including medicines to treat herpes or cytomegalovirus (CMV);
  • pain or arthritis medicines; or
  • injected (IV) antibiotics.

There are many other drugs that can interact with emtricitabine, rilpivirine, and tenofovir. Below is just a partial list. Tell your doctor if you are using:

  • 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 other drugs may interact with emtricitabine, rilpivirine, and tenofovir. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

Where can I get more information?

Your pharmacist can provide more information about emtricitabine, rilpivirine, and tenofovir.


Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

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