emtricitabine, rilpivirine, and tenofovir

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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 (Complera)?

There are many other drugs that can make rilpivirine less effective and should not be used at the same time as Complera. Tell your doctor about all your the medicines you use.

Complera may cause a serious condition called lactic acidosis. 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. Your doctor may want to check your liver function for several months after you stop using this medicine.

What is emtricitabine, rilpivirine, and tenofovir (Complera)?

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).

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

Complera 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 Complera?

You should not take this medicine 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 Complera is safe for you, tell your doctor if you have:

  • kidney disease;
  • liver disease (including hepatitis B or C);
  • a history of depression or mental illness;
  • a personal or family history of Long QT syndrome; or
  • osteoporosis, 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. 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 Complera on the baby.

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.

Complera is not approved for use by anyone younger than 18 years old.

How should I take Complera?

Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended.

Complera is usually taken once per day with a meal. Always take this medicine with food.

While using Complera, you may need frequent blood tests. 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 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?

Take the missed dose as soon as you remember. Be sure to take the medicine with a meal. If you are more than 12 hours late, skip the missed 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 while taking Complera?

If you also take an antacid, (Maalox, Milk of Magnesia, Mylanta, Rolaids, Tums, and others), 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 Complera will not prevent you from passing HIV to other people. Do not have unprotected sex or share 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 Complera?

Get emergency medical help if you have signs of an allergic reaction: hives, blistering skin rash with fever; mouth sores, eye redness; 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:

  • confusion, severe depression, unusual thoughts or behavior, suicidal thoughts or actions;
  • increased thirst and urination, loss of appetite, weakness, constipation;
  • kidney problems --little or no urinating, painful or difficult urination, swelling in your feet or ankles, feeling tired or short of breath;
  • liver problems --nausea, upper stomach pain, itching, tired feeling, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes); or
  • signs of inflammation in your body --swollen glands, flu symptoms, easy bruising or bleeding, severe tingling or numbness, muscle weakness, upper stomach pain, jaundice (yellowing of the skin or eyes), chest pain, new or worsening cough with fever, trouble breathing;

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 side effects may include:

  • headache, dizziness;
  • depressed mood, tiredness;
  • sleep problems (insomnia), strange dreams;
  • rash;
  • nausea, diarrhea; 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 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 current medicines and any you start or stop using, especially:

  • methadone;
  • an antibiotic --clarithromycin, erythromycin, telithromycin;
  • antifungal medicine --fluconazole, itraconazole, ketoconazole, posaconazole, voriconazole; or
  • antiviral medicine --acyclovir, cidofovir, ganciclovir, valacyclovir, valganciclovir.

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 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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