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

Complera is used to treat HIV in people who have never taken HIV medicines before. This medicine is for use in adults and children who are at least 12 years old.

Complera is not a cure for HIV or AIDS.

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

There are many other drugs that can make Complera less effective and should not be used at the same time. 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.

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

Always take Complera with food.

If a child is using Complera, tell your doctor if the child has any changes in weight. Doses are based on weight in children, and any changes may affect your child's dose.

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 this medicine.

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.

Usual Adult Dose of Complera for HIV Infection:

1 tablet orally once a day

Comments:
-Efficacy was established in virologically-suppressed (HIV-1 RNA less than 50 copies/mL) patients on stable ritonavir-boosted protease inhibitor-containing regimen.
-Replacement of current regimen with this drug may be considered if: patients have no history of virologic failure; patients have been stably suppressed (HIV-1 RNA less than 50 copies/mL) for at least 6 months before switching therapy; patients are currently on first or second antiretroviral regimen before switching therapy; patients have no history of resistance to any of the 3 components.
-After replacing therapy, additional monitoring of HIV-1 RNA and regimen tolerability recommended to assess potential virologic failure or rebound.

Use: As a complete regimen for the treatment of HIV-1 infection in antiretroviral therapy-naive patients with HIV-1 RNA 100,000 copies/mL or less at the start of therapy, and in certain virologically-suppressed (HIV-1 RNA less than 50 copies/mL) patients on a stable antiretroviral regimen at start of therapy in order to replace their current antiretroviral treatment regimen

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, tenofovir, adefovir, or lamivudine.

There are many other drugs that can make rilpivirine less effective and should not be used at the same time:

• 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 ever had:

• kidney disease;

• liver disease (including hepatitis B or C);

• depression or mental illness; or

• long QT syndrome (in you or a family member).

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 the medicine on the baby.

Women with HIV or AIDS should not breastfeed 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 12 years old or weighing less than 77 pounds (35 kilograms).

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

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.

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, Zantac), take it at least 12 hours before or 4 hours after taking Complera.

Get emergency medical help if you have signs of an allergic reaction to Complera: 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 HIV medication. 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 - swelling around your midsection, upper stomach pain, 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. 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, dizziness, tiredness;

• depressed mood, 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.

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 Advil, Motrin, and Aleve).

Many drugs can interact with emtricitabine, rilpivirine, and tenofovir, and some drugs should not be used together. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide. Tell your doctor about all medicines you use, and those you start or stop using during your treatment with Complera. Give a list of all your medicines to any healthcare provider who treats you.