Emtricitabine, rilpivirine, and tenofovir is a combination antiviral medicine that is used to treat human immunodeficiency virus (HIV), the virus that can cause acquired immunodeficiency syndrome (AIDS). emtricitabine, rilpivirine, and tenofovir is not a cure for HIV or AIDS.

Emtricitabine, rilpivirine, and tenofovir is for use in adults and children who are at least 12 years old and who weigh at least 77 pounds (35 kilograms).

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

Tell your doctor about all your current medicines and any you start or stop using. Many drugs can interact, and some drugs should not be used together.

If you've ever had hepatitis B, it may become active or get worse after you stop using this medicine. You may need frequent liver function tests for several months.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Always take this medicine with food.

Complera and Odefsey doses are based on weight in children. Your child's dose needs may change if the child gains or loses weight.

You will need frequent medical tests. Your bone density may also need to be tested.

If you've ever had hepatitis B, this virus may become active or get worse in the months after you stop using this medicine. You may need frequent liver function tests during treatment and for several months after your last dose.

Do not change your dose or dosing schedule without your doctor's advice. Every person with HIV should remain under the care of a doctor.

Store this medicine in original container at room temperature away from moisture and heat.

Usual Adult Dose for HIV Infection:

1 tablet orally once a day

Comments:
-Pregnant patients who were already taking this drug before pregnancy and who are virologically suppressed (HIV-1 RNA less than 50 copies/mL) may continue 1 tablet orally once a day; since lower rilpivirine exposures were seen during pregnancy, viral load should be monitored.

Use: As a complete regimen for the treatment of HIV-1 infection, as initial therapy in patients with no antiretroviral treatment history with HIV-1 RNA up to 100,000 copies/mL or to replace a stable antiretroviral regimen in patients who are virologically-suppressed (HIV-1 RNA less than 50 copies/mL) for at least 6 months with no history of treatment failure and no known substitutions associated with resistance to the individual components

Usual Pediatric Dose for HIV Infection:

At least 35 kg: 1 tablet orally once a day

Comments:
-Pregnant patients who were already taking this drug before pregnancy and who are virologically suppressed (HIV-1 RNA less than 50 copies/mL) may continue 1 tablet orally once a day; since lower rilpivirine exposures were seen during pregnancy, viral load should be monitored.

Use: As a complete regimen for the treatment of HIV-1 infection, as initial therapy in patients with no antiretroviral treatment history with HIV-1 RNA up to 100,000 copies/mL or to replace a stable antiretroviral regimen in patients who are virologically-suppressed (HIV-1 RNA less than 50 copies/mL) for at least 6 months with no history of treatment failure and no known substitutions associated with resistance to the individual components

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

This medicine is not approved for use by anyone younger than 12 years old or weighing less than 77 pounds (35 kilograms).

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

• dexamethasone (more than 1 dose);

• St. John's wort;

• tuberculosis medication--rifampin, rifapentine;

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

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

Tell your doctor if you have ever had:

• kidney disease;

• liver disease (including hepatitis B or C);

• depression or suicidal thoughts; or

• bone problems.

Your doctor will perform blood tests to make sure you do not have hepatitis B.

Tell your doctor if you are pregnant, and use your medications properly to control your infection. HIV can be passed to your baby if the virus is not controlled during pregnancy. Your name may be listed on a registry to track any effects of antiviral 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.

Take the medicine with a meal as soon as you can, but skip the missed dose if you are more than 12 hours late for the dose. Do not take two doses at one time.

Get your prescription refilled before you run out of medicine completely.

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

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

Unless your doctor tells you otherwise, continue your normal diet.

Using this medicine will not prevent your disease from spreading. 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.

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

Seek medical treatment if you have a serious drug reaction that can affect many parts of your body. Symptoms may include: a blistering skin rash, fever, mouth sores, eye redness, swollen glands, trouble breathing or swallowing, right-sided upper stomach pain, unusual bruising, or dark urine.

Emtricitabine, rilpivirine, and tenofovir may cause serious side effects. Call your doctor at once if you have:

• depression or mood changes, anxiety, restlessness, suicidal thoughts or actions;

• kidney problems--little or no urination, swelling in your feet or ankles, feeling tired or short of breath;

• lactic acidosis--unusual muscle pain, trouble breathing, stomach pain, vomiting, irregular heart rate, dizziness, feeling cold, or feeling very weak or tired; or

• liver problems--stomach pain, nausea, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

This medicine affects your immune system, which may cause certain side effects (even weeks or months after you've taken this medicine). Tell your doctor if you have:

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

• trouble speaking or swallowing, problems with balance or eye movement, weakness or prickly feeling; or

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

Common side effects of emtricitabine, rilpivirine, and tenofovir may include:

• headache, dizziness, tiredness;

• depressed mood, trouble sleeping, strange dreams;

• rash; or

• nausea, diarrhea.

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.

Some medicines can make Complera or Odefsey much less effective when taken at the same time. If you take any of the following medicines, take them separately from your HIV medication:

• An antacid--take it at least 2 hours before or 4 hours after taking Complera or Odefsey.

• A stomach acid reducer (such as Tagamet, Pepcid, Zantac)--take it at least 12 hours before or 4 hours after taking Complera or Odefsey.

Complera or Odefsey can harm your kidneys or cause a serious heart problem. Your risk may be higher if you also use certain other medicines for infections, asthma, heart problems, high blood pressure, depression, mental illness, cancer, malaria, osteoporosis, organ transplant rejection, bowel disorders, or pain or arthritis (including Advil, Motrin, and Aleve).

Many drugs can affect Complera or Odefsey, and some drugs should not be used at the same time. Tell your doctor about all your current medicines and any medicine you start or stop using. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

Keep a supply of emtricitabine, rilpivirine, and tenofovir on hand. Do not wait until you run out of medication to refill your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.