emtricitabine, rilpivirine, and tenofovir

What is the most important information I should know about this medicine?

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.

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

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). This medicine 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.

What should I discuss with my healthcare provider before taking this medicine?

• 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.

How should I take this medicine?

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

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.

What happens if I miss a dose?

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.

What happens if I overdose?

What should I avoid while taking this medicine?

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.

What are the possible side effects of this medicine?

• 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 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.

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

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.

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.

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.

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 1996-2023 Cerner Multum, Inc. Version: 4.02. Revision date: 2/26/2021.