Acquired Immunodeficiency Syndrome (AIDS):
A disease of the immune system caused by the human immunodeficiency virus (HIV). When someone has AIDS, their CD4+ cells die. This exposes the body to life-threatening infections.
Treatment with drugs that keep viruses from multiplying in the body. The antiretroviral therapy recommended for HIV infection is known as highly active antiretroviral therapy (HAART).
A type of white blood cell that fights infections. The more CD4+ cells a person has, the healthier their immune system is. HIV infects and kills CD4+ cells, weakening the immune system.
CD4+ Cell Count:
The number of CD4+ cells in a blood sample. Helps healthcare professionals decide when to begin HIV therapy and may show whether treatment is working. Even if your CD4+ cell count has increased with treatment, you can still pass HIV on to others.
A research study that uses human volunteers to help find new treatments for diseases and conditions.
The amount of a medicine that should be taken during a given time period.
A group of drugs that have certain things in common and work in a similar way.
Highly Active Antiretroviral Therapy (HAART):
Treatment regimens that stop or slow the HIV virus from copying itself and keep HIV disease from progressing. The usual HAART regimen combines 2 or more HIV drugs from at least 2 different classes.
Human Immunodeficiency Virus (HIV):
The virus that causes AIDS.
Can happen when someone’s CD4+ cell count goes up after they start HIV treatment. Fever, swelling, redness, or discharge may mean that their immune system is getting stronger. But this reaction can be very serious and must be treated accordingly.
When the body defends itself against a foreign invader, such as a virus or bacteria.
The group of cells and organs whose job is to protect the body from infections.
Inability to produce normal amounts of the disease-fighting cells that protect the body against infections.
Non-Nucleoside Reverse Transcriptase Inhibitor (NNRTI):
A class of HIV drug that blocks an enzyme in the body called HIV reverse transcriptase. HIV needs this enzyme to make more virus.
When a drug causes a reaction in the body that it is not meant to cause. Usually refers to something unwanted, such as dizziness, headache, or tiredness.
A type of white blood cell that fights disease. T cells include CD4+ cells.
Undetectable Viral Load:
When the amount of HIV in the blood is too low to be seen on a viral load blood test. Getting to undetectable is a good thing, but it does not mean your HIV is cured, and you can still pass it to others.
The amount of HIV found in a blood sample. When viral load goes up or down, your healthcare professional can get an idea of how well treatment is working.
Important Safety Information
Can EDURANT® be taken with other medicines?
EDURANT® may affect the way other medicines work and other medicines may affect how EDURANT® works and may cause serious side effects. If you take certain medicines with EDURANT®, the amount of EDURANT® in your body may be too low and it may not work to help control your HIV infection, and the HIV virus in your body may become resistant to EDURANT® or other HIV medicines that are like it. To help get the right amount of medicine in your body, you should always take EDURANT® with a meal. A protein drink alone does not replace a meal.
Do not take EDURANT® if:
- Your HIV infection has been previously treated with HIV medicines
You are taking any of the following medicines:
- Anti-seizure medicines: carbamazepine (Carbatrol®, Equetro®, Tegretol®, Tegretol-XR®, Teril®, Epitol®), oxcarbazepine (Trileptal®), phenobarbital (Luminal®), phenytoin (Dilantin®, Dilantin-125®, Phenytek®)
- Anti-tuberculosis (anti-TB) medicines: rifampin (Rifater®, Rifamate®, Rimactane®, Rifadin®), rifapentine (Priftin®)
- Proton pump inhibitor (PPI) medicine for certain stomach or intestinal problems: esomeprazole (Nexium®, Vimovo®), lansoprazole (Prevacid®), omeprazole (Prilosec®, Zegerid®), pantoprazole sodium (Protonix®), rabeprazole (Aciphex®)
- More than 1 dose of the steroid medicine dexamethasone or dexamethasone sodium phosphate
- St. John’s wort (Hypericum perforatum)
Especially tell your doctor if you take:
- Rifabutin (Mycobutin®), a medicine to treat some bacterial infections. Talk to your doctor or pharmacist about the right amount of EDURANT® you should take if you also take rifabutin
- Medicines used to treat HIV
- An antacid medicine that contains aluminum, magnesium hydroxide, or calcium carbonate. Take antacids at least 2 hours before or at least 4 hours after you take EDURANT®
- Medicines to block acid in your stomach, including cimetidine (Tagamet®), famotidine (Pepcid®), nizatidine (Axid®), or ranitidine hydrochloride (Zantac®). Take these medicines at least 12 hours before or at least 4 hours after you take EDURANT®
- Any of these medicines (if taken by mouth or injection): clarithromycin (Biaxin®), erythromycin (E-Mycin®, Eryc®, Ery-Tab®, PCE®, Pediazole®, Ilosone®), fluconazole (Diflucan®), itraconazole (Sporanox®), ketoconazole (Nizoral®), methadone (Dolophine®), posaconazole (Noxafil®), telithromycin (Ketek®), voriconazole (Vfend®)
This is not a complete list of medicines. Before starting EDURANT®, be sure to tell your healthcare professional about all the medicines you are taking or plan to take, including prescription and nonprescription medicines, vitamins, and herbal supplements.
Before taking EDURANT®, also tell your healthcare professional if you have had or currently have liver problems (including hepatitis B or C), have ever had a mental health problem, are pregnant or planning to become pregnant, or breastfeeding. It is not known if EDURANT® will harm your unborn baby. You and your healthcare professional will need to decide if taking EDURANT® is right for you.
Do not breastfeed if you are taking EDURANT®. You should not breastfeed if you have HIV because of the chance of passing HIV to your baby
What are the possible side effects of EDURANT®?
EDURANT® can cause serious side effects including:
- Severe skin rash and allergic reactions. Call your doctor right away if you get a rash. Stop taking EDURANT® and seek medical help right away if you get a rash with any of the following symptoms: severe allergic reaction causing swelling of the face, eyes, lips, mouth, tongue, or throat (which may lead to difficulty swallowing or breathing); mouth sores or blisters on your body; inflamed eye (conjunctivitis); fever; dark urine; or pain on the right side of the stomach area (abdominal pain)
- Depression or mood changes. Tell your doctor right away if you have any of the following symptoms: feeling sad or hopeless, feeling anxious or restless, have thoughts of hurting yourself (suicide), or have tried to hurt yourself
- Liver problems. People with a history of hepatitis B or C virus infection or who have certain liver function test changes may have an increased risk of developing new or worsening liver problems during treatment. Liver problems were also reported during treatment in some people without a history of liver disease. Your healthcare professional may need to do tests to check liver function before and during treatment
- Changes in body shape or body fat have been seen in some patients taking HIV medicines. The exact cause and long-term health effects of these conditions are not known
- Changes in your immune system (immune reconstitution syndrome). Your immune system may get stronger and begin to fight infections. Tell your healthcare professional right away if you start having any new symptoms of infection
Other common side effects of EDURANT® include depression, headache, trouble sleeping (insomnia), and rash.
This is not a complete list of all side effects. If you experience these or other symptoms, contact your healthcare professional right away. Do not stop taking EDURANT® or any other medications without first talking to your healthcare professional.
You are encouraged to report side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088. You may also report side effects to Janssen Products, LP, at 1-800-JANSSEN (1-800-526-7736).
Please see accompanying full Product Information for more details.
EDURANT® (rilpivirine) is a prescription HIV medicine that is used with other antiretroviral medicines to treat Human Immunodeficiency Virus-1 (HIV-1)
- Who have never taken HIV medicines before, and
- Who have an amount of HIV in their blood (called “viral load”) that is no more than 100,000 copies/mL. Your healthcare professional will measure your viral load
- EDURANT® should be taken in combination with other HIV medicines. Your healthcare professional will work with you to find the right combination of HIV medicines
- It is important that you remain under the care of your healthcare professional during treatment with EDURANT®
- EDURANT® is not recommended for patients less than 12 years of age
EDURANT® does not cure HIV infection or AIDS. You should remain on your HIV medications without stopping to ensure that you control your HIV infection and decrease the risk of HIV-related illnesses. Ask your healthcare professional about how to prevent passing HIV to other people.
Please read Important Safety Information below, and talk to your healthcare professional to learn if EDURANT® is right for you.