Frequently Asked Questions About EDURANT® (rilpivirine) tablets

Frequently Asked Questions

What are my CD4+ and viral load numbers?

What are my current HIV treatment goals?

What other HIV medicines will I be taking?

Will other medicines I am taking interfere with EDURANT® treatment?

How will I know if my treatment is working?

What is my dosing schedule?

What should I do if I have side effects?

What if I want to become pregnant?

How can I remember to take my medicine?

Where can I get additional support?

What are my CD4+ and viral load numbers?

To determine the number of CD4+ cells in your body, your healthcare professional will do a simple blood test called a CD4+ cell count. The CD4+ cell count is used to help determine when it’s time for you to start HIV treatment. This test is also used to keep track of how well treatment is working. Your healthcare professional will probably perform this test regularly during your treatment.

Your healthcare professional will also measure the amount of HIV in your blood. This is called your viral load. As HIV progresses, the amount of HIV in the blood—the viral load—will increase. The viral load test will help to decide when treatment should be started and how well treatment is working.

What are my current HIV treatment goals?

Two important goals of treatment for people with HIV are to

  • Increase your CD4+ cell count
  • Keep your viral load (the amount of HIV in your blood) as low as possible

Increasing your CD4+ cell count and reducing the amount of HIV in your blood may make your immune system stronger. As a result, this may reduce the risk of serious problems that can happen when your immune system is weak.

What other HIV medicines will I be taking?

EDURANT® must be taken in combination with other HIV medicines. Your healthcare professional will work with you to find the right combination of HIV medicines.

Will other medicines I am taking interfere with EDURANT® treatment?

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.

How will I know if my treatment is working?

EDURANT® blocks an enzyme in the body called HIV reverse transcriptase. HIV needs this enzyme to make more virus. When this enzyme is blocked, less virus is made in your body. When used with other HIV medicines, EDURANT® may help:

  • Reduce the amount of HIV in your blood (your viral load)
  • Increase the number of CD4+ cells in your blood that help fight infection

Reducing the amount of HIV (your viral load) and increasing the CD4+ (T) cells in your blood may help improve your immune system. This may reduce your risk of death or getting infections that can happen when your immune system is weak (opportunistic infections).

What is my dosing schedule?

  • Stay under the care of your doctor during treatment with EDURANT®
  • Take EDURANT® every day exactly as prescribed by your doctor
  • Always take EDURANT® with a meal. Taking EDURANT® with a meal is important to help get the right amount of medicine in your body. A protein drink alone does not replace a meal
  • Do not change your dose or stop taking EDURANT® without first talking with your doctor. See your doctor regularly while taking EDURANT®
  • When your supply of EDURANT® starts to run low, get more from your doctor or pharmacy. It is important not to run out of EDURANT®. The amount of HIV in your blood may increase if the medicine is stopped even for a short time
  • If you miss a dose of EDURANT® within 12 hours of the time you usually take it, take your dose of EDURANT® with a meal as soon as possible. Then, take your next dose of EDURANT® at the regularly scheduled time. If you miss a dose of EDURANT® by more than 12 hours of the time you usually take it, wait and then take the next dose of EDURANT® at the regularly scheduled time
  • Do not take more than your prescribed dose to make up for a missed dose
  • If you take too much EDURANT®, go to your local emergency room right away

Do not stop taking EDURANT® or any other medicines without first talking to your healthcare professional. These are not all of the possible side effects with EDURANT®. For more information, ask your doctor or pharmacist.

What should I do if I have side effects?

Tell your doctor if you have any side effect that bothers you or does not go away.

These are not all of the possible side effects with EDURANT®. For more information, ask your doctor or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1‐800‐FDA‐1088. You may also report side effects to Janssen Pharmaceuticals, Inc., at 1-800-JANSSEN (1-800-526-7738).

What if I want to become pregnant?

There is a pregnancy registry for women who take antiviral medicines during pregnancy. The purpose of this registry is to collect information about the health of you and your baby. Talk to your doctor about how you can take part in this registry.

Before taking EDURANT®, tell your doctor if you:

  • Are breastfeeding or plan to breastfeed. You should not breastfeed if you have HIV because of the risk of passing HIV to your baby. Do not breastfeed if you take EDURANT®. We do not know if EDURANT® can be passed to your baby in your breast milk and whether it could harm your baby. Talk with your doctor about the best way to feed your baby

How can I remember to take my medicine?

  • Connect your pills with something you do every day. EDURANT® must be taken with a meal, so plan to take it with breakfast, lunch, or dinner every day
  • Keep your pills in a pillbox and carry them with you when you go out. This way, wherever you are, you’ll always have them handy
  • Use beepers, computer reminders, telephone reminders, and watches, anything that trains you to remember. Forgetting is the most common reason for missing pills
  • Place a reminder note near something you use every day—your refrigerator or television, for example. When you see your note, you’ll remember to take your medicine
  • Make an appointment with a treatment counselor for support. Talking to a professionally trained counselor can make things easier

Do not stop taking EDURANT® or any other medicines without first talking to your healthcare professional.

Where can I get additional support?

The Patient Assistance Program (PAP)

Janssen Therapeutics, the maker of EDURANT®, has a PAP that will provide HIV medicines at no cost to eligible patients. For more information, call 1‐800‐652‐6227, fax 1‐888‐526‐5168, or visit our Patient Assistance Program page.

The Patient Savings Program

This program is for eligible people with prescription coverage who pay high out–of–pocket costs for their HIV medicine. For more information, call 1‐866‐961‐7169.

The Janssen Therapeutics Line

Call 1‐866‐836‐0114, a convenient, toll–free hotline for more information about EDURANT®. Call Monday through Friday from 9 AM to 8 PM ET. You can also reach us by fax at 1‐866‐836‐0567.

Janssen Therapeutics Medical Information

Janssen Therapeutics Medical Information is committed to providing current, accurate, and unbiased medical information about our products. If you have a question regarding our products, please call us at 1‐800‐JANSSEN (1‐800‐526‐7736).

If you need to report a possible adverse event or product quality complaint, please call us immediately at 1‐800‐JANSSEN (1‐800‐526‐7736).

 

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.

039972-151112

About EDURANT®

  • EDURANT® (rilpivirine) is a prescription HIV medicine that is used with other antiretroviral medicines to treat Human Immunodeficiency Virus-1 (HIV-1)
    in patients:
    • 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.