Importance of Maintaining HIV Drug Treatment – EDURANT® (rilpivirine) tablets

Keeping Up With Your HIV Treatment

When you decide with your healthcare professional that you should take HIV medicines, it is very important that you take the medicines according to your healthcare professional’s directions, including:

  • What time your medication should be taken
  • Whether it should be taken with food or on an empty stomach
  • If you should avoid taking it with other medicines

Taking medicines correctly can have a significant impact on how well your HIV medicines work. When a dose of medicine is skipped, it gives the virus the opportunity to copy itself and spread more rapidly (increasing the viral load). Keeping the viral load as low as possible may help slow the progression of HIV. Missing doses could also lead to resistance. This is when HIV mutates or changes and stops responding to the medicine.

Follow your healthcare professional’s instructions carefully. Staying on your HIV treatment as directed can help you get the most out of your HIV therapy. Sometimes a busy schedule and other things on your mind can make it hard to remember to take your medicine. These suggestions may help:

  • Connect your pills with something you do 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 your medicines without first talking to your healthcare professional.

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 adults:
    • 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 18 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 and talk to your healthcare professional to learn if EDURANT® is right for you.

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:

  • 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 negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

Please see accompanying full Product Information for more details.