Rilpivirine (By mouth)

Brand Name(s)

Edurant

There may be other brand names for this medicine.

When This Medicine Should Not Be Used

You should not use this medicine if you have had an allergic reaction to rilpivirine, or if you have received other HIV medicines in the past. Do not use this medicine if you are also taking the following medicines: a seizure medicine (such as carbamazepine, oxcarbazepine, phenobarbital, phenytoin, Dilantin®, Tegretol®, or Trileptal®), medicine to treat tuberculosis (such as rifabutin, rifampin, rifapentine, Mycobutin®, Priftin®, Rifadin®, or Rimactane®), certain stomach medicine (such as esomeprazole, lansoprazole, omeprazole, pantoprazole, rabeprazole, Aciphex®, Nexium®, Prevacid®, Prilosec®, or Protonix®), a steroid medicine (such as dexamethasone, Decadron®), or St. John's wort. Using these medicines together may cause more serious side effects.

How to Use This Medicine

Tablet

• Your doctor will tell you how much of this medicine to use and how often. Do not use more medicine or use it more often than your doctor tells you to.
• It is best to take this medicine with food or milk.
• Take all other medicines your doctor prescribed as part of your combination treatment. Do not change your dose or stop using your medicine unless your doctor tells you to.
• This medicine works best if there is a constant amount in the blood. To keep blood levels constant, take this medicine at the same time each day and do not miss any doses. Also, when your supply of this medicine is running low, contact your doctor or pharmacist ahead of time. Do not allow yourself to run out of this medicine.
• This medicine comes with patient instructions. Read and follow these instructions carefully. Ask your doctor or pharmacist if you have any questions.

If a dose is missed:

• If you miss a dose or forget to use your medicine within 12 hours, take it with a meal as soon as you can. If your next regular dose is less than 12 hours away, wait until then to use the medicine and skip the missed dose. Do not use extra medicine to make up for a missed dose.

How to Store and Dispose of This Medicine

• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.
• Ask your pharmacist, doctor, or health caregiver about the best way to dispose of any outdated medicine or medicine no longer needed.
• Keep all medicine away from children and never share your medicine with anyone.

Drugs and Foods to Avoid

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Make sure your doctor knows if you are also using certain medicines to treat HIV infection such as delavirdine, efavirenz, etravirine, nevirapine, Intelence?, Rescriptor®, Sustiva®, or Viramune®, unless your doctor says it is okay.
• Tell your doctor if you are also using arsenic trioxide (Trisenox®), cisapride (Propulsid®), dofetilide (Tikosyn®), medicine for depression (such as amitriptyline, fluoxetine, nortriptyline, Elavil®, Pamelor®, Prozac®, Sarafem®, or Vivactil®), medicines to treat infection (such as clarithromycin, erythromycin, levofloxacin, moxifloxacin, sparfloxacin, troleandomycin, Avelox®, Biaxin®, Ery-Tab®, Levaquin®, Tao®, or Zagam®), or medicine to treat mental illness (such as haloperidol, mesoridazine, pimozide, prochlorperazine, quetiapine, thioridazine, ziprasidone, Compazine®, Geodon®, Haldol®, Mellaril®, Orap®, Serentil®, or Seroquel®).
• If you are taking certain stomach medicines (such as cimetidine, famotidine, nizatidine, ranitidine, Axid®, Pepcid®, Tagamet®, or Zantac®), take these medicines at least 12 hours before or at least 4 hours after taking rilpivirine.
• If you are taking aluminum, magnesium, or calcium-containing antacids or didanosine (Videx®), take these medicines on an empty stomach and at least 2 hours before or at least 4 hours after taking rilpivirine.

Introduction

Rilpivirine Hydrochloride (ril-pi-VIR-een hye-droe-KLOR-ide)

Used with other medicines to treat human immunodeficiency virus (HIV) infection in patients who have not received any HIV treatments in the past. HIV causes acquired immune deficiency syndrome (AIDS). Rilpivirine does not cure HIV or AIDS, but it may slow the worsening of the disease.

Warnings While Using This Medicine

• It is important to tell your doctor if you become pregnant. Your doctor may want you to join a pregnancy registry for patients taking this medicine.
• Make sure your doctor knows if you have kidney disease, liver disease (including hepatitis B or C), heart rhythm problems (such as QT prolongation), or a history of depression or mental problems.
• You should not breast feed if you have HIV or AIDS, because you may give the infection to your baby through your breast milk.
• This medicine will not keep you from giving HIV to your partner during sex. Make sure you understand and practice safe sex, even if your partner also has HIV. Do not share needles with anyone.
• Tell your doctor right away if you start to feel more depressed and have thoughts about hurting yourselves. Report any unusual thoughts or behaviors that trouble you, especially if they are new or get worse quickly.
• This medicine may cause you to have excess body fat. Tell your doctor if you notice changes in your body shape, such as an increased amount of fat in the upper back and neck, or around the chest and stomach area. You might also lose fat from your legs, arms, or face.
• When you start taking HIV medicines, your immune system may get stronger. If you have certain infections, such as pneumonia or tuberculosis, you may notice new symptoms when your body tries to fight them. If this occurs, be sure to tell your doctor.
• Do not change your dose or stop using this medicine without checking first with your doctor.
• Make sure any doctor or dentist who treats you knows that you are using this medicine. This medicine may affect the results of certain medical tests.
• Your doctor will need to check your progress at regular visits while you are using this medicine. Be sure to keep all appointments. Blood tests may be needed to check for unwanted effects.

Possible Side Effects While Using This Medicine

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Fast, pounding, or uneven heartbeat.
• Feeling sad or depressed, anxious, or restless.
• Trouble sleeping.
• Unusual behavior or thoughts of killing oneself.
• Unusual tiredness or weakness.
• Yellowing of your skin or the whites of your eyes.

If you notice these less serious side effects, talk with your doctor:

• Abnormal dreams.
• Diarrhea, nausea, vomiting, or stomach pain.
• Gaining weight around your neck, upper back, breast, face, or waist.
• Headache.
• Rash.

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088