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

Treats HIV infection. This medicine does not cure HIV or AIDS, but it may slow the progress of the disease.

Brand Name(s):

Edurant

When This Medicine Should Not Be Used:

How to Use This Medicine:

Liquid, Tablet

• Your doctor will tell you how much medicine to use. Do not use more than directed. Take this medicine with a meal. A protein drink alone does not replace a meal.
• Take all of the medicines your doctor has prescribed at the right time of day and in the correct order. Do not change your dose or stop using any of your medicines unless your doctor tells you to.
• Do not stop using this medicine without checking first with your doctor. If you stop the medicine even briefly, the virus may become harder to treat. Contact your doctor or pharmacist when your supply is running low so you do not run out.
• Rilpivirine contains a fixed amount of each medicine in the tablets and the tablets for suspension (oral liquid). Do not substitute these dosage forms for each other. Always check your medicine each time your prescription is filled to make sure you receive the correct dosage form.
• Oral liquid:
  • Gently peel back the foil to remove the tablet. Do not push the tablets out of the foil.
  • Place the tablets in a small cup. Do not crush it.
  • Add 5 milliliters (mL) of room temperature drinking water. Swirl the cup gently for 1 to 2 minutes to dissolve the tablet. The mixture will become cloudy.
  • Swallow the liquid right away or add another 5 mL of drinking water, milk, orange juice, or applesauce to help take the medicine. Swirl the mixture and take all the medicine right away.
  • You may add another 5 mL drinking water, milk, orange juice, or applesauce to the cup to make sure your child gets the full dose.
  • Do not swallow whole, crush, or chew the tablet for suspension.
• Read and follow the patient instructions that come with this medicine. Talk to your doctor or pharmacist if you have any questions.
• Missed dose: If it is within 12 hours of your regular time, take a dose with a meal as soon as you can. If your next dose is less than 12 hours away, wait until then and take a regular dose. Do not use extra medicine to make up for a missed dose.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.

Drugs and Foods to Avoid:

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

• Do not use this medicine if you are also using dexamethasone, St John's wort, medicine to treat tuberculosis (including rifampin, rifapentine), seizure medicine (including carbamazepine, oxcarbazepine, phenobarbital, phenytoin), or stomach medicine (including esomeprazole, lansoprazole, omeprazole, pantoprazole, rabeprazole).
• Many other drugs can affect how rilpivirine works. Tell your doctor about all other medicines you are using.
• Take didanosine on an empty stomach and at least 2 hours before or 4 hours after you take rilpivirine.
• Take antacids that contain aluminum, magnesium, or calcium at least 2 hours before or 4 hours after you take rilpivirine.
• Take medicine for heartburn or ulcers (including cimetidine, famotidine, nizatidine, ranitidine) at least 12 hours before or 4 hours after you take rilpivirine.

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant, or if you have kidney disease, liver disease (including hepatitis B or C), or a history of depression.
• Do not breastfeed. You can spread HIV or AIDS to your baby through your breast milk.
• This medicine may cause the following problems:
  • Drug reaction with eosinophilia and systemic symptoms (DRESS), which may damage organs including the liver, kidney, or heart
  • Liver problems
  • Changes in mood or behavior, including thoughts or attempts of suicide
• Your immune system may get stronger when you start using HIV medicines. This could cause a hidden infection in your body to become active. Tell your doctor right away if you notice any changes in your health.
• Always practice safe sex, even if your partner also has HIV. If you stop taking this medicine or do not take it as prescribed, you may spread HIV to others. Do not reuse or share needles, or other items, that may have blood or body fluids on them.
• Tell any doctor or dentist who treats you that you are using this medicine. This medicine may affect certain medical test results.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

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
• Blistering, peeling, red skin rash
• Dark urine or pale stools, nausea, vomiting, loss of appetite, stomach pain, yellow skin or eyes
• Depression, unusual changes in behaviors or moods, thoughts or attempts of hurting yourself
• Fever, swollen glands in your armpits, neck, or groin, mouth sores, redness or swelling around your eye

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

• Weight gain around your neck, upper back, breast, or waist

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