Rilpivirine Tablets

What is this medication?

RILPIVIRINE (RIL pi VIR een) helps manage the symptoms of HIV infection. It works by limiting the spread of HIV in the body. This medication is not a cure for HIV or AIDS and it may still be possible to spread HIV to others while taking it. It does not prevent other sexually transmitted infections (STIs).

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): EDURANT

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• Heart disease
• Kidney disease
• Liver disease
• Mental health condition
• An unusual or allergic reaction to rilpivirine, other medications, foods, dyes, or preservatives
• Pregnant or trying to get pregnant
• Breast-feeding

How should I use this medication?

Take this medication by mouth with water. Take it with food at the start of a meal. For your therapy to work as well as possible, take each dose exactly as prescribed on the prescription label. Do not skip doses. Skipping doses can make the virus resistant to this and other medications. Keep taking this therapy unless your care team tells you to stop.

Take antacids or other products that contain aluminum, calcium carbonate, or magnesium hydroxide in them at a different time of day than this medication. Take these products 2 hours BEFORE or 4 hours AFTER this medication.

Take H2-receptor antagonists (famotidine, cimetidine, nizatidine, or ranitidine) at a different time of day than this medication. Take these products 12 hours BEFORE or 4 hours AFTER this medication.

Talk to your care team about the use of this medication in children. While it may be prescribed to children as young as 12 years for selected conditions, precautions do apply.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose and it is within 12 hours of the time you normally take it, take your dose with food as soon as possible. Then take your next dose at the regularly scheduled time. If you miss a dose by more than 12 hours of the time you normally take it, wait and then take the next dose at the regularly scheduled time. Do not take double or extra doses.

What may interact with this medication?

Do not take this medication with any of the following:

• Certain medications for fungal infections like fluconazole, itraconazole, ketoconazole, posaconazole, voriconazole
• Certain medications for seizures like carbamazepine, oxcarbazepine, phenobarbital, phenytoin
• Certain medications for stomach problems like esomeprazole, pantoprazole, omeprazole, lansoprazole, rabeprazole
• Cisapride
• Dexamethasone (more than 1 dose)
• Dronedarone
• Lumacaftor; ivacaftor
• Pimozide
• Rifampin
• Rifapentine
• St. John's Wort
• Thioridazine

This medication may also interact with the following:

• Certain antibiotics like clarithromycin, erythromycin, troleandomycin, rifabutin
• Certain medications for stomach problems like aluminum hydroxide, magnesium hydroxide, calcium carbonate, cimetidine, famotidine, nizatidine, ranitidine
• Methadone
• Other antiviral medications for HIV
• Other medications that cause heart rhythm changes

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Visit your care team for regular checks on your progress. Discuss any new symptoms with your care team.

You may need bloodwork while taking this medication.

HIV is spread to others through sexual or blood contact. Talk to your care team about how to stop the spread of HIV.

This medication may cause serious skin reactions. They can happen weeks to months after starting the medication. Contact your care team right away if you notice fevers or flu-like symptoms with a rash. The rash may be red or purple and then turn into blisters or peeling of the skin. You may also notice a red rash with swelling of the face, lips, or lymph nodes in your neck or under your arms.

What side effects may I notice from receiving this medication?

Side effects that you should report to your care team as soon as possible:

• Allergic reactions or angioedema—skin rash, itching or hives, swelling of the face, eyes, lips, tongue, arms, or legs, trouble swallowing or breathing
• Liver injury—right upper belly pain, loss of appetite, nausea, light-colored stool, dark yellow or brown urine, yellowing skin or eyes, unusual weakness or fatigue
• Redness, blistering, peeling, or loosening of the skin, including inside the mouth
• Thoughts of suicide or self-harm, worsening mood, feelings of depression

Side effects that usually do not require medical attention (report to your care team if they continue or are bothersome):

• Headache
• Trouble sleeping

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medication?

Keep out of the reach of children and pets.

Store at room temperature between 20 and 25 degrees C (68 and 77 degrees F). Keep this medication in the original container to protect from light. Get rid of any unused medication after the expiration date.

To get rid of medications that are no longer needed or have expired:

• Take the medication to a medication take-back program. Check with your pharmacy or law enforcement to find a location.
• If you cannot return the medication, check the label or package insert to see if the medication should be thrown out in the garbage or flushed down the toilet. If you are not sure, ask your care team. If it is safe to put it in the trash, pour the medication out of the container. Mix the medication with cat litter, dirt, coffee grounds, or other unwanted substance. Seal the mixture in a bag or container. Put it in the trash.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.