Edurant Ped 2.5 mg tablet for oral suspension

Generic name:
Rilpivirine tablet - for oral suspension

Pronunciation
(RIL-pi-VIR-een)

Brand name(s)
Edurant Ped

Rilpivirine is used with other HIV medications to help control HIV infection. It helps to decrease the amount of HIV in your body so your immune system can work better. This lowers your chance of getting HIV complications (such as new infections, cancer) and improves your quality of life. Rilpivirine is a non-nucleoside reverse transcriptase inhibitor (NNRTI). It blocks the virus from growing and infecting more cells.

Rilpivirine is not a cure for HIV infection. To decrease your risk of spreading HIV disease to others, continue to take all HIV medications exactly as prescribed by your doctor. Use an effective barrier method (latex or polyurethane condoms/dental dams) during sexual activity as directed by your doctor. Do not share personal items (such as needles/syringes, toothbrushes, and razors) that may have contacted blood or other body fluids. Consult your doctor or pharmacist for more details.

This form of rilpivirine should only be used by children.

This section contains uses of this drug that are not listed in the approved professional labeling for the drug but that may be prescribed by your health care professional. Use this drug for a condition that is listed in this section only if it has been so prescribed by your health care professional.

This product may also be used to lessen the risk of HIV infection after contact with the virus (for example, due to a needle stick). Ask your doctor for more details.

Read the Patient Information Leaflet and Instructions for Use if available from your pharmacist before you start using rilpivirine and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

Do not change dosage forms of this medication without checking with your doctor or pharmacist.

Take this medication by mouth with a meal as directed by your doctor, usually once daily. The dosage is based on weight.

Carefully remove the tablets from the blister pack. Do not push the tablets through the foil. Do not chew, crush, or swallow the tablets whole. Place the tablets in a cup and add one teaspoon (5 milliliters) of room temperature water to the cup. Swirl the cup for 1 to 2 minutes to dissolve the tablets. Take the mixture right away. To help with taking the mixture, you may also add another teaspoon (5 milliliters) of liquid (such as water, milk, orange juice) or apple sauce as directed before taking. If there is any medicine left in the cup after taking the mixture, add another teaspoon (5 milliliters) of water or other liquid to the cup, swirl, and drink the mixture right away. Prepared medication that is not used right away should be thrown away and a new dose should be prepared.

Medications that reduce stomach acid (such as antacids, proton pump inhibitors/PPIs, H2 blockers) may make rilpivirine work less well. Do not take PPIs (such as omeprazole, lansoprazole) while using this medication. If you take antacids, take the antacids at least 2 hours before or at least 4 hours after rilpivirine. If you take H2 blockers (such as famotidine, ranitidine), take them at least 12 hours before or at least 4 hours after rilpivirine.

It is very important to keep taking this medication (and other HIV medications) exactly as prescribed by your doctor. Do not skip any doses.

For the best effect, take this medication at evenly spaced times. To help you remember, take this medication at the same time every day.

Do not take more or less of this drug than prescribed or stop taking it (or other HIV medicines) even for a short time unless directed to do so by your doctor. Doing so may cause the amount of virus to increase, make the infection more difficult to treat (resistant), or worsen side effects.

Headache or trouble sleeping may occur. If either of these effects lasts or gets worse, tell your doctor or pharmacist promptly.

Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

As your immune system gets stronger, it can begin to fight off infections you already had, possibly causing disease symptoms to come back. You could also have symptoms if your immune system becomes overactive. This reaction may happen at any time (soon after starting HIV treatment or many months later). Tell your doctor right away if you have any serious symptoms, including:

• unexplained weight loss
• severe tiredness
• muscle aches/weakness that doesn't go away
• headaches that are severe or don't go away
• joint pain
• numbness/tingling of the hands/feet/arms/legs
• vision changes
• signs of infection (such as sore throat that doesn't go away, fever, chills, non-healing skin sores)
• signs of an overactive thyroid (such as irritability, nervousness, heat intolerance, fast/pounding/irregular heartbeat)
• signs of liver disease (such as nausea/vomiting that doesn't stop, loss of appetite, stomach/abdominal pain, yellowing eyes/skin, dark urine)

Tell your doctor right away if you have any serious side effects, including:

• mental/mood changes (such as depression, thoughts of suicide)

Rilpivirine can commonly cause a rash that is usually not serious. However, you may not be able to tell it apart from a rare rash that could be a sign of a severe reaction. Get medical help right away if you develop any rash.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including:

• swollen lymph nodes
• rash
• itching/swelling (especially of the face/tongue/throat)
• severe dizziness
• trouble breathing

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Before taking rilpivirine, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of:

• kidney disease
• liver disease (such as hepatitis B, hepatitis C)
• mental/mood disorders (such as depression)

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Tell your doctor if you are pregnant before using this medication. Treatment can lower the risk of passing HIV infection to your baby, and rilpivirine may be part of that treatment. Discuss the risks and benefits with your doctor.

This medication passes into breast milk. Because breast milk may transmit HIV, consult your doctor before breastfeeding.

See also How to Use section.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Some products that may interact with this drug are:

• orlistat
• other HIV NNRTIs (such as efavirenz, nevirapine)
• a certain combination HIV medication (elvitegravir/cobicistat/emtricitabine/tenofovir)
• proton pump inhibitors (PPIs such as esomeprazole, lansoprazole, omeprazole, pantoprazole, rabeprazole)

Other medications can affect the removal of rilpivirine from your body, which may affect how rilpivirine works. Examples include dexamethasone, macrolide antibiotics (such as erythromycin), rifamycins (such as rifampin, rifapentine), St. John's wort, certain drugs used to treat seizures (such as carbamazepine, oxcarbazepine, phenobarbital, phenytoin, primidone), among others.

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call 1-800-222-1222. Canada residents can call 1-844-764-7669. Symptoms of overdose may include: fast/irregular heartbeat, severe dizziness, fainting.

Do not share this medication with others.

Lab and/or medical tests (such as viral load, T-cell counts, liver function) should be done before you start taking this medication and while you are taking it. Keep all medical and lab appointments. Consult your doctor for more details.

If you miss a dose, take it with a meal as soon as you remember. If it is more than 12 hours after the missed dose, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up.

Store at room temperature away from light and moisture. Keep the medication in the original blister pack until ready to use. Do not store in the bathroom. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.