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Edurant

GENERIC NAME(S): RILPIVIRINE HCL

Uses

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. This medication is usually prescribed to people who have not taken any HIV medications before. 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, do all of the following: (1) continue to take all HIV medications exactly as prescribed by your doctor, (2) always use an effective barrier method (latex or polyurethane condoms/dental dams) during all sexual activity, and (3) 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.

How to use Edurant

Read the Patient Information Leaflet 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.

Take this medication by mouth with a meal as directed by your doctor, usually once daily. The dosage may be based on other medications you are taking. Be sure to tell your doctor and pharmacist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Medications which reduce or block stomach acid (such as proton pump inhibitors/PPIs, H2 blockers, antacids) may reduce the absorption of rilpivirine, making it 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 continue taking this medication (and other HIV medications) exactly as prescribed by your doctor. Do not take 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 and/or make the infection more difficult to treat (resistant).

Do not increase your dose or take this medication more often than prescribed. Your condition will not improve any faster, and the risk of serious side effects may increase.

This medication works best when the amount of drug in your body is kept at a constant level. Therefore, take this drug at evenly spaced intervals. To help you remember, take it at the same time each day.

Side Effects

Headache or trouble sleeping may occur. If either of these effects persists or worsens, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she 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.

Some people may experience worsening of a previous medical condition (such as an old infection) as their immune systems improve, or develop new conditions because their immune systems have become overactive. This reaction may occur at any time (soon after starting HIV treatment or many months later). Tell your doctor right away if you have any serious side effects, including: unexplained weight loss, persistent muscle aches/weakness, joint pain, numbness/tingling of the hands/feet/arms/legs, severe tiredness, vision changes, severe/persistent headaches, signs of infection (such as fever, chills, trouble breathing, cough, non-healing skin sores), signs of an overactive thyroid (such as irritability, nervousness, heat intolerance, fast/pounding/irregular heartbeat, bulging eyes, unusual growth in the neck/thyroid known as a goiter), signs of a certain nerve problem known as Guillain-Barre Syndrome (such as difficulty breathing/swallowing/moving your eyes, drooping face, paralysis, slurred speech).

Tell your doctor right away if you have any serious side effects, including: mental/mood changes (such as depression, thoughts of suicide), signs of liver problems (such as dark urine, persistent nausea, vomiting, stomach/abdominal pain, yellowing eyes/skin).

Get medical help right away if you have any very serious side effects, including: fast/irregular heartbeat, severe dizziness, fainting.

Changes in body fat may occur while you are taking this medication (for example, increased fat in the upper back and stomach areas, decreased fat in the arms and legs). The cause and long-term effects of these changes are unknown. Discuss the risks and benefits of treatment with your doctor, as well as the possible use of exercise to reduce this side effect.

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: 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.

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

Precautions

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).

Rilpivirine may cause a condition that affects the heart rhythm (QT prolongation). QT prolongation can infrequently result in serious (rarely fatal) fast/irregular heartbeat and other symptoms (such as severe dizziness, fainting) that need medical attention right away.

The risk of QT prolongation may be increased if you have certain medical conditions or are taking other drugs that may cause QT prolongation. Before using rilpivirine, tell your doctor or pharmacist of all the drugs you take and if you have any of the following conditions: certain heart problems (heart failure, slow heartbeat, QT prolongation in the EKG), family history of certain heart problems (QT prolongation in the EKG, sudden cardiac death).

Low levels of potassium or magnesium in the blood may also increase your risk of QT prolongation. This risk may increase if you use certain drugs (such as diuretics/"water pills") or if you have conditions such as severe sweating, diarrhea, or vomiting. Talk to your doctor about using rilpivirine safely.

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

Older adults may be more sensitive to the side effects of this drug, especially QT prolongation (see above).

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is unknown if this medication passes into breast milk. Because breast milk can transmit HIV, do not breast-feed.

Interactions

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 include: other HIV NNRTIs (such as efavirenz, nevirapine, delavirdine), 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), among others.

Overdose

If overdose is suspected, contact a poison control center or emergency room immediately. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: fast/irregular heartbeat, severe dizziness, fainting.

Notes

Do not share this medication with others.

Laboratory and/or medical tests (such as viral load, T-cell counts, liver function tests) should be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.

Keep all medical and laboratory appointments.

Missed Dose

If you miss a dose and it is within 12 hours of the time you usually take the dose, take it with a meal as soon as you remember. If it is more than 12 hours from the time you usually take the dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

Storage

Store at room temperature away from light and moisture. Store this drug in its original bottle. 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.

Information last revised May 2014. Copyright(c) 2014 First Databank, Inc.

Images

EDURANT 25 MG TABLET
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color
white
shape
round
imprint
TMC, 25
EDURANT 25 MG TABLET

Identification

color
white
shape
round
imprint
TMC, 25
This medicine is a white, round, film-coated tablet imprinted with "TMC" and "25".

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Selected from data included with permission and copyrighted by First Databank, Inc. This copyrighted material has been downloaded from a licensed data provider and is not for distribution, expect as may be authorized by the applicable terms of use.

CONDITIONS OF USE: The information in this database is intended to supplement, not substitute for, the expertise and judgment of healthcare professionals. The information is not intended to cover all possible uses, directions, precautions, drug interactions or adverse effects, nor should it be construed to indicate that use of a particular drug is safe, appropriate or effective for you or anyone else. A healthcare professional should be consulted before taking any drug, changing any diet or commencing or discontinuing any course of treatment.

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