Edurant

The recommended dose of rilpivirine is one 25 mg tablet taken once daily. This medication must be taken with a meal to allow your body to absorb as much of the medication as possible. Swallow the tablet whole with water.

Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.

It is important to take this medication exactly as prescribed by your doctor. The effectiveness of the medication depends on there being the right amount of this medication in the bloodstream.

If you miss a dose within 12 hours of the usual time you take the dose, take it as soon as possible with a meal, and then continue with your regular schedule. If you miss a dose by more than 12 hours, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.

Store this medication at room temperature, in its tightly closed, original container. Protect it from light and moisture, and keep it out of the reach of children.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

Each white-to-off-white, film-coated, round, biconvex tablet, engraved with "TMC" on one side and "25" on the other side, contains 25 mg of rilpivirine as rilpivirine hydrochloride. *Nonmedicinal ingredients: *croscarmellose sodium, magnesium stearate, lactose monohydrate, povidone K30, polysorbate 20, and silicified microcrystalline cellulose; tablet coating: hypromellose 2910 6 mPa.s, lactose monohydrate, polyethylene glycol 3000, titanium dioxide, and triacetin.

Do not take this medication if you:

• are allergic to rilpivirine or any ingredients of this medication

• are taking any of the following medications:

  • carbamazepine

  • dexamethasone (more than one dose)

  • oxcarbazepine

  • phenobarbital

  • phenytoin

  • proton pump inhibitors (esomeprazole, lansoprazole, omeprazole, pantoprazole, rabeprazole)

  • rifampin

  • St. John's wort

Do not give this medication to children under 12 years of age.

Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.

The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.

The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

• decreased appetite

• diarrhea

• dizziness

• drowsiness

• fatigue

• headache

• nausea

• stomach pain

• trouble sleeping

• unusual dreams

• vomiting

Although most of the side effects listed below don't happen very often, they could lead to serious problems if you do not seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

• signs of depression (e.g., poor concentration, changes in weight, changes in sleep, decreased interest in activities, thoughts of suicide)

• skin rash

• symptoms of immune system changes (e.g., fever, joint or muscle pain; redness; rash; swelling; or fatigue)

• symptoms of liver problems (e.g., abdominal pain, persistent vomiting, feeling unwell, fever, itching, yellowing of the skin and eyes, dark urine)

Seek immediate medical attention if any of the following occur:

• signs of a serious allergic reaction (e.g., abdominal cramps, difficulty breathing, nausea and vomiting, or swelling of the face and throat)

• signs of a severe skin reaction such as blistering, peeling, a rash covering a large area of the body, a rash that spreads quickly, or a rash combined with fever or discomfort

• symptoms of heart rhythm disturbance, such as abnormal heart rhythms (e.g., fast or slow heart rate, palpitations), fainting, or seizures

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.

Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.

Abnormal heart rhythms: This medication can cause abnormal heart rhythms. Certain medications (e.g., sotalol, thioridazine, chlorpromazine, pimozide, gatifloxacin, moxifloxacin, mefloquine, tacrolimus) can increase the risk of a type of abnormal heart rhythm called QT prolongation, and should not be used in combination with rilpivirine.

If you have heart disease and abnormal heart rhythms, or are taking certain medications that can affect heart rhythm, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

**Cholesterol: **Rilpivirine can cause increases in cholesterol and other lipids in the blood. If you are already at an increased risk of developing high cholesterol, for example if you have a family history of high cholesterol, diabetes, are overweight, or have an increased alcohol intake, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Depression: Antiretroviral medications have been known to cause mood swings and symptoms of depression. If you have depression or a history of depression, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

If you experience symptoms of depression such as poor concentration, changes in weight, changes in sleep, decreased interest in activities, or notice them in a family member who is taking this medication contact your doctor as soon as possible.

Diabetes: Rilpivirine may cause an increase in blood sugar levels (may cause a loss of blood glucose control) and glucose tolerance may change. ****People with diabetes may find it necessary to monitor their blood sugar more frequently while using this medication.

If you have diabetes or are at risk for developing diabetes, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

**Galactose intolerance: **Rilpivirine contains lactose. If you have hereditary galactose intolerance you should not take this medication.

Hypersensitivity syndrome: A severe allergic reaction called hypersensitivity syndrome can occur with the use of rilpivirine. This reaction involves a number of organs in the body and may be fatal if not treated quickly. Stop taking the medication and get immediate medical attention if you have symptoms of a severe allergic reaction, including fever, swollen glands, yellowing of the skin or eyes, or flu-like symptoms with skin rash or blistering.

Immune reconstitution inflammatory syndrome: This medication may cause immune reconstitution syndrome, where signs and symptoms of inflammation from previous infections appear. These symptoms occur soon after starting anti-HIV medication and can vary. They are thought to occur as a result of the immune system improving and being able to fight infections that have been present without symptoms (such as pneumonia, herpes or tuberculosis). Report any new symptoms to your doctor immediately.

Kidney function: If you have reduced kidney function, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

**Liver function: **Rilpivirine is largely removed from the body by the liver and may cause liver problems. Decreased liver function may cause this medication to build up in the body, causing increased side effects. People with hepatitis B or C may be at increased risk for liver problems. If you have liver disease or decreased liver function, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

This medication should not be used by people with severely reduced liver function.

If you experience symptoms of liver problems (e.g., abdominal pain, persistent vomiting, feeling unwell, fever, itching, yellowing of the skin and eyes, dark urine), contact your doctor immediately.

Stopping the medication: If you stop taking this medication, your HIV infection could get worse. Take the medication exactly as prescribed by your doctor, and do not stop taking the medication without checking with your doctor first.

Pregnancy: This medication should not be used during pregnancy unless the benefits outweigh the risks. If you become pregnant while taking this medication, contact your doctor immediately.

Breast-feeding: It is not known if rilpivirine passes into breast milk. People who have HIV infection should not breast-feed because of the risk of passing HIV to a baby who does not have the infection.

Children: The safety and effectiveness of using this medication have not been established for children less than 12 years of age or weighing less than 35 kg.

**Seniors: **The effects of this medication on seniors have not been well studied. It is likely that people over the age of 65 will experience more side effects and should report any unusual effects to their doctor as soon as possible.

There may be an interaction between rilpivirine and any of the following:

• amiodarone

• antacids (e.g., aluminum hydroxide, calcium carbonate, magnesium hydroxide, sodium bicarbonate)

• certain antipsychotics (e.g., chlorpromazine, haloperidol, ziprasidone)

• apalutamide

• "azole" antifungals (e.g., itraconazole, ketoconazole, voriconazole)

• bosentan

• cobicistat

• dexamethasone

• disopyramide

• domperidone

• dronedarone

• elagolix

• enzalutamide

• ergonovine

• grapefruit or grapefruit juice

• H2 antagonists (e.g., cimetidine, famotidine, nizatidine, ranitidine)

• other HIV non-nucleoside reverse transcriptase inhibitors (NNRTIs; e.g., doravirine, efavirenz, etravirine, nevirapine)

• HIV protease inhibitors (e.g., atazanavir, darunavir, lopinavir, ritonavir)

• lumacaftor and ivacaftor

• macrolide antibiotics (e.g., clarithromycin, erythromycin)

• methadone

• mifepristone

• mitotane

• modafinil

• nirmatrelvir and ritonavir

• orlistat

• phenobarbital

• procainamide

• protein kinase inhibitors (e.g., dabrafenib, lenvatinib, tucatinib)

• proton pump inhibitors (e.g., esomeprazole, lansoprazole, omeprazole, pantoprazole, rabeprazole)

• rifabutin

• rifampin

• St. John's wort

• seizure medications (e.g., carbamazepine, phenobarbital, phenytoin, oxcarbazepine)

• sotalol

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

• stop taking one of the medications,

• change one of the medications to another,

• change how you are taking one or both of the medications, or

• leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with this medication. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

All material copyright MediResource Inc. 1996 – 2024. Terms and conditions of use. The contents herein are for informational purposes only. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition. Source: www.medbroadcast.com/drug/getdrug/Edurant