Edurant

Generic name: rilpivirine
Drug class: NNRTIs

Medically reviewed by A Ras MD.

What is Edurant?

Edurant is a prescription medicine that is used to treat HIV infection.

Description

EDURANT® (rilpivirine) is a non-nucleoside reverse transcriptase inhibitor (NNRTI) of human immunodeficiency virus type 1 (HIV-1). EDURANT is available as a white to off-white, film-coated, round, biconvex, 6.4 mm tablet for oral administration. Each tablet contains 27.5 mg of rilpivirine hydrochloride, which is equivalent to 25 mg of rilpivirine.

The chemical name for rilpivirine hydrochloride is 4-[[4-[[4-[(E)-2-cyanoethenyl]-2,6-dimethylphenyl]amino]-2-pyrimidinyl]amino]benzonitrile monohydrochloride. Its molecular formula is C22H18N6 ∙ HCl and its molecular weight is 402.88. Rilpivirine hydrochloride has the following structural formula:

Rilpivirine hydrochloride is a white to almost white powder. Rilpivirine hydrochloride is practically insoluble in water over a wide pH range.

Each EDURANT tablet also contains the inactive ingredients croscarmellose sodium, lactose monohydrate, magnesium stearate, polysorbate 20, povidone K30 and silicified microcrystalline cellulose. The tablet coating contains hypromellose 2910 6 mPa.s, lactose monohydrate, PEG 3000, titanium dioxide and triacetin.

Before taking Edurant, tell your doctor:

For all patients taking Edurant:

If you are allergic to Edurant; any part of this medicine; or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.
If you are taking any of these drugs: Carbamazepine, delavirdine, dexamethasone, dexlansoprazole, efavirenz, esomeprazole, etravirine, lansoprazole, nevirapine, omeprazole, oxcarbazepine, pantoprazole, phenobarbital, phenytoin, rabeprazole, rifampin, rifapentine, or St. John’s wort.
If you are breast-feeding. Do not breast-feed while you take Edurant.

Children:

If your child is younger than 12 years of age. Do not give Edurant to a child younger than 12 years of age.
If your child weighs less than 77 pounds (35 kilograms).

This is not a list of all drugs or health problems that interact with this medicine.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take Edurant with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take Edurant?

Tell all of your health care providers that you take Edurant. This includes your doctors, nurses, pharmacists, and dentists.
High cholesterol has happened with Edurant. If you have questions, talk with the doctor.
Have blood work checked as you have been told by the doctor. Talk with the doctor.
This medicine is not a cure for HIV. Stay under the care of your doctor.
This medicine does not stop the spread of diseases like HIV or hepatitis that are passed through blood or having sex. Do not have any kind of sex without using a latex or polyurethane condom. Do not share needles or other things like toothbrushes or razors.
Do not take more than what your doctor told you to take. Taking more than you are told may raise your chance of very bad side effects.
Certain drugs or herbal products could cause Edurant to not work as well. Be sure your doctor and pharmacist know about all of your drugs.
Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using Edurant while you are pregnant.

How is Edurant best taken?

Use Edurant as ordered by your doctor. Read all information given to you. Follow all instructions closely.

Take Edurant at the same time of day.
Take with a meal.
Do not use a protein drink in place of a meal.
Keep taking Edurant as you have been told by your doctor or other health care provider, even if you feel well.
It is important that you do not miss or skip a dose of Edurant during treatment.
Do not take antacids within 2 hours before Edurant or 4 hours after Edurant.
Some other drugs may need to be taken at some other time than Edurant. If you take other drugs, check with your doctor or pharmacist to see if you need to take them at some other time than Edurant.

What do I do if I miss a dose?

Take a missed dose as soon as you think about it, with a meal.
If it has been 12 hours or more since the missed dose, skip the missed dose and go back to your normal time.
Do not take 2 doses at the same time or extra doses.
If you are not sure what to do if you miss a dose, call your doctor.

What are the side effects of Edurant that I need to call my doctor about immediately?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
New or worse behavior or mood changes like depression or thoughts of killing yourself.
A heartbeat that does not feel normal.
Change in body fat.
Changes in your immune system can happen when you start taking drugs to treat HIV. If you have an infection that you did not know you had, it may show up when you take Edurant. Tell your doctor right away if you have any new signs after you start Edurant, even after taking it for several months. This includes signs of infection like fever, sore throat, weakness, cough, or shortness of breath.
Very bad skin and allergic reactions have happened with Edurant. Skin reactions have happened along with fever or problems in body organs like the liver. Call your doctor right away if you have red, swollen, blistered, or peeling skin (with or without fever); red or irritated eyes; sores in your mouth, throat, nose, or eyes; trouble swallowing; or signs of liver problems like dark urine, feeling tired, not hungry, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or eyes.

What are some other side effects of Edurant?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

Headache.
Trouble sleeping.
Feeling sleepy.
Upset stomach or throwing up.
Dizziness.
Stomach pain.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

If overdose is suspected:

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

How do I store and/or throw out Edurant?

Store in the original container at room temperature.
Protect from light.
Store in a dry place. Do not store in a bathroom.
Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.

Label

PRINCIPAL DISPLAY PANEL – 25 MG TABLET BOTTLE LABEL

30 Tablets
NDC 59676-278-01
EDURANT®
(rilpivirine) tablets
25 mg
Each tablet contains 27.5 mg of rilpivirine
hydrochloride, which is equivalent to 25 mg
of rilpivirine.
ALERT: Find out about
medicines that should NOT be
taken with EDURANT® from
your healthcare provider.
Rx only