Edurant is an antiviral medicine that prevents human immunodeficiency virus (HIV) from multiplying in your body.

Edurant is used in combination with other antiviral medicines to treat HIV. Edurant is for use in adults and children at least 12 years old who weigh at least 77 pounds (35 kilograms) who have never before taken an HIV medicine and who have an amount of HIV-1 in their blood (this is called 'viral load') that is no more than 100,000 copies/mL. Edurant is not a cure for HIV or AIDS..

Edurant is sometimes used with a medicine called cabotegravir as a daily "lead-in dose" to help determine that you can safely use a combination form of these medicines given as a monthly injection. Edurant and cabotegravir may also be given short-term in place of the monthly injectable combination for up to 2 months. When used with cabotegravir for these purposes, Edurant is only for adults with HIV who have already used other antiviral medicines that have controlled their viral load.

Before you take Edurant, tell your doctor if you have liver disease (including hepatitis B or C), kidney disease, a history of depression or mental illness, or if you have ever taken any HIV medication in the past.

Some medicines can interact with rilpivirine and should not be used at the same time. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.

Do not take Edurant as your only HIV medication. Rilpivirine must be used in combination with other HIV medicines that your doctor has prescribed.

Call your doctor at once if you have mood changes, anxiety, severe depression, feeling hopeless, or thoughts about suicide or hurting yourself.

Taking this medication will not prevent you from passing HIV to other people.

Before taking this medicine

You should not use Edurant if you are allergic to rilpivirine.

Some medicines can cause unwanted or dangerous effects when used with Edurant. Your doctor may change your treatment plan if you also use:

• carbamazepine, oxcarbazepine, phenobarbital, phenytoin;

• rifampin, rifapentine;

• esomeprazole, lansoprazole, omeprazole, pantoprazole, rabeprazole;

• St John's wort; or

• more than one dose of dexamethasone.

Tell your doctor if you have ever had:

• a serious skin rash or allergic reaction after taking a medcine that contains rilpivirine;

• p>liver disease (rilpivirine can cause hepatitis B or C to come back or get worse);

• kidney disease; or

• depression or mental illness.

Tell your doctor if you are pregnant, and use your medications properly to control your infection. HIV can be passed to your baby if the virus is not controlled during pregnancy. Your name may be listed on a registry to track any effects of antiviral medicine on the baby.

Women with HIV or AIDS should not breastfeed a baby. Even if your baby is born without HIV, the virus may be passed to the baby in your breast milk.

Edurant is not approved for use by anyone younger than 12 years old or weighing less than 77 pounds (35 kilograms).

Take Edurant exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Edurant is usually taken once per day with a full meal (not just a protein drink). Always take the medicine with food.

When given together, Edurant and cabotegravir are usually taken once per day starting at least 28 days before you switch to the monthly injectable combination. On the last day you take Edurant and cabotegravir, you will receive your first monthly injectable dose of these medicines.

If you take Edurant with cabotegravir to replace a missed dose of the injectable combination, take Edurant and cabotegravir tablets each day until your next monthly injection is due.

If you plan to miss a monthly injection by more than 7 days, start taking Edurant and cabotegravir tablets about 1 month after your last injection was given. Keep taking the tablets each day until your next monthly injection is due

If needed, daily Edurant and cabotegravir tablets can replace the injectable combination for up to 2 months in a row.

You may need frequent medical tests while taking this medicine, and for several months after your last dose.

Use all HIV medications as directed and read all medication guides you receive. Do not change your dose or stop using a medicine without your doctor's advice. Every person with HIV should remain under the care of a doctor.

Store in the original container at room temperature away from moisture, heat, and light.

Usual Adult Dose for HIV Infection:

25 mg orally once a day

Comments (for Treatment of HIV-1 in Combination with Cabotegravir):
-The manufacturer product information for cabotegravir-rilpivirine IM should be consulted before starting this drug to ensure therapy with cabotegravir-rilpivirine IM is appropriate.
-This drug should be taken with cabotegravir tablets (30 mg orally once a day) at about the same time each day with a meal; the manufacturer product information for cabotegravir tablets should be consulted.
-To assess tolerability of this drug, oral lead-in should be used for about 1 month (at least 28 days) before the initiation of cabotegravir-rilpivirine IM.
-The final oral dose should be administered on the same day injections with cabotegravir-rilpivirine are started.
-If a patient plans to miss a scheduled cabotegravir-rilpivirine injection visit by more than 7 days, daily oral therapy may be used to replace up to 2 consecutive monthly injection visits; the first dose of oral therapy should be administered about 1 month after the last injection dose of cabotegravir-rilpivirine IM and continued until the day injection dosing is restarted. The manufacturer product information for cabotegravir-rilpivirine IM should be consulted to resume monthly injection dosing.

Uses:
-In combination with other antiretroviral agents, for the treatment of HIV-1 infection in antiretroviral therapy-naive patients with plasma HIV-1 RNA up to 100,000 copies/mL at the start of therapy
-In combination with cabotegravir tablets, for short-term treatment of HIV-1 infection in patients who are virologically suppressed (HIV-1 RNA less than 50 copies/mL) on a stable antiretroviral regimen with no history of treatment failure and with no known/suspected resistance to either cabotegravir or rilpivirine, for use as:
---Oral lead-in to assess tolerability of this drug before starting rilpivirine IM (a component of cabotegravir-rilpivirine IM)
---Oral therapy for patients who will miss planned injection dosing with cabotegravir-rilpivirine IM

Usual Pediatric Dose for HIV Infection:

12 years or older, weighing at least 35 kg: 25 mg orally once a day

Use: In combination with other antiretroviral agents, for the treatment of HIV-1 infection in antiretroviral therapy-naive patients with plasma HIV-1 RNA up to 100,000 copies/mL at the start of therapy

You should not use Edurant if you are allergic to rilpivirine.

Some medicines can cause unwanted or dangerous effects when used with Edurant. Your doctor may change your treatment plan if you also use:

• carbamazepine, oxcarbazepine, phenobarbital, phenytoin;

• rifampin, rifapentine;

• esomeprazole, lansoprazole, omeprazole, pantoprazole, rabeprazole;

• St John's wort; or

• more than one dose of dexamethasone.

Tell your doctor if you have ever had:

• a serious skin rash or allergic reaction after taking a medcine that contains rilpivirine;

• p>liver disease (rilpivirine can cause hepatitis B or C to come back or get worse);

• kidney disease; or

• depression or mental illness.

Tell your doctor if you are pregnant, and use your medications properly to control your infection. HIV can be passed to your baby if the virus is not controlled during pregnancy. Your name may be listed on a registry to track any effects of antiviral medicine on the baby.

Women with HIV or AIDS should not breastfeed a baby. Even if your baby is born without HIV, the virus may be passed to the baby in your breast milk.

Edurant is not approved for use by anyone younger than 12 years old or weighing less than 77 pounds (35 kilograms).

Take the medicine with food as soon as you can, but skip the missed dose if you are more than 12 hours late for the dose. Do not use two doses at one time.

Get your prescription refilled before you run out of medicine completely.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Using this medicine will not prevent your disease from spreading. Do not have unprotected sex or share razors or toothbrushes. Ask your doctor how to prevent HIV transmission during sex. Sharing drug or medicine needles is never safe.

Get emergency medical help if you have signs of an allergic reaction to Edurant (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning in your eyes, skin pain, red or purple skin rash that spreads and causes blistering and peeling).

Seek medical treatment if you have a serious drug reaction that can affect many parts of your body. Symptoms may include: skin rash, fever, swollen glands, flu-like symptoms, muscle aches, severe weakness, unusual bruising, or yellowing of your skin or eyes.

Call your doctor at once if you have:

• mood changes, anxiety, feeling sad or hopeless, thoughts about suicide or hurting yourself;

• liver problems - right-sided upper stomach pain, dark urine, jaundice (yellowing of the skin or eyes); or

• symptoms of depression - mood changes, feelings of low self-worth, loss of interest in things you once enjoyed, new sleep problems, thoughts about hurting yourself.

Edurant affects your immune system, which may cause certain side effects (even weeks or months after you've taken this medicine). Tell your doctor if you have:

• signs of a new infection - fever, night sweats, swollen glands, cold sores, cough, wheezing, diarrhea, weight loss;

• trouble speaking or swallowing, problems with balance or eye movement, weakness or prickly feeling; or

• swelling in your neck or throat (enlarged thyroid), menstrual changes, impotence.

Common Edurant side effects may include:

• sleep problems (insomnia);

• depression;

• skin rash;

• headache; or

• changes in the shape or location of body fat (especially in your arms, legs, face, neck, breasts, and waist).

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Some medicines can make Edurant much less effective when taken at the same time. If you take any of the following medicines, take them separately from your dose of Edurant:

• An antacid or didanosine (Videx EC): take either of these medicines at least 2 hours before or 4 hours after you take rilpivirine.

• A stomach acid reducer (such as cimetidine, nizatidine, ranitidine, Pepcid, Tagamet, Zantac): take it at least 12 hours before or 4 hours after you take rilpivirine.

Edurant can cause a serious heart problem. Your risk may be higher if you also use certain other medicines for infections, asthma, heart problems, high blood pressure, depression, mental illness, cancer, malaria, or HIV.

Many drugs can interact with rilpivirine, and some drugs should not be used at the same time. Tell your doctor about all your current medicines and any medicine you start or stop using. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here.