Edurant

(Rilpivirine Hydrochloride)

The active ingredient in Edurant is rilpivirine hydrochloride. It is an antiretroviral agent used to help control HIV-1 infection when combined with other HIV medicines.

Specifically, it is a non-nucleoside reverse transcriptase inhibitor (NNRTI) that blocks the HIV reverse transcriptase enzyme. By inhibiting this enzyme, Edurant prevents the virus from converting its RNA into DNA, a crucial step needed for HIV to replicate inside human cells, helping reduce viral load and slow disease progression.

Follow all directions given to you by your doctor and read all documents provided, including the full Prescribing Information, FDA-Approved Product Labeling, Instructions for Use, and Medication Guide before using Edurant. However, the following is a synopsis of the general guidelines for the use of Edurant:

• Edurant is taken by mouth as a tablet.
• It must be taken once daily with a meal to ensure proper absorption.
• Taking Edurant on an empty stomach can lower the amount of medicine absorbed and increase the risk of virologic failure.
• Swallow the tablet whole with water. Do not crush, chew, or split the tablet.
• Edurant should always be taken with other antiviral medicines as part of combination therapy.
• Try to take Edurant at the same time each day to maintain consistent drug levels.
• Edurant can also be used for short-term treatment with cabotegravir (Vocabria) before starting a monthly injectable combination of these medicines (Cabenuva).
• Your healthcare provider will monitor your viral load, immune system response, and liver enzymes through regular blood tests while you are taking Edurant.

Some mild or common side effects of Edurant seen in clinical trials include:

• Increased liver enzyme, cholesterol, and creatine levels.
• Headache.
• Depression.
• Trouble sleeping or insomnia.
• Dizziness.
• Nausea.
• Skin rash.
• Fatigue.

Some individuals may experience serious side effects while using Edurant. These side effects may require immediate medical attention. If you experience any of the following, contact your healthcare provider or seek emergency medical help:

• Severe depressive disorders, including feelings of sadness, hopelessness, or thoughts of self-harm.
• Severe skin reactions or allergic reaction symptoms such as swelling of the face, lips, or throat, or trouble breathing.
• Liver problems, which may present as yellowing of the skin or eyes, dark urine, abdominal pain, or unusual tiredness.
• Changes in heart rhythm, especially in people taking interacting medicines.

These are not all of the possible side effects of Edurant. You should always seek medical advice from your healthcare provider for any questions or concerns about your medical condition or treatment. Read all patient information, medication guides, or drug information sheets that come with this medication. You can also report adverse effects to the Food and Drug Administration at www.fda.gov/medwatch or 1-800-FDA-1088.

Before starting Edurant, it is crucial to discuss any existing health conditions with your healthcare provider. You should be sure that your healthcare provider is aware of all your medical conditions, including:

• Liver disease, including hepatitis B or hepatitis C.
• A history of depressive disorders or other mental health conditions.
• Heart rhythm problems or a history of QT prolongation.
• Low stomach acid or conditions that require acid-reducing medicines.
• Any allergies to rilpivirine or other ingredients in Edurant.

Edurant must be taken with food and should not be combined with certain medications that significantly reduce stomach acid, as this can lower drug levels and increase the risk of treatment failure.

Edurant should not be used in patients taking certain medications that strongly affect drug levels or stomach acid, including specific proton pump inhibitors and seizure medications. It is also contraindicated in patients with known hypersensitivity to rilpivirine or any component of the formulation.

Edurant begins working after the first dose, but it may take several weeks to see a significant reduction in HIV-1 RNA levels. Viral load testing is used to measure response to treatment. Consistent daily use is essential to maintain viral suppression and protect the immune system.

When Edurant is taken with other prescription drugs, over-the-counter medications, vitamins, and supplements, it may change how they work or increase the frequency or severity of side effects. Make sure that you tell your healthcare professional about anything that you are taking to avoid any negative drug interactions, including:

• Proton pump inhibitors such as omeprazole, esomeprazole, lansoprazole, pantoprazole, and rabeprazole significantly reduce Edurant absorption.
• Certain seizure medicines, such as carbamazepine, phenytoin, phenobarbital, and oxcarbazepine, can lower rilpivirine levels.
• Rifampin, rifapentine, and rifabutin, which can reduce the effectiveness of Edurant.
• St. John’s wort and other herbal products containing hypericum perforatum, which may cause virologic failure.
• H2-receptor antagonists such as famotidine, ranitidine, cimetidine, and nizatidine, which must be taken at specific times if used together.
• Antacids containing magnesium hydroxide or aluminum, which should be spaced apart from Edurant doses.
• Certain antibiotics, such as clarithromycin or erythromycin, may affect rilpivirine levels.
• Methadone, which may require monitoring for dose adjustments.
• Dexamethasone (more than a single dose).
• Other combination medications that contain rilpivirine, like Complera (emtricitabine, rilpivirine, and tenofovir)
• Efavirenz.

Edurant tablets are available as 25 mg tablets. The usual recommended dose for adults and adolescents who meet treatment criteria is one 25 mg tablet taken once daily with a meal, in combination with other antiretroviral agents.

It should be stored at room temperature, away from the reach of children or pets.

Edurant is manufactured by Janssen Pharmaceuticals.

At this time, Edurant is available as a brand-name medication.

Do not stop taking Edurant without first speaking to your healthcare provider. Stopping HIV medicines suddenly can cause an increase in viral load, reduce treatment effectiveness, and increase the risk of drug resistance. Your provider will guide you if a treatment change is needed.

Talk to your doctor if you are already pregnant or if you have any plans to become pregnant. Edurant should only be used during pregnancy if the possible benefits outweigh the potential risks. Enrollment in a pregnancy registry may be recommended to help monitor outcomes if you take it during your pregnancy.

Talk to your doctor if you are already breastfeeding or if you have any plans to breastfeed. Breastfeeding is generally not recommended for people with HIV-1 infection because of the risk of HIV transmission through breast milk, regardless of treatment.