EDURANT (Rilpivirine)
Non-nucleoside reverse transcriptase inhibitor (NNRTI) for HIV-1 treatment
Quick Facts About EDURANT
Key Takeaways
- EDURANT (rilpivirine) is an NNRTI used in combination with other antiretroviral drugs to treat HIV-1 infection in adults and children aged 2+ years weighing at least 14 kg.
- It must always be taken with a meal to ensure proper absorption – a nutritional drink or yoghurt alone is not sufficient.
- Proton pump inhibitors (PPIs) are strictly contraindicated with EDURANT due to significant drug interaction reducing rilpivirine blood levels.
- The most common side effects include headache, nausea, insomnia, dizziness, and elevated liver enzymes or cholesterol.
- EDURANT does not cure HIV – treatment must be continued as prescribed to suppress the virus and prevent resistance.
What Is EDURANT and What Is It Used For?
EDURANT contains the active substance rilpivirine, which works by targeting and inhibiting a key enzyme called reverse transcriptase. This enzyme is essential for HIV to replicate inside human cells. By blocking reverse transcriptase, rilpivirine reduces the amount of HIV in the blood (known as the viral load), allowing the immune system to recover and function more effectively.
Rilpivirine belongs to a group of medicines called non-nucleoside reverse transcriptase inhibitors, or NNRTIs. Unlike nucleoside analogues, NNRTIs bind to a different site on the reverse transcriptase enzyme and block its activity through a non-competitive mechanism. This makes rilpivirine an important component of combination antiretroviral therapy (cART), the standard approach to HIV treatment worldwide.
EDURANT is never used on its own. It must always be combined with other HIV medicines, typically two nucleoside reverse transcriptase inhibitors (NRTIs), to form a complete treatment regimen. Your prescribing healthcare provider will determine the best combination of medicines based on your individual medical history, previous treatments, resistance profile, and overall health status.
The medication is available in two formulations. The standard film-coated tablet contains 25 mg of rilpivirine and is designed for adults and children weighing 25 kg or more. A dispersible tablet formulation containing 2.5 mg of rilpivirine is available for younger children (aged 2 years and older) weighing between 14 kg and less than 25 kg. The dispersible tablets must be dissolved in water before administration.
EDURANT was first approved by the European Medicines Agency (EMA) and has been an important option in HIV treatment guidelines published by organisations including the Department of Health and Human Services (DHHS), the European AIDS Clinical Society (EACS), and the World Health Organization (WHO). Rilpivirine is also available as a component of several fixed-dose combination tablets, making it possible to take a complete HIV regimen in a single daily pill.
What Should You Know Before Taking EDURANT?
Contraindications
EDURANT must not be used in combination with certain medicines that can significantly reduce rilpivirine blood levels, potentially leading to loss of antiviral effectiveness and the development of drug-resistant HIV. The following medicines are contraindicated with EDURANT:
- Anticonvulsants: Carbamazepine, oxcarbazepine, phenobarbital, and phenytoin (used to treat epilepsy and prevent seizures). These are potent enzyme inducers that dramatically reduce rilpivirine concentrations.
- Antimycobacterials: Rifampicin and rifapentine (used to treat certain bacterial infections including tuberculosis). These drugs are among the strongest known CYP3A4 inducers.
- Proton pump inhibitors (PPIs): Omeprazole, esomeprazole, lansoprazole, pantoprazole, and rabeprazole. PPIs reduce stomach acid, which significantly decreases rilpivirine absorption.
- Systemic corticosteroids: Dexamethasone taken orally or by injection (except as a single dose). Repeated doses can reduce rilpivirine levels through enzyme induction.
- Herbal products: St. John's wort (Hypericum perforatum), a herbal remedy used for mild depression and anxiety. It is a potent CYP3A4 inducer.
If you are currently taking any of these medicines, do not start EDURANT. Speak with your healthcare provider about alternative treatment options. If you are unsure whether any of your current medicines interact with EDURANT, consult your doctor or pharmacist before starting treatment.
Warnings and Precautions
Before starting EDURANT, inform your healthcare provider about your complete medical history. The following conditions require special attention:
- Liver disease: Tell your doctor if you have or have had liver problems, including hepatitis B and/or hepatitis C. Your doctor will assess the severity of your liver condition before deciding whether EDURANT is appropriate for you. Liver function tests should be monitored regularly during treatment.
- Kidney disease: Inform your doctor about any kidney problems, as dose adjustments or alternative treatments may be necessary.
- QT prolongation: Tell your doctor if you are taking any medicines known to cause an irregular heart rhythm known as Torsade de Pointes, as rilpivirine may have additive effects on the QT interval at supratherapeutic doses.
When HIV treatment is started, the recovering immune system may react to previously hidden infections, causing symptoms such as fever, chills, and sweating. This is known as immune reconstitution inflammatory syndrome (IRIS). It typically occurs within the first few weeks to months of treatment and is more common in patients with advanced HIV infection. Additionally, autoimmune disorders (conditions where the immune system attacks healthy tissue) may also develop after starting antiretroviral therapy, sometimes months after treatment initiation. Symptoms may include muscle weakness starting in the hands or feet, palpitations, tremor, or hyperactivity. Report any new symptoms to your healthcare provider promptly.
EDURANT is not a cure for HIV infection. It is part of a treatment regimen designed to reduce the amount of virus in the blood, but it does not eliminate HIV from the body. You must continue taking your HIV medicines exactly as prescribed, even when you feel well. Stopping treatment can lead to viral rebound and the development of drug resistance.
Pregnancy and Breastfeeding
If you are pregnant, planning to become pregnant, or think you may be pregnant, inform your healthcare provider immediately. The decision to use EDURANT during pregnancy should be made in consultation with your doctor, weighing the potential benefits of HIV treatment against any possible risks to the developing baby. Effective HIV treatment during pregnancy is critical to prevent mother-to-child transmission of the virus.
Breastfeeding is not recommended for women living with HIV, regardless of whether they are on antiretroviral therapy. HIV can be transmitted to the infant through breast milk. If you are breastfeeding or considering breastfeeding, discuss safe feeding alternatives with your healthcare provider as soon as possible.
Driving and Operating Machinery
Some patients may experience tiredness, dizziness, or drowsiness during treatment with EDURANT. If you are affected by any of these symptoms, do not drive, cycle, or operate machinery until the symptoms resolve. These effects are generally mild and tend to diminish as your body adjusts to the medication.
Use in Children
EDURANT has not been studied in children under 2 years of age or in those weighing less than 14 kg. The medicine should not be used in these patients. For children aged 2 years and older who weigh between 14 kg and less than 25 kg, the dispersible tablet formulation (2.5 mg) should be used, with dosing determined by body weight. Children weighing 25 kg or more may use the standard 25 mg film-coated tablet.
How Does EDURANT Interact with Other Drugs?
Drug interactions are a critical consideration when using EDURANT. Rilpivirine is primarily metabolised by cytochrome P450 3A (CYP3A) enzymes in the liver, and its absorption is dependent on stomach acid. Medicines that affect CYP3A activity or gastric pH can significantly alter rilpivirine blood levels, potentially compromising treatment efficacy or increasing the risk of side effects.
It is also recommended not to combine EDURANT with other NNRTIs such as delaviridine, efavirenz, etravirine, or nevirapine, as there is no expected therapeutic benefit and the risk of side effects may increase.
Major Interactions (Contraindicated)
| Medicine | Category | Reason |
|---|---|---|
| Carbamazepine, Oxcarbazepine, Phenobarbital, Phenytoin | Anticonvulsants | Strong CYP3A4 inducers – dramatically reduce rilpivirine levels |
| Rifampicin, Rifapentine | Antimycobacterials | Potent CYP3A4 inducers – reduce rilpivirine to subtherapeutic levels |
| Omeprazole, Esomeprazole, Lansoprazole, Pantoprazole, Rabeprazole | Proton pump inhibitors | Significantly decrease gastric acid – drastically reduce rilpivirine absorption |
| Dexamethasone (systemic, repeated doses) | Corticosteroid | CYP3A4 inducer – reduces rilpivirine levels (single dose is acceptable) |
| St. John's wort (Hypericum perforatum) | Herbal supplement | Potent CYP3A4 inducer – unpredictable reduction in rilpivirine levels |
Medicines Requiring Careful Timing or Monitoring
| Medicine | Category | Recommended Timing |
|---|---|---|
| Aluminium/magnesium hydroxide, Calcium carbonate | Antacids | At least 2 hours before OR at least 4 hours after EDURANT |
| Cimetidine, Famotidine, Nizatidine, Ranitidine | H2-receptor antagonists | At least 12 hours before OR at least 4 hours after EDURANT; do not use twice daily |
| Clarithromycin, Erythromycin | Macrolide antibiotics | May increase rilpivirine levels – consider alternatives such as azithromycin |
| Methadone | Opioid substitution therapy | Monitor for withdrawal symptoms; dose adjustment may be needed |
| Dabigatran etexilate | Anticoagulant | Monitor closely for signs of bleeding or reduced anticoagulant effect |
| Didanosine | NRTI (HIV treatment) | Take didanosine on an empty stomach at least 2 hours before or 4 hours after EDURANT |
Always inform your healthcare provider and pharmacist about all medicines you are taking, including prescription medicines, over-the-counter products, vitamins, supplements, and herbal products. Never start or stop a medicine while taking EDURANT without consulting your healthcare provider first, as this could lead to treatment failure or increased side effects.
What Is the Correct Dosage of EDURANT?
Always take EDURANT exactly as prescribed by your healthcare provider or pharmacist. Do not change your dose or stop taking the medicine without medical advice. Consistent daily dosing with food is critical for maintaining effective drug levels in your blood and preventing viral resistance.
Adults and Children Weighing 25 kg or More
Standard Dosage
Dose: One 25 mg film-coated tablet once daily
Administration: Swallow whole with a meal. A full meal is essential – a nutritional drink (such as a protein shake) or yoghurt alone does not replace a meal. Food significantly increases the absorption of rilpivirine, ensuring therapeutic blood levels are achieved.
Children Aged 2 Years and Older (14 kg to Less Than 25 kg)
Pediatric Dosage (Dispersible Tablets)
Formulation: 2.5 mg dispersible tablets – must be dissolved in water before taking
Dose: Determined by your child's healthcare provider based on body weight
Administration: Dissolve the prescribed number of tablets in 5 mL (1 teaspoon) of room-temperature water. Gently swirl until dissolved. Take immediately with a meal. Additional water, milk, orange juice, or applesauce may be added to help with administration.
Important: Do not substitute the 25 mg film-coated tablet with multiple dispersible tablets (e.g., do not use ten 2.5 mg dispersible tablets instead of one 25 mg tablet). Do not chew or swallow the dispersible tablets whole.
Missed Dose
If you remember within 12 hours of your usual dosing time, take the missed dose as soon as possible with a meal. Then continue with your normal schedule. If more than 12 hours have passed since your usual dosing time, skip the missed dose entirely and take your next scheduled dose with a meal as normal.
Never take a double dose to make up for a forgotten one. If you are unsure about what to do after missing a dose, contact your healthcare provider or pharmacist for guidance.
Vomiting After a Dose
If you vomit less than 4 hours after taking EDURANT, take another dose with a meal as soon as possible. If you vomit more than 4 hours after taking your dose, you do not need to take another dose until your next regularly scheduled time.
Overdose
If you take more EDURANT than prescribed, contact your healthcare provider or local poison control centre immediately. Symptoms of overdose may include headache, nausea, dizziness, and abnormal dreams. There is no specific antidote for rilpivirine overdose, and treatment is supportive.
HIV treatment does not cure HIV infection. Even if you feel well, do not stop taking EDURANT or your other HIV medicines without consulting your doctor first. Stopping treatment prematurely allows the virus to multiply rapidly and may lead to the development of drug-resistant HIV, making future treatment more difficult. If you experience side effects that concern you, speak with your healthcare provider about possible adjustments to your regimen rather than stopping on your own.
What Are the Side Effects of EDURANT?
Like all medicines, EDURANT can cause side effects, although not everyone experiences them. Most side effects associated with rilpivirine are mild to moderate in severity and tend to diminish as the body adjusts to the medication over the first few weeks of treatment. However, some side effects may require medical attention.
Very Common
May affect more than 1 in 10 people
- Headache
- Nausea
- Difficulty sleeping (insomnia)
- Dizziness
- Changes in liver enzyme levels (transaminases)
- Elevated cholesterol and/or pancreatic amylase in the blood
Common
May affect up to 1 in 10 people
- Abnormal dreams
- Rash
- Abdominal pain
- Depression
- Fatigue (feeling very tired)
- Vomiting
- Drowsiness
- Decreased appetite
- Sleep disturbances
- Stomach discomfort
- Depressed mood
- Dry mouth
- Low white blood cell count and/or platelet count
- Decreased haemoglobin
- Elevated triglycerides, lipase, and/or bilirubin in the blood
Uncommon
May affect up to 1 in 100 people
- Immune reconstitution inflammatory syndrome (IRIS) – signs or symptoms of inflammation or infection, including fever, chills, and sweating
If you experience any side effects that concern you, or if you notice any effects not listed above, contact your healthcare provider. It is particularly important to seek medical attention if you develop symptoms suggestive of a severe allergic reaction (such as facial swelling, difficulty breathing, or widespread rash), signs of liver problems (yellowing of the skin or eyes, dark urine, persistent nausea), or symptoms of depression or mood changes.
Reporting suspected side effects after a medicine has been authorised is important for ongoing safety monitoring. Healthcare professionals and patients can report adverse reactions to their national pharmacovigilance authority (e.g., the FDA MedWatch programme in the United States, the Yellow Card Scheme in the United Kingdom, or the EMA EudraVigilance system in the European Union).
How Should You Store EDURANT?
Proper storage of EDURANT is essential to maintain the effectiveness and safety of the medication. Follow these guidelines:
- Keep out of reach of children: Store this medicine where children cannot see or reach it.
- Expiry date: Do not use EDURANT after the expiry date printed on the carton and blister pack (after "EXP"). The expiry date refers to the last day of the stated month.
- Original packaging: Keep EDURANT in its original packaging to protect it from light and moisture.
- Temperature: No special temperature storage conditions are required.
- Disposal: Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer need. This helps protect the environment.
What Does EDURANT Contain?
Film-Coated Tablets (25 mg)
Each film-coated tablet contains rilpivirine hydrochloride equivalent to 25 mg of rilpivirine. The tablets also contain inactive ingredients necessary for tablet manufacture and stability.
Dispersible Tablets (2.5 mg)
Each dispersible tablet contains rilpivirine hydrochloride equivalent to 2.5 mg of rilpivirine. The inactive ingredients include croscarmellose sodium (E468), lactose monohydrate, mannitol (E421), microcrystalline cellulose (E460), polysorbate 20, povidone K30 (E1201), sodium lauryl sulfate (E487), and sodium stearyl fumarate.
The dispersible tablets are white to almost white, round, 6.5 mm in diameter, marked "TMC" on one side and "PED" on the other. They are packaged in perforated aluminium unit-dose blisters with a desiccant in the inner layer and a peelable aluminium foil. Each child-resistant blister contains 10 tablets. Each carton contains 90 tablets.
EDURANT contains lactose. If you have been told by your doctor that you have an intolerance to certain sugars, contact your doctor before taking this medicine. EDURANT contains less than 1 mmol (23 mg) of sodium per tablet, meaning it is essentially sodium-free.
Frequently Asked Questions About EDURANT
Medical References
All medical information is based on peer-reviewed research and international guidelines. Evidence Level 1A.
- European Medicines Agency (EMA). EDURANT Summary of Product Characteristics (SmPC). Last updated 2025. Available at: ema.europa.eu/en/medicines/human/EPAR/edurant
- World Health Organization (WHO). Consolidated Guidelines on HIV Prevention, Testing, Treatment, Service Delivery and Monitoring: Recommendations for a Public Health Approach. Geneva: WHO; 2021.
- Panel on Antiretroviral Guidelines for Adults and Adolescents. Guidelines for the Use of Antiretroviral Agents in Adults and Adolescents with HIV. Department of Health and Human Services (DHHS). Updated 2024.
- European AIDS Clinical Society (EACS). Guidelines for the Clinical Management and Treatment of HIV-Infected Adults in Europe. Version 12.0, October 2023.
- Cohen CJ, Andrade-Villanueva J, Clotet B, et al. Rilpivirine versus efavirenz with two background nucleoside or nucleotide reverse transcriptase inhibitors in treatment-naive adults infected with HIV-1 (THRIVE): a phase 3, randomised, non-inferiority trial. Lancet. 2011;378(9787):229-237.
- Molina JM, Cahn P, Grinsztejn B, et al. Rilpivirine versus efavirenz with tenofovir and emtricitabine in treatment-naive adults infected with HIV-1 (ECHO): a phase 3 randomised double-blind active-controlled trial. Lancet. 2011;378(9787):238-246.
- U.S. Food and Drug Administration (FDA). EDURANT Prescribing Information. Revised 2024.
- British National Formulary (BNF). Rilpivirine. National Institute for Health and Care Excellence (NICE). Updated 2025.
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