Standard DoseOne 25 mg tablet once daily with a standard meal (more than 390 calories). For adults and children 12 years of age and older weighing at least 77 pounds (35 kg). Must be taken in combination with another antiretroviral(s) which does not contain the medication in this drug or medication from the same drug class. No dose adjustment needed for pregnant patients with undetectable viral load on a stable rilpivirine-based regimen, but monitor viral load closely because lower rilpivirine drug exposure has been seen during pregnancy.
Viral load (HIV RNA) must be less than 100,000 copies/mL and CD4 T-cell count must be above 200 cells/mm3 before starting Edurant due to higher rates of virologic failure in these patients.
Take missed dose as soon as possible with a meal, unless it is closer to the time of your next dose. Do not double up on your next dose.
Must be taken with a meal that you chew—not just nutritional drinks or protein shakes. Taking rilpivirine without food could result in a 40% decrease in drug absorption and may lead to resistance.
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Potential Side Effects and Toxicity
- See package insert for more complete information on potential side effects and interactions.
Moderate to severe side effects are uncommon. Most common side effects occurring in 3–5% of study subjects were insomnia, headache, rash, and depressive disorders. Tell your doctor right away if you experience feelings of sadness, hopelessness, anxiety or restlessness, or have suicidal thoughts or actions. A small study showed a higher rate of depressive disorders in adolescents (19.4%—seven out of 36 youths—vs. 9% for adults), which may or may not have been related to Edurant. Two different studies comparing Edurant to Sustiva showed that Edurant was slightly better tolerated. Edurant also has minimal negative effects on LDL (“bad”) cholesterol, total cholesterol, and triglycerides when compared to Sustiva. Edurant improved HDL (“good”) cholesterol slightly less than Sustiva. Liver problems can occur with Edurant (even in patients without a history of liver disease). Edurant can cause a small, reversible increase in kidney function test (serum creatinine) within the first few weeks of treatment without affecting actual kidney function.
Potential Drug Interactions
Edurant cannot be taken with the anti-seizure medications carbamazepine, oxcarbazepine, phenobarbital, or phenytoin; the anti-TB drugs rifampin and rifapentine; proton pump inhibitors (Aciphex, Dexilant, Nexium, Prevacid, Protonix, and Prilosec); or the herb St. John’s wort. Do not take with more than one systemic dose of the steroid dexamethasone. Antacids should be taken two hours before or at least four hours after Edurant. Acid-reducing drugs (Pepcid, Tagamet, Zantac, and Axid) should be taken 12 hours before or four hours after an Edurant dose. If administered with rifabutin, the dose of Edurant should be increased to two 25 mg tablets once daily with a meal. When rifabutin is stopped, Edurant dose should be decreased to 25 mg daily. Monitor for worsening of any fungal infections when Edurant is used with antifungal medications like fluconazole, itraconazole, ketoconazole, posaconazole, and voriconazole; dose adjustment for these medications may be needed. Use azithromycin when possible instead of the antibiotics clarithromycin, erythromycin, and telithromycin. Methadone levels are reduced slightly and patients should be monitored for symptoms of withdrawal. Should be used with caution when taken with other medications with a known risk of torsades de pointes or QT prolongation (these abnormal heart rhythms can make the heart stop). No dose adjustment needed with hepatitis C medications Daklinza, Epclusa, Harvoni, Olysio, Sovaldi, or Zepatier. Cannot be taken with Viekira Pak. Tell your provider or pharmacist about all medications, herbals, and supplements you are taking or thinking of taking, prescribed or not, as there are other drug interactions which are not listed here.
A new medication combining rilpivirine with dolutegravir was approved by the FDA in late 2017; see Juluca. Edurant is not recommended for treatment-naïve patients with a pre-treatment viral load greater than 100,000 copies/mL or CD4 less than 200 cells/mm3. A rilpivirine-based regimen may be advantageous in people with high risk for heart disease due to its relatively low impact on lipid profile. While its tolerability and safety profiles are advantages for Edurant, the greater potential for virologic failure in patients with high viral loads or low CD4 counts, food restrictions, and cross-resistance to the other NNRTIs puts Edurant at a disadvantage for first-time treatment—people may not be able to switch to another NNRTI if their HIV develops NNRTI resistant mutations to Edurant. Data for use of rilpivirine in combination with an abacavir/lamivudine background are insufficient to recommend at this time. For individuals with HIV-2, commonly found in some other countries, an NNRTI would not be recommended as HIV-2 is inherently resistant to NNRTIs. Edurant can be used during pregnancy, and is listed as a DHHS alternative NNRTI to use in pregnancy in combination with a two-NRTI backbone. According to the FDA, lower exposures of rilpivirine were observed during pregnancy, therefore, viral load should be monitored closely.
Dr. David Hardy says:
Edurant was approved in 2011 as the second “second generation” NNRTI to be used as an ART regimen in treatment-naïve PLWH. Its upside is its excellent tolerability (side effects occur uncommonly); its downside is that it lacks potency for PLWH with high viral loads (greater than 100,000 copies/ml). Edurant has been used in three STRs, Complera, Juluca, and Odefsey (see those pages). Due to its potency concerns, it has never been considered the best choice for all PLWH starting their first ART regimens, but only those with lower viral loads (less than 100,000 copies/mL).
Activist Moisés Agosto-Rosario says:
Rilpivirine is an NNRTI shown not to be inferior to efavirenz in individuals with a viral load less than 100,000. It was first approved as a single agent but nowadays it is used in various single-tablet regimens: Complera, Odefsey, and Juluca. The resistance profile of this drug is complicated. If resistance to rilpivirine develops, cross-resistance to Intelence (etravirine) occurs. It is well tolerated and needs to be taken with food. It works well when used to switch regimens in individuals who have an undetectable viral load. It is important to know the drug-drug interactions of rilpivirine. It should not be taken with antacids because it will affect drug absorption. Rilpivirine plus cabotegravir is under investigation as a once-a-month long-acting fixed-dose HIV treatment.