Standard DoseOne 25 mg tablet once daily with a meal. For adults and children (12 years of age and older weighing at least 77 pounds, or 35 kg) taking HIV treatment for the first time (treatment-naïve). Must be taken in combination with another antiretroviral(s) which does not contain this medication 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 observed 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.
See package insert for more complete information on potential side effects and interactions.
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Potential Side Effects and Toxicity
Edurant is a very tolerable medication. 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. Stop taking Edurant and see a medical provider right away if allergic reaction or rash occurs with any of the following: fever, trouble breathing or swallowing, blisters, mouth sores, redness or swelling of the eyes, or swelling of the face, lips, mouth, tongue, or throat. 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, but are very rare. The risk may be greater for people with a history of hepatitis B or C, but may occur 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 oral dose of the steroid dexamethasone. Antacids or other products containing aluminum, calcium carbonate, or magnesium hydroxide 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. Edurant 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 Epclusa, Harvoni, or Zepatier.
A newer medication combining rilpivirine with dolutegravir was approved by the FDA in late 2017; see Juluca. A long-acting injectable formulation of rilpivirine may be approved this year along with a long-acting injectable formulation of cabotegravir to form a complete regimen given once a month; see the long-acting cabotegravir/long-acting rilpivirine page. 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. The clinical benefits, however, are not known at this time. 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. Ross Slotten says:
No comment provided because of redundancy. Edurant is almost exclusively used as part of combination tablets.
Activist Bridgette Picou says:
Rilpivirine can be found in several of the single-tablet regimens used today, and also in the soon-to-be-approved once- or twice-monthly injectable with cabotegravir called Cabenuva. In pill form it needs to be taken with a meal. It is well tolerated and often best used as a switch regimen for stable persons with an undetectable viral load. There are drug-drug interactions so communicate what you are taking to your doctor, especially antacids, whether prescribed or over-the-counter. Take as directed daily to avoid resistance, which can cause cross resistance with another HIV medication (etravirine).