In addition to the drugs included in Table 5, the interaction between Edurant and the following drugs was evaluated in clinical studies and no dose adjustment is needed for either drug [see Clinical Pharmacology Rilpivirine did not have a clinically significant effect on the pharmacokinetics of digoxin or metformin. No clinically relevant drug-drug interaction is expected when Edurant is coadministered with maraviroc, ribavirin or the NRTIs abacavir, emtricitabine, lamivudine, stavudine and zidovudine. QT Prolonging Drugs There is limited information available on the potential for a pharmacodynamic interaction between rilpivirine and drugs that prolong the QTc interval of the electrocardiogram. In a study of healthy subjects, 75 mg once daily and mg once daily 3 times and 12 times the dose in Edurant have been shown to prolong the QTc interval of the electrocardiogram [see Clinical Pharmacology
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Liver problems have also occurred in people taking rilpivirine who have no history of liver disease. While taking rilpivirine, it is important to keep all of your appointments with your health care provider.
What is rilpivirine? Rilpivirine is a prescription medicine approved by the U. Rilpivirine is always used in combination with other HIV medicines. What should I tell my health care provider before taking rilpivirine?
Before taking rilpivirine, tell your health care provider: If you are allergic to rilpivirine or any other medicines. If you have kidney problems. If you have ever had a mental health problem.
If you have any other medical conditions. If you are pregnant or plan to become pregnant. Whether rilpivirine can harm an unborn baby is unknown. Talk to your health care provider about possible risks with taking rilpivirine when pregnant. If you are breastfeeding or plan to breastfeed. Do not breastfeed if you have HIV or are taking rilpivirine.
If you are using hormone -based birth control such as pills, implants, or vaginal rings. About other prescription and nonprescription medicines, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Rilpivirine may affect the way other medicines or products work, and other medicines or products may affect how rilpivirine works. How should I take rilpivirine? Each tablet contains 25 mg rilpivirine. Always take rilpivirine with a meal. A protein drink alone does not replace a meal.
Always take rilpivirine in combination with other HIV medicines. If you take too much rilpivirine, contact your health care provider or local poison control center right away, or go to the nearest hospital emergency room.
What should I do if I forget a dose? If you miss a dose of rilpivirine within 12 hours of the time you usually take it, take your dose with a meal as soon as possible. Then take your next dose at the regularly scheduled time. If you miss a dose by more than 12 hours from the time you usually take it, wait and then take the next dose at the regularly scheduled time.
Do not take two doses at the same time to make up for a missed dose. What side effects can rilpivirine cause? Rilpivirine may cause side effects. Many side effects from HIV medicines, such as nausea or occasional dizziness, are manageable. Some side effects of rilpivirine can be serious.
See section above: What are the most important things to know about rilpivirine? Other possible side effects of rilpivirine include: Changes in body fat lipodystrophy syndrome. Changes in your immune system called immune reconstitution inflammatory syndrome or IRIS. IRIS is a condition that sometimes occurs when the immune system begins to recover after treatment with an HIV medicine. As the immune system gets stronger, it may have an increased response to a previously hidden infection.
Tell your health care provider if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of rilpivirine. To learn more about possible side effects of rilpivirine, read the drug label or package insert or talk to your health care provider or pharmacist. How should rilpivirine be stored? Keep rilpivirine in the container that it came in to protect the drug from light.
Keep the container tightly closed. Do not use rilpivirine if the original seal over the container opening is broken or missing. Throw away rilpivirine that is no longer needed or expired out of date.
Keep rilpivirine and all medicines out of reach of children. Where can I find more information about rilpivirine? More information about rilpivirine is available: The rilpivirine drug label. The Patient Counseling Information section of the label includes information for people taking rilpivirine. Manufacturer Information.
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AIDSinfo provides the following drug label solely as an example of the labels available for rilpivirine. Search Drugs FDA to access more information on rilpivirine, including additional drug labels and any generic equivalents. Immediately discontinue treatment if hypersensitivity or rash with systemic symptoms or elevations in hepatic serum biochemistries develop and closely monitor clinical status, including hepatic serum biochemistries. A few cases of hepatotoxicity have occurred in patients with no pre-existing hepatic disease. Monitor liver function tests before and during treatment with EDURANT in patients with underlying hepatic disease, such as hepatitis B or C virus co-infection, or marked elevations in transaminase. Also consider monitoring liver functions tests in patients without pre-existing hepatic dysfunction or other risk factors.
EDURANT® Prescribing Information—EDURANT® (rilpivirine)
Nyberg, PharmD, Brooke Y. Patterson, PharmD, and Meghan M. Treatment is often complicated by the shifting demographic of HIV-infected patients that now includes a large aging population in which patients often have multiple comorbidities. HIV clinicans are challenged with choosing the optimal combination of antiretrovirals based on potency, tolerability, bioavailability, and ease of administration. The issue of bioavailability is of paramount importance for those patients who can t swallow tablets, are unable to take anything by mouth before a procedure, or who need medication through a nasogastric tube or percutaneous endoscopic gastrostomy tube. A thorough search of several drug databases, a literature search of MEDLINE through Ovid, and a review of full prescribing information for each currently available antiretroviral drug, was performed to obtain insight into the bioavailability of antiretrovirals. Implications for the findings are discussed as they relate to adherence, resistance, alternative methods of administration, and the sometimes conflicting information on bioavailability that exists for various antiretroviral agents.