The art of managing drugdrug interactions in patients with hiv bradley l. Food and drug administration fda in may 2011 for adults with hiv1 infection. Request permission export citation add to favorites. Rilpivirine is used along with other medications to treat human immunodeficiency virus infection hiv in certain adults and children 12 years of age and older who weigh at least 77 lb 35 kg and have not received antiretroviral treatment in the past. Click the image and it will be inserted into the slide. Eplerenone is chemically described as pregn4ene7,21dicarboxylic acid, 9,11epoxy17. The effects of tmc278, a nextgeneration nnrti, on the pharmacokinetics of acetaminophen and cyp2ei activity in hivnegative volunteers. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Data sources include ibm watson micromedex updated 10 apr 2020, cerner multum updated 6 apr 2020. Inclusion or absence of a drug label on the aidsinfo site does not imply endorsement or lack thereof by aidsinfo. Edurant rilpivirine dosing, indications, interactions.
Leucovorin calcium for injection rx only description leucovorin is one of several active, chemically reduced derivatives of folic acid. Edurant is a human immunodeficiency virus type 1 hiv1 specific, nonnucleoside reverse transcriptase inhibitor nnrti indicated in combination with other antiretroviral agents for the treatment of hiv1 infection in treatmentnaive patients 12 years of age and older and weighing at least 35 kg with hiv1 rna less than or equal to 100,000 copiesml. Officesuite lets you easily view, edit, and create word, excel, and powerpoint documents, and perform advanced pdf operations. Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the. Predicted residual activity of rilpivirine in hiv1 infected patients. Dosing and administration for cinvanti, a syntheticsurfactantfree aprepitant formulation1 use cinvanti prior to hec or mec in combination with other antiemetics to prevent nausea and vomiting. Inhibitorof at the recommendeddoseof25 mg oncedaily, rilpivirine is not likely tohave a clinically relevant effecton the exposure of medicinalproducts metabolised by cyp enzymes. Rilpivirine needs an acid environment in the stomach to be absorbed. Officesuite office, pdf, word, excel, powerpoint 10. Each odefsey tablet contains 200 mg of emtricitabine ftc, 25 mg of rilpivirine rpv equivalent to 27. After reconstitution, it should be administered by intramuscular im or intravenous iv routes see dosage and administration. Patients or carers should be given advice on how to administer rilpivirine tablets. Do not take antacids within 2 hours before rilpivirine or 4 hours after rilpivirine.
This enzyme changes hivs genetic material rna into the form of dna. Rilpivirine, in combination with other agents, is indicated for the treatment of hiv1 infections in antiretroviral treatmentnaive patients with hiv1 rna. Proton pump inhibitors such as omeprazole, lansoprazole and pantoprazole, should not be taken with rilpivirine. It blocks the virus from growing and infecting more cells. Rilpivirine is metabolized by the cytochrome p450 cyp isoenzyme 3a. Rilpivirine is used to treat human immunodeficiency virus infection. The art of managing drugdrug interactions in patients with hiv. In addition based upon the clinical and nonclinical data the chmp concluded that rilpivirine may have a proarrhytmic effect.
This medicine is usually given to patients who have not received any hiv treatment in the past. Several fdaapproved drug labels may be available for rilpivirine. Rilpivirine has a halflife of 50 hours and is metabolized by cyp3a4mediated hepatic oxidation. Effects of temsavir, active moiety of antiretroviral agent. Insert the syringe with sterile water into the fuzeon vial at an angle. Prescribing information, clinical studies, and slide decks all materials are available for download in their original formats as pdf or powerpoint. Pentamidine isethionate is a white crystalline powder soluble in water and glycerin. Missed doses if a dose is more than 12 hours late, the missed dose should not be taken and the next dose should be taken at the normal time. An nnrtidependent impact on rilpivirine resistance was detected. Edurant rilpivirine, in combination with other antiretroviral agents, is a nonnucleoside reverse transcriptase inhibitor nnrti indicated for the treatment of human immunodeficiency virus type 1 hiv1 infection in antiretroviral treatmentnaive patients 12 years of age and older and weighing at least 35 kg with hiv1 rna less.
Highlights of prescribing information these highlights do not include all the information needed to use juluca safely and effectively. It is a secondgeneration nonnucleoside reverse transcriptase inhibitor nnrti with higher potency, longer halflife and reduced sideeffect profile compared with older nnrtis, such as efavirenz. List of the ethics committees and respective centres. Rilpivirine infectious disease and antimicrobial agents. Insert sterile syringe needle into the vial through the center of the stopper. More recently, solid drug nanoparticles for targeting 18 and. Each tablet contains 200 mg of emtricitabine ftc, 27. Australian public assessment report for rilpivirine. Edurant rilpivirine is a nonnucleoside reverse transcriptase inhibitor nnrti of human immunodeficiency virus type 1 hiv1. These are not all the possible side effects of rilpivirine. This medicine does not cure hiv or aids, but it may slow the progress of the disease. Turn the vial upside down and draw 1mlof the sterile water into the syringe then remove the needle and syringe from the vial. You can report side effects to fda at 1800fda1088 18003321088 or online. The patient should also be monitored for discontinuation symptoms of the antidepressant see package insert of the specified agents for a description of the associated discontinuation symptoms.
Confidential ideas are draft and subject to discussion with gappac and legal viiv healthcare meet the management david redfern chairman deborah waterhouse ceo kimberly smith md. Take rilpivirine at around the same time every day. Aidsinfo provides the following drug label solely as an example of the labels available for rilpivirine. Mar 06, 2020 keep taking rilpivirine as you have been told by your doctor or other health care provider, even if you feel well. Rebetol monotherapy is not effective for the treatment of chronic hepatitis c virus infection and should not be used alone for this indication see warnings and precautions 5. Antiretroviral agent about this pubmed health uses uses of this medicine. Juluca dolutegravirand rilpivirine tablets, for oral use. The apparent volume of distribution at steady state ranged from 43 to 90 l. Pentam 300 pentamidine isethionate for injection, an antiprotozoal agent, is a sterile, nonpyrogenic, lyophilized product. Edurant is available as a white to offwhite, filmcoated. The art of managing drugdrug interactions in patients. Our integrated file manager, chat client with document exchanging capabilities and a multitude of other handy tools, make this the most featurerich mobile office solution available on android. It is intended for use in initial therapy, in combination with other antiretroviral agents, for patients with pretreatment hiv rna levels of package insert. Emtricitabinerilpivirinetenofovir is indicated for treatment of hiv1 in adults naive to hiv1 medications where the virus has not developed.
Take an additional 25mg tablet of rilpivirine with juluca once daily with a meal for the duration of the rifabutin coadministration. The views, opinions and content expressed in this presentation do not necessarily reflect the views, opinions or policies of the center for mental health services cmhs, the substance abuse and mental health services administration samhsa or the u. Instantly, all shapes, fonts, text, and attributes can be selected and changed. May 20, 2019 rilpivirine hydrochloride is a white to almost white powder. Each edurant tablet also contains the inactive ingredients croscarmellose sodium, lactose monohydrate, magnesium stearate, polysorbate 20, povidone k30 and silicified microcrystalline cellulose. These drugs stop hiv from multiplying by preventing the reverse transcriptase enzyme from working. Highlights of prescribing information these highlights do not.
Plasma tenofovir, emtricitabine, and rilpivirine and intracellular. Concomitant use with drugs that induce cyp3a may result in decreased plasma rilpivirine concentrations and may result in possible loss of virologic response and development of resistance to rilpivirine or the nonnucleoside reverse transcriptase inhibitor nnrti class. Rilpivirine is available as a white to offwhite, filmcoated, round, biconvex, 6. Based on invitro results with25 mg oncedaily, rilpivirine may act asa p. No authors listed in previously untreated hiv1 infection, one firstline therapeutic option is to combine efavirenz, a nonnucleoside reverse transcriptase inhibitor, with tenofovir and emtricitabine. Depressive disorders see warnings and precautions 5. Welcome to the edurant patients and caregivers website like most people, you probably have questions about hiv and how its treated. Among 686 patients receiving rilpivirine, 72 10% experienced vf versus 39 of 682 6% receiving efavirenz. Open your powerpoint presentation on the page you want to insert the pdf within. Safety, tolerability and pharmacokinetics of rilpivirine following. L1030 the fda combination therapy approval of rilpivirine and dolutegravir is indicated for adults with hiv1 infections whose virus is currently suppressed infection.
Highlights of prescribing information nss are frequent nss. Rilpivirine compared favourably with efv with lower discontinuations due to adverse events 4% vs 9%, grade 24 adverse events related to treatment 17% versus 33%, rash 4% versus 15%, dizziness 8% vs 27% and abnormal dreams 8% vs %, and grade 24 lipid derangements. Rilpivirine hydrochloride is a white to almost white powder. Rilpivirine is a non competitive non nucleoside inhibitor of hiv1 reverse transcriptase rt, having no measurable activity against human dna deoxyribonucleic acid polymerases. Just open the pdf file in powerpoint as a slide and then ungroup it. Proton pump inhibitors such as omeprazole, lansoprazole and pantoprazole, should not be. Complera emtricitabine, rilpivirine, tenofovir disoproxil fumarate tablets, for oral usehighlights of prescribing information. The request for special attention for potential effects on qtc was addressed by the applicant.
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. Edurant is available as a white to offwhite, filmcoated, round, biconvex, 6. Rilpivirine is a nonnucleoside reverse transcriptase inhibitor nnrti. In patients with high baseline vl 100,000 copies per milliliter, the proportion of vfs was higher. When rilpivirine was taken with only a protein rich nutritional drink, exposures were 50%. Coadministration with drugs eg, cyp inducers like phenobarbital, dexamethasone, oxcarbazepine, phenytoin, or carbamazepine where significant decreases in rilpivirine plasma concentrations may occur, which may result in loss of virologic response and possible resistance and crossresistance to other nnrtis. Download the full us prescribing information for edurant rilpivirine tablets. The following adverse drug reaction adr is discussed in greater detail in other sections of the package insert. Switch to dolutegravir plus rilpivirine dual therapy in cart.
This medicine can lower, but not fully prevent, the risk of spreading hiv to others. Because clinical trials are conducted under widely varying. Edurant prescribing informationedurant rilpivirine. Dailymed edurant rilpivirine hydrochloride tablet, film. Drugs that reduce stomach acidity, such as omeprazole, lansoprazole, ranitidine or calcium can stop rilpivirine from being absorbed properly. The pdf file should be the first option within the insert dialog window. Taf equivalent to 28 mg of tenofovir alafenamide fumarate.
Insert pdf for powerpointmodify pdf graphics in microsoft powerpoint with insert pdf. May 21, 2018 provides accurate and independent information on more than 24,000 prescription drugs, overthecounter medicines and natural products. Rilpivirine hydrochloride is practically insoluble in water over a wide ph range. Highlights of prescribing information these highlights do not include all the information needed to use complera safely and effectively. Rilpivirine is a nonnucleoside reverse transcriptase inhibitor. More rilpivirinetreated subjects with hiv1 rna greater than 100,000 copiesml at the start of therapy experienced virologic failure hiv1 rna. This site was created to answer some of your questions and help you learn about edurant rilpivirine 25mg tablets, a prescription medicine used with other arv medicines in patients who have never taken hiv medicines before and who have an amount of. Vasostrict vasopressin injection, usp is a clear, practically colorless solution for intravenous administration available as 20 unitsml in a single dose vial and 200 units10 ml 20 unitsml in a multiple dose vial. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. Easy to read fda package insert, drug facts, dosage and administration, and adverse effects for priftin rifapentine. One subject discontinued the study drug at week 24 for headache, one for drug.
Drug labeling package insert rilpivirine edurant class. It is important that you do not miss or skip a dose of rilpivirine during treatment. Clinical data were retrieved from a drug resistance database of hiv1. It is usually taken with a meal not just a protein drink once a day. Learn about the treatment of hiv in antiretroviral. Rilpivirine is a nonnucleoside reverse transcriptase inhibitor a nonnuke or nnrti. Feb 12, 2018 edurant rilpivirine tablets for oral use. Find patient medical information for rilpivirine oral on webmd including its uses, side effects and safety, interactions, pictures, warnings and user ratings. Rilpivirine tmc278, trade name edurant is a pharmaceutical drug, developed by tibotec, for the treatment of hiv infection. Keep taking rilpivirine as you have been told by your doctor or other health care provider, even if you feel well.
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