Edurant package insert pdf

The interaction between rilpivirine and the medicinal product was evaluated in a clinical study. Read all of this leaflet carefully before you start taking this medicine because it contains important information for you. Edurant, innrilpivirine european medicines agency europa eu. These are not all the possible side effects of rilpivirine.

Edurant is available as a white to offwhite, filmcoated, round, biconvex, 6. Supporting documents older than three years kedbumin. Refer to the full prescribing information for important drug interactions. Call your healthcare provider right away if you get a rash. Lower exposures of rilpivirine were observed during pregnancy. 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. Read the patient information leaflet if available from your pharmacist before you start using rilpivirine and each time you get a refill. Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the. Edurant prescribing informationedurant rilpivirine.

The recommended dosage of edurant in patients 12 years of age and older and weighing at least 35 kg is one 25 mg tablet taken orally once daily with a meal see use in specific populations 8. For patients concomitantly receiving rifabutin, the edurant dose should be increased to 50 mg. Complera emtricitabine, rilpivirine, tenofovir disoproxil fumarate tablets, for oral use. Learn about the treatment of hiv in antiretroviral. For patients concomitantly receiving rifabutin, the edurant. Hiv1 is the virus that causes acquired immune deficiency syndrome aids. Edurant rilpvirine prescribing information package insert. If you have any questions about this leaflet or the medicines described please speak. The 14day leadin period with viramune 200 mg daily dosing must be strictly followed as the leadin period has been observed to decrease the incidence of rash. The recommended dose for viramune is one 200 mg tablet daily for the first 14 days, followed by one 200 mg tablet twice daily, in combination with other antiretroviral agents. Viread oral powder should be mixed in a container with 2 to 4 ounces of soft food not requiring. Patients should receive retrovir injection only until oral therapy can be administered. When rifabutin coadministration is stopped, the edurant dose should be decreased to 25 mg taken once daily with a meal. Depressive disorders see warnings and precautions 5.

Fda approves prescribing information update for edurant. Edurant rilpivirine is a nonnucleoside reverse transcriptase inhibitor nnrti of human immunodeficiency virus type 1 hiv1. Edurant is a nonnucleoside reverse transcriptase inhibitor hiv medication. London, 29 april 2019 viiv healthcare, the global specialist hiv company majority owned by gsk, with pfizer inc.

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. Edurant, in combination with other antiretroviral medicinal products, is indicated. Welcome to the edurant patients and caregivers website like most people, you probably have questions about hiv and how its treated. Edurant package insert pdf admin may 23, 2019 leave a comment. Delstrigo doravirinelamivudinetenofovir disoproxil. Dailymed edurant rilpivirine hydrochloride tablet, film. For patients concomitantly receiving rifabutin, the edurant dose should be. Drug information on rilpivirine tablet film coated for health care professionals. The calculated dose should be removed from the 20ml vial and added to 5% dextrose injection solution to achieve a concentration no greater than 4 mg per ml. Have an amount of hiv in their blood called viral load that is no more than 100,000 copiesml. If you have any further questions, ask your doctor or pharmacist. Viiv healthcare submits new drug application to us fda for.

Retrovir injection must be diluted prior to administration. The following adverse drug reaction adr is discussed in greater detail in other sections of the package insert. Edurant fda prescribing information, side effects and uses. People who have severe liver or kidney disease should use this drug with caution.

Edurant is a human immunodeficiency virus type 1 hiv1 specific, nonnucleoside reverse. One level scoop delivers 1 g of powder, which contains 40 mg of tdf. Edurant is a human edurant package insert pdf drug information on rilpivirine tablet film coated for health care professionals. Tivicay is a human immunodeficiency virus type 1 hiv1 integrase strand transfer inhibitor insti indicated in combination with. Rilpivirine is a type of antitretroviral drug called a nonnucleoside reverse. In some cases, rash and allergic reaction may need to be treated in a hospital. This is the standard dose for everyone using this drug, regardless of age or weight. Download the full us prescribing information for edurant rilpivirine tablets. Do not miss any doses, as it can make the medication less effective. Refer to the full prescribing information for important drug interactions with juluca. The recommended edurant dosage for the treatment of hiv or aids is one 25mg tablet taken once a day with a meal. 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. Read all of this leaflet carefully before you start taking this medicine. Highlights of prescribing information these highlights do not include all the information needed to use delstrigo safely and effectively.