WebCall our toll free number 1-866-495-0654 to report any of the following:. An Adverse Event: If you or someone you know has experienced an adverse event, please call 1-866-495-0654. A Pregnancy: If you are an activated prescriber, report pregnancy results by logging in and clicking on “Manage Patients.” Otherwise, please call 1-866-495-0654
WebThe iPLEDGE PROGRAM REMS (Risk Evaluation and Mitigation Strategy) The iPLEDGE PROGRAM REMS is a safety program to manage the risk of isotretinoin’s teratogenicity and to minimize fetal exposure. The REMS is required by the U.S. Food and Drug Administration (FDA) to ensure the benefits of isotretinoin outweigh its risks.
WebThe iPLEDGE® REMS is a computer-based risk management system that uses verifiable, traceable links between prescriber, patient pharmacy, and wholesaler to control prescribing, using, dispensing, and distribution of isotretinoin.
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iPLEDGE Risk Evaluation and Mitigation Strategy (REMS) | FDA
WebJan 14, 2022 · This tool is intended to allow prescribers and designees to send login links directly to their patients’ desired email address through the Manage Patients page of the iPLEDGE REMS portal....
WebPatients can access their unique QR code by logging into their account on the iPLEDGE REMS Website . Patients can consult their prescriber, call the iPLEDGE Contact Center at (866)...
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Fact Sheet for the iPLEDGE Program - My Doctor Online
Webprogram called a Risk Evaluation and Mitigation Strategy (REMS) for isotretinoin. The iPLEDGE Program is a single, shared REMS (includes multiple manufacturers) system with requirements for prescribers, pharmacies, and patients. The iPLEDGE Program also includes a pregnancy registry for patients who get pregnant. The goal of the iPLEDGE …
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The iPLEDGE Program The Pharmacist Guide For the …
WebThe pharmacist must call the iPLEDGE program at 1-866-495-0654, log in, and select the option to “Obtain Approval to Fill or Reverse a Prescription,” or log in to the web site and select...
WebThe iPLEDGE program is a program by the U.S. Food and Drug Administration (FDA) intended to manage the risk of birth defects caused by isotretinoin (also known as Accutane), [1] a prescription medication used for the treatment of acne.
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What to Know About the iPledge Program - Verywell Health
WebAug 6, 2023 · Before you take isotretinoin medication like Accutane, Claravis, or Amnesteem, you will learn about the iPledge program. iPledge is a computer-based system for patients and healthcare providers whose primary goal is to ensure you do not get pregnant before starting therapy or while using isotretinoin.
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iPLEDGE Program Overview: Definition, Requirements, and …
WebFeb 1, 2019 · Once you complete these steps, you’ll be given instructions on how to sign in to the iPLEDGE system online. Your pharmacist will also have access to this system. Each month, before your...