30 hours ago The 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. >> Go To The Portal
To login to iPLEDGE go to www.ipledgeprogram.com and locate the Login section in the middle of the screen. Type your username and password into the appropriate boxes. For example, if your username is ABC123, type exactly ABC123 in the Username box. If your password is 1234, type 1234 in the Password box.
activated in the iPLEDGE system, neither the prescriber nor the designated office staff can register a patient. The prescriber is responsible for any actions of all designees under him/her. 5 How does an Office Staff Designee register and become affiliated to a Prescriber? Registration and affiliation is a two-step process.
If the patient loses his or her iPLEDGE ID card and/or number, he or she should contact the prescriber for the number. Call center agents cannot provide patient ID numbers over the phone to patients, but can provide this
How do I find an iPLEDGE participating pharmacy? Patients should login to www.ipledgeprogram.com and consult with online pharmacy finder to make sure a pharmacy is participating in iPLEDGE.
Once registered, you will receive your username and password in the mail. Upon first login to iPLEDGE you will be asked to select a personal 4-digit numeric password and select a date of personal significance. The selection of a personal password is a security feature that ensures password confidentiality.
Call 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.
Patients, prescribers, and pharmacists: if you do not have access to your account on the iPLEDGE website, you can contact the iPLEDGE call center at 1-866-495-0654 for assistance.
Yes. The iPledge program requires monthly visits for both male and female patients.
A scheduled change to the iPLEDGE Risk Evaluation and Mitigation Strategy (REMS) has led to a delay in isotretinoin prescriptions. Physicians and their teams have been unable to access the iPLEDGE site during an update to incorporate an FDA-approved modification to the iPLEDGE REMS that took effect December 13, 2021.
The Food and Drug Administration has approved system changes to the iPLEDGE Risk Evaluation and Mitigation Strategy (REMS) program for isotretinoin products. The system changes will go into effect starting December 13, 2021 for health care professionals, pharmacies, and patients.
It's ok if you run out of your medication before your next appointment. Accutane stays in your system for several days and missing a few days (or even weeks) will not impact the final outcome!
If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses. If you miss a dose of Absorica®, skip the missed dose and take your next dose at the regular time.
People sometimes mention weight gain or weight loss when talking about Accutane. However, the FDA do not currently list weight change as a side effect of this drug.
If you were never mailed or emailed one (or you just forgot it) use the forgot password link or call iPledge 1-866-495-0654 and get one. Click to see full answer. In this way, how do I get my iPLEDGE username? To login to iPLEDGE go to www.ipledgeprogram.com and locate the Login section in the middle of the screen.
The iPLEDGE program is a risk management distribution program mandated by the U.S. Food and Drug Administration (FDA) for isotretinoin, marketed as Absorica, Claravis, Amnesteem, Myorisan, and Zenatane, and sometimes referred to by its former brand name, Accutane. Herein, how do I find my iPLEDGE number?
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Because isotretinoin medications (like Absorica, Claravis, etc.) can cause severe birth defects when taken during pregnancy, the iPledge program was created to help reduce the number of babies born with birth defects caused by isotretinoin.
Once you have completed all of these requirements, and they are entered into the iPledge computer system, you will be able to fill your prescription. Your pharmacist will access this system to receive authorization to give you your medication.
Does this mean men and women who can't get pregnant have to participate in the iPledge Program too? Yes! Anyone taking isotretinoin must be enrolled in and meet the requirements of iPledge. But men and women who can't get pregnant have different requirements than those who can get pregnant.