patient login to ipkedge

by Stefan Gislason 4 min read

iPLEDGE REMS

27 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


How do I contact the iPLEDGE Program?

The iPLEDGE Program Contact Center is available toll-free by calling 1-866-495-0654. Prescribers will not be able to interact with the iPLEDGE Program, Patients will not be able to complete Patient Monthly Comprehension Questions, and

What happens if my iPLEDGE account is locked?

If your account is locked it will unlock itself in a few hours, The patient is also presented with the option of choosing to stay logged into their patient portal for up to 30 days, Close Overlay, Charlottesville, When you call iPledge, expires after 30 minutes.

What are the new risk categories for iPLEDGE?

Starting on December 13, 2021, patients will be assigned to one of two risk categories: patients who can get pregnant and patients who cannot get pregnant. Patients will also have the option of presenting a unique QR code at the pharmacy on their smartphone instead of providing their iPLEDGE identification number.

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How do I log into iPLEDGE as a patient?

To login using the telephone, dial 1-866-495-0654 and when you hear the main menu press 1 to login. The system first asks for your iPLEDGE user ID followed by the pound sign. Enter each digit of your user ID/username followed by the * key on your telephone touchpad. Then press the # key at the end of your username.

How do I access iPLEDGE questions?

Have Questions? Call our toll-free number 1-866-495-0654.About iPLEDGE.About Isotretinoin.

How do I find my iPLEDGE REMS ID?

Patients 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) 495-0654 or visit the iPLEDGE website for more information about this change.

What is wrong with iPLEDGE?

iPLEDGE Update (December 23, 2021): FDA is aware that patients, prescribers, and pharmacies are experiencing difficulties with the implementation of the modified iPLEDGE program, including the inability of many participants to log in to the website or long call center wait times, resulting in disrupted access to ...

How much is Accutane a month?

Accutane FAQs The normal cash cost of Accutane without health insurance is $643.39 per 30, 30 Capsules Capsule though you can save money using a SingleCare Accutane coupon to pay only $192.98.

Can you get pregnant on Accutane?

Accutane must not be used by female patients who are or may become pregnant. There is an extremely high risk that severe birth defects will result if pregnancy occurs while taking Accutane in any amount, even for short periods of time.

Why is iPLEDGE shut down?

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.

How many days can you skip Accutane?

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!

When will iPLEDGE be working again?

“Isotretinoin manufacturers anticipate the phone and internet systems for the modified iPLEDGE REMS will be available on December 13, 2021,” the FDA website stated.

Can a 14 year old take Accutane?

Pediatric. Appropriate studies have not been performed on the relationship of age to the effects of isotretinoin in children younger than 12 years of age. Safety and efficacy have not been established. This medicine should be used with caution in teenagers, especially those with bone problems or diseases.

What is the FDA's iPledge?

iPLEDGE Update (10/2007): FDA is providing an update about iPLEDGE, a risk management program to reduce the risk of fetal exposure to isotretinoin (a drug to treat severe recalcitrant nodular acne). FDA approved several changes to the program. See IPLEDGE Update

What is the iPledge program?

It is a “shared system” REMS, meaning that it includes all FDA-approved isotretinoin products. It provides a centralized system for prescribers, pharmacies, and patients to manage patient risk, regardless of which isotretinoin product is being used.

When was iPledge approved?

iPLEDGE Update (10/22/2010): Today, FDA approved iPledge as a Risk Evaluation and Mitigation Strategy (REMS) in accordance with the Food and Drug Administration Amendments Act of 2007 (FDAAA). This approval does not substantively change the program for patients, prescribers, dispensers, and wholesalers for approved uses of isotretinoin. FDAAA required the conversion to REMS of those RiskMAPs approved before FDAAA was enacted that contained certain features such as those of the iPledge program requiring prescriber and pharmacist certification, and documentation of safe use conditions before the drug can be dispensed, including pregnancy testing and agreement to use contraception.

Does the FDA post updates on isotretinoin?

In an effort to provide timely isotretinoin information to prescribers, pharmacies, patients, and distributors, the FDA will post any related updates on isotretinoin and the iPLEDGE REMS on this page.

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