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  1. Isotretinoin is indicated for the treatment of severe recalcitrant nodular acne in non-pregnant patients 12 years of age and older with multiple inflammatory nodules with a diameter of 5 mm or greater. iPLEDGE REMS Overview. Only enrolled and activated healthcare providers can prescribe isotretinoin.

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      This system is for the use of authorized users only....

    • iPLEDGE REMS

      Call our toll free number 1-866-495-0654 to report any of...

    • Prescriber Guide

      enter the iPLEDGE REMS website. ☐ Enroll . patient in the...

  2. The iPLEDGE® REMS is a computer-based risk management program designed to reduce risk of birth defects and inform you of the risks that Accutane® can bring.

  3. 14 sty 2022 · Starting on December 13, 2021, all pharmacists need to obtain an RMA prior to dispensing isotretinoin by accessing the iPLEDGE REMS website or the iPLEDGE REMS Contact Center.

  4. 1 gru 2023 · Question 2: What is the iPLEDGE REMS program? Answer: The iPLEDGE program is an FDA required risk management program with the goal of preventing fetal exposure to isotretinoin.

  5. Accutane is only for patients who can understand and agree to follow all the instructions in the iPLEDGE® REMS. Patients taking Accutane must register in the iPLEDGE® Pregnancy Registry at 1-866-495-0654 or www.ipledgeprogram.com .

  6. For updates related to the iPLEDGE REMS , visit the FDA iPLEDGE webpage. The iPLEDGE Program was originally implemented in early 2005 and approved as the iPLEDGE REMS in 2010. It is a “shared...

  7. Isotretinoin is indicated for the treatment of severe recalcitrant nodular acne in non-pregnant patients 12 years of age and older with multiple inflammatory nodules with a diameter of 5 mm or greater. iPLEDGE REMS Overview. Only enrolled and activated healthcare providers can prescribe isotretinoin.

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