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1. ipledgeprogram.comiPLEDGE REMS

   ipledgeprogram.com

   Assess a patient’s pregnancy status using pregnancy tests that are not performed in a CLIA-certified laboratory. Rely on the patient to perform home pregnancy tests and report the dates and results of these tests to the prescriber during and after isotretinoin treatment.

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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

     pregnancy test at the completion of the entire course of...

2. ipledgeprogram.comiPLEDGE REMS - Home - iPLEDGE PROGRAM

   ipledgeprogram.com

   Educate patients on the risks of isotretinoin and the contraception requirements of the iPLEDGE REMS for patients who can get pregnant. Enroll those patients in the REMS who meet all the requirements of the iPLEDGE REMS. Isotretinoin is only available through this restricted distribution program.

3. www.fda.gov › questions-and-answers-ipledge-remsQuestions and Answers on the iPLEDGE REMS | FDA

   www.fda.gov › questions-and-answers-ipledge-rems

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   1 gru 2023 · Assess a patient’s pregnancy status using pregnancy tests that are not performed in a CLIA-certified laboratory. Rely on the patient to perform home pregnancy tests and report the dates...

4. www.fda.gov › drugs › postmarket-drug-safety-information-patients-and-providersiPLEDGE Risk Evaluation and Mitigation Strategy (REMS)

   www.fda.gov › drugs › postmarket-drug-safety-information-patients-and-providers

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   Revise the pregnancy registry requirement to remove the objective to document the pregnancy and fetal outcomes (and associated data collection) for each pregnancy.

5. cdn.prod.website-files.com › 609c3423f0bff63d73c2bc1b › 62556c7f7909be81fdbd0312The iPLEDGE Program Patient Introductory Brochure

   cdn.prod.website-files.com › 609c3423f0bff63d73c2bc1b › 62556c7f7909be81fdbd0312

   WHAT IS THE iPLEDGE PROGRAM? The iPLEDGE program is a set of steps all patients, doctors, and pharmacists must follow. The main goal is preventing pregnancy and birth defects, but both male patients and female patients must follow the iPLEDGE program. To get isotretinoin, all patients must: • Sign the Patient Information/Informed Consent form(s)

6. mydoctor.kaiserpermanente.org › ncal › ImagesGuide Guide to for Isotretinoin Patients For Who Female Can Get...

   mydoctor.kaiserpermanente.org › ncal › Images

   requirements for prescribers, pharmacies, and patients. The iPLEDGE REMS also includes a pregnancy registry for patients who get pregnant. The goal of the iPLEDGE REMS is to • prevent pregnancies in patients taking isotretinoin and to • prevent pregnant patients from taking isotretinoin

7. www.verywellhealth.com › ipledge-requirements-for-people-who-cant-get-pregnant-15674iPledge Requirements for Men and Women - Verywell Health

   www.verywellhealth.com › ipledge-requirements-for-people-who-cant-get-pregnant-15674

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   30 wrz 2021 · Even if you have had a tubal ligation you will still have to follow the iPledge requirements for women who can get pregnant (including using two forms of birth control). If you are male, or you are a woman who can't get pregnant, you are required by iPledge to do the following.