REMS@FDA has been updated with the following new or updated information. This information can be found on the following REMS-specific webpage(s):
1. Adempas REMS modified (December 4, 2015) and the Opsumit REMS modified (November 17, 2015) to:
⋅ Change the REMS document to modify a statement in the REMS document to ensure that all certified outpatient pharmacies will be audited within 180 days after they are certified in the REMS program and make changes to clarify the roles and responsibilities of the inpatient and outpatient pharmacy authorized representatives.
⋅ Change the Reproductive Potential Status form to change the title to “Change in Reproductive Potential Status and Pre-pubertal Annual Verification Form” and add a field (Reason for change in classification) to capture reasons for previous misclassification of reproductive status.
⋅ Add a new female of non-reproductive potential subcategory (“Other medical reasons for permanent, irreversible infertility”) and update all relevant sections of the REMS document and related forms to reflect this change.
2. Tracleer REMS modified (December 4, 2015) to:
⋅ Change the REMS program name to “the Tracleer REMS Program” from “Tracleer Access Program”,
⋅ Replace the "Tracleer Renewal Form" with the "Change in Reproductive Potential Status and Pre-pubertal Annual Verification Form",
⋅ Replace the Hospital Certification with Inpatient Pharmacy Certification and addition of an Inpatient Pharmacy Enrollment Form,
⋅ Change to the roles and responsibilities of the inpatient and outpatient pharmacy authorized representatives,
⋅ Remove of the monthly wallet reminder card,
⋅ Remove of form FRM-549-COP-US that was required for patients to receive Tracleer when traveling outside of the United States, and
⋅ Add a new female of non-reproductive potential subcategory (“Other medical reasons for permanent, irreversible infertility”) to all relevant sections of the REMS document and related forms.
3. Soliris REMS modified (December 3, 2015) to align with the prescriber information revisions regarding the level of fever needed to seek medical attention being approved in S-412, and to include contact information for reporting adverse events.
4. Thalomid, Revlimid, and Pomalyst REMS modified (December 1, 2015) to add links to Spanish language REMS materials to the REMS website, add additional links from CelgeneRiskManagement.com to the individual product REMS websites, and add functionality to the Prescriber Calendar, Review Authorization, and Reports in the prescriber portal in CelgeneRiskManagement.com.
5. Tikosyn REMS modified (November 25, 2015) to add an authorized generic to the existing REMS.
6. Mycophenolate shared system REMS modified (November 13, 2015) to include modified and new REMS materials to address the knowledge and behavior gaps identified in the prescriber and patient surveys from the Year 2 REMS assessment, increase exposure of both healthcare providers and patients to the important safe use messages, and reinforce the importance of healthcare provider-patient dialogue. In addition, the following changes to the REMS were also made: modify the goals and remove the Medication Guide as an element of the REMS.
7. Ionsys REMS modified (November 13, 2015) to add:
⋅ Editorial changes to the REMS document and the following REMS appended materials:Ionsys REMS Knowledge Assessment, Ionsys REMS Safety Brochure: Guide for Nurses and Pharmacists, and Ionsys REMS ⋅ Hospital Enrollment Form.
⋅ Functionality to the Ionsys REMS website that allows for Authorized Representatives, nurses, and pharmacists to log in and access educational materials and the Ionsys REMS Knowledge Assessment as well as the ability to link user accounts with the corresponding Authorized Representative.
8. Testosterone 1% gel REMS added (November 5, 2015).
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