Approved Risk Evaluation and Mitigation Strategies (REMS)
Isotretinoin iPLEDGE
Shared System REMS
REMS last update: 12/09/2020
What medicines are included in the REMS?
Product Name | Application Number | Application Holder | Added to REMS | DailyMed Link | FDA Link |
---|---|---|---|---|---|
Absorica (isotretinoin) ( PI and MG at DailyMed , Info at Drugs@FDA ) | NDA 021951 | SUN PHARM INDS INC | 05/25/2012 | 3ef0cff8-19c1-4441-b780-fca6c7ee1615 | http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=021951 |
Absorica LD (isotretinoin) (Info at Drugs@FDA) | NDA 211913 | SUN PHARM | 11/05/2019 | ||
Amnesteem (isotretinoin) ( PI and MG at DailyMed , Info at Drugs@FDA ) | ANDA 075945 | MYLAN PHARMS INC | 10/22/2010 | b2cb63c9-f825-4991-9a2c-6260f1bbcc2c | http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=075945 |
Claravis (isotretinoin) ( PI and MG at DailyMed , Info at Drugs@FDA ) | ANDA 076356 | TEVA PHARMS USA | 10/22/2010 | A31FD109-D0FD-4AB9-BA98-A3D64333C18D | http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=076356 |
Claravis (isotretinoin) ( PI and MG at DailyMed , Info at Drugs@FDA ) | ANDA 076135 | TEVA PHARMS USA | 10/22/2010 | a31fd109-d0fd-4ab9-ba98-a3d64333c18d | http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=076135 |
Myorisan (isotretinoin) ( PI and MG at DailyMed , Info at Drugs@FDA ) | ANDA 076485 | DOUGLAS PHARMS | 01/19/2012 | 51ff6346-9256-4c01-9f52-417d13f2df05 | http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=076485 |
Zenatane (isotretinoin) ( PI and MG at DailyMed , Info at Drugs@FDA ) | ANDA 202099 | DR REDDYS LABS LTD | 03/25/2013 | 27b3cf26-f22e-5b70-1c24-009933b7c6ee | http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=202099 |
isotretinoin ( PI and MG at DailyMed , Info at Drugs@FDA ) | ANDA 207792 | AMNEAL PHARMS NY | 09/29/2017 | c2917c3d-3499-48a0-ba53-120cb979195d |
What is the purpose of the REMS?
The goals of the isotretinoin risk evaluation and mitigation strategy are:
- To prevent fetal exposure to isotretinoin
- To inform prescribers, pharmacists, and patients about isotretinoin’s serious risks and safe-use conditions
What do participants need to know?
Below is a general overview of the REMS for all REMS participants (e.g., patients, pharmacies, and healthcare providers). See the application holder(s) REMS Website or the approved REMS materials for more information.
View application holder(s) REMS Website
Health Care Providers who prescribe isotretinoin products must
To become certified to prescribe |
|
Before treatment initiation |
|
During treatment; before each prescription |
|
At all times |
|
Pharmacies that dispense isotretinoin products must
To become certified to dispense |
|
Before dispensing |
|
To maintain certification to dispense, every year |
|
At all times |
|
Patients who are prescribed isotretinoin products
Before the first prescription |
|
During treatment; before each prescription |
|
During treatment |
|
After treatment discontinuation |
|
At all times |
|
Wholesalers that distribute isotretinoin products must
To be able to distribute |
|
To maintain certification to distribute, every year |
|
What materials are included in the REMS?
The REMS includes a REMS Document. In addition, the REMS includes the following materials intended for patients and healthcare providers. For a specific Medication Guide of a product in the Isotretinoin iPLEDGE REMS, see the DailyMed link on the Products tab.
Material Name | Material Name Link |
---|---|
DVDs for Prescriber Use in Patient Counseling: Be Prepared, Be Protected and Be Aware: The Risk of Pregnancy While on Isotretinoin (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/rems/Isotretinoin_2020_12_09_DVDs_for_prescriber_use_in_patient_counseling_Be_Prepared_Be_Protected_and_Be_Aware_The_Risk_of_Pregnancy_While_on_Isotretinoin.pdf |
Guide to Isotretinoin for Female Patients who Can Get Pregnant (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/rems/Isotretinoin_2020_12_09_Guide_to_Isotretinoin_For_Female_Patients_Who_Can_Get_Pregnant.pdf |
Guide to Isotretinoin for Male Patients and Female Patients Who Cannot Get Pregnant (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/rems/Isotretinoin_2020_12_09_Guide_to_Isotretinoin_for_Male_Patients_and_Female_Patients_who_Cannot_Get_Pregnant.pdf |
Instructions for Managing Office Staff Designees (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/rems/Isotretinoin_2020_12_09_Instructions_for_Managing_Office_Staff_Designees.pdf |
Isotretinoin Educational Kit for Female Patients Who Can Get Pregnant (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/rems/Isotretinoin_2020_12_09_Isotretinoin_Educational_Kit_for_Female_Patients_Who_Can_Get_Pregnant.pdf |
Isotretinoin Educational Kit for Male Patients and Female Patients of Non-Reproductive Potential (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/rems/Isotretinoin_2020_12_09_Isotretinoin_Educational_Kit_for_Male_Patients_and_Female_Patients_Who_Cannot_Get_Pregnant.pdf |
Office Staff Designee Registration/Activation Form (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/rems/Isotretinoin_2020_12_09_Office_Staff_Designee_Registration_Activation_Form.pdf |
Patient Information/Informed Consent for All Patients (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/rems/Isotretinoin_2020_12_09_Patient_Information_Informed_Consent_for_all_patients.pdf |
Patient Information/Informed Consent for Females of Reproductive Potential (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/rems/Isotretinoin_2020_12_09_Patient_Information_Informed_Consent_About_Birth_Defects_for_female_patients_who_can_get_pregnant.pdf |
Patient Introductory Brochure (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/rems/Isotretinoin_2020_12_09_Patient_Introductory_Brochure.pdf |
Patient Monthly Comprehension Questions (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/rems/Isotretinoin_2020_12_09_Patient_Monthly_Comprehension_Questions.pdf |
Pharmacist Guide for the iPLEDGE Program (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/rems/Isotretinoin_2020_12_09_Pharmacist_Guide_for_the_iPLEDGE_Program.pdf |
Pharmacy Enrollment Form (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/rems/Isotretinoin_2020_12_09_Pharmacy_Enrollment_Form.pdf |
Prescriber Contraception Counseling Guide (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/rems/Isotretinoin_2020_12_09_Prescriber_Contraception_Counseling_Guide.pdf |
Prescriber Enrollment Form (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/rems/Isotretinoin_2020_12_09_Prescriber_Enrollment_Form.pdf |
Recognizing Psychiatric Disorders in Adolescents and Young Adults (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/rems/Isotretinoin_2020_12_09_Recognizing_Psychiatric_Disorders_in_Adolescents_And_Young_Adults.pdf |
REMS Document (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/rems/Isotretinoin_2020_12_09_REMS_Document.pdf |
REMS Full (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/rems/Isotretinoin_2020_12_09_REMS_Full.pdf |
REMS Program Website Screenshots (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/rems/Isotretinoin_2020_12_09_REMS_Program_Website_Screenshots.pdf |
Steps to Request an Exemption for Female Patients with Serious Medical Reasons (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/rems/Isotretinoin_2020_12_09_Steps_to_Request_an_Exemption_for_Female_Patients_with_Serious_Medical_Reasons.pdf |
The Guide to Best Practices for the iPLEDGE Program (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/rems/Isotretinoin_2020_12_09_The_Guide_to_Best_Practices_For_The_iPLEDGE_Program.pdf |
What updates have been made to the REMS?
Date | Summary of change |
---|---|
12/09/2020 | Modified to remove specific product information tables of currently approved isotretinoin products from the REMS@FDA Website Screenshots |
01/24/2020 | Modified to make changes to the Medication Guide, an element of the iPLEDGE REMS. This modification does not provide for any changes to the REMS document, appended materials, or REMS supporting document. |
04/23/2018 | Modified to add a new sponsor, remove a product name (which is no longer available), update a name change for a sponsor, bold text to highlight “The Do Not Dispense After Date”, replacing radio buttons and a table with drop down menus and editorial changes for consistency by aligning the list of birth control methods options with the listing on the approved Birth Control Information Sheet. |
06/17/2017 | Modified to provide for implementation of a REMS Pharmacy Network and use of an electronic verification system for iPLEDGE Program certified pharmacies to request and receive a Risk Management Authorization (RMA) directly through the prescription claim adjudication process workflow at the point of dispensing an isotretinoin prescription. It also provides for the changes made to the REMS educational materials to streamline and improve clarity. |
07/08/2016 | Modified to
|
02/04/2016 | Modified to
|
09/03/2015 | Modified to
|
04/12/2012 | Modified to
|
10/22/2010 | Approval of the REMS. |
Disclaimer: This webpage provides general information about REMS programs to various REMS participants (e.g., patients, pharmacies, and healthcare providers). The summary information provided herein is not comprehensive and may not include all of the information relevant to REMS participants. This webpage does not constitute a replacement, modification, or revision of the approved REMS document, including any appended REMS materials. Refer to the approved REMS document for complete information on the REMS requirements for each approved application.
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English