Approved Risk Evaluation and Mitigation Strategies (REMS)

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Isotretinoin iPLEDGE
Shared System REMS
REMS last update: 06/17/2017

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 setid=3ef0cff8-19c1-4441-b780-fca6c7ee1615 http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=021951
Amnesteem (isotretinoin) ( PI and MG at DailyMed , Info at Drugs@FDA ) ANDA 075945 MYLAN PHARMS INC 10/22/2010 setid=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 setid=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 setid=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 setid=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 setid=27b3cf26-f22e-5b70-1c24-009933b7c6ee http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=202099
isotretinoin Info at Drugs@FDA ANDA 207792 AMNEAL PHARMS NY 09/29/2017

What is the purpose of the REMS?

The goals of the isotretinoin risk evaluation and mitigation strategy are:

  1. To prevent fetal exposure to isotretinoin
  2. 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 See Disclaimer page regarding links to external sites

Health Care Providers who prescribe isotretinoin products must

To become certified to prescribe
Before treatment initiation
  • Counsel the patient on the risks of isotretinoin.
  • For a female of reproductive potential: counsel the patient on contraception or refer to an expert for such counseling.
  • For a female of reproductive potential: assess the patient’s pregnancy status by ordering and reviewing two CLIA-certified pregnancy tests and document the results.
  • For a female of reproductive potential: assess the patient’s two chosen forms of contraception (unless continuously abstinent) and document.
  • Enroll the patient by completing and submitting the patient information to the REMS Program.
  • Prescribe no more than a 30 days’ supply.
  • Do not prescribe refills.
During treatment; before each prescription
  • Counsel the patient on the risks of isotretinoin.
  • For a female of reproductive potential: counsel the patient on the importance of complying with contraceptive methods.
  • For a female of reproductive potential: assess the patient’s pregnancy status by ordering and reviewing a CLIA-certified pregnancy test and document the result.
  • For a female of reproductive potential: assess the patient’s reproductive status to determine if there was a change.
  • For a female of reproductive potential: assess the patient’s two chosen forms of contraception (unless continuously abstinent) and document.
  • Prescribe no more than a 30 days’ supply.
  • Do not prescribe refills.
At all times
  • Report any pregnancies in patients to the REMS Program.

Patients who are prescribed isotretinoin products

Before the first prescription
  • Enroll in the REMS Program by completing the appropriate Patient Information/Informed Consent form with the prescriber. | Pharmacy Enrollment Form | | Guide to Isotretinoin for Female Patients Who Can Get Pregnant |
  • For a female who can get pregnant: get two pregnancy tests.
  • For a female who can get pregnant: receive counseling from the prescriber on contraception.
  • For a female who can get pregnant: adhere to the safe use conditions, including use of two forms of contraception (unless continuously abstinent) one month before treatment initiation.
  • For a female who can get pregnant: complete Patient Monthly Comprehension Questions via the REMS Program. | Patient Introductory Brochure |
During treatment; before each prescription
  • For a female who can get pregnant: get a pregnancy test.
  • For a female who can get pregnant: complete Patient Monthly Comprehension Questions via the REMS Program. | Patient Introductory Brochure |
During treatment
  • For a female who can get pregnant: adhere to the safe use conditions, including use of two forms of contraception (unless continuously abstinent).
  • For a female who can get pregnant: immediately report a pregnancy to the prescriber.
  • Do not donate blood.
  • Do not share isotretinoin with anyone, even someone with similar symptoms.
  • Immediately stop taking isotretinoin if engaged in unprotected heterosexual intercourse.
After treatment discontinuation
  • For a female who can get pregnant: adhere to the safe use conditions, including use of two forms of contraception (unless continuously abstinent) for at least one month.
  • For a female who can get pregnant: at one month, complete Patient Monthly Comprehension Questions via the REMS Program.
  • For a female who can get pregnant: immediately, report a pregnancy that occurs within one month of the last dose of taking isotretinoin to the prescriber.
  • For one month, do not donate blood.
  • For a female who can get pregnant: adhere to the safe use conditions, including use of two forms of contraception (unless continuously abstinent).
At all times
  • Inform the prescriber if she becomes pregnant.

Pharmacies that dispense isotretinoin products must

To become certified to dispense
Before dispensing
  • Provide the patient with the Medication Guide.
  • Obtain authorization to dispense each prescription by contacting the iPLEDGE Program via an electronic verification system or web or voice-based system. Document the Risk Management Authorization (RMA) number on the prescription.
  • Dispense prior to the “do not dispense to a patient after” date provided by the iPLEDGE Program.
  • Dispense no more than a 30 days’ supply.
  • Do not dispense refills.
To maintain certification to dispense, every year
At all times
  • Return unused product to the manufacturer.
  • Do not distribute, transfer, loan, or sell isotretinoin products.

Wholesalers that distribute isotretinoin products must

To be able to distribute
  • Enroll in the REMS by completing the Wholesaler Agreement Form and submitting it to the REMS Program. | REMS document |
To maintain certification to distribute, every year
  • Enroll in the REMS by completing the Wholesaler Agreement Form and submitting it to the REMS Program. | REMS document |

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/Istoretinoin_2017-06-17_DVDs_for_prescriber_use_in_patient_counseling_Be_Prepared_Be_Protected_and_Be_Aware_The_Risk_of_Pregnancy.pdf
Guide to Isotretinoin for Female Patients Who Can Get Pregnant (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Isotretinoin_2017-06-17_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_2017-06-17_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_2017-06-17_Instructions_for_Managing_Office_Staff_Designees.pdf
Isotretinoin Educational Kit for Females of Reproductive Potential (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Isotretinoin_2017-06-17_Educational_Kit_for_Female_Patients_Who_Can_Get_Pregnant.pdf
Isotretinoin Educational Kit for Males and Females of Non-Reproductive Potential (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Isotretinoin_2017-06-17_Educational_Kit_for_Males_and_Females_of_Non_Reproductive_Potential.pdf
Office Staff Designee Registration/Activation Form (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Isotretinoin_2017-06-17_Office_Staff_Designee_Registration_Activation_Form.pdf
Patient Information/Informed Consent for all patients (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Isotretinoin_2017-06-17_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_2017-06-17_Patient_Information_Informed_Consent_for_Females_of_Reproductive_Potential.pdf
Patient Introductory Brochure (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Isotretinoin_2017-06-17_Patient_Introductory_Brochure.pdf
Patient Monthly Comprehension Questions (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Isotretinoin_2017-06-17_Patient_Monthly_Comprehension_Questions.pdf
Pharmacist Guide (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Isotretinoin_2017-06-17_Pharmacist_Guide.pdf
Pharmacy Enrollment Form (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Isotretinoin_2017-06-17_Pharmacy_Enrollment_Form.pdf
Prescriber Contraception Counseling Guide (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Isotretinoin_2017-06-17_Prescriber_Contraception_Counseling_Guide.pdf
Prescriber Enrollment Form (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Isotretinoin_2017-06-17_Prescriber_Enrollment_Form.pdf
Recognizing Psychiatric Disorders in Adolescents and Young Adults (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Isotretinoin_2017-06-17_Recognizing_Psychiatric_Disorders_in_Adolescents_and_Young_Adults.pdf
REMS document (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Isotretinoin_2017-06-17_REMS_Document.pdf
REMS full (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Isotretinoin_2017-06-17_Full.pdf
REMS Website Screenshots (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Isotretinoin_2017-06-17_REMS_Website_Screenshots.pdf
Request for Exemption for Patients with Serious Medical Reasons (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Isotretinoin_2017-06-17_Request_for_Exemption_for_Patients_with_Serious_Medical_Reasons.pdf
The Guide to Best Practices (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Istoretinoin_2017-06-17_The_Guide_to_Best_Practices.pdf
Wholesaler Agreement (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Isotretinoin_2017-06-17_Wholesaler_Agreement.pdf
Wholesaler to Wholesaler Shipment Request Form (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Isotretinoin_2017-06-17_Wholesaler_to_Wholesaler_Shipment_Request_Form.pdf

What updates have been made to the REMS?

Date Summary of change
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

  1. make minor typographical and formatting changes.
  2. add the iPLEDGE Terms of Use text, which includes the Privacy Statement;
  3. add the following statement in the Interactive Voice Recognition System (IVRS) public prompts for all stakeholders: “I understand and will comply with the iPLEDGE Terms of Use and Non-Compliance Action Policy. The iPLEDGE Terms of Use and the Non-Compliance Action Policy are available at www.ipledgeprogram.com”;
  4. add a button to the www.ipledgeprogram.com website home page, “For Office Staff Designees”;
  5. add “Find a Patient” functionality for pharmacies. This link will be accessible via the pharmacy menu, post-login; and
  6. change the Date of Personal Significance (DOPS) Entry to prepopulate the DOPS field with forward slashes “/” and prompt users with MM/DD/YYYY.
02/04/2016 Modified to

  1. add a Notice to Deter Patient Misclassification on select Prescriber and Designee screens to increase awareness and compliance with the appropriate classification of female patients of reproductive potential on the iPLEDGE Website
  2. remove the Sponsor addresses from the Pregnancy Registry Protocol title page in the Appended Materials.
09/03/2015 Modified to

  1. change the Request for Exemption for Patients with Serious Medical Reasons form as follows:
    1. use of the Tanner Staging to classify Female Patients of Non-Childbearing Potential (FNCBP)
    2. add an attestation requiring prescribers to evaluate patient reproductive status while receiving isotretinoin, and notify the iPLEDGE program within 10 business days of any change in the patient’s reproductive status
    3. revise the Female Patients of Childbearing Potential (FCBP) exemption category to reflect that use of the Request for Exemption for Patients with Serious Medical Reasons is only for the first month of isotretinoin therapy
    4. add an attestation to the monthly comprehension testing exemption category to reflect that patients are still required to successfully complete monthly pregnancy testing
  2. standardize the terminology for female patients of childbearing potential in the REMS document, and appended REMS materials to “Females of Reproductive Potential (FRP)” and “Females of Non-Reproductive Potential (FNRP),” where applicable.
04/12/2012 Modified to
  1. remove “Accutane” and “Roche” from the iPLEDGE materials
  2. relocate the Non-Compliance Action Policy from the REMS document into the REMS supporting documents
  3. relocate the following iPLEDGE website screen shots from the REMS document into the REMS supporting documents:
    1. iPLEDGE website Prescriber web pages
    2. iPLEDGE website Pharmacy web pages
    3. iPLEDGEprogram.com home page
  4. relocate the “What’s New” document from the REMS document to the REMS supporting document
  5. remove references to specific brand names, and respective sponsor names, for isotretinoin from the REMS educational materials
  6. revise the “Effective Date” on the REMS educational materials to reflect the approved REMS modification approval date
  7. make editorial changes to the Medication Guide
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.

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