Approved Risk Evaluation and Mitigation Strategies (REMS)

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Isotretinoin iPLEDGE

Shared System REMS

REMS last update: 04/23/2018

Products
Goals
Summary
REMS Materials
Update history

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
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	Be able to correctly identify and document females of reproductive potential, females of non-reproductive potential, or male Enroll in the REMS by completing the Prescriber Enrollment Form and submitting it to the REMS Program.
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 methods 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 or a female of reproductive potential: assess the patient’s two chosen methods 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(s) with the prescriber. 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 methods 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 Comprehension Questions \|
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 Comprehension Questions \|
During treatment	For a female who can get pregnant: adhere to the safe use conditions, including use of two methods 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 methods 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 methods 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	Designate an authorized representative to carry out the certification process on behalf of the pharmacy. Have the authorized representative enroll in the REMS Program by completing the Pharmacy Enrollment Form.
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	Designate an authorized representative to carry out the certification process on behalf of the pharmacy. Have the authorized representative reattest in the REMS Program by completing the Pharmacy Enrollment Form.
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. \| Wholesaler Agreement \|
To maintain certification to distribute, every year	Enroll in the REMS by completing the Wholesaler Agreement Form and submitting it to the REMS Program. \| Wholesaler Agreement \|

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
Educational Kit for Males and Females of Non-Reproductive Potential (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/rems/Isotretinoin _2018_04_23_ Educational Kit for Males and Females of Non-Reproductive Potential.pdf
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_2018_04_23_DVDs for prescriber use in patient counseling.pdf
Guide to Isotretinoin for Female Patients Who Can Get Pregnant (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/rems/Isotretinoin_2018_04_23_Guide to Isotretinoin for Female Patients Who Can Get Pregnant.pdf
Instructions for Managing Office Staff Designees (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/rems/Isotretinoin_2018_04_23Instructions for Managing Office Staff Designees .pdf
Office Staff Designee Registration/Activation Form (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/rems/Isotretinoin_2018_04_23_Office Staff Designee Registration Form.pdf
Patient Comprehension Questions (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/rems/Isotretinoin_2018_04_23_Patient Comprehension Questions.pdf
Patient Information/Informed Consent for all patients (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/rems/Isotretinoin_2018_04_23_Patient 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_2018_04_23_Patient Informed Consent for Females of Reproductive Potential.pdf
Patient Introductory Brochure (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/rems/Isotretinoin_2018_04_23_Patinet_Introductory_Brochure.pdf
Pharmacists Guide (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/rems/Isotretinoin_2018_04_23_Pharmacists Guide.pdf
Pharmacy Enrollment Form (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/rems/Isotretinoin_2018_04_23_Pharmacy_Enrollment-form.pdf
Prescriber Contraception Counseling Guide (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/rems/Isotretinoin_2018_04_23_Prescriber_Contraception_Counseling_Guide.pdf
Recognizing Psychiatric Disorders in Adolescents and Young Adults (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/rems/Isotretinoin_2018_04_23_Recognizing Psychiatric Disorders in Adolescents and Young Adults.pdf
REMS Document (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/rems/Isotretinoin_2018_04_23_REMS_Document.pdf
REMS Full (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/rems/Isotretinoin_2018_04_23_REMS_Full.pdf
REMS Website Screenshots (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/rems/Isotretinoin_2018_04_23_website screenshots.pdf
Request for Exemption for Patients with Serious Medical Reasons (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/rems/Isotretinoin_2018_04_23_Request for Exemption for Patients with Serious Medical Reasons.pdf
The Guide to Best Practices (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/rems/Isotretinoin_2018_04_23_The_Guide_to_Best_Practices .pdf
Wholesaler Agreement (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/rems/Isotretinoin_2018_04_23_Wholesaler Agreement.pdf
Wholesaler Shipment Request Form (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/rems/Isotretinoin_2018_04_23_Wholesaler Shipment Request Form.pdf

What updates have been made to the REMS?

Date	Summary of change
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 make minor typographical and formatting changes. add the iPLEDGE Terms of Use text, which includes the Privacy Statement; 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”; add a button to the www.ipledgeprogram.com website home page, “For Office Staff Designees”; add “Find a Patient” functionality for pharmacies. This link will be accessible via the pharmacy menu, post-login; and 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 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 remove the Sponsor addresses from the Pregnancy Registry Protocol title page in the Appended Materials.
09/03/2015	Modified to change the Request for Exemption for Patients with Serious Medical Reasons form as follows: use of the Tanner Staging to classify Female Patients of Non-Childbearing Potential (FNCBP) 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 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 add an attestation to the monthly comprehension testing exemption category to reflect that patients are still required to successfully complete monthly pregnancy testing 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 remove “Accutane” and “Roche” from the iPLEDGE materials relocate the Non-Compliance Action Policy from the REMS document into the REMS supporting documents relocate the following iPLEDGE website screen shots from the REMS document into the REMS supporting documents: iPLEDGE website Prescriber web pages iPLEDGE website Pharmacy web pages iPLEDGEprogram.com home page relocate the “What’s New” document from the REMS document to the REMS supporting document remove references to specific brand names, and respective sponsor names, for isotretinoin from the REMS educational materials revise the “Effective Date” on the REMS educational materials to reflect the approved REMS modification approval date 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.