Approved Risk Evaluation and Mitigation Strategies (REMS)

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Isotretinoin iPLEDGE
Shared System REMS
REMS last update: 07/08/2016

What are Isotretinoin iPLEDGE products?

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The Isotretinoin iPLEDGE REMS Program includes the following products:

Product Name Application Number Application Holder Added to REMS
Absorica (isotretinoin) ( PI and MG at DailyMed , Info at Drugs@FDA ) NDA 021951 Ranbaxy Laboratories Inc 05/25/2012
Amnesteem (isotretinoin) ( PI and MG at DailyMed , Info at Drugs@FDA ) ANDA 075945 Mylan Pharmaceuticals Inc 10/22/2010
Claravis (isotretinoin) ( PI and MG at DailyMed , Info at Drugs@FDA ) ANDA 076356 Teva Pharmaceuticals USA 10/22/2010
Claravis (isotretinoin) ( PI and MG at DailyMed , Info at Drugs@FDA ) ANDA 076135 Teva Pharmaceuticals USA 10/22/2010
Myorisan (isotretinoin) ( PI and MG at DailyMed , Info at Drugs@FDA ) ANDA 076485 VersaPharm Incorporated 01/19/2012
Sotret (isotretinoin) ( PI and MG at DailyMed , Info at Drugs@FDA ) ANDA 076503 Sun Pharmaceutical Industries, Inc. 10/22/2010
Sotret (isotretinoin) ( PI and MG at DailyMed , Info at Drugs@FDA ) ANDA 076041 Sun Pharmaceutical Industries, Inc. 10/22/2010
Zenatane (isotretinoin) ( PI and MG at DailyMed , Info at Drugs@FDA ) ANDA 202099 Dr. Reddy's Laboratories, Ltd. 03/25/2013

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

Healthcare Providers who prescribe isotretinoin products must

To be able to prescribe
  • Be able to correctly identify and document females of reproductive potential, females not of reproductive potential, or males.
  • Enroll in the REMS by completing the Prescriber Enrollment Form and submitting it to the sponsor.
Before the first prescription
  • 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.
  • For a female of reproductive potential: assess the patient’s two chosen forms of contraception and document.
  • Enroll the patient by completing and submitting the patient information via the iPLEDGE Program.
  • Prescribe no more than a 30 days’ supply.
  • Do not prescribe refills.
Before each prescription after the first prescription
  • Counsel the patient on the risks of isotretinoin.
  • For a female: assess the patient’s reproductive status to determine a change.
  • 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.
  • For a female of reproductive potential: assess the patient’s two chosen forms of contraception and document.
  • Prescribe no more than a 30 days’ supply.
  • Do not prescribe refills.

Patients who are prescribed isotretinoin products

Before the first prescription
  • Enroll in the REMS by completing the appropriate Patient Information/Informed Consent 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: complete Patient Monthly Comprehension Questions via the iPLEDGE Program.
Before each subsequent 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 iPLEDGE Program.
During treatment
  • For a female who can get pregnant: Use contraception (unless continuously abstinent).
  • For a female who can get pregnant: immediately report a pregnancy to the prescriber.
  • Do not donate blood.
  • Immediately stop taking isotretinoin if engaged in unprotected heterosexual intercourse.
After discontinuing
  • For a female who can get pregnant: Use 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 iPLEDGE 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.

Pharmacies that dispense isotretinoin products must

To be able 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 by completing the Pharmacy Enrollment Form and submitting it to the REMS Program.
Before dispensing
  • Provide the patient with the Medication Guide.
  • Obtain authorization to dispense by contacting the iPLEDGE Program via 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.
Every year
  • Re-enroll in the iPLEDGE Program.
At all times
  • Return unused product to the manufacturer.
  • Do not distribute, transfer, loan, or sell product.

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:


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Material Name
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)
Guide to Isotretinoin for Male Patients and Female Patients who Cannot Get Pregnant (PDF)
Instructions for Managing Office Staff Designees (PDF)
iPLEDGE Program Wholesaler Agreement (PDF)
Isotretinoin Educational Kit for Females of Reproductive Potential (PDF)
Isotretinoin Educational Kit for Males and Females of Non-Reproductive Potential (PDF)
Office Staff Designee Registration/Activation Form (PDF)
Patient Information/Informed Consent for all patients (PDF)
Patient Information/Informed Consent for Females of Reproductive Potential (PDF)
Patient Monthly Comprehension Questions (PDF)
Pharmacist Guide for the iPLEDGE Program (PDF)
Pharmacy Enrollment Form (PDF)
Prescriber Contraception Counseling Guide (PDF)
Prescriber Enrollment Form (PDF)
Prescriber Istoretinoin Educational Kit (PDF)
Recognizing Psychiatric Disorders In Adolescents And Young Adults (PDF)
REMS document (PDF)
REMS full (PDF)
REMS Website Screenshots (PDF)
Request for Exemption for Patients with Serious Medical Reasons (PDF)
The Guide to Best Practices For the iPLEDGE Program (PDF)
The iPLEDGE Program Patient Introductory Brochure (PDF)
Wholesaler to Wholesaler Shipment Request Form (PDF)

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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