Approved Risk Evaluation and Mitigation Strategies (REMS)

REMS@FDA

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Letairis (ambrisentan)
NDA #022081
REMS last update: 11/30/2018



What is the purpose of the REMS?

The goals of the Letairis Risk Evaluation and Mitigation Strategy (REMS) Program are:

  1. To inform prescribers, patients, and pharmacists about the serious risk of teratogenicity and safe-use conditions for Letairis.
  2. To minimize the risk of fetal exposure and adverse fetal outcomes in Females of Reproductive Potential (FRP) prescribed Letairis
    1. Females who are pregnant must not be prescribed Letairis.
    2. Females taking Letairis must not become pregnant.

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

Pharmacies that dispense Letairis must

To become certified to dispense
  • Designate an authorized representative to carry out the certification process on behalf of the pharmacy.
  • Train all relevant staff involved in the dispensing on the REMS program, procedures, and materials.
Before dispensing
  • For a female of reproductive potential (FRP): counsel the patient on the risk of serious birth defects; the need to use highly reliable contraception during treatment and one month after stopping treatment; the need to complete monthly pregnancy tests, and to inform their prescriber if they suspect they may be pregnant.
  • For a FRP: verify that a pregnancy testing was completed by asking the patient. If the patient is unable to confirm, then ask the prescriber. If both the patient and prescriber are unable to confirm, then ask the prescriber to authorize a refill and remind the prescriber of their obligation to order and review a monthly pregnancy test.
  • Provide the patient with the Medication Guide.
  • Obtain authorization to dispense by contacting the Letairis REMS Coordinating Center.
  • Dispense no more than a 30 days’ supply.
At all times
  • Report adverse events or reports of pregnancy to Gilead.
  • Maintain records of daily product dispensing data for a FRP.
  • Cooperate with audits carried out by the REMS program to ensure that all processes and procedures are in place and are being followed.

Pre-Pubertal females and/or their guardian who are prescribed Letairis

Before the first prescription
  • Enroll in the REMS by completing the Patient Enrollment and Consent Form with the prescriber.
  • Receive counseling from the prescriber on the risk of teratogenicity using the Medication Guide.
At all times
  • Inform the prescriber if a change in reproductive status.
During treatment
  • Age 8 and older: get evaluated by prescriber for a change in reproductive status at least annually.

Healthcare Providers who prescribe Letairis must

To become certified to prescribe
  • Be able to determine whether each female is of reproductive potential using the Prescriber Guide to the Letairis REMS Program.
  • Review the drug’s prescribing information.
  • Review the following educational materials: Medication Guide and Prescriber Guide to the Letairis REMS Program.
  • Enroll in the REMS by completing the Prescriber Enrollment and Agreement Form and submitting it to the sponsor.
Before the first prescription
  • For a female: counsel that drug is only available through a restricted distribution program.
  • For a female of reproductive potential (FRP): counsel about the risk of teratogenicity, the need to use highlight reliable contraception during treatment and for one month following treatment discontinuation, and the need to use emergency contraception using the Medication Guide and Letairis REMS Program Guide for Females Who Can Get Pregnant.
  • For a FRP: assess the patient’s pregnancy status by ordering and reviewing a pregnancy test.
  • For a pre-pubertal female patient and/or their guardian: cCounsel about the risk of teratogenicity using the Medication Guide.
  • Enroll the female patient by completing and submitting the Patient Enrollment and Consent Form to the REMS program.
Before each prescription after the first prescription
  • For a FRP not complying with the required testing: counsel the patient on the required testing and appropriate contraception.
  • For a FRP: assess the patient’s pregnancy status by ordering and reviewing a pregnancy test.
During treatment
  • For a pre-pubertal female: assess the patient’s change in reproductive status regularly.
  • For a pre-pubertal female at least age 8 or older: assess the patient’s reproductive status. At least annually, complete and submit the Change in Reproductive Potential Status and Pre-Pubertal Annual Verification Form.
After treatment discontinuation
  • For a FRP: At 1 month following discontinuation, assess the patient’s pregnancy status by ordering and reviewing a pregnancy test.
At all times
  • For a female: Within 10 business days of becoming aware of a change or misclassification in reproductive status, report the change or misclassification to the REMS program using the Change in Reproductive Potential Status and Pre-Pubertal Annual Verification Form.
  • Report adverse events and any pregnancies to Gilead.

Females of reproductive potential who are prescribed Letairis

Before the first prescription
  • Enroll in the REMS by completing the Patient Enrollment and Consent Form with the prescriber.
  • Get a pregnancy test.
  • Receive counseling from the prescriber on the risk of birth defects using the Medication Guide and Letairis REMS Program Guide for Females Who Can Get Pregnant.
Before each subsequent prescription
  • Get a pregnancy test.
During treatment
  • For females who can get pregnant: Use contraception.
At one month after discontinuing
  • For females who can get pregnant: Use contraception.
  • Get a pregnancy test.
At all times
  • Inform the prescriber if you become pregnant.

Post-Menopausal Females or Females with other medical reasons for permanent, irreversible infertility who are prescribed Letairis

Before the first prescription
  • Enroll in the REMS by completing the Patient Enrollment and Consent Form with the prescriber.
At all times
  • Inform the prescriber if a misclassification in reproductive status.

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 Letairis REMS, see the DailyMed link(s).
Material Name Material Name Link
Change in Reproductive Potential Status and Pre-Pubertal Annual Verification Form (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Letairis_2018-11_30_Change_in_Reproductive_Potential_Status_and_PrePubertal_Annual_Verification_Form.pdf
Guide for Female Patients (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Letairis_2018_11_30_Guide_for_Female_Patients.pdf
Patient Enrollment and Consent Form (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Letairis_2018_11_30_Patient-Enrollment_and_Consent_Form.pdf
Prescriber Enrollment and Agreement Form (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Letairis_2018_11_30_Prescriber_Enrollment_and_Agreement_Form.pdf
Prescriber Guide (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Letairis_2018_11_30_Prescriber_Guide.pdf
REMS Document (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Letairis_2018_11_30_REMS_Document.pdf
REMS Full (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Letairis_2018_11_30_REMS_Full.pdf
Website Screenshots (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Letairis_2018_11_30_REMS_Website_Screenshots.pdf

What updates have been made to the REMS?

Date Summary of change
11/30/2018 Modified to update the Prescriber Guide to conform with the PLLR conversion and retitle Guide for Females Who Can Get Pregnant to Guide for Female Patients. The Medication Guide is no longer necessary as an element of the approved REMS but will continue to be part of the approved labeling.
09/27/2017 Modified to add an online enrollment option for patient and prescriber enrollment.
07/21/2017 Modified to update the Letairis REMS Patient Enrollment and Consent Form.
12/15/2016 Modified to update the following REMS document and materials including the Letairis REMS; Supporting Document, Prescriber Enrollment and Agreement Form, Prescriber Guide to the Letairis REMS Program, Program Guide for Females Who Can Get Pregnant, Patient Enrollment and Consent Form, Website.
10/02/2015 Modified to incorporate the revised indication into the REMS appended material, Prescriber Guide for the Letairis REMS Program.
10/29/2014 Modified to:

  1. Clarify the change in classification categories by changing the name of the Reproductive Potential Status Form to the Change in Reproductive Potential Status and Pre-pubertal Annual Verification Form.
  2. Change the definition of females of non-reproductive potential (FNRP) in the REMS Document, the Reproductive Potential Status and Pre-pubertal Annual Verification Form, Prescriber Guide for the Letairis REMS Program, and the Letairis REMS Program Guide for Females Who Can Get Pregnant and REMS website.
  3. Communicate that Gilead is paying pharmacies for health information in order to conduct the REMS program in the Patient Enrollment and Consent Form.
01/31/2014 Modified to align the contraceptive information in these appended REMS materials with the acceptable contraceptive options that are listed in the package insert made revisions to the Prescriber Guide for the Letairis REMS Program and the Letairis REMS Program Guide for Females Who Can Get Pregnant.
08/17/2013 Modified to:

  1. Conform to the content of the labeling changes made revisions to the Medication Guide and revisions to relevant sections of the appended REMS materials.
  2. Eliminate enrollment of males in the REMS program.
  3. Revise the requirements applicable to females (females of reproductive potential and females of non-reproductive potential).
10/19/2012 Modified to align the content with the above referenced labeling changes made revisions to the Medication Guide and revisions to relevant sections of the appended REMS materials, specifically, the REMS website
02/15/2012 Modified to align the content with the above referenced labeling changes made revisions to the Medication Guide and revisions to the relevant sections of the REMS document and appended REMS materials, specifically, the Prescriber Guide: Letairis and LEAP Program, and Patient Enrollment Guide.
03/03/2011 Modified to align the content with the above referenced labeling changes made revisions to the Medication Guide and revisions to the relevant sections of the REMS document and appended REMS materials, specifically, the Prescriber Guide: Letairis and LEAP Program, and Patient Enrollment Guide.
10/13/2010 Modified to align with labeling changes made revisions to the Medication Guide and revisions to relevant section of the REMS materials, specifically, the Prescriber Educational Brochure, Patient Enrollment Guide, and Patient Educational Brochure.
08/24/2010 Modified to revise the timetable for submission of assessments.
08/05/2009 Modified to align with labeling changes made revisions to the REMS Prescriber Enrollment Guide, Patient Enrollment Guide (For starting therapy with Letairis) and Patient Education Brochure (Letairis therapy: What you need to know).
07/01/2009 Modified to align with labeling changes made revisions to the REMS Prescriber Education Brochure and the REMS Patient Education Brochure (Letairis Therapy: What You Need to Know).
05/29/2009 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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