Prescriber Certification
Prescriber's Role in the Bosentan REMS Program:

1. READ

READ the Prescribing Information for bosentan and Medication Guide for the prescribed product and the Bosentan REMS Program Prescriber Guide to understand the risks of bosentan and to learn about the Bosentan REMS Program

  • You must understand the risks of bosentan and become familiar with the Bosentan REMS Program.

2. COMPLETE

COMPLETE a Bosentan REMS Program Prescriber Enrollment Form

  • By signing the form, you attest to understanding the risks of bosentan and agree to comply with the requirements of the Bosentan REMS Program
  • You can complete the Bosentan REMS Program Prescriber Enrollment Form online or download the form from the Bosentan REMS Program Website here, and fax the form to the Bosentan REMS Program at 1-800-730-8231

3. DETERMINE

DETERMINE the reproductive potential for female patients

  • You should identify female patients (captured on Bosentan REMS Program Patient Enrollment Form) as one of the following categories:
    • Females of reproductive potential
    • Females of non-reproductive potential (choose one of the options below)
      • Pre-pubertal female of non-reproductive potential
      • Post-menopausal female of non-reproductive potential
      • Female with other medical reasons for permanent, irreversible infertility
  • Expanded definitions are provided in the Bosentan REMS Program Prescriber Guide

4. EDUCATE & COUNSEL

EDUCATE & COUNSEL all patients about the risks of bosentan

  • For all patients, you must:
    • Counsel all patients on the risk of hepatotoxicity associated with bosentan, the signs and symptoms of hepatotoxicity, and program requirements including the need to complete liver function testing and, as appropriate, pregnancy testing by reviewing and providing the patient the Medication Guide, and Bosentan REMS Program Guide for Patients
    • Complete the Bosentan REMS Program Patient Enrollment Form with every new bosentan patient and submit the form to the Bosentan REMS Program prior to initiating treatment
    • Educate patients about the Bosentan REMS Program
    • Order and review pretreatment liver function tests
    • Order and review monthly liver function tests
    • Notify the Bosentan REMS Program of all adverse events including those suggestive of hepatotoxicity
    • Notify the Bosentan REMS Program of any pregnancy and all available information during treatment with bosentan
  • For females of reproductive potential, you must:
    • Counsel patients about the risk of embryo-fetal toxicity, the need to complete monthly pregnancy tests, and the need to use reliable contraception prior to initiating treatment, during bosentan treatment and for one month after ending treatment
    • Counsel the patient to immediately contact her healthcare provider if she misses a menstrual period or suspects pregnancy
    • Order and review pregnancy tests prior to initiation of bosentan treatment, monthly during treatment, and for one month after ending treatment
  • For pre-pubertal females, you must:
    • Counsel the patient and/or a parent/legal guardian about the risk of embryo-fetal toxicity and the need to use reliable contraception
    • Counsel the patient and/or a parent/legal guardian to immediately contact her healthcare provider if she begins to menstruate
    • Evaluate patients age 8 years and older at least annually for any change in reproductive status and submit a Bosentan REMS Program Change in Reproductive Potential Status and Pre-pubertal Annual Verification Form to the Bosentan REMS Program within 10 business days of becoming aware of the change

5. ENROLL

ENROLL all patients in the Bosentan REMS Program by ensuring patients complete the Bosentan REMS Program Patient Enrollment Form

  • Confirm the patient has agreed to comply with program requirements and has signed the form where indicated.
  • Fax the completed form to the Bosentan REMS Program at 1-800-730-8231, or complete the form here.
  • Keep the original form with the patient's records.

6. TEST

TEST each patient's liver function and pregnancy status of females of reproductive potential

  • Order and review liver function tests for all patients:
    • Prior to initiating treatment
    • Monthly during treatment
  • Order and review pregnancy tests for females of reproductive potential:
    • Prior to initiating treatment
    • Monthly during treatment
    • One month after ending bosentan treatment

7. REVIEW

REVIEW all required test results and monitor patients throughout treatment

  • For all patients:
    • Order and review liver function tests each month during treatment with bosentan
    • You may, though you are not required to, confirm the completion of liver function tests and counseling each month by one of the following methods:
      • Submitting a Bosentan REMS Program Testing and Patient Counseling Reporting Form by fax to the Bosentan REMS Program at
        1-800-730-8231
      • Completing the Bosentan REMS Program Testing and Patient Counseling Reporting Form here
      • Calling the Bosentan REMS Program at 1-866-359-2612
    • For changes in aminotransferase levels, adjust the monitoring and treatment with bosentan
    • Discontinue bosentan if aminotransferase elevations are accompanied by signs or symptoms of liver dysfunction or injury or increase in bilirubin
      ≥2 x ULN
  • For all females of reproductive potential:
    • Order and review pregnancy tests monthly during treatment with bosentan and for one month after ending treatment
    • You may, though you are not required to, confirm the completion of pregnancy tests and counseling each month by one of the following methods:
      • Submitting a Bosentan REMS Program Testing and Patient Counseling Reporting Form by fax to the Bosentan REMS Program at
        1-800-730-8231
      • Completing the Bosentan REMS Program Testing and Patient Counseling Reporting Form online here
      • Calling the Bosentan REMS Program at 1-866-359-2612
    • Report any pregnancy and all available information during treatment with bosentan to the Bosentan REMS Program
    • Monitor patient's reproductive status during treatment with bosentan and report any change or misclassification in reproductive potential status by submitting a Bosentan REMS Program Change in Reproductive Potential Status and Pre-pubertal Annual Verification Form to the Bosentan REMS Program within 10 business days of becoming aware of the change
  • For females of non-reproductive potential:
    • Monitor patient's reproductive status during treatment with bosentan and report any change or misclassification in reproductive potential status by submitting a Bosentan REMS Program Change in Reproductive Potential Status and Pre-pubertal Annual Verification Form to the Bosentan REMS Program within 10 business days of becoming aware of the change
    • For each patient who is 8 years of age or older, verify annually and report the reproductive status by completing and submitting the Bosentan REMS Program Change in Reproductive Potential Status and Pre-pubertal Annual Verification Form

8. NOTIFY

NOTIFY the Bosentan REMS Program of all adverse events including those suggestive of hepatotoxicity

9. REPORT

REPORT any pregnancy and all available information during treatment with bosentan to the Bosentan REMS Program

For additional information about the Bosentan REMS Program, please call 1-866-359-2612.