The Tracleer® (bosentan) REMS (Risk Evaluation
and Mitigation Strategy) Program

For Prescribers

Prescriber's Role in the Tracleer REMS Program

  1. Read the Tracleer Prescribing Information and the Prescriber and Pharmacy Guide for the REMS Program to understand the risks of Tracleer and to learn about the Tracleer REMS Program
    • Prescribers must understand the risks of Tracleer and become familiar with the Tracleer REMS Program
  2. Complete a Tracleer REMS Prescriber Enrollment and Agreement
    • By signing the form, you attest to understanding the risks of Tracleer and agree to comply with the Tracleer REMS Program
    • You can download the Tracleer REMS Prescriber Enrollment and Agreement Form here and fax it to Actelion Pathways® at 1-866-279-0669. Actelion Pathways administers the Tracleer REMS Program
  3. Determine the reproductive potential for female patients
    • Prescribers should identify female patients (captured on the Tracleer REMS Patient Enrollment and Consent Form) as one of the following categories:
      • Female of Reproductive Potential (FRP)
      • or
      • Female of Non-Reproductive Potential (FNRP) (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
    Definitions are provided in the "Tracleer REMS Program Overview" section of the Prescriber and Pharmacy Guide for the Tracleer REMS Program.
  4. Educate and counsel all patients about the risks of Tracleer
    • For all patients, prescribers must:
      • Advise the patient that Tracleer is only available through a restricted distribution program called the Tracleer REMS Program
      • Educate and counsel patients about the risks of Tracleer, including the risk of hepatotoxicity
      • Provide the Tracleer Medication Guide to each patient and instruct him or her to read it
      • Advise the patient of the requirement for initial and monthly liver function tests to enable monitoring of their liver and so they can begin and continue to receive Tracleer
      • Counsel the patient to contact their healthcare provider immediately if they have signs or symptoms of liver injury such as nausea, vomiting, fever, unusual tiredness, stomach area (abdominal) pain, or yellowing of the skin or the whites of the eyes (jaundice)
      • Prescribers must counsel any patient who fails to comply with the program requirements
      • Counsel patients that they must agree to be contacted prior to each shipment to confirm that a liver function test and, if applicable, a pregnancy test, has been completed
    • For Females of Reproductive Potential, prescribers must:
      • Review with her the Tracleer Medication Guide and the Tracleer REMS Guide for Patients
      • Educate her about the risk of teratogenicity, the need to use reliable contraception during Tracleer treatment and for one month following treatment discontinuation; as well as her need to consider medical options in the event of unprotected sexual intercourse or known or suspected contraception failure
      • Advise the patient of the requirement for initial and monthly pregnancy tests to confirm she is not pregnant, so she can begin and continue to receive Tracleer
      • Counsel her to immediately contact her healthcare provider if she misses a menstrual period or suspects she is pregnant
    • For Pre-pubertal Females of Non-Reproductive Potential, prescribers must:
      • Review with her and/or her parent/guardian the Tracleer Medication Guide
      • Educate her and her parent/guardian about the risk of serious birth defects
      • Counsel her and her parent/guardian to immediately contact her healthcare provider if she gets her menstrual period
  5. Enroll all patients into the Tracleer REMS Program by ensuring patients complete the Tracleer Patient Enrollment and Consent Form
    • Confirm the patient has agreed to comply with program requirements and has signed the form where indicated
    • Fax the completed form, along with all patient insurance information, including prescription drug benefits and medical benefits, to Actelion Pathways® at 1-866-279-0669. Actelion Pathways administers the Tracleer REMS Program
    • Keep the original form with the patient’s records
  6. Check patient's liver function and pregnancy status (if patient is a Female 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 female patients of reproductive potential:
      • Prior to initiating treatment
      • Monthly during treatment
      • One month after stopping treatment
  7. Monitor all patients throughout treatment
    • For all patients, prescribers must
      • Order and review liver function tests monthly during treatment with Tracleer
      • For changes in aminotransferase levels, adjust the monitoring and treatment with Tracleer
      • Discontinue Tracleer if aminotransferase elevations are accompanied by signs or symptoms of liver dysfunction or injury or increases in bilirubin ≥2 x ULN
    • For Females of Reproductive Potential, prescribers must:
      • Order and review pregnancy tests monthly during treatment with Tracleer and for one month after stopping treatment
      • Notify the patient and Actelion if her pregnancy test is positive
      • Monitor patients' reproductive status during treatment with Tracleer and report any changes or misclassifications to the Tracleer REMS Program by completing and submitting the Tracleer REMS Change in Reproductive Potential Status and Pre-pubertal Annual Verification Form within 10 business days of becoming aware of the change
    • For Females of Non-Reproductive Potential, prescribers must:

Reporting to Actelion
To report any pregnancies and suspected adverse reactions, including liver injury, contact Actelion at 1-866-228-3546.
Reporting to FDA MedWatch
Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.