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

Pharmacy Certification

Due to the risk of hepatotoxicity and teratogenicity, Tracleer is only available through a network of certified pharmacies.

Outpatient Pharmacy Certification

Tracleer will be dispensed to outpatients by a limited number of certified pharmacies. Prior to dispensing Tracleer, the pharmacy will confirm that the prescriber who wrote the prescription and the patient are enrolled in the Tracleer REMS Program. If either the patient or prescriber is not enrolled, Tracleer will not be dispensed.

All patients will only be able to get a 30-day supply of Tracleer at one time. The Tracleer Medication Guide will be provided to all patients each time Tracleer is dispensed.

All patients will be contacted each month by the pharmacy to arrange dispensing of Tracleer.

For all patients, the pharmacy will:

  • Ask if he/she has had a liver function test within the last month (30 days)

For Females of Reproductive Potential, the pharmacy will:

  • Ask the patient if she has had a pregnancy test within the last month
  • Counsel her on the need to use reliable contraception during Tracleer treatment and for one month after stopping treatment
  • Counsel her to inform her prescriber immediately if she misses a menstrual period or suspects that she may be pregnant or if her reproductive status changes

For Pre-pubertal Females, the pharmacy will:

  • Counsel her to inform her prescriber immediately if her reproductive status changes

Inpatient Pharmacy Certification

Only inpatient pharmacies (including, but not limited to, hospitals, long-term care facilities, prisons, and state psychiatric units) that are certified in the Tracleer REMS Program may stock and dispense Tracleer for patients being treated in the inpatient setting.

By certifying in to the Tracleer REMS Program, the inpatient pharmacy agrees to:

  • Complete training in the Tracleer REMS Program by reading the Prescribing Information, Medication Guide and the Prescriber and Pharmacy Guide for the Tracleer REMS Program
  • Train all dispensing staff on the Tracleer REMS Program requirements and Tracleer REMS materials before they dispense Tracleer
  • Put processes and procedures in place to ensure the REMS requirements are met
  • Dispense only to those patients under the supervision and care of a healthcare provider who is enrolled in the Tracleer REMS Program
  • Dispense to a patient only after he/she has been enrolled in the Tracleer REMS Program or if he/she will be enrolled prior to discharge from the healthcare facility. A patient who has not been enrolled by the certified prescriber will not have access to Tracleer in the outpatient setting until registration has been completed
  • Dispense no more than a fifteen (15) day temporary supply of Tracleer upon discharge of any patient
  • Notify Actelion or FDA of any adverse events, including hepatotoxicity, and report any pregnancy during Tracleer treatment
  • Not transfer Tracleer to any pharmacy, practitioner or any healthcare setting not certified by Actelion Pathways
  • Develop a process to track compliance with the conditions above and provide information about its compliance to Actelion

To be certified in the Tracleer REMS Program, an authorized representative of the inpatient pharmacy must:

  • Agree to follow the REMS requirements by completing and submitting a Tracleer REMS Inpatient Pharmacy Enrollment Form to the Tracleer REMS Program
  • Fax the completed form to Actelion Pathways at 1-866-279-0669
  • Agree that the pharmacy may be subject to an audit by the FDA, Actelion, or a designated third party

If an inpatient pharmacy needs Tracleer and is not enrolled in the Tracleer REMS Program, the inpatient pharmacy can contact Actelion Pathways at 1-866-228-3546 for assistance in obtaining a 15 day supply of Tracleer while initiating enrollment.

Certified Pharmacies

For information on any changes to the list of Tracleer certified pharmacies, please call Actelion Pathways® at 1-866-228-3546.

  • Accredo Specialty Pharmacy
  • Aetna Specialty Pharmacy
  • Axium Healthcare Pharmacy
  • CVS Specialty Pharmacy
  • Cigna Pharmacy
  • Humana RightSource Specialty Pharmacy
  • Kaiser Specialty Pharmacy
  • OptumRx Specialty Pharmacy
  • Walgreens Specialty Pharmacy