Tracleer medication guide

Classified as non-formulary. Automatic interchange for ADULT patients.

Interchange not appropriate for pediatric patients: Inpatients may use home supply of bosentan, or physician to be contacted to discuss alternatives.

1. If a new start (male or female), confirm with the Bosentan REMS (1-866-359-2612) that the prescriber is authorized.
2. If a new start (male or female) verify with the REMS that the patient is enrolled OR verify with the prescriber that the patient will be enrolled prior to discharge and that counseling on pregnancy (for females of reproductive potential) and liver testing has been completed.
3. For new starts and continuance of home med, verify in all patients that liver testing has been done and that AST/ALT are < 3 x the ULN, and a pregnancy test for females of reproductive potential.
4. For continuance of home med (male or female), verify patient is enrolled in the REMS, check that AST/ALT are < 3 x ULN, and a pregnancy test for females of reproductive potential.
5. For all patients, complete a REMS progress note.  A Dispense Authorization # is not needed for inpatient pharmacies.

For Formulary Substitution from bosentan to macitentan for ADULT patients:

1. If the patient was on bosentan as an outpatient and auto-subbed to macitentan as an inpatient, verify patient enrolled in the bosentan REMS.
2. For short-term substitution while an inpatient, the patient does NOT need to be enrolled in the macitentan REMS. 
3. The prescriber continuing the outpatient medication does NOT need to be an authorized prescriber with the REMS program.

Reviewed: April 27, 2005

Updated: June 2020

REMS: View FDA REMS Info

• Micromedex
• UpToDate
• Lippincott Advisor