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The goal of the Bosentan REMS Program is to mitigate the risk of hepatotoxicity and embryofetal
toxicity associated with bosentan by:
Ensuring prescribers are educated on the following:
the risks of hepatotoxicity and embryo-fetal toxicity
Ensuring prescribers are educated on and adhere to the following:
counseling patients about these risks and the need for monthly monitoring
enrolling patients in the Bosentan REMS Program
monitoring patients at baseline and monthly
Ensuring that pharmacies are educated on the following:
the risks of hepatotoxicity and embryo-fetal toxicity
Ensuring that pharmacies are educated on and adhere to the following:
confirming that the appropriate patient monitoring and counseling has occurred before dispensing bosentan
Ensuring that patients are informed about:
the risks of hepatotoxicity and embryo-fetal toxicity
appropriate baseline and monthly patient monitoring
appropriate contraception
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.
REMS assessment plan unavailable for posting at this time.
What updates have been made to the REMS?
Date
Summary of change
04/29/2022
Modified to:
Changes to the outpatient pharmacy operations to verify safe use conditions for the
REMS Pre-Dispense Authorization (PDA).
Addition of the Prescriber Designee role on the REMS website to allow prescribers
to delegate certain administrative activities.
Changes to the REMS website to allow certified pharmacies to enter testing and
counseling information through the REMS website and allow pharmacists requesting a PDA to confirm counsling information.
Changes to the pre-recorded messages in the Interactive Voice Response (IVR)
system to align with the proposed modifications and new workflow.
Conversion of the REMS Document to the new, standardized format.
05/20/2019
Revised to make an editorial change.
04/26/2019
Modified to establish a Single Shared System REMS for the elements to assure safe use and the implementation system required for the reference listed drug (RLD) Tracleer and ANDAs referencing Tracleer, called the Bosentan REMS Program. This modification also removes the Medication Guide as an element 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.
