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The goal of the Macitentan-Containing Products REMS is to mitigate the risk of embryo-fetal toxicity associated with
macitentan-containing products by:
Ensuring prescribers are educated on the following:
the risks of 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 Macitentan-Containg Products REMS
monitoring patients at baseline and monthly
Ensuring that pharmacies are educated on the following:
the risks of 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 macitentan-containing products
Ensuring that patients are informed about:
the risks of 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
03/22/2024
The approval of Opsynvi (NDA 218490) on 3/22/2024 effectively replaced the Macitentan SS REMS with the Macitentan-Containing Products REMS. The 4/11/2024 approval to the DMF was to bring the reference drug and the ANDA application holders into compliance with the Macitentan-Containing Products REMS (approved on 3/22/2024). The changes with the REMS described in 4/11/2024 occurred with the approval of Opsynvi (3/22/2024). We are providing a REMS document with the most recent approval date (which is 3/2024) to include on the REMS@FDA website.
02/01/2023
Modified to:
Streamline the REMS by removing redundancies and unnecessary features
including the Patient Enrollment Form – For VA Use Only, Patient Pre-Enrollment
functionality, Patient Portal, and patient’s ability to initiate Prescriber Transfer.
Change the outpatient pharmacy certification and REMS Dispensing
Authorization (RDA) processes to ensure REMS requirements are met prior to
dispensing.
Update the Prescriber and Pharmacy Guide to include additional instructions
for pharmacies to provide reasons for dispensing a greater than 30 days’ for a
female of reproductive potential and to provide reasons for treatment interruption.
Update the REMS assessment timetable.
Update the REMS website URL and website functionality to remove duplicate
screens and to align with updated processes.
04/06/2021
Approval of the Shared System 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.
