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The goal of the Ambrisentan REMS Program is to mitigate the risk of embryo-fetal toxicity associated
with ambrisentan by:
Ensuring prescribers are educated on the following:
the risk of embryo-fetal toxicity
Ensuring prescribers are educated on and adhere to the following:
counseling patients about the risk and the need for monthly monitoring
enrolling patients in the Ambrisentan REMS Program
monitoring patients at baseline and monthly
Ensuring that pharmacies are educated on the following:
the risk 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 ambrisentan
Ensuring that patients are informed about:
the risk 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
06/08/2021
Modified to:
Remove the pop-up on the Ambrisentan REMS website home page.
Align the inpatient and outpatient pharmacy requirements within the Prescriber and Pharmacy guide and the REMS website with the REMS document.
Remove the term "for approval" from the Outpatient Pharmacy requirement regarding the authorization to dispense a greater than 30-day supply in the Prescriber and Pharmacy Guide and REMS Website.
12/22/2020
Modified the Prescriber and Pharmacy Guide and on the REMS website changes were
made to:
Clarify inpatient pharmacy requirements for when an enrolled patient is continuing ambrisentan in the inpatient setting and is already under the
supervision and care of a certified prescriber to align with the existing inpatient pharmacy requirements in the approved REMS document.
Include a provision for prescribers to authorize a greater than 30-day supply for females of reproductive potential due to travel or personal
extenuating circumstances at the prescriber’s medical discretion. Addition of certified outpatient pharmacy listings and links to Spanish language
REMS materials on the REMS website. A new office contact portal.
03/28/2019
Approval of 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.
