The .gov means it's official. Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.
The site is secure. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.
The goal of the Ambrisentan REMS is to mitigate the risk of embryo-fetal toxicity associated with
ambrisentan by:
Ensuring prescribers are educated about the risk of embryo-fetal toxicity
Ensuring prescribers are educated on and adhere to counseling patients about the risk and the
need for monthly monitoring; enrolling patients in the Ambrisentan REMS; and monitoring patients
at baseline and monthly
Ensuring that pharmacies are educated about the risk of embryo-fetal toxicity
Ensuring that pharmacies are educated on and adhere to 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, and 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.
For all females: Assess the patient’s reproductive status using the
definitions in the Prescriber and Pharmacy Guide. Document and submit
the results to the REMS using the Patient Enrollment Form.
| Prescriber and Pharmacy Guide |
| Patient Enrollment and Consent Form |
For all females: Counsel the patient that the drug is only available
through a restricted distribution program.
For females of reproductive potential: Counsel the patient on the risk of
embryo-fetal toxicity, the need to use highly reliable contraception during
treatment and for one month following treatment discontinuation, and
emergency contraception using the Guide for Female Patients.
| Guide for Female Patients |
For females of reproductive potential: Assess the patient’s pregnancy
status by ordering and reviewing her pregnancy test result.
For pre-pubertal females: Counsel the patient on the risk of embryo-fetal
toxicity using the Guide for Female Patients.
| Guide for Female Patients |
For females of reproductive potential: Counsel the patient if she is not
complying with the required testing or if she is not using appropriate
contraception.
For females of reproductive potential: Assess the patient’s pregnancy
status by ordering and reviewing her pregnancy test result.
Enroll in the REMS by completing the Patient Enrollment Form with the
prescriber. Enrollment information will be provided to the REMS.
| Patient Enrollment and Consent Form |
Receive counseling from the prescriber on the risk of embryo-fetal toxicity
and the need to use highly reliable contraception during treatment and for
one month following treatment discontinuation, and emergency
contraception using the Guide for Female Patients.
| Guide for Female Patients |
During treatment, before dispensing
Receive counseling from the pharmacy or healthcare provider who
dispenses ambrisentan on the risk of embryo-fetal toxicity, the need to use
highly reliable contraception during treatment and for one month following
treatment discontinuation, emergency contraception, to get monthly
pregnancy tests, and to report a pregnancy immediately.
Get a pregnancy test.
Adhere to the safe use condition: Communicate with the pharmacy to
confirm completion of pregnancy testing.
During treatment and
after treatment
discontinuation for
one month
Adhere to the safe use condition: Use highly reliable contraception as
described in the Guide for Female Patients.
| Guide for Female Patients |
After treatment
discontinuation, for
one month
Get a pregnancy test.
Pre-pubertal females who are prescribed ambrisentan:
Enroll in the REMS by completing the Patient Enrollment Form with the
prescriber. Enrollment information will be provided to the REMS.
| Patient Enrollment and Consent Form |
Receive counseling from the prescriber on the risk of embryo-fetal toxicity
using the Guide for Female Patients.
| Guide for Female Patients |
At all times
If over the age of 8: Be monitored for a change in reproductive status.
Inform the prescriber if there is a change in your reproductive status.
Post-menopausal females or females with other medical reasons for permanent,
irreversible infertility who are prescribed ambrisentan:
Enroll in the REMS by completing the Patient Enrollment Form with the
prescriber. Enrollment information will be provided to the REMS.
| Patient Enrollment and Consent Form |
At all times
Inform the prescriber if there is a change in your reproductive status.
Outpatient pharmacies and healthcare providers that dispense ambrisentan must:
To become certified to dispense
Designate an authorized representative to carry out the certification
process and oversee implementation and compliance with the REMS on
behalf of the pharmacy.
Have the authorized representative enroll in the REMS by completing the
Outpatient Pharmacy Enrollment Form and submitting it to the REMS.
| Outpatient Pharmacy Enrollment Form |
Train all relevant staff involved in dispensing ambrisentan on the REMS
requirements using the Prescriber and Pharmacy Guide.
| Prescriber and Pharmacy Guide |
For females of reproductive potential: Establish processes and procedures
to verify that pregnancy testing is complete or the prescriber authorizes
the refill.
Before dispensing
For females of reproductive potential: Counsel the patient on the risk of
embryo-fetal toxicity, the need to use highly reliable contraception during
treatment and for one month following treatment discontinuation,
emergency contraception, to get monthly pregnancy tests, and inform the
prescriber of a pregnancy immediately.
Obtain authorization to dispense each prescription by contacting the REMS
to verify the female patient is enrolled, the reproductive status has not
changed, and the prescriber is certified.
For females of reproductive potential: Verify that the pregnancy testing is
complete or the prescriber authorizes the refill through the processes and
procedures established as a requirement of the REMS.
For females of reproductive potential: Dispense no more than a 30 days’
supply.
At all times
Report pregnancies to the REMS.
Report a change or misclassification in reproductive status to the REMS.
Not distribute, transfer, loan, or sell ambrisentan, except to certified
dispensers.
For females of reproductive potential: Maintain and submit records of daily
product dispensing data.
Maintain records that all processes and procedures are in place and are
being followed.
Comply with audits carried out by the manufacturers or a third party
acting on behalf of the manufacturers to ensure that all processes and
procedures are in place and are being followed.
Inpatient pharmacies that dispense ambrisentan must:
To become certified
to dispense
Designate an authorized representative to carry out the certification
process and oversee implementation and compliance with the REMS on
behalf of the pharmacy.
Have the authorized representative enroll in the REMS by completing
Inpatient Pharmacy Enrollment Form and submitting it to the REMS.
| Inpatient Pharmacy Enrollment Form |
Train all relevant staff involved in dispensing ambrisentan on the REMS
requirements using the Prescriber and Pharmacy Guide.
| Prescriber and Pharmacy Guide |
Establish processes and procedures to verify the female patient is enrolled
or will be enrolled in the REMS prior to discharge, her reproductive status,
and the female patient is under the supervision and care of a certified
prescriber.
For females of reproductive potential: Establish processes and procedures
to verify pregnancy testing is complete, the patient is counseled on the
risk of embryo-fetal toxicity, the need to use highly reliable contraception
during treatment and for one month following treatment discontinuation,
to get monthly pregnancy tests, and to inform the prescriber of a
pregnancy immediately.
Before Dispensing
Verify the female patient is under the supervision and care of a certified
prescriber, her reproductive status, she is enrolled or will be enrolled in
the REMS prior to discharge through the processes and procedures
established as a requirement of the REMS.
For females of reproductive potential: Verify that pregnancy testing is
complete, the patient is counseled on the risk of embryo-fetal toxicity, the
need to use highly reliable contraception during treatment and for one
month after stopping treatment, to get monthly pregnancy tests, and to
inform the prescriber of a pregnancy immediately through the processes
and procedures established as a requirement of the REMS.
At discharge
Dispense no more than a 15 days’ supply.
At all times
Report pregnancies to the REMS.
Report a change or misclassification in reproductive status to the REMS.
Not distribute, transfer, loan, or sell ambrisentan, except to certified
dispensers.
Maintain records that all processes and procedures are in place and are
being followed.
Comply with audits carried out by the manufacturers or a third party
acting on behalf of the manufacturers to ensure that all processes and
procedures are in place and are being followed.
Wholesalers-distributors that distribute ambrisentan must:
To be able to distribute
Establish processes and procedures to ensure that the drug is distributed
only to certified pharmacies.
Train all relevant staff involved in distribution on the REMS requirements.
At all times
Distribute only to certified pharmacies.
Maintain records of drug distribution.
Comply with audits carried out by the manufacturers, or a third party
acting on behalf of the manufacturers to ensure that all processes and
procedures are in place and are being followed.
What materials are included in the REMS?
The REMS includes a REMS Document.
In addition, the REMS includes the following materials intended for patients and healthcare providers. For a specific Medication Guide of a product in the Ambrisentan Shared System REMS, see the DailyMed link on the Products tab.
This webpage provides REMS assessment plan measures, metrics, and indicators for drug and biological products with a REMS. The REMS assessment plan measures, metrics, and indicators are part of the overall REMS assessment plan used by FDA to evaluate the performance of a REMS and are included in FDA approval letters. The current REMS assessment plan measures, metrics, and indicators are extracted from regulatory letters that contain REMS information, including FDA approval letters, and posted here as they become available.
What updates have been made to the REMS?
Date
Summary of change
08/19/2024
Modified to:
Change the timetable for submission of assessments to September 28, 2024
and annually thereafter.
Update the REMS Document formatting to include the risk of embryofetal
toxicity in the Administrative Information section and adding section VI for
Statutory Elements.
Update pharmacy requirements in the REMS Document and Outpatient
Pharmacy Enrollment Form to align with REMS operations. Additional updates
clarify the Role of Certified Pharmacies in the Prescriber and Pharmacy Guide
and REMS Website.
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.