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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.
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 Program 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 |
Enroll all female patients by completing the Patient Enrollment
Form and submitting it to the REMS Program.
| Patient Enrollment and Consent Form |
During treatment; before each prescription
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 Program by completing the Patient Enrollment Form with the
prescriber. Enrollment information will be provided to the REMS Program.
| 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 discontuation; one month
Get a pregnancy test.
Pre-pubertal females who are prescribed ambrisentan:
Enroll in the REMS Program by completing the Patient Enrollment Form with the
prescriber. Enrollment information will be provided to the REMS Program.
| 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 Program by completing the Patient Enrollment Form with the
prescriber. Enrollment information will be provided to the REMS Program.
| 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 Program on behalf of the
pharmacy.
Have the authorized representative enroll in the REMS Program by completing the
Outpatient Pharmacy Enrollment Form and submitting it to the REMS Program.
| Outpatient Pharmacy Enrollment Form |
Train all relevant staff involved in dispensing ambrisentan on the REMS Program
requirements using the Prescriber and Pharmacy Guide.
| Prescriber and Pharmacy Guide |
Establish processes and procedures to verify the female patient is enrolled, the
reproductive status of the patient has not changed, and the prescriber is certified
for all patients.
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 embryofetal
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.
Verify the female patient is enrolled, the reproductive status has not changed,
and the prescriber is certified through the processes and procedures established
as a requirement of the REMS Program.
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 Program.
For females of reproductive potential: Dispense no more than a 30 days’ supply.
At all times
Report pregnancies to the REMS Program.
Report a change or misclassification in reproductive status to the REMS
Program.
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 Program on
behalf of the pharmacy.
Have the authorized representative enroll in the REMS Program by completing
Inpatient Pharmacy Enrollment Form and submitting it to the REMS Program.
| Inpatient Pharmacy Enrollment Form |
Train all relevant staff involved in dispensing ambrisentan on the REMS
Program 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 Program 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 Program prior to discharge through the processes and procedures
established as a requirement of the REMS Program.
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 Program.
At discharge
Dispense no more than a 15 days’ supply.
At all times
Report pregnancies to the REMS Program.
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 Program
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.
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.
