PS Ambrisentan Pharmacy Guide

PS-AMBRISENTAN RISK EVALUATION AND MITIGATION STRATEGY (REMS)

Please visit www.PSAmbrisentanREMS.com or call 1-888-301-0333 9am to 5pm ET, Monday - Friday

Pharmacy Guide for the
PS-Ambrisentan REMS

This document is part of an FDA-approved REMS
Version 1.0 March 2019

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Table of Contents 3
4
PS-Ambrisentan REMS 6
Outpatient Pharmacy Overview of the PS-Ambrisentan REMS 7
Central Fill Pharmacies in the PS-Ambrisentan REMS 9
Originating Pharmacies using a Central Fill Pharmacy in the PS-Ambrisentan REMS 11
Specialty Pharmacies in the PS-Ambrisentan REMS 12
Validating or Obtaining a REMS Dispense Authorization
Inpatient Pharmacy Overview of the PS-Ambrisentan REMS

This document is part of an FDA-approved REMS
Version 1.0 March 2019

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PS-Ambrisentan REMS PS-Ambrisentan REMS

Indication Because of the risk of serious birth defects,
ambrisentan is only available to females through a
Ambrisentan is an endothelin receptor antagonist restricted distribution program under an FDA-
indicated for the treatment of pulmonary arterial required REMS. The PS-Ambrisentan REMS
hypertension (PAH) (WHO Group1): helps ensure the benefits of ambrisentan outweigh
the risk of embryo-fetal toxicity. The goal of the
• To improve exercise ability and delay PS-Ambrisentan REMS is to mitigate the risk of
clinical worsening. embryo-fetal toxicity associated with ambrisentan
by:
Studies establishing effectiveness included trials 1.Ensuring prescribers are educated on the
predominantly in patients with WHO Functional Class
II–III symptoms and etiologies of idiopathic or following:
heritable PAH (60%) or PAH associated with
connective tissue diseases (34%). • the risk of embryo-fetal toxicity

Risk of embryo-fetal toxicity 2.Ensuring prescribers are educated on

Ambrisentan may cause fetal harm when and adhere to the following:
administered to a pregnant female and is
contraindicated during pregnancy. There are • counseling patients about the risk
limited data on ambrisentan use in pregnant and the need for monthly monitoring
females; the possibility of serious birth defects in
humans cannot be excluded. • enrolling patients in the
PS-Ambrisentan REMS
Pregnancy must be excluded prior to the initiation
of ambrisentan treatment, monthly thereafter, and • monitoring patients at baseline and
for one month after stopping treatment. monthly

3.Ensuring that pharmacies are educated

on the following:

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• the risk of embryo-fetal toxicity implementation of and compliance with the
4.Ensuring that pharmacies are educated REMS on behalf of the pharmacy.

on and adhere to the following: • Have the authorized representative review the
• confirming that the appropriate Pharmacy Guide.

patient monitoring and counseling • Have the authorized representative enroll in the
has occurred before dispensing REMS by completing the Outpatient Pharmacy
ambrisentan Enrollment Form and submitting it to the REMS.
5.Ensuring that patients are informed Outpatient pharmacies must enroll as one of the
about: following pharmacy types:
• the risk of embryo-fetal toxicity 1. A retail pharmacy that agrees to order
• appropriate baseline and monthly ambrisentan on a per patient per prescription
patient monitoring basis
• appropriate contraception 2. A central fill pharmacy
3. A specialty pharmacy
Outpatient Pharmacy Overview
of the PS-Ambrisentan REMS Each of these pharmacy types have specific
requirements that must be followed to dispense an
Outpatient pharmacies must be specially certified ambrisentan prescription.
in the PS-Ambrisentan REMS to dispense
ambrisentan, even if the pharmacy has previously • Train all relevant staff involved in dispensing
enrolled in the Letairis REMS. ambrisentan on the REMS requirements using the
Pharmacy Guide.
To become certified to dispense, an outpatient
pharmacy must: • Establish processes and procedures to verify if the
female of reproductive potential is counseled and
• Designate an authorized representative to carry the authorization number is valid.
out the certification process and oversee

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Before dispensing ambrisentan, an outpatient • Not distribute, transfer, loan, or sell ambrisentan,
pharmacy must: except to certified dispensers.

• Obtain authorization to dispense each prescription • For pharmacies authorized to receive bulk
from the REMS to verify female patients are shipments: Maintain and submit records of daily
enrolled, the reproductive status has not changed, product dispensing data.
the prescriber is certified, and pregnancy test is
completed for females of reproductive potential or • Maintain records that all processes and procedures
the prescriber authorizes the refill through the are in place and are being followed.
processes and procedures established as a
requirement of the REMS. • Comply with audits carried out by the
manufacturers or a third party acting on behalf of
• For patients who provide the authorization the manufacturers to ensure that all processes and
number: Verify the authorization number is valid procedures are in place and are being followed.
through the processes and procedures established
as a requirement of the REMS. The following sections explain the roles and
requirements of the different pharmacy types in the
• For Females of Reproductive Potential: Verify PS-Ambrisentan REMS.
that the patient is counseled 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, an outpatient pharmacy must: in
• Report pregnancies to the REMS.
• Report a change or misclassification

reproductive status to the REMS.

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Central Fill Pharmacies in the • Train all relevant staff involved in
PS-Ambrisentan REMS dispensing ambrisentan on the REMS
requirements using the Pharmacy Guide.
A central fill pharmacy is a pharmacy that fills
prescriptions on behalf of an originating pharmacy • Establish processes and procedures to verify
with which it has a contractual agreement to if the female of reproductive potential is
provide such services or with which it shares a counseled and the authorization number is
common owner. valid.

Note: A central fill pharmacy may provide a list When a central fill pharmacy receives an
of their participating originating pharmacies to the ambrisentan prescription for a female patient from
PS-Ambrisentan REMS. These pharmacies will an originating pharmacy, the central fill pharmacy
be listed in the "Find a Pharmacy" search provided may fill the prescription only after validating or
to patients and prescribers. obtaining a REMS Dispense Authorization (RDA)
from the PS-Ambrisentan REMS website
In the PS-Ambrisentan REMS, an authorized (www.PSAmbrisentanREMS.com) or REMS
representative of the pharmacy must complete the Coordinating Center.
following steps in the PS-Ambrisentan REMS:
The RDA verifies female patients are enrolled, the
• Carry out the certification process and reproductive status has not changed, the prescriber
oversee implementation of and compliance is certified, and pregnancy test is completed.
with the REMS on behalf of the pharmacy.
The central fill pharmacy shall not fill the
• Review the Pharmacy Guide. prescription if an RDA cannot be obtained or
verified for the patient. The central fill pharmacy
• Enroll in the REMS by completing and must instruct the patient to call the REMS
submitting the Outpatient Pharmacy Coordinating Center to provide the missing
Enrollment Form. information.

For females of reproductive potential: Verify that

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the patient is counseled through the processes and Originating Pharmacies using a
procedures established as a requirement of the Central Fill Pharmacy in the PS-
REMS. If monthly counseling has not been Ambrisentan REMS
completed when an RDA is issued, the RDA will
contain counseling guidelines and a message An originating pharmacy is a retail pharmacy that
indicating to counsel the patient, OR call the fills ambrisentan prescriptions through an
REMS Coordinating Center to receive counseling associated central fill pharmacy. In the PS-
guidelines and then counsel the patient, OR Ambrisentan REMS, originating pharmacies are
instruct the patient to call the REMS Coordinating not required to be certified or enrolled. However,
Center to receive counseling. originating pharmacies must not stock ambrisentan
and must fill ambrisentan prescriptions through a
The central fill pharmacy must record the NDC central fill pharmacy certified in the REMS.
number and days' supply of the dispensed drug
with the REMS once an RDA is validated or When the originating pharmacy receives an
obtained. ambrisentan prescription, the prescription must be
sent to a certified central fill pharmacy to be filled.
For Females of Reproductive Potential, the central
fill pharmacy must dispense no more than a 30 Please see page 6 for the requirements on the
days’ supply of ambrisentan. filling of an ambrisentan prescription by a
Central Fill Pharmacy.
Once the RDA is obtained, the central fill
pharmacy may ship the prescription directly to the
patient or back to the originating pharmacy for
dispensing to the patient.

A central fill pharmacy must maintain and submit
records of daily product dispensing data for
Females of Reproductive potential.

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Pharmacies Ordering on a • Establish processes and procedures to verify
Just-in-Time Basis in the PS- if the female of reproductive potential is
Ambrisentan REMS counseled and the authorization number is
valid.
Pharmacies that do not use a central fill pharmacy
may still certify and enroll in the PS-Ambrisentan • Agree to not stock ambrisentan
REMS. To do so, these pharmacies must agree to
not stock ambrisentan and to only order ambrisentan • Order ambrisentan just-in-time on a per
on a Just-in-Time, per patient per prescription basis patient per prescription basis from a
from a wholesale distributor registered in the PS- wholesale distributor registered in the
Ambrisentan REMS. REMS and provide with the order an
indication that the patient is male or the
In the PS-Ambrisentan REMS, an authorized RDA for a female patient.
representative of the pharmacy must complete the
following steps in the P S - Ambrisentan REMS: • Order and dispense no more than a 30-day
supply to Females of Reproductive
• Carry out the certification process and Potential.
oversee implementation of and compliance
with the REMS on behalf of the pharmacy. When a pharmacy receives an ambrisentan
prescription, the pharmacy must order
• Review the Pharmacy Guide. ambrisentan for this patient and this prescription
from a wholesaler/distributor registered in the PS-
• Enroll in the REMS by completing and Ambrisentan REMS.
submitting the Outpatient Pharmacy
Enrollment Form. Before ordering ambrisentan for a female patient,
the pharmacy must validate or obtain an RDA
• Train all relevant staff involved in from the PS-Ambrisentan REMS website
dispensing ambrisentan on the REMS (www.PSAmbrisentanREMS.com) or the REMS
requirements using the Pharmacy Guide. Coordinating Center. The RDA verifies female
patients are enrolled, the reproductive status has

This document is part of an FDA-approved REMS
Version 1.0 March 2019

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not changed, the prescriber is certified, and Specialty Pharmacies in the PS-
pregnancy test is completed. Ambrisentan REMS

For females of reproductive potential: Verify that In the PS-Ambrisentan REMS, an authorized
the patient is counseled through the processes representative of the specialty pharmacy must
and procedures established as a requirement of complete the following steps in the P S -
the REMS. If monthly counseling has not been Ambrisentan REMS:
completed when an RDA is issued, the RDA will
contain counseling guidelines and a message • Carry out the certification process and
indicating to counsel the patient, OR call the oversee implementation of and compliance
REMS Coordinating Center to receive with the REMS on behalf of the pharmacy.
counseling guidelines and then counsel the
patient, OR instruct the patient to call the REMS • Review the Pharmacy Guide.
Coordinating Center to receive counseling.
• Enroll in the REMS by completing and
The pharmacy must not order ambrisentan for the submitting the Outpatient Pharmacy
prescription if an RDA cannot be obtained or Enrollment Form.
verified for the patient. The pharmacy must
instruct the patient to call the REMS Coordinating • Train all relevant staff involved in
Center to provide the missing information. dispensing ambrisentan on the REMS
requirements using the Pharmacy Guide.
When the ambrisentan is received from the
wholesaler/distributor, the pharmacy may • Establish processes and procedures to verify
dispense to the patient. if the female of reproductive potential is
counseled and the authorization number is
valid.

When a specialty pharmacy receives an
ambrisentan prescription for a female patient, the
pharmacy may fill the prescription only after
validating or obtaining an RDA from the PS-

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Version 1.0 March 2019

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Ambrisentan REMS website For Females of Reproductive Potential, the
(www.PSAmbrisentanREMS.com) or REMS pharmacy must dispense no more than a 30 days’
Coordinating Center. supply of ambrisentan.

The RDA verifies female patients are enrolled, the A specialty pharmacy must maintain and submit
reproductive status has not changed, the prescriber records of daily product dispensing data for
is certified, and pregnancy test is completed. females of reproductive potential.

The pharmacy shall not fill the prescription if an Once the RDA is obtained, the specialty pharmacy
RDA cannot be obtained or verified for the may ship the prescription to the patient.
patient. The pharmacy must instruct the patient to
call the REMS Coordinating Center to provide the
missing information.

For females of reproductive potential: Verify that
the patient is counseled through the processes and
procedures established as a requirement of the
REMS. If monthly counseling has not been
completed when an RDA is issued, the RDA will
contain counseling guidelines and a message
indicating to counsel the patient, OR call the
REMS Coordinating Center to receive counseling
guidelines and then counsel the patient, OR
instruct the patient to call the REMS Coordinating
Center to receive counseling.

The pharmacy must record the NDC number and
days' supply of the dispensed drug with the REMS
once an RDA is validated or obtained.

This document is part of an FDA-approved REMS
Version 1.0 March 2019

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Validating or Obtaining a REMS PS-Ambrisentan REMS Coordinating Center and
Dispense Authorization providing the patient’s name, the patient’s date of
birth and the pharmacy’s NPI number.
Outpatient pharmacies may fill ambrisentan
prescriptions for female patients only after If an RDA cannot be obtained for the patient, the
validating an RDA provided by the patient or by pharmacy should direct the patient to call the PS-
obtaining an RDA from the REMS website or the Ambrisentan REMS Coordinating Center.
REMS Coordinating Center. A new RDA will be
issued for each prescription/refill. Once the RDA is obtained, the pharmacist must
record the NDC number and days supply of the
The female patient may present the RDA to the dispensed product in the PS-Ambrisentan REMS
pharmacist in either a paper or electronic format. website or through the REMS Coordinating
The pharmacist must confirm that the RDA Center. To record the NDC number and days
presented by the patient is valid. The validity can supply, the pharmacy will be required to confirm
be confirmed on the PS-Ambrisentan REMS the patient’s name and date of birth and provide the
system website pharmacy’s NPI number, and the RDA number.
(www.PSAmbrisentanREMS.com) or by
contacting the REMS Coordinating Center at If monthly counseling has not been completed for
1-888-301-0333 and providing the RDA number, the patient when the RDA is issued, the RDA will
and the patient’s date of birth from the RDA as contain counseling guidelines and a message
well as the pharmacy’s NPI number. indicating that the pharmacist must do one of the
following:
If the patient does not provide the RDA, the
pharmacist may obtain the RDA on the PS- 1. Counsel the patient using the counseling
Ambrisentan REMS website or by contacting the guidelines on the RDA

2. Call the REMS Coordinating Center to
receive counseling guidelines and then

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Version 1.0 March 2019

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counsel the patient • Train all relevant staff involved in
dispensing on REMS procedures and
3. Instruct the patient to call the REMS materials using the Pharmacy Guide.
Coordinating Center to receive the
counseling • Establish processes and procedures to verify
the female patient is enrolled or will be
Inpatient Pharmacy Overview of enrolled in the REMS prior to discharge, her
the PS-Ambrisentan REMS reproductive status, and the female patient is
under the supervision and care of a certified
Inpatient pharmacies must be specially certified and prescriber.
enrolled in the PS-Ambrisentan REMS and comply
with the following PS-Ambrisentan REMS • For Females of Reproductive Potential:
requirements to dispense ambrisentan, even if the establish processes and procedures to verify
pharmacy has previously enrolled in the Letairis the pregnancy testing is complete, and the
REMS. patient is counseled on the risk of embryo-
fetal toxicity, the need to use highly reliable
An authorized representative of the inpatient contraception during treatment and for one
pharmacy must: month after stopping treatment, to get
monthly pregnancy tests, and to inform the
• Carry out the certification process and prescriber of a pregnancy immediately.
oversee implementation of and compliance
with the REMS on behalf of the pharmacy. Prior to dispensing, the inpatient pharmacy must:

• Review the Pharmacy Guide. • Verify the female inpatient is under the
• Enroll in the REMS by completing and supervision and care of a certified
prescriber, her reproductive status, and she
submitting the Inpatient Pharmacy is enrolled or will be enrolled in the REMS
Enrollment Form. prior to discharge through the processes and

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procedures established as a requirement of • Maintain records that all processes and
the REMS. procedures are in place and are being
• For Females of Reproductive Potential: followed.
Verify the pregnancy testing is complete,
the patient is counseled on the risk of • Comply with audits carried out by the
embryo-fetal toxicity, the need to use highly manufacturers or a third party acting on
reliable contraception during treatment and behalf of the manufacturers to ensure that all
for one month after stopping treatment, to processes and procedures are in place and
get monthly pregnancy tests, and to inform are being followed.
the prescriber of a pregnancy immediately
through the processes and procedures Options for Enrolling in the PS-
established as a requirement of the REMS. Ambrisentan REMS

At discharge of a patient, the inpatient pharmacy Pharmacies may enroll in the PS-Ambrisentan
must: REMS online at www.PSAmbrisentanREMS.com
or by completing a paper enrollment form and
• Dispense no more than a 15-days’ supply of faxing it to the REMS Coordinating Center at
ambrisentan upon discharge. 1-888-870-1819.

At all times, the inpatient pharmacy must:
• 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.

This document is part of an FDA-approved REMS
Version 1.0 March 2019

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Additional questions

Please visit www.PSAmbrisentanREMS.com or call the PS-Ambrisentan REMS
Coordinating Center at 1-888-301-0333 for more information about the PS-
Ambrisentan REMS.

This document is part of an FDA-approved REMS
Version 1.0 March 2019

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This document is part of an FDA-approved REMS
Version 1.0 March 2019

15