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REMS that have more than one drug product but are not Shared System REMS will not display the product name and ingredient properly on this website due to database limitations. Please refer to the REMS document for the correct product names.
The goal of the TRYVIO (aprocitentan) REMS is to mitigate the risk of embryo-fetal toxicity associated with
TRYVIO.
Objective: Ensure that prescribers are aware of the risk of embryo-fetal toxicity associated with
TRYVIO and the need to counsel patients who can become pregnant on the actions
necessary to prevent pregnancy and minimize exposure to a fetus.
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.
Enroll in the REMS by completing and submitting the Prescriber
Enrollment Form to the REMS.
| Prescriber Enrollment Form |
Before treatment
initiation (First dose)
Assess the patient’s reproductive status using the definitions in
the Prescriber and Pharmacy Guide.
| Prescriber and Pharmacy Guide |
For patients who can become pregnant: Counsel the patient on
the risk of embryo-fetal toxicity, to use acceptable contraception,
pregnancy testing recommendations before initiating treatment,
monthly during treatment, and one month after discontinuing
treatment, and the use of emergency contraception using the
Patient Guide. Provide a copy of the material to the patient.
| Patient Guide |
At all times
Report pregnancies to the REMS.
Patients who are prescribed TRYVIO:
Before treatment
For patients who can become pregnant: Review the Patient
Guide.
| Patient Guide |
For patients who can become pregnant: Receive counseling from
the prescriber on the risk of embryo-fetal toxicity, the need to
use acceptable contraception, pregnancy testing
recommendations before initiating treatment, monthly during
treatment, and one month after discontinuing treatment, and the
use of emergency contraception using the Patient Guide.
| Patient Guide |
During treatment
Receive a Risk of Birth Defects with TRYVIO from the
pharmacy or the prescriber who dispenses the drug.
| Risk of Birth Defects with TRYVIO |
At all times
For patients who can become pregnant: Inform the prescriber
immediately if you miss a menstrual period or suspect a
pregnancy.
Outpatient pharmacies and prescribers that dispense TRYVIO must:
To become certified to
dispense
For outpatient pharmacies: Designate an authorized
representative to carry out the certification process and oversee
implementation and compliance with the TRYVIO REMS on behalf
of the outpatient pharmacy.
For outpatient pharmacies: Have the authorized representative
enroll in the TRYVIO REMS by completing and submitting the
Outpatient Pharmacy Enrollment Form to the REMS.
| Outpatient Pharmacy Enrollment Form |
For prescribers who dispense: Complete the certified dispenser
section of the Prescriber Enrollment Form.
| Prescriber Enrollment Form |
Train all relevant staff involved in dispensing on the REMS
requirements, procedures, and REMS materials.
Establish processes and procedures to report a pregnancy to the
REMS.
Establish processes and procedures to provide the Risk of Birth
Defects with TRYVIO to each patient each time TRYVIO is
dispensed.
| Risk of Birth Defects with TRYVIO |
Before dispensing
For outpatient pharmacies: Obtain authorization to dispense each
prescription by contacting the REMS to verify the prescriber is
certified.
Provide the patient with the Risk of Birth Defects with TRYVIO
through the processes and procedures established as a
requirement of the REMS.
| Risk of Birth Defects with TRYVIO |
For prescribers who dispense: Report dispensing TRYVIO to the
REMS.
To maintain certification to dispense
Have a new authorized representative enroll by completing and
submitting the Outpatient Pharmacy Enrollment Form, if the
authorized representative changes.
| Outpatient Pharmacy Enrollment Form |
At all times
Report pregnancies to the REMS.
Not distribute, transfer, loan, or sell TRYVIO except to certified
pharmacies.
Maintain records that all processes and procedures are in place
and are being followed.
Comply with audits carried out by Idorsia Pharmaceuticals Ltd or
a third party acting on behalf of Idorsia Pharmaceuticals Ltd to
ensure that all processes and procedures are in place and are
being followed.
Inpatient pharmacies that dispense TRYVIO 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 review the Prescribing
Information and the Prescriber and Pharmacy Guide.
| Prescriber and Pharmacy Guide |
Have the authorized representative enroll in the TRYVIO REMS by
completing and submitting the Inpatient Pharmacy Enrollment
Form to the REMS.
| Inpatient Pharmacy Enrollment Form |
Train all relevant staff involved in dispensing TRYVIO on the REMS
requirements, procedures, and REMS materials.
Establish processes and procedures to verify the prescriber is
certified or the patient is under the supervision and care of a
certified prescriber.
Establish processes and procedures to report pregnancies to the
REMS.
Establish processes and procedures to provide the Risk of Birth
Defects with TRYVIO to each patient each time TRYVIO is
dispensed at patient discharge.
| Risk of Birth Defects with TRYVIO |
Before dispensing
Verify the prescriber is certified or the patient is under the
supervision and care of a certified prescriber through the
processes and procedures established as a requirement of the
REMS.
To maintain certification
to dispense
Have a new authorized representative enroll by completing and
submitting the Inpatient Pharmacy Enrollment Form if the
authorized representative changes.
| Inpatient Pharmacy Enrollment Form |
At discharge
Provide the patient with the Risk of Birth Defects with TRYVIO
through the processes and procedures established as a
requirement of the REMS.
| Risk of Birth Defects with TRYVIO |
At all times
Report pregnancies to the REMS.
Not distribute, transfer, loan, or sell TRYVIO except to certified
pharmacies.
Maintain records that all processes and procedures are in place
and are being followed.
Comply with audits carried out by Idorsia Pharmaceuticals Ltd or
a third party acting on behalf of Idorsia Pharmaceuticals Ltd to
ensure that all processes and procedures are in place and are being followed.
Wholesalers-distributors that distribute TRYVIO must:
To be able to distribute
Establish processes and procedures to ensure that the drug is
distributed only to certified pharmacies and certified prescribers who
can dispense.
Train all relevant staff involved in distribution on the REMS
requirements.
At all times
Distribute only to certified pharmacies and certified prescribers who
can dispense.
Maintain records that all processes and procedures are in place and are
being followed.
Comply with audits carried out by Idorsia Pharmaceuticals Ltd or a third
party acting on behalf of Idorsia Pharmaceuticals Ltd 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 Tryvio REMS, see the DailyMed link(s).
REMS assessment plan unavailable for posting at this time.
What updates have been made to the REMS?
Date
Summary of change
03/19/2024
Approval of the 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.
