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The goal of the Riociguat REMS Program is to mitigate the risk of embryo-fetal toxicity associated with riociguat 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 Riociguat 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 riociguat
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.
Enroll in the REMS by completing the Prescriber Enrollment and Agreement
Form and submitting it to the REMS Program.
| Prescriber Enrollment and Agreement Form |
Before treatment
initiation (first
dose)
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 and
Consent 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 effective contraception during
treatment and for one month following treatment discontinuation,
emergency contraception, and to immediately contact her prescriber if she
misses a menstrual period or suspects that she is pregnant 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 and to immediately contact her prescriber if she begins to
menstruate using the Guide for Female Patients.
| Guide for Female Patients |
Enroll all female patients by completing and submitting the Patient
Enrollment and Consent 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 effective
contraception, and to immediately contact her prescriber if she misses a
menstrual period or suspects that she is pregnant.
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 and
Consent 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,
the need to use effective contraception during treatment and for one month
following treatment discontinuation, emergency contraception, and to
immediately contact her prescriber if she misses a menstrual period or
suspects that she is pregnant using the Guide for Female Patients.
| Guide for Female Patients |
Adhere to the safe use condition: Communicate with the pharmacy to confirm
completion of pregnancy testing.
Before dispensing
Receive counseling from the pharmacy or the prescriber who dispenses
riociguat on the risk of embryo-fetal toxicity, the need for effective
contraception during treatment and for one month after stopping treatment,
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 effective contraception as described in
the Guide for Female Patients.
| Guide for Female Patients |
Agree to be contacted by REMS Program if you become pregnant.
After treatment
discontinuation;
one month
Get a pregnancy test.
At all times
discontinuation;
one month
Inform the prescriber immediately if you miss a menstrual period or suspect a
pregnancy.
Pre-pubertal females who are prescribed riociguat:
Enroll in the REMS Program by completing the Patient Enrollment and
Consent 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 to immediately contact your prescriber if you begin to menstruate 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 change in reproductive status.
Post-menopausal females or females with other medical reason for permanent, irreversible
infertility who are prescribed riociguat:
Enroll in the REMS Program by completing the Patient Enrollment and Consent
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 prescribers that dispense riociguat 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 REMS Program on behalf of the outpatient pharmacy.
For outpatient pharmacies: 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 |
For prescribers who dispense: Complete the certified dispenser section of the
Prescriber Enrollment and Agreement Form.
| Prescriber Enrollment and Agreement Form |
Train all relevant staff involved in dispensing on the Riociguat REMS
requirements, procedures, and REMS materials 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, the prescriber is certified,
and if the prescriber dispensed a 30 days’ supply of riociguat.
For females of reproductive potential: Establish processes and procedures to
verify that pregnancy testing is complete, or the prescriber authorizes the refill
through the processes and procedures established as a requirement of the
REMS program.
Before dispensing
For females of reproductive potential: Counsel the patient on the risk of
embryo-fetal toxicity, the need to use effective contraception during
treatment and for one month after stopping treatment, to get monthly
pregnancy tests, and inform her prescriber immediately if she misses a
menstrual period or suspects she may be pregnant.
Verify the female patient is enrolled, the reproductive status has not
changed, the prescriber is certified, and if the prescriber dispensed a 30
days’ supply of riociguat through the processes and procedures established
as a requirement of the REMS Program.
For females of reproductive potential: Verify that 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.
For prescribers who dispense: Report dispensing riociguat to the REMS
Program using the Patient Enrollment and Consent Form.
| Patient Enrollment and Consent Form |
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 riociguat except to certified
pharmacies.
For outpatient pharmacies: Maintain and submit records of daily product
dispensing data for females of reproductive potential.
Maintain records of all processes and procedures including compliance with
those processes and procedures.
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 riociguat 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 Inpatient Pharmacy Enrollment Form and submitting it to the REMS
Program.
| Inpatient Pharmacy Enrollment Form |
Train all relevant staff involved in dispensing riociguat on the REMS Program
requirements, procedures and REMS materials using the Prescriber and
Pharmacy Guide.
| Prescriber and Pharmacy Guide |
Establish processes and procedures to verify the female patient is enrolled in
the REMS Program or will be enrolled 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 and that the patient is counseled on the
risk of embryo-fetal toxicity, the need to use effective contraception, 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, and that 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 pregnancy testing is complete,
and that the patient is counseled on the risk of embryo-fetal toxicity, the
need to use effective contraception, 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
Verify female patient is enrolled in the REMS Program through the processes
and procedures established as a requirement of the REMS.
Dispense no more than a 15-day's supply.
At all times
Report pregnancies to the REMS Program.
Not distribute, transfer, loan, or sell riociguat except to certified pharmacies.
Maintain records of all processes and procedures including compliance with
those processes and procedures.
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 riociguat 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
riociguat.
Train all relevant staff involved in distribution on the Riociguat REMS
requirement.
At all times
Distribute only to certified pharmacies and certified prescribers who can
dispense riociguat.
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 Riociguat Shared System REMS 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
09/01/2022
Approval of the 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.
