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Enroll in the REMS by completing the Prescriber Enrollment Form and
submitting it to the REMS.
| Prescriber Enrollment Form |
Before treatment
initiation (first dose)
Counsel the patient on the risk of hepatotoxicity associated with
FILSPARI, the signs and symptoms of liver problems, to contact the
prescriber if the patient has any signs or symptoms of liver problems, on
the REMS requirements including the need to complete liver testing
monthly for the first 12 months, then every 3 months during treatment,
and that FILSPARI is only available through a restricted distribution
program using the Patient Guide.
| Patient Guide |
Assess the patient’s liver function. Document and submit to the REMS
using the Patient Enrollment Form.
| Patient Enrollment Form |
Assess the patient’s reproductive status using the definitions in the
Prescriber and Pharmacy Guide. Document and submit to the REMS
using the Patient Enrollment Form.
| Prescriber and Pharmacy Guide |
| Patient Enrollment Form |
For patients who can become pregnant: Counsel the patient about the
risk of embryo-fetal toxicity, the need to use effective contraception
during treatment and for one month following treatment discontinuation,
the need to complete monthly pregnancy tests, the potential need for
emergency contraception, and to immediately contact their prescriber if
the patient misses a menstrual period or if pregnancy is suspected using
the Patient Guide.
| Patient Guide |
For patients who can become pregnant: Assess the patient’s pregnancy
status by ordering a pregnancy test and reviewing the result. Document
and submit to the REMS using the Patient Enrollment Form.
| Patient Enrollment Form |
Provide the patient with the Patient Guide.
| Patient Guide |
Enroll the patient by completing the Patient Enrollment Form and
submitting it to the REMS.
| Patient Enrollment Form |
During treatment;
monthly for the first
12 months, then
every 3 months
Assess the patient’s liver function.
Counsel the patient on the risk of hepatotoxicity and if they are not
complying with the required liver testing.
During treatment;
monthly
For patients who can become pregnant: Assess the patient’s pregnancy
status by ordering a pregnancy test and reviewing the result.
For patients who can become pregnant: Counsel the patient on the risk
of embryo-fetal toxicity, to immediately contact their prescriber if they
miss a menstrual period or if pregnancy is suspected, and counsel the
patient if they are not complying with the required monthly pregnancy
testing or if they are not using effective contraception.
After treatment
discontinuation; one
month
For patients who can become pregnant: Assess the patient’s pregnancy
status by ordering a pregnancy test and reviewing the result.
At all times
Report adverse events suggestive of hepatotoxicity to the REMS.
Report pregnancies to the REMS.
Assess the patient’s reproductive status.
At all times, within
10 business days
Report a change or misclassification in reproductive status to the REMS
using the Change in Reproductive Potential Status Form.
| Change in Reproductive Potential Status Form |
Patients who can become pregnant who are prescribed FILSPARI:
Receive counseling from the prescriber on the risk of liver problems, the
signs and symptoms of liver problems, the need to contact the
prescriber if you have any signs or symptoms of liver problems, and the
need to complete liver testing monthly for the first 12 months, then
every 3 months during treatment using the Patient Guide.
| Patient Guide |
Receive counseling from the prescriber on the risk of serious birth
defects, the need to use effective contraception during treatment and for
one month following treatment discontinuation, the need to complete
monthly pregnancy tests, the potential need for emergency
contraception, and to immediately contact the prescriber if you miss a
menstrual period or suspect that you are pregnant using the
Patient Guide.
| Patient Guide |
Enroll in the REMS by completing the Patient Enrollment Form with the
prescriber. Enrollment information will be provided to the REMS.
| Patient Enrollment Form |
During treatment;
monthly for the first
12 months, then
every 3 months
Get a liver test.
Adhere to the safe use condition: Communicate with the pharmacy to
confirm completion of liver testing.
During treatment;
monthly
Get a pregnancy test.
Receive counseling from the pharmacy on the risks of liver problems and
serious birth defects associated with FILSPARI treatment.
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 Patient Guide.
| Patient Guide |
After treatment
discontinuation; one
month
Get a pregnancy test.
At all times
Inform the prescriber if you have any signs or symptoms of liver
problems as described in the Patient Guide.
| Patient Guide |
Inform the prescriber immediately if you suspect you may be pregnant.
Inform the prescriber if there is a change in reproductive status.
Patients who cannot become pregnant who are prescribed FILSPARI:
Receive counseling from the prescriber on the risk of liver problems, the
signs and symptoms of liver problems, the need to contact the
prescriber if you have any signs or symptoms of liver problems, and the
need to complete liver testing monthly for the first 12 months, then
every 3 months during treatment using the Patient Guide.
| Patient Guide |
Enroll in the REMS by completing the Patient Enrollment Form with the
prescriber. Enrollment information will be provided to the REMS.
| Patient Enrollment Form |
During treatment;
monthly for the first
12 months, then
every 3 months
Get a liver test.
Adhere to the safe use condition: Communicate with the pharmacy to
confirm completion of liver testing.
During treatment;
monthly
Receive counseling from the pharmacy on the risk of liver problems
associated with FILSPARI treatment.
At all times
Inform the prescriber if you have any signs or symptoms of liver
problems as described in the Patient Guide.
| Patient Guide |
Inform the prescriber if there is a change in reproductive status.
Outpatient pharmacies that dispense FILSPARI 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 certify by enrolling 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 on the REMS requirements
using the Prescriber and Pharmacy Guide.
| Prescriber and Pharmacy Guide |
Establish processes and procedures to verify the patient is enrolled and
the prescriber is certified.
Establish processes and procedures to document and submit
confirmation of counseling on the risks of hepatotoxicity and embryofetal
toxicity.
Establish processes and procedures to verify and document the patient’s
liver testing is complete or the prescriber authorizes the refill, and the
reproductive status has not changed.
For patients who can become pregnant: Establish processes and
procedures to verify and document pregnancy testing is complete or the
prescriber authorizes the refill.
Before dispensing
Verify the patient is enrolled and the prescriber is certified through the
processes and procedures established as a requirement of the REMS.
Counsel the patient on the risk of hepatotoxicity. Document and submit
confirmation of counseling through the processes and procedures
established as a requirement of the REMS.
For patients who can become pregnant: Counsel the patient on the risk
of embryo-fetal toxicity. Document and submit confirmation of
counseling through the processes and procedures established as a
requirement of the REMS.
Verify and document the patient’s liver testing is complete or the
For patients who can become pregnant: Verify and document pregnancy
testing is complete or the prescriber authorizes the refill through the
processes and procedures established as a requirement of the REMS.
At all times
Dispense no more than a 30-days’ supply.
Report pregnancies to the REMS.
Report adverse events suggestive of hepatotoxicity to the REMS.
Not distribute, transfer, loan, or sell FILSPARI.
Maintain and submit records of product dispensing to the REMS.
Maintain records that all processes and procedures are in place and are
being followed.
Comply with audits carried out by Travere Therapeutics, Inc. or a third
party acting on behalf of Travere Therapeutics, Inc. to ensure that all
processes and procedures are in place and are being followed.
To maintain
certification to
dispense
Have a new authorized representative enroll by completing and
submitting an Outpatient Pharmacy Enrollment Form, if the authorized
representative changes.
| Outpatient Pharmacy Enrollment Form |
Inpatient pharmacies that dispense FILSPARI must:
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 certify by enrolling in the REMS by
completing the Inpatient Pharmacy Enrollment Form and submitting it to
the REMS.
| Inpatient Pharmacy Enrollment Form |
Train all relevant staff involved in dispensing on the REMS requirements
using the Prescriber and Pharmacy Guide.
| Prescriber and Pharmacy Guide |
Establish processes and procedures to verify and document the patient is
For patients who can become pregnant: Establish processes and
procedures to verify and document pregnancy testing is complete.
Before dispensing
Counsel the patient on the risk of hepatotoxicity. Document and submit
confirmation of counseling through the processes and procedures
established as a requirement of the REMS.
For patients who can become pregnant: Counsel the patient on the risk
of embryo-fetal toxicity. Document and submit confirmation of
counseling through the processes and procedures established as a
requirement of the REMS.
Verify and document the patient is enrolled or will be enrolled prior to
discharge, the patient is under the care of a certified prescriber, and
liver testing is complete.
For patients who can become pregnant: Verify and document pregnancy
testing is complete.
At discharge
Dispense no more than a 30-days’ supply.
At all times
Report pregnancies to the REMS.
Report adverse events suggestive of hepatotoxicity to the REMS.
Not distribute, transfer, loan, or sell FILSPARI.
Maintain records that all processes and procedures are in place and are
being followed.
Comply with audits carried out by Travere Therapeutics, Inc. or a third
party acting on behalf of Travere Therapeutics, Inc. to ensure that all
processes and procedures are in place and are being followed.
To maintain
certification to
dispense
Have a new authorized representative enroll by completing and
submitting an Inpatient Pharmacy Enrollment Form, if the authorized
representative changes.
| Inpatient Pharmacy Enrollment Form |
Wholesalers-distributors that distribute FILSPARI must:
To be able to
distribute
Establish processes and procedures to ensure that FILSPARI 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 and submit records of drug distribution to the REMS.
Maintain records that all processes and procedures are in place and are
being followed.
Comply with audits carried out by Travere Therapeutics, Inc., or a third
party acting on behalf of Travere Therapeutics, Inc. 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 Filspari 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
12/20/2023
Revised to make formatting changes.
10/18/2023
Modified to update to the Patient Enrollment Form to include language making patients aware that they may be contacted by Travere or its representatives about voluntary participation in a required post-marketing study on the risk of hepatotoxicity in patient’s taking Filspari.
02/17/2023
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.
