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The goal of the JYNARQUE REMS is to mitigate the risk of serious and potentially fatal liver injury by:
Ensuring that healthcare providers are educated on the following:
the risk of serious and potentially fatal liver injury associated with the use of JYNARQUE
the requirement for monitoring at baseline and periodic monitoring as described in the Prescribing Information
the need to counsel patients about the risk of serious and potentially fatal liver injury and the
need for monitoring at baseline and periodic monitoring as described in the Prescribing
Information
Ensuring that healthcare providers adhere to:
the requirement for monitoring at baseline and periodic monitoring as described in the Prescribing Information
Ensuring that patients are informed about:
the risk of serious and potentially fatal liver injury associated with the use of JYNARQUE
the requirement for monitoring at baseline and periodic monitoring as described in the Prescribing Information
Enrollment of all patients in a registry to further support long term safety and safe use of JYNARQUE
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 Form and submitting it to the REMS Program.
| Prescriber Enrollment Form |
Before treatment initiation (first dose)
Counsel the patient on the risk of serious and potentially fatal liver injury and the requirement for liver function monitoring at baseline and at specific intervals during treatment using the Patient Guide. Provide a copy of the material to the patient.
| Patient Guide |
Assess the patient's liver function and appropriateness of initating treatment. Document and submit to the REMS Program using the Patient Enrollment Form. Provide a completed copy of the form to the patient.
| Patient Enrollment Form |
Enroll the patient by completing and submitting the Patient Enrollment Form to the REMS Program.
| Patient Enrollment Form |
During treatment; 2 weeks and 4 weeks after treatment initiation, then monthly for the first 18 months and every 3 months thereafter
Assess the patient's liver function and appropriateness of continuing treatment.
During treatment; every 3 months for the first 18 months and every 6 months thereafter
Assess the patient's liver function and appropriateness of continuing treatment. Document appropriateness of continuing treatment and submit to the REMS Program using the Patient Status Form.
| Patient Status Form |
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 Form |
Get a blood test to check your liver.
Receive counseling from the prescriber on the risk of serious and potentially fatal liver injury and requirements to get blood tests using the Patient Guide.
| Patient Guide |
During treatment; 2 weeks and 4 weeks after treatment initiation, then monthly for the first 18 months and every 3 months thereafter
Get a blood test to check your liver.
At all times
Inform the prescriber of signs and symptoms of serious liver injury.
Outpatient Pharmacies that dispense Jynarque 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 review the Program Overview.
| Program Overview |
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 Jynarque using the Program Overview.
| Program Overview |
Establish processes and procedures to dispense no more than a 30 days supply.
Before dispensing
Obtain authorization to dispense each prescription by contacting the REMS Program to verify the prescriber is certified, and the patient is enrolled and authorized to receive the drug.
Dispense no more than 30 days supply.
To maintain certification to dispense
Have a new authorized representative enroll in the REMS Program by completing the Outpatient Pharmacy Enrollment Form and submitting it to the REMS Program if the authorized representative changes.
| Outpatient Pharmacy Enrollment Form |
At all times
Report adverse events suggestive of serious and potentially fatal liver injury by contacting the REMS Program by phone or using the Liver Adverse Events Reporting Form.
| Liver Adverse Events Reporting Form |
Not distribute, transfer, loan, or sell Jynarque except to certified pharmacies.
Maintain records documenting staff's completion of REMS training.
Maintain records that all processes and procedures are in place and are being followed.
Comply with audits carried out by Otsuka Pharmaceuticals or third party acting on behalf of the applicant to ensure that all processes and procedures are in place and are being followed.
Inpatient Pharmacies that dispense Jynarque 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 review the Program Overview.
| Program Overview |
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 Jynarque using the Program Overview.
| Program Overview |
Establish processes and procedures to verify the prescriber is certified, and the patient is enrolled in the REMS Program.
Establish processes and procedures to dispense no more than a 15 days supply of Jynarque upon discharge of the patient.
Before dispensing
Verify the prescriber is certified and the patient is enrolled in the REMS Program.
At/upon discharge
Dispense no more than a 15 days supply.
To maintain certification to dispense
Have a new authorized representative enroll in the REMS Program by completing the Inpatient Pharmacy Enrollment Form and submitting it to the REMS Program if the authorized representative changes.
| Inpatient Pharmacy Enrollment Form |
At all times
Report adverse events suggestive of serious and potentially fatal liver injury by contacting the REMS Program by phone or using the Liver Adverse Events Reporting Form.
| Liver Adverse Events Reporting Form |
Not distribute, transfer, loan, or sell Jynarque.
Maintain records documenting staff's completion of REMS training.
Maintain records that all processes and procedures are in place and are being followed.
Comply with audits carried out by Otsuka Pharmaceutical Company, Ltd or third party acting on behalf of the applicant to ensure that all processes and procedures are in place and are being followed.
Wholesalers that distribute Jynarque 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 distributing on the REMS requirements.
At all times
Distribute only to certified pharmacies.
Maintain and submit records of drug distribution to the REMS Program.
Comply with audits carried out by Otsuka Pharmaceutical Company, Ltd or third party acting on behalf of the applicant 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.
REMS assessment plan unavailable for posting at this time.
What updates have been made to the REMS?
Date
Summary of change
11/25/2020
Modified to:
Allow certified outpatient pharmacies to transfer product between their certified
sites, should one location close or have a surplus of JYNARQUE.
Provide healthcare providers and delegates the ability to print or view previous
completed Patient Status and Liver Adverse Event Reporting Forms.
Allow addition of the Patient REMS ID to the patient grid in the patient list of the prescriber portal.
Allow addition of a pop-up message on the Specialty Pharmacy portal that will display when the pharmacy generates an authorization code for a patient whose last
shipment was filled by the Otsuka Patient Assistance Foundation.
Update the resources page on the REMS public website to include a link to Spanish translated prescriber forms and materials.
12/03/2019
Modified to update the Liver Adverse Events Reporting Form, Patient Status Form, Prescriber Training, Prescriber Enrollment Form, Patient Online Enrollment, and the Patient Enrollment Form, more specifically:
Liver Adverse Events Reporting Form and Patient Status Form:
Updated instructions, definitions, and criteria for serious liver event reporting
Added patient and prescriber REMS ID
Added space for general liver laboratory information
Added a checkbox to indicate whether treatment was discontinued due to a liver event
Added text indicating Otsuka will reach out for additional information on reported liver events
Prescriber Training:
Added definition for serious and potentially fatal liver injury
Prescriber Enrollment Form:
Added attestation that the prescriber will be contacted for further information regarding reports of serious and potentially fatal liver injury
Patient Online Enrollment:
Updated patient online enrollment process
Patient Enrollment Form:
Added REMS Coordinating Center fax number
03/04/2019
Revised to reflect editorial changes.
12/01/2018
Modified to reflect updates to the Patient Enrollment Form, Prescriber Enrollment Form, REMS document, and website screenshots, more specifically:
The addition of "Race" and "Ethnicity" fields in the Patient Information Section on the Patient Enrollment Form
The addition of a Medical History Section on the Patient Enrollment Form
An update to the Patient Agreement Section to provide insight into how the collected information will be used on the Patient Enrollment Form
The addition of office liaison contact fields to the Prescriber Enrollment Form
A change to the trigger date for the due date of the Patient Status Form in the REMS document
Changes to the website screenshots:
Corresponding updates to incorporate the changes listed above
Addition of links to the Chinese and Spanish translations of the Patient Guide and Patient Enrollment Form
Addition of progress wizard to the online prescriber enrollment process
Enlarged "Complete Online Enrollment" button
07/30/2018
Modified to:
update website screenshots of the Liver Adverse Events Reporting Form
update the Patient Enrollment Form to delete a checkbox and the following sentence: "By checking this box, I agree to be contacted by the manufacturer's patient support program which provides patient support for the purposes of reimbursement, financial assistance, prescription tracking, patient advocacy, and coordinating care as necessary."
05/29/2018
Revised to reflect editorial changes.
04/23/2018
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.
