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The goal of the KYNAMRO REMS is to mitigate the risk of hepatotoxicity associated with the use of KYNAMRO by ensuring that:
prescribers are educated about the approved indication for KYNAMRO, the risk of hepatotoxicity associated with the use of KYNAMRO, and the need to monitor patients during treatment with KYNAMRO as per product labeling
KYNAMRO is dispensed only to patients with a clinical or laboratory diagnosis consistent with homozygous familial hypercholesterolemia (HoFH)
patients are informed about the risk of hepatotoxicity associated with the use of KYNAMRO and the need for baseline and periodic monitoring.
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
Counsel the patient about the appropriate use and risks associated with Kynamro using the Patient Guide. Provide a copy of the material to the patient.
| Patient Guide |
Enroll in the REMS Program by completing the Patient-Prescriber Acknowledgement Form with the prescriber. Enrollment information will be provided to the REMS Program.
2. Enroll in the REMS Program by completing the Patient-Prescriber Acknowledgement Form with the prescriber. Enrollment information will be provided to the REMS Pro
| Patient-Prescriber Acknowledgement Form |
Receive counseling from the prescriber on the risk of hepatotoxicity, periodic liver function monitoring, and appropriate patient selection.
Pharmacies that dispense Kynamro 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 drug’s Prescribing Information.
Have the authorized representative enroll in the REMS Program by completing the Pharmacy Enrollment Form and submitting it to the REMS Program.
| Pharmacy Enrollment Form |
Establish processes and procedures to ensure pharmacy staff obtain authorization to dispense each prescription by contacting the REMS Program Coordinating Center.
Before dispensing
Obtain authorization to dispense each prescription by contacting the REMS Program Coordinating Center to verify the prescriber is certified, the Patient-Prescriber Acknowledgement Form is completed, and a Prescription Authorization Form is received for each new prescription.
| Patient-Prescriber Acknowledgement Form |
| Prescription Authorization Form |
To maintain certification to dispense, if the pharmacy designates a new authorized pharmacy representative
Have the authorized representative review the drug’s Prescribing Information
Have the new authorized representative enroll in the REMS Program by completing the Pharmacy Enrollment Form.
| Pharmacy Enrollment Form |
At all times
Maintain records of training, prescription data, and documentation that all processes and procedures are in place and are being following for the REMS Program and provid upon request to Kastle Therapeutics, FDA, or a third party acting on behalf of Kastle Therapeutics or FDA.
Comply with audits carried out by Kastle Therapeutics, FDA, or a third party acting on behalf of Kastle Therapeutics or FDA to ensure that all processes and procedures are in place and are being followed.
Wholesalers that distribute Kynamro 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 distribution on the REMS Program requirements.
At all times
Distribute only to certified pharmacies.
Maintain appropriate documentation and make it available for audits.
Maintain and submit distribution records of all shipments to the REMS Program.
Comply with audits carried out by Kastle Therapeutics, FDA, or a third party acting on behalf of Kastle Therapeutics or FDA 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 Kynamro REMS, see the DailyMed link(s).
This webpage provides REMS assessment plan measures, metrics, and indicators for drug and biological products with a REMS. The REMS assessment plan measures, metrics, and indicators are part of the overall REMS assessment plan used by FDA to evaluate the performance of a REMS and are included in FDA approval letters. The current REMS assessment plan measures, metrics, and indicators are extracted from regulatory letters that contain REMS information, including FDA approval letters, and posted here as they become available.
What updates have been made to the REMS?
Date
Summary of change
10/25/2017
Modified to make changes to the REMS document and existing REMS materials and to add the following new REMS materials: Patient Guide and Patient-Prescriber Acknowledgment Form.
07/28/2015
Modified to:
Change the trademark symbol ™ to a registered symbol ® throughout the appended REMS materials.
Add an updated logo that includes “200 mg/mL” to the appended REMS materials.
Update the email address used to conduct REMS functions throughout the REMS materials, and to add a scan and email option for submitting the Prescription Authorization Form.
05/07/2014
Modified to change the REMS document, the REMS forms, the REMS website, and the pharmacy auditing schedule.
01/29/2013
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.