Approved Risk Evaluation and Mitigation Strategies (REMS)

Kynamro (mipomersen sodium)

NDA #203568

REMS last update: 10/25/2017

• View the Kynamro Prescribing Information and Medication Guide at DailyMed.
• View Kynamro's Regulatory Information at Drugs@FDA

• Goals
• Summary
• REMS Materials
• Assessment Plan
• Update history

What is the purpose of the REMS?

The goal of the KYNAMRO REMS is to mitigate the risk of hepatotoxicity associated with the use of KYNAMRO by ensuring that:

1. 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
2. KYNAMRO is dispensed only to patients with a clinical or laboratory diagnosis consistent with homozygous familial hypercholesterolemia (HoFH)
3. 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.

View application holder(s) REMS Website

Healthcare Providers who prescribe Kynamro must

To become certified to prescribe	Review the drug’s Prescribing Information Review the REMS Program: An Introduction. | Kynamro REMS Program: An Introduction | Successfully complete the Knowledge Assessment that is included in the Prescriber Certification Training Module and submit it to the REMS Program. | Prescriber Certification Training Module and Knowledge Assessment | 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 the patient by completing and submitting the Patient-Prescriber Acknowledgment Form to the REMS Program. | Patient-Prescriber Acknowledgement Form |
During treatment; before each prescription	Complete the Prescription Authorization Form and submit it to the REMS Program. | Prescription Authorization Form |

Patients who are prescribed Kynamro

Before treatment initiation

Receive the Patient Guide. | 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 review the REMS Program: An Introduction. | Kynamro REMS Program: An Introduction | Have the authorized representative successfully complete the Knowledge Assessment that is included in the Pharmacy Certification Training Module and submit it to the REMS Program. | Pharmacy Certification Training Module and Knowledge Assessment | 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 | Train all relevant staff involved in dispensing on the REMS Program requirements using the Pharmacy Certification Training Module and Knowledge Assessment. | Pharmacy Certification Training Module and Knowledge Assessment | 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 authorized representative review the REMS Program: An Introduction. | Kynamro REMS Program: An Introduction | Have the authorized representative successfully complete the Knowledge Assessment that is included in the Pharmacy Certification Training Module and submit it to the REMS Program. | Pharmacy Certification Training Module and Knowledge Assessment | 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).

Material Name	Material Name Link
Kynamro REMS Program: An Introduction (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/rems/Kynamro_2017_10_25_An_Introduction.pdf
Letter for Healthcare Providers (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/rems/Kynamro_2017_10_25_Letter_for_Healthcare_Providers.pdf
Letter for Pharmacists (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/rems/Kynamro_2017_10_25_Letter_for_Pharmacists.pdf
Patient Guide (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/rems/Kynamro_2017_10_25_Patient_Guide.pdf
Patient-Prescriber Acknowledgement Form (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/rems/Kynamro_2017_10_25_Patient_Prescriber_Acknowledgment_Form.pdf
Pharmacy Certification Training Module and Knowledge Assessment (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/rems/Kynamro_2017_10_25_Pharmacy_Certification_Training_Module_and_Knowledge_Assessment.pdf
Pharmacy Enrollment Form (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/rems/Kynamro_2017_10_25_Pharmacy_Enrollment_Form.pdf
Prescriber Certification Training Module and Knowledge Assessment (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/rems/Kynamro_2017_10_25_Prescriber_Certification_Training_Module_and_Knowledge_Assessment .pdf
Prescriber Enrollment Form (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/rems/Kynamro_2017_10_25_Prescriber_Enrollment_Form.pdf
Prescription Authorization Form (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/rems/Kynamro_2017_10_25_Prescription_Authorizaton_Form .pdf
REMS document (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/rems/Kynamro_2017_10_25_REMS_document.pdf
REMS full (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/rems/Kynamro_2017_10_25_REMS_full.pdf
REMS Website Screenshot (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/rems/Kynamro_2017_10_25_REMS_Website_Screenshot.pdf

What assessment is available to the REMS?

Assessment Plan
REMS assessment plan unavailable for posting at this time.

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.