Approved Risk Evaluation and Mitigation Strategies (REMS)

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Kynamro (mipomersen sodium)
NDA #203568
REMS last update: 07/28/2015



What is the purpose of the REMS?

The goals of the KYNAMRO REMS Program are:

  1. To educate prescribers about:
    1. the risk of hepatotoxicity associated with the use of KYNAMRO; and
    2. the need to monitor patients during treatment with KYNAMRO as per product labeling.
  2. To restrict access to therapy with KYNAMRO to patients with a clinical or laboratory diagnosis consistent with homozygous familial hypercholesterolemia (HoFH).

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 See Disclaimer page regarding links to external sites

Healthcare Providers who prescribe Kynamro

To be able to prescribe Kynamro
  • Review the prescribing information for Kynamro.
  • Complete the Prescriber Training, including the knowledge assessment.
  • Enroll in the REMS by completing and submitting the Prescriber Enrollment Form.
    | Prescriber Enrollment Form |
Before writing the first prescription for a patient
  • Assess the patient’s medical history for clinical or laboratory diagnosis consistent with homozygous familial hypercholesterolemia (HoFH).
  • Complete and submit the Prescription Authorization Form.
    | Prescription Authorization Form |
While patient is being treated with Kynamro
  • At intervals specified in the Prescribing Information, assess patient’s liver-related tests.
Before writing each prescription after the first prescription

Pharmacies that dispense Kynamro

To be able to dispense Kynamro
  • Designate an authorized representative to carry out the certification process on behalf of the pharmacy.
  • Train all relevant staff involved in the dispensing of Kynamro.
  • Establish processes and procedures to verify that the prescriber is certified and receipt of the Prescription Authorization Form.
    | Prescription Authorization Form |
Ongoing
  • Provide sponsor with records of prescription data.
  • Cooperate with audits carried out by the sponsor 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
Prescriber Enrollment Form (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Kynarmo_2015-07-28_Prescriber_Enrollment_Form.pdf
Prescriber Training slide set (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Kynarmo_2015-07-28_Prescriber_Training_slide_set.pdf
Prescription Authorization Form (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Kynarmo_2015-07-28_Prescription_Authorization_Form.pdf
REMS document (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Kynarmo_2015-07-28_REMS_document.pdf
REMS full (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Kynamro_2015.07.28_REMS_full.pdf
REMS website screenshot (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Kynarmo_2015-07-28_REMS_website_screenshot.pdf
Summary of Monitoring Recommendations (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Kynarmo_2015-07-28_Summary_of_Monitoring_Recommendations.pdf

What updates have been made to the REMS?

Date Summary of change
07/28/2015 Modified to:

  1. Change the trademark symbol ™ to a registered symbol ® throughout the appended REMS materials.
  2. Add an updated logo that includes “200 mg/mL” to the appended REMS materials.
  3. 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.

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