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Approved Risk Evaluation and Mitigation Strategies (REMS)

Kynamro (mipomersen sodium)
NDA #203568
REMS last update: 10/25/2017



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 See Disclaimer page regarding links to external sites

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:

  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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