Risk Evaluation and Mitigation Strategies (REMS) Summary

Goal of the Kynamro (mipomersen sodium) Injection REMS Program

The goal of the KYNAMRO REMS Program 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.

REMS Elements

• Elements to Assure Safe Use

• Implementation System

Open the Full REMS Notification

REMS Summary of Terms