Approved Risk Evaluation and Mitigation Strategies (REMS)

Kynamro (mipomersen sodium)

NDA 203568
REMS last update: 10/25/2017

What is Kynamro?

Why is Kynamro required to have a REMS?

The goals of the KYNAMRO REMS Program are:

1. To educate prescribers about:

a. the risk of hepatotoxicity associated with the use of KYNAMRO; and

b. 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).

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.