The Food and Drug Administration (FDA) announced changes to the Kynamro (mipomersen sodium; Genzyme) Approved Risk Evaluation and Mitigation Strategies (REMS) program.

As of July 28, 2015, the REMS page includes a new e-mail address for Kynamro for REMS functions throughout the material. This includes an addition of a scan and e-mail option to submit the Prescription Authorization Form. Further changes in the label are found in the REMS-specific webpage.

RELATED: Dyslipidemia Drug Indications

Kynamro is an oligonucleotide inhibitor of Apo B-100 synthesis indicated as adjunct to lipid-lowering medications and diet to reduce low density lipoprotein-cholesterol (LDL-C), apolipoprotein B (Apo B), total cholesterol (TC), and non-high density lipoprotein-cholesterol (non HDL-C) in patients with homozygous familial hypercholesterolemia (HoFH).

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