Updated Kynamro REMS Provides New Ways to Submit PA Form

Updated Kynamro REMS Provides New Ways to Submit PA Form
Updated Kynamro REMS Provides New Ways to Submit PA Form

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).

For more information call (888) 463-6332 or visit FDA.gov.

Loading links....