Review of Mipomersen Sodium (Kynamro®) for Familial Hypercholesterolemia

Authors

  • Lunawati L. Bennett Union University
  • Megan Chalk Union University

Keywords:

HoFH, HeFH, FH, ASO, ISIS 301012, LDL-C.

Abstract

Objective: To review the pharmacology and pharmacokinetics, and to evaluate the clinical efficacy, safety, and place in therapy of mipomersen sodium (Kynamro®) for the treatment of familial hypercholesterolemia (FH).

Data Sources: A literature search through Pub Med and clinicaltrials.gov (1984–May 2014; English language) was performed using the key words: homozygous familial hypercholesterolemia (HoFH), heterozygous familial hypercholesterolemia (HeFH), FH, dyslipidemia, apolipoprotein B-100 (apoB-100), low density lipoprotein cholesterol (LDL-C), antisense oligonucleotides (ASOs), and ISIS 301012. Searches were limited to published studies in humans.

Study Selection and Data Extraction: All articles in English identified from reviews, abstracts, presentations, and clinical trials of mipomersen in humans were selected and included.

Data Synthesis: Mipomersen sodium (Kynamro®), an oligonucleotide inhibitor of apoB-100 synthesis, is approved for reducing apoB-100, LDL-C, total cholesterol (TC), and non-high density lipoprotein cholesterol (non-HDL-C) in HoFH patients as an adjunctive treatment with other lipid lowering drugs and low fat diet.

Conclusion: Mipomersen is effective in decreasing LDL-C, apoB-100, TC, and non-HDL-C in patients that are refractory to other lipid lowering drugs. Mipomersen is administered as 200 mg subcutaneous (s.c.) once weekly injection. The drug is contraindicated in patients with moderate to severe hepatic impairment. The most common adverse reactions include injection site reaction (ISRs), influenza-like symptoms and increases in serum hepatic transaminase. Kynamro® is only available through restricted program under Risk Evaluation and Mitigation Strategy (REMS) called Kynamro® REMS

Author Biographies

Lunawati L. Bennett, Union University

Pharmaceutical Sciences

Megan Chalk, Union University

Pharmacy

Downloads

Published

2014-11-13

Issue

Vol. 1 (2014)

Section

Articles

License

Policy for Journals/Articles with Open Access

Authors who publish with this journal agree to the following terms:
    1. Authors retain copyright and grant the journal right of first publication with the work simultaneously licensed under a Creative Commons Attribution License that allows others to share the work with an acknowledgement of the work's authorship and initial publication in this journal.

  1. Authors are permitted and encouraged to post links to their work online (e.g., in institutional repositories or on their website) prior to and during the submission process, as it can lead to productive exchanges, as well as earlier and greater citation of published work

Policy for Journals / Manuscript with Paid Access

Authors who publish with this journal agree to the following terms:
    1. Publisher retain copyright .

  1. Authors are permitted and encouraged to post links to their work online (e.g., in institutional repositories or on their website) prior to and during the submission process, as it can lead to productive exchanges, as well as earlier and greater citation of published work .