Where can I find the Evkeeza FDA package insert?

You can find the Evkeeza FDA package insert on the Drugs@FDA website, under the FDA Professional Drug Information section on drugclasses.com and on the Regeneron Evkeeza website.

Evkeeza consumer information written in plain language may also be helpful to read. You can access Evkeeza consumer drug information written specifically for patients on the drugclasses.com website. The FDA Evkeeza Patient Medication Guide can be found here.

The Evkeeza (pronounced ev-kee'-zah) package insert is developed by Regeneron, the drug manufacturer, and approved by the FDA. It includes information such as:

• FDA-approved uses (called “indications”)
• when not to use Evkeeza (called “contraindications”)
• warnings and precautions for use
• side effects ("adverse reactions")
• drug, food or disease interactions
• doses, strengths, and dosage forms
• instructions for use, storage and disposal
• clinical research studies
• Medication Guide or patient-specific information.

Package inserts and Medication Guides are updated frequently when new uses are approved, when there is new side effect or safety data, and for other important information pertaining to the use and safety of the drug.

Related questions

• What is the mechanism of action for Evkeeza (evinacumab-dgnb)?
• Is Evkeeza FDA approved as a high cholesterol treatment?
• What are the 10 most effective ways to lower cholesterol?

What are the Evkeeza FDA-approved uses?

• Evkeeza (evinacumab-dgnb) is approved to be used in addition to other cholesterol lowering therapies to treat Homozygous Familial Hypercholesterolemia (HoFH) in adults and children 5 years of age and older.
• HoFH is a rare but serious inherited medical condition that limits the body’s ability to remove unwanted “bad” cholesterol (low-density lipoprotein-cholesterol or LDL-C). This can quicken the development of serious or fatal heart disease, like a heart attack.

Evkeeza was approved in February 2021 and is classified as an angiopoietin-like 3 (ANGPTL3) inhibitor. It works by binding and blocking ANGPTL3, a protein that plays a key role in lipid metabolism. It is given as a 60 minute intravenous (IV) infusion once every 4 weeks.

Common side effects (≥5%) include nasopharyngitis (common cold symptoms), influenza-like illness, dizziness, rhinorrhea (a runny nose), and nausea.

This is not all the information you need to know about Evkeeza (evinacumab-dgnb) for safe and effective use and does not take the place of your doctor’s directions. Review the full Evkeeza information and discuss any questions you have with your doctor or other health care provider.