Support for your patients at every step

The myRARE™ program provides your patients support and resources to help make EVKEEZA a part of their current HoFH treatment regimen.

Fill out the myRARE Start Form to enroll

myRARETM for EVKEEZA (evinacumab-dgnb) Injection logo

If you have questions for us, call myRARE

1-877-EVKEEZA

(1-877-385-3392), select option 1

Monday-Friday, 9 AM-7 PM ET

Start Form

Get patients started on EVKEEZA and enrolled in myRARE

Annotated Start Form

A step-by-step guide to completing the Start Form

Annotated Summary of Benefits

A helpful guide to understand the details of your patient's coverage

Billing & Coding Guide

A guide to the codes needed to assist with understanding reimbursement for EVKEEZA

Patient Support Program Overview

Eligibility information and program details

Dosing Guide

Important infusion instructions, including preparation and administration for EVKEEZA

Appeal Checklist and Appeal Sample Letter

A helpful reference to use when submitting appeals for your patients prescribed EVKEEZA

Sample Letter of Medical Exception

An example of the information that may be required when writing a letter of medical exception for your patients prescribed EVKEEZA

Sample Letter of Medical Necessity

An example of a letter that may be sent to payers to explain why EVKEEZA is medically necessary for your patient

Product Acquisition Guide

A guide to help your practice understand how to acquire EVKEEZA

Prior Authorization Checklist

A helpful checklist to reference when filling out and submitting a Prior Authorization Request Form

IMPORTANT SAFETY INFORMATION

Contraindication

EVKEEZA® is contraindicated in patients with a history of serious hypersensitivity reactions to evinacumab-dgnb or to any of the excipients in EVKEEZA. Serious hypersensitivity reactions, including anaphylaxis, have occurred.

Warnings and Precautions

Serious Hypersensitivity Reactions: Serious hypersensitivity reactions have occurred with EVKEEZA. If signs or symptoms of serious allergic reactions occur, discontinue EVKEEZA infusion, treat according to the standard-of-care, and monitor until signs and symptoms resolve.

Embryo-Fetal Toxicity: EVKEEZA may cause fetal harm when administered to pregnant patients. Advise patients who may become pregnant of the risk to a fetus. Consider obtaining a pregnancy test prior to initiating treatment with EVKEEZA. Advise patients who may become pregnant to use effective contraception during treatment and for at least 5 months following the last dose.

Adverse Reactions

Common adverse reactions (≥5%) were nasopharyngitis (16%), influenza-like illness (7%), dizziness (6%), rhinorrhea (5%), and nausea (5%).

Use in Specific Populations

Pregnancy: EVKEEZA may cause fetal harm when administered to a pregnant woman. Advise pregnant women of the potential risk to a fetus. If a patient becomes pregnant while receiving EVKEEZA, healthcare providers should report EVKEEZA exposure by calling 1-833-385-3392.

Lactation: There are no data on the presence of evinacumab-dgnb in human milk or animal milk, the effects on the breastfed infant, or the effects on milk production. Maternal IgG is known to be present in human milk. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for EVKEEZA and any potential adverse effects on the breastfed infant from EVKEEZA or from the underlying maternal condition.

Females and Males of Reproductive Potential: Consider pregnancy testing in patients who may become pregnant prior to starting treatment with EVKEEZA. EVKEEZA may cause fetal harm when administered to a pregnant woman. Females of reproductive potential should use effective contraception during treatment with EVKEEZA and for at least 5 months following the last dose of EVKEEZA.

Pediatrics: The safety and efficacy of EVKEEZA have not been established in pediatric patients with HoFH who are younger than 12 years old.

INDICATION

EVKEEZA is an ANGPTL3 (angiopoietin-like 3) inhibitor indicated as an adjunct to other low-density lipoprotein-cholesterol (LDL-C) lowering therapies for the treatment of adult and pediatric patients, aged 12 years and older, with homozygous familial hypercholesterolemia (HoFH).

Limitations of Use:

  • The safety and effectiveness of EVKEEZA have not been established in patients with other causes of hypercholesterolemia, including those with heterozygous familial hypercholesterolemia (HeFH).
  • The effects of EVKEEZA on cardiovascular morbidity and mortality have not been determined.

Please see full Prescribing Information.