Evkeeza (evinacumab) belongs to a class of medications called angiopoietin-like protein 3 (ANGPTL3) inhibitor monoclonal antibodies.

Evkeeza injection is used with other medications to lower cholesterol in adults and children at least 5 years old who have an inherited type of high cholesterol.

Evkeeza reduces the amount low-density lipoprotein (LDL) cholesterol ('bad cholesterol') and other fatty substances in the blood in patients that have homozygous familial hypercholesterolemia (HoFH; an inherited condition in which cholesterol cannot be removed from the body normally). This medicine is not for use in treating high cholesterol that is caused by diet or other factors.

Evkeeza works by decreasing the production of LDL cholesterol and increasing the breakdown of LDL cholesterol and other fatty substances in the body.

Use Evkeeza only as directed. tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take..

Tell your doctor and pharmacist if you are allergic to evinacumab, any other medications, or any of the ingredients in Evkeeza injection.

Evkeeza is given as an infusion, through an intravenous (IV) line, into a vein, usually once per month. A healthcare provider will give you this injection.

This medicine must be given slowly over 60 minutes.

If you miss any infusion appointments, call your healthcare provider as soon as possible to reschedule.

Your healthcare provider may slow down your infusion rate, temporarily stop, or permanently stop treatment with Evkeeza if you have certain side effects.

Your healthcare provider may prescribe other cholesterol-lowering medicines, to use with Evkeeza. Use the other prescribed medicines exactly as your healthcare provider tells you to.

Usual Adult Dose for Homozygous Familial Hypercholesterolemia:

15 mg/kg via IV infusion once a month (every 4 weeks)

Comments:
-Assess LDL-C (low density lipoprotein cholesterol) when clinically appropriate; LDL-C may be measured as soon as 2 weeks after initiating therapy.
-The effects on cardiovascular morbidity and mortality have not been determined.

Use: As an adjunct to other LDL-C lowering therapies for the treatment of homozygous familial hypercholesteremia.

Usual Pediatric Dose for Homozygous Familial Hypercholesterolemia:

12 years or older: 15 mg/kg via IV infusion once a month (every 4 weeks)

Comments:
-Assess LDL-C (low density lipoprotein cholesterol) when clinically appropriate; LDL-C may be measured as soon as 2 weeks after initiating therapy.
-The effects on cardiovascular morbidity and mortality have not been determined.

Use: As an adjunct to other LDL-C lowering therapies for the treatment of homozygous familial hypercholesteremia.

You should not be treated with Evkeeza if you are allergic to evinacumab.

Evinacumab may harm an unborn baby. You may need a pregnancy test to make sure you are not pregnant. Use effective birth control while using evinacumab and for at least 5 months after your last dose.

Tell your doctor if you become pregnant, or plan to become pregnant. You may need to take a pregnancy test before beginning treatment with Evkeeza. You should not become pregnant during your treatment with evinacumab injection. You should use effective birth control to prevent pregnancy during your treatment and for 5 months after your final dose. If you become pregnant while receiving Evkeeza, call your doctor immediately.

Ask a doctor if it is safe to breastfeed while using this medicine.

Call your doctor for instructions if you miss an appointment for your Evkeeza injection.

In a medical setting an overdose would be treated quickly.

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Get emergency medical help if you have signs of an allergic reaction to Evkeeza: hives, rash, itching; feeling light-headed; wheezing, difficult breathing; swelling of your face, lips, tongue, or throat.

Some side effects may occur during the injection. Tell your medical caregivers if you feel dizzy, nauseated, light-headed, itchy, sweaty, or have a headache, chest tightness, back pain, trouble breathing, or swelling in your face.

Your treatment may be delayed or permanently discontinued if you have certain side effects.

Common Evkeeza side effects may include:

• cold or flu symptoms such as fever, chills, body aches, stuffy nose, sneezing, sore throat;

• dizziness;

• pain in your arms or legs;

• nausea; or

• lack of energy.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Other drugs may interaction with evinacumab, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all other medicines you use.