Evinacumab 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.

Evinacumab is not for use in treating high cholesterol that is caused by diet or other factors.

Evinacumab may also be used for purposes not listed in this medication guide.

Use only as directed. Tell your doctor if you use other medicines or have other medical conditions or allergies.

Evinacumab is given as an infusion into a vein, usually once per month. A healthcare provider will give you this injection.

This medicine must be given slowly over 60 minutes.

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 evinacumab if you are allergic to it.

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.

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

Call your doctor for instructions if you miss an appointment for your evinacumab 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: 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 evinacumab treatments may be delayed or permanently discontinued if you have certain side effects.

Common side effects of evinacumab 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 affect evinacumab, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all other medicines you use.