Evinacumab

Evinacumab is used along with diet, exercise, and other medicines that lower low-density lipoprotein cholesterol (LDL-C) to reduce LDL-C levels in adults and children 1 year of age and older who have a type of high cholesterol known as homozygous familial hypercholesterolemia (HoFH).

Evinacumab may also be used for reasons that are not mentioned in this medication guide.

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

This medicine must be given slowly over 60 minutes.

Doses are based on weight. Your dose may change if you gain or lose weight.

Use only as directed. Inform your doctor if you are taking other medicines or if you have other medical conditions or allergies.

You should not be treated with evinacumab if you are allergic to it or any of its ingredients.

It may harm an unborn baby. You may need to take a pregnancy test before starting this treatment. 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.

Get emergency medical help if you have signs of an allergic reaction: hives, difficulty breathing, swelling of your face, lips, tongue, or throat.

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

Your treatment may be reduced, delayed, or permanently stopped if you have certain side effects.

Common side effects of evinacumab may include:

• cold or flu symptoms such as fever, chills, body aches, runny or stuffy nose, sneezing, sore throat;
• dizziness;
• nausea; or
• feeling weak or tired.

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

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.

Call your doctor for guidance if you miss your appointment for the evinacumab infusion.

An overdose of this product is unlikely to happen. However, if an overdose does occur in a medical setting, it would be treated quickly.

Follow your doctor's instructions regarding any restrictions on food, drinks, or activities.

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.