Evinacumab

Evinacumab

Evinacumab

What is Evinacumab?

Evinacumab is not used to treat high cholesterol levels caused by diet or other factors.

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

Evinacumab side effects

If necessary, get emergency medical helpSigns of an allergic reaction:hives, rash, itching; dizziness; wheezing, difficulty breathing; Swelling of your face, lips, tongue, or throat.

Some side effects may occur during the injection. Tell your healthcare provider if you experience dizziness, nausea, lightheadedness, itching, or sweating, or if you have a headache, chest tightness, back pain, difficulty breathing, or facial swelling.

If you experience certain side effects, your treatment with evinacumab may be delayed or permanently stopped.

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 can report side effects to FDA at 1-800-FDA-1088.

Warnings

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

Before you take this medicine

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

May harm an unborn child.You may need a pregnancy test to make sure you are not pregnant. Use effective contraception 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.

How is evinacumab administered?

Evinacumab is usually given as an infusion into a vein once a month. A doctor will give you this injection.

This medicine must be administered slowly over 60 minutes.

Evinacumab dosage information

Usual Adult Dose for Homozygous Familial Hypercholesterolemia:

15 mg/kg as an intravenous infusion once a month (every 4 weeks)

Comments:
-Assess LDL-C (low density lipoprotein cholesterol) when clinically appropriate. LDL-C can be measured as early as 2 weeks after starting therapy.
-The impact on cardiovascular morbidity and mortality has not been determined.

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

Usual Pediatric Dose for Homozygous Familial Hypercholesterolemia:

12 years or older: 15 mg/kg as an intravenous infusion once a month (every 4 weeks)

Comments:
-Assess LDL-C (low density lipoprotein cholesterol) when clinically appropriate. LDL-C can be measured as early as 2 weeks after starting therapy.
-The impact on cardiovascular morbidity and mortality has not been determined.

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

What happens if I miss a dose?

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

What happens if I overdose?

In the medical field, an overdose would be treated quickly.

What should I avoid during treatment with evinacumab?

Follow your doctor's instructions regarding any food, drink, or activity restrictions.

What other drugs affect evinacumab?

Other medications can affect evinacumab, including prescription and over-the-counter medications, vitamins, and herbal products. Tell your doctor about all other medicines you are taking.

More information

Remember to keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medicine only for the prescribed indication.