Evinacumab-dgnb Injection

Evinacumab-dgnb is used in combination with other treatments to reduce the amount low-density lipoprotein (LDL) cholesterol ('bad cholesterol') and other fatty substances in the blood in adults and children 5 years of age or older that have homozygous familial hypercholesterolemia (HoFH; an inherited condition in which cholesterol cannot be removed from the body normally). Evinacumab-dgnb is in a class of medications called angiopoietin-like protein 3 (ANGPTL3) inhibitor monoclonal antibodies. It works by decreasing the production of LDL cholesterol and increasing the breakdown of LDL cholesterol and other fatty substances in the body.

Accumulation of cholesterol and fats along the walls of your arteries (a process known as atherosclerosis) decreases blood flow and, therefore, the oxygen supply to your heart, brain, and other parts of your body. Lowering your blood level of cholesterol and fats may help prevent heart disease, angina (chest pain), strokes, and heart attacks.

Evinacumab-dgnb comes as a solution (liquid) to be mixed with liquid and injected slowly into a vein over 60 minutes by a doctor or nurse. It is usually given once every 4 weeks.

Evinacumab-dgnb injection may cause serious reactions during the infusion of the medication. A doctor or nurse will monitor you carefully while you are receiving the medication. Tell your doctor or nurse immediately if you experience any of the following symptoms during the infusion: itching at the infusion site, muscle weakness; fever; nausea; or nasal congestion.

Your doctor may need to slow down your infusion or stop your treatment if you experience certain side effects. Be sure to tell your doctor how you are feeling during your treatment with evinacumab-dgnb.

Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

Before receiving evinacumab-dgnb,

• tell your doctor and pharmacist if you are allergic to evinacumab-dgnb, any other medications, or any of the ingredients in evinacumab-dgnb injection. Ask your pharmacist for a list of the ingredients.
• 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 if you are pregnant, or plan to become pregnant. You may need to take a pregnancy test before beginning treatment with evinacumab-dgnb. You should not become pregnant during your treatment with evinacumab-dgnb injection. You should use effective birth control to prevent pregnancy during your treatment with evinacumab-dgnb injection and for 5 months after your final dose. If you become pregnant while receiving evinacumab-dgnb, call your doctor immediately.
• tell your doctor if you are breastfeeding.

Eat a low-fat, low-cholesterol diet. Be sure to follow all exercise and dietary recommendations made by your doctor or dietitian. You can also visit the National Cholesterol Education Program (NCEP) website for additional dietary information at: https://www.nhlbi.nih.gov/health/public/heart/chol/chol_tlc.pdf.

Call your doctor right away if you are unable to keep an appointment to receive a dose of evinacumab-dgnb injection.

Evinacumab-dgnb may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• runny nose
• nasal congestion
• sore throat
• flu-like symptoms
• dizziness
• nausea
• pain in legs or arms
• decreased energy
• feeling tired or weak

Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately or get emergency medical treatment:

• hives; rash; itching; swelling of the lips, tongue, or throat; shortness of breath; difficulty breathing or swallowing

Evinacumab-dgnb may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (https://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests to check your body's response to evinacumab-dgnb.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

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