Evolocumab Injection

Evolocumab injection is used to lower cholesterol (a fat-like substance in the blood) and to lower risk of a stroke or a heart attack in patients with cardiovascular disease (disease of the heart or blood vessels). Evolocumab injection is in a class of medications called proprotein convertase subtilisin kexin type 9 (PCSK9) inhibitor monoclonal antibody. It works by stopping the production of cholesterol.

Accumulation of cholesterol 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.

Evolocumab injection comes as a solution (liquid) in a prefilled syringe, a prefilled autoinjector, and in an on-body infusor with a prefilled cartridge to inject subcutaneously (just under the skin).It is injected every 2 weeks or once a month.

Use evolocumab injection exactly as directed. Do not use more or less of this medication or use it more often or for a longer period of time than prescribed by your doctor.

Your first dose of evolocumab injection will be given in your doctor's office. After that, you may be allowed to inject the medication yourself or have a caregiver give the injections. Before you use evolocumab injection yourself the first time, carefully read the written instructions that come with it. Ask your doctor or pharmacist if you have any questions on how to inject the medication.

Use each injection only once and inject all of the solution in the autoinjector, syringe or on-body infusor. It may take up to 15 seconds to inject the medication using an autoinjector or a syringe and about 5 minutes using an on-body infusor. Dispose of used needles, syringes, and devices in a puncture-resistant container. Talk to your doctor or pharmacist about how to dispose of the puncture-resistant container.

Inject evolocumab on the front of your thighs or stomach area, except for the 2-inch area around your navel (belly button). If a caregiver is giving the injection, the back of the upper arm can be used. Use a different spot for each injection. Do not inject into a spot that is tender, bruised, red, hard, or areas with scars or stretch marks.

Remove the syringe, autoinjector, or on-body infuser with prefilled cartridge from the refrigerator. Allow the syringe and autoinjector to warm to room temperature for 30 minutes before using. Allow the on-body infusor and prefilled cartridge to warm to room temperature for 45 minutes before using. Do not warm the medication in hot water, microwave, or place it in sunlight.

Before you use evolocumab injection, look at the solution closely. The medication should be clear to pale yellow and free of floating particles. Do not use evolocumab injection if it is cloudy or contains flakes or solid particles. Do not shake it.

Evolocumab injection helps to control cholesterol levels and reduce the risk of a stroke, heart attack, or coronary artery bypass surgery, but it does not cure these conditions or eliminate these risks. Continue to use evolocumab injection even if you feel well. Do not stop using evolocumab injection without talking to your doctor.

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 using evolocumab injection,

• tell your doctor or pharmacist if you are allergic to this drug, any part of this drug, or any other drugs, foods or substances. Tell your doctor or pharmacist about the allergy and what symptoms you had.
• tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
• tell your doctor if you have or have ever had any medical conditions.
• tell your doctor if you are pregnant, plan to become pregnant, or are breastfeeding. If you become pregnant while using evolocumab injection, call your doctor.

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.

If it is within 7 days of the missed dose, inject it as soon as you remember it and continue your regular dosing schedule. If it is more than 7 days from your missed dose, skip it and continue your regular dosing schedule. Start your new monthly schedule from this new date.

Call your doctor if you miss a dose and have questions about what to do.

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

• redness, itching, swelling, pain, or tenderness at the injection site
• flu-like symptoms, runny nose, cough, sore throat, fever, or chills
• pain or burning during urination
• muscle or back pain
• dizziness
• headache
• stomach pain

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

• itching; rash; hives; difficulty breathing or swallowing; or swelling of the face, throat, tongue, lips, and eyes

Evolocumab injection may cause other side effects. Call your doctor if you have any unusual problems while using 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).

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it in the original carton in the refrigerator, protected from light. Do not freeze. Evolocumab injection may also be kept at room temperature in the original carton for up to 30 days.

Keep all medication out of sight and reach of children as many containers are not child-resistant. Always lock safety caps. Place the medication in a safe location – one that is up and away and out of their sight and reach. https://www.upandaway.org

Dispose of unneeded medications in a way so that pets, children, and other people cannot take them. Do not flush this medication down the toilet. Use a medicine take-back program. Talk to your pharmacist about take-back programs in your community. Visit the FDA's Safe Disposal of Medicines website https://goo.gl/c4Rm4p for more information.

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 evolocumab injection.

Ask your pharmacist any questions you have about evolocumab injection.

Keep a written list of all of the prescription and nonprescription (over-the-counter) medicines, vitamins, minerals, and dietary supplements you are taking. Bring this list with you each time you visit a doctor or if you are admitted to the hospital. You should carry the list with you in case of emergencies.

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