Repatha (Evolocumab)

(e'' voe lok' ue mab)

Evolocumab injection is used to reduce the risk of a stroke or heart attack or the need for coronary artery bypass (CABG) surgery in people with cardiovascular disease. Evolocumab injection is also used along with diet alone or in combination with other cholesterol-lowering medications such as HMG-CoA reductase inhibitors (statins) or ezetimbe (Zetia) to decrease the amount of low-density lipoprotein (LDL) cholesterol ('bad cholesterol') in the blood, including people who have familial heterozygous hypercholesterolemia (HeFH; an inherited condition in which cholesterol cannot be removed from the body normally). It is also used along with diet changes and other treatments to reduce the amount low-density lipoprotein (LDL) cholesterol ('bad cholesterol')in the blood in people that have homozygous familial hypercholesterolemia (HoFH; an inherited condition in which cholesterol cannot be removed from the body normally). Evolocumab injection is in a class of medications called proprotein convertase subtilisin kexin type 9 (PCSK9) inhibitor monoclonal antibody. It works by blocking the production of LDL cholesterol in the body to decrease the amount of cholesterol that may build up on the walls of the arteries and block blood flow to the heart, brain, and other parts of the body. 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). When evolocumab injection is used to treat HeFH or cardiovascular disease or to reduce the risk of a stroke, heart attack, and coronary artery bypass surgery, it is usually injected every 2 weeks or once every month. When evolocumab injection is used to treat HoFH, it is usually injected once every month. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. 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. If you are using evolocumab injection once every month (420 mg dose), inject it once over 9 minutes with the on-body infusor and prefilled cartridge for each injection or inject 3 separate injections one after the other within 30 minutes, using a different prefilled syringe or prefilled autoinjector for each injection. 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. Evolocumab injection comes in a prefilled autoinjector, prefilled syringes, and in an infusor with a prefilled cartridge that contain enough medication for one dose. Always inject evolocumab in its own prefilled autoinjector, syringe, or infusor with a prefilled cartridge; never mix it with any other medication. 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. You can inject evolocumab injection under the skin on your thighs or stomach area, except for the 2-inch area around your navel (belly button). If someone else will be injecting the medication for you, that person can also inject it into your upper arm. Use a different spot for each injection. Do not inject evolocumab injection into a spot that is tender, bruised, red, or hard. Also, do not inject into areas with scars or stretch marks. Carefully read the manufacturer's instructions for use that comes with the medication. These instructions describe how to inject a dose of evolocumab injection. Be sure to ask your pharmacist or doctor if you or the person who will be injecting have any questions about how to inject this medication. Remove the prefilled syringe or prefilled autoinjector from the refrigerator and allow it to warm to room temperature for 30 minutes before using it. Remove the infusor with a prefilled cartridge from the refrigerator and allow it to warm to room temperature for 45 minutes before using it. Do not warm evolocumab injection 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 shake the prefilled syringe, prefilled autoinjector, or infusor with a prefilled cartridge containing evolocumab injection.

Before using evolocumab injection,
• tell your doctor and pharmacist if you are allergic to evolocumab injection, any other medications, latex, rubber, or any of the ingredients in evolocumab 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. 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: http://www.nhlbi.nih.gov/health/public/heart/chol/chol_tlc.pdf.

If you administer evolocumab injection every 2 weeks and if it is within 7 days from your missed scheduled dose, inject it as soon as you remember it and continue your regular dosing schedule. However, if there are more than 7 days from your missed dose, skip it and continue your regular dosing schedule. Do not inject a double dose to make up for a missed dose. Call your doctor if you miss a dose and have questions about what to do. If you administer evolocumab injection once a month and if it is within 7 days from your missed scheduled dose, inject it as soon as you remember it and continue your regular dosing schedule. However, if you administer evolocumab injection once a month and there is more than 7 days from your missed dose, inject it immediately and start a new dosing schedule based on this date. Do not inject a double dose to make up for a missed dose. 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, sore throat, fever, or chills
• pain or burning during urination
• muscle or back pain
• dizziness
• 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
• 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.

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it in the refrigerator, but do not freeze it. Do not leave evolocumab injection outside of the refrigerator for more than 30 days. Evolocumab injection can be kept at room temperature in the original carton for up to 30 days. Keep evolocumab injection away from direct light. It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

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. 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.