Evolocumab Injection

Evolocumab injection comes as a solution (liquid) in a prefilled syringe and a prefilled autoinjector to inject subcutaneously (just under the skin). When evolocumab injection is used to treat HeFH or cardiovascular disease, it is usually injected every 2 weeks or once every month. When evolocumab injection is used to treat HoFH, it is usually injected it 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 3 separate injections one after the other within 30 minutes, using a different syringe or autoinjector for each injection.

Evolocumab injection helps to control cholesterol levels, but does not cure these conditions. 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 prefilled autoinjector and prefilled syringes that contain enough medication for one dose. Always inject evolocumab in its own prefilled autoinjector or syringe; 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. Do not warm the prefilled syringe or prefilled autoinjector in hot water, microwave, or place in sunlight.

Before you use evolocumab injection, look at the solution in the prefilled syringe or autoinjector or closely. The medication should be clear to pale yellow and free of floating particles. Do not shake the prefilled syringe or prefilled autoinjector 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 breast-feeding. 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.

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

1. redness, itching, swelling, pain, or tenderness at the injection site
2. flu-like symptoms, runny nose, sore throat, fever, or chills
3. pain or burning during urination
4. muscle or back pain
5. dizziness
6. 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:

1. itching
2. rash
3. hives
4. difficulty breathing or swallowing
5. 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 (http://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 refrigerator, but do not freeze it. Do not leave evolocumab injection outside of the refrigerator for more than 30 days. Keep evolocumab injection away from light.

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.

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

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