evolocumab

What is the most important information I should know about evolocumab?

Follow all directions on your medicine label and package. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.

What is evolocumab?

Evolocumab works by helping the liver reduce levels of "bad" cholesterol (low-density lipoprotein, or LDL) circulating in your blood.

Evolocumab is used together with a low-fat diet and other cholesterol-lowering medications in people with homozygous or heterozygous familial hypercholesterolemia (inherited types of high cholesterol). These conditions can cause high blood levels of LDL cholesterol, and can also cause plaque to build up inside your arteries.

Evolocumab is also used to help lower the risk of stroke, heart attack, or other heart complications in people with heart or blood vessel problems caused by plaque build-up or hardening in the arteries (also called atherosclerosis, or arteriosclerosis).

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

What should I discuss with my healthcare provider before using evolocumab?

Tell your doctor if you have ever had:

• liver or kidney disease; or
• a latex allergy.

If you are pregnant, your name may be listed on a pregnancy registry to track the effects of evolocumab on the baby.

How is evolocumab given?

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Evolocumab is injected under the skin. A healthcare provider may teach you how to properly use the medication by yourself.

Evolocumab is available in a prefilled syringe, a SureClick prefilled autoinjector, or a Pushtronex on-body infusor with prefilled cartridge. Read and carefully follow any Instructions for Use provided with your medicine. Ask your doctor or pharmacist if you have questions, or call the manufacturer at 1-844-737-2842.

The Pushtronex on-body infusor is a special device placed on the skin that delivers your evolocumab dose slowly. You will need to wear the device for about 9 minutes to get the full dose. While wearing the on-body infusor, you may perform moderate activities such as walking, bending, or reaching.

Your care provider will show you the best places on your body to inject evolocumab or place the on-body infusor. Use a different place each time you give an injection. Do not inject into the same place two times in a row.

Each single-use prefilled syringe, cartridge, or injection device is for one use only. Throw away after one use, even if there is still some medicine left inside. Follow any state or local laws about throwing away used needles and syringes. Use a puncture-proof "sharps" container. Follow state or local laws about how to dispose of this container. Keep it out of the reach of children and pets.

Take the medicine out of the refrigerator and let it reach room temperature for 30 to 45 minutes before injecting your dose. Do not heat a syringe or injection device.

Handle this medicine carefully. Dropping an injection device can cause it to break. Do not use an injection device that has been dropped onto a hard surface, even if you cannot see a break in it. Call your pharmacist for new medicine.

Do not shake this medicine. Do not use if the medicine has changed colors or has particles in it. Call your pharmacist for new medicine.

Evolocumab is only part of a complete treatment program that also includes diet, statin medication, and regular blood testing. Follow your doctor's instructions very closely.

What happens if I miss a dose?

Use the missed dose within 7 days after that injection was due, but skip the missed dose if you are more than 7 days late. After a missed dose, go back to your original schedule and use the medicine again when your next scheduled dose is due.

Do not use two doses at one time.

What happens if I overdose?

What should I avoid while using evolocumab?

What are the possible side effects of evolocumab?

• high blood sugar --increased thirst, increased urination, dry mouth, fruity breath odor.

Common side effects may include:

• redness, pain, or bruising where an injection was given;
• back pain;
• flu symptoms; or
• cold symptoms such as stuffy nose, sneezing, sore throat.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect evolocumab?

Other drugs may affect evolocumab, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.

Where can I get more information?

Your pharmacist can provide more information about evolocumab.