Repatha is a human monoclonal antibody. It works by helping the liver reduce levels of "bad" cholesterol (low-density lipoprotein, or LDL) circulating in your blood.

Repatha 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.

Repatha 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).

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.

Before taking this medicine

You should not use Repatha if you are allergic to evolocumab.

To make sure Repatha is safe for you, 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.

It may not be safe to breast-feed while using this medicine. Ask your doctor about any risk.

Do not give Repatha to a child without medical advice. Evolocumab is not approved for use by anyone younger than 10 years old. For certain conditions, Repatha should not be given to a child of any age.

Use Repatha exactly as it was prescribed for you. Follow all directions on your prescription label and read all medication guides or instruction sheets.

Repatha is injected under the skin. You may be shown how to use injections at home. Do not give yourself this medicine if you do not understand how to use the injection and properly dispose of used needles and syringes.

Repatha is usually given once a month, or once every 2 weeks. Depending on your dose amount, you may need to use up to 3 separate injections at one time. Follow your doctor's dosing instructions very carefully.

Repatha is available in a prefilled syringe, a SureClick prefilled autoinjector, or a Pushtronex on-body infusor with prefilled cartridge. Read all patient information, medication guides, and instruction sheets provided to you. Ask your doctor or pharmacist if you have any questions about your injection device, or call the manufacturer at 1-844-737-2842.

It may take up to 15 seconds to inject this medicine using a prefilled syringe or a SureClick autoinjector. If you use more than one injection at a time, be sure to finish all injections within 30 minutes.

The Pushtronex on-body infusor is a special hands-free device placed on the skin that delivers your evolocumab dose slowly. Read and carefully follow all instructions for using this product. 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 Repatha 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 (ask your pharmacist where to get one and how to throw it away). Keep this container out of the reach of children and pets.

Store Repatha in the refrigerator in its original carton and protect from light and heat. Do not freeze. Throw away any medicine that has been frozen.

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

You may also store Repatha in the original carton at cool room temperature, away from light and heat. Use the medicine within 30 days if it is kept at room temperature.

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.

You should not stop using Repatha without your doctor's advice, or your LDL cholesterol levels may increase.

Repatha 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.

Usual Adult Dose for Hyperlipidemia:

140 mg subcutaneously every 2 weeks OR 420 mg subcutaneously once a month

Comments:
-Low-density lipoprotein cholesterol (LDL-C) can be assessed when clinically appropriate; the LDL lowering effect may be measured as early as 4 weeks after initiation.
-For patients receiving 420 mg once a month, LDL-C should be measured just prior to next scheduled dose.
-When switching dosage regimens, administer the first dose of the new regimen on the next scheduled date of prior regimen.

Uses:
-In adults with established cardiovascular disease to reduce the risk of myocardial infarction, stroke, and coronary revascularization.
-As an adjunct to diet, alone or in combination with other LDL-C lowering therapies for the treatment of primary hyperlipidemia, including heterozygous familial hypercholesterolemia (HeFH), to reduce LDL-C.

Usual Adult Dose for Heterozygous Familial Hypercholesterolemia:

140 mg subcutaneously every 2 weeks OR 420 mg subcutaneously once a month

Comments:
-Low-density lipoprotein cholesterol (LDL-C) can be assessed when clinically appropriate; the LDL lowering effect may be measured as early as 4 weeks after initiation.
-For patients receiving 420 mg once a month, LDL-C should be measured just prior to next scheduled dose.
-When switching dosage regimens, administer the first dose of the new regimen on the next scheduled date of prior regimen.

Uses:
-In adults with established cardiovascular disease to reduce the risk of myocardial infarction, stroke, and coronary revascularization.
-As an adjunct to diet, alone or in combination with other LDL-C lowering therapies for the treatment of primary hyperlipidemia, including heterozygous familial hypercholesterolemia (HeFH), to reduce LDL-C.

Usual Adult Dose for Cardiovascular Risk Reduction:

140 mg subcutaneously every 2 weeks OR 420 mg subcutaneously once a month

Comments:
-Low-density lipoprotein cholesterol (LDL-C) can be assessed when clinically appropriate; the LDL lowering effect may be measured as early as 4 weeks after initiation.
-For patients receiving 420 mg once a month, LDL-C should be measured just prior to next scheduled dose.
-When switching dosage regimens, administer the first dose of the new regimen on the next scheduled date of prior regimen.

Uses:
-In adults with established cardiovascular disease to reduce the risk of myocardial infarction, stroke, and coronary revascularization.
-As an adjunct to diet, alone or in combination with other LDL-C lowering therapies for the treatment of primary hyperlipidemia, including heterozygous familial hypercholesterolemia (HeFH), to reduce LDL-C.

Usual Adult Dose for Homozygous Familial Hypercholesterolemia:

Initial dose: 420 mg subcutaneously once a month
-May increase to 420 mg every 2 weeks if clinically meaningful response is not achieved in 12 weeks

Concomitant Use with Lipid Apheresis:
-Patients on lipid apheresis may initiate treatment with 420 mg subcutaneously every 2 weeks to correspond with their apheresis schedule; administer after apheresis session is complete.

Comments:
-Low-density lipoprotein cholesterol (LDL-C) can be assessed when clinically appropriate; the LDL lowering effect may be measured as early as 4 weeks after initiation.
-For patients receiving 420 mg once a month, LDL-C should be measured just prior to next scheduled dose.

Use: As an adjunct to other LDL-lowering therapies for the treatment of homozygous familial hypercholesterolemia (HoFH) to reduce LDL-C.

Usual Pediatric Dose for Homozygous Familial Hypercholesterolemia:

10 years or older:
Initial dose: 420 mg subcutaneously once a month
-May increase to 420 mg every 2 weeks if clinically meaningful response is not achieved in 12 weeks

Concomitant Use with Lipid Apheresis:
-Patients on lipid apheresis may initiate treatment with 420 mg subcutaneously every 2 weeks to correspond with their apheresis schedule; administer after apheresis session is complete.

Comments:
-Low-density lipoprotein cholesterol (LDL-C) can be assessed when clinically appropriate; the LDL lowering effect may be measured as early as 4 weeks after initiation.
-For patients receiving 420 mg once a month, LDL-C should be measured just prior to next scheduled dose.

Use: Uses: As an adjunct to other LDL-lowering therapies in pediatric patients 10 years or older for the treatment of homozygous familial hypercholesterolemia (HoFH) to reduce LDL-C.

Usual Pediatric Dose for Heterozygous Familial Hypercholesterolemia:

10 years or older: 140 mg subcutaneously every 2 weeks OR 420 mg subcutaneously once a month

Comments:
-Low-density lipoprotein cholesterol (LDL-C) can be assessed when clinically appropriate; the LDL lowering effect may be measured as early as 4 weeks after initiation.
-For patients receiving 420 mg once a month, LDL-C should be measured just prior to next scheduled dose.
-When switching dosage regimens, administer the first dose of the new regimen on the next scheduled date of prior regimen.

Use: As an adjunct to diet and other LDL-C-lowering therapies in pediatric patients 10 years or older with HeFH, to reduce LDL-C.

You should not use Repatha if you are allergic to evolocumab.

To make sure Repatha is safe for you, 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.

It may not be safe to breast-feed while using this medicine. Ask your doctor about any risk.

Do not give Repatha to a child without medical advice. Evolocumab is not approved for use by anyone younger than 10 years old. For certain conditions, Repatha should not be given to a child of any age.

Use the missed dose within 7 days after that injection was due. Skip the missed dose if you are more than 7 days late for the injection. 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 extra medicine to make up a missed dose.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Do not inject Repatha into skin that is bruised, sore, scarred, or hardened.

Get emergency medical help if you have signs of an allergic reaction to Repatha: hives, severe itching; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

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

Common Repatha 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.

Other drugs may interact with evolocumab, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.