Repatha

Generic name: Evolocumab
Drug class: PCSK9 inhibitors

Usage of Repatha

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).

Repatha side effects

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.

Before taking Repatha

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.

Relate drugs

How to use Repatha

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:

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.

Warnings

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 other drugs will affect Repatha

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.

Disclaimer

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