Evolocumab, Injection

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KEY POINTS

• This medicine is given by injection to lower LDL (bad) cholesterol in some people with heterozygous or homozygous familial hypercholesterolemia or heart disease. It is used along with cholesterol-lowering therapies and a healthy diet. Use it exactly as directed.
• Keep all appointments for tests to see how this medicine affects you.
• This medicine may cause unwanted side effects. Tell your healthcare provider if you have any side effects that are serious, continue, or get worse.
• Tell all healthcare providers who treat you about all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take.

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What are other names for this medicine?

Type of medicine: PCSK9 inhibitor; cholesterol-lowering medicine

Generic and brand names: evolocumab, injection; Repatha

What is this medicine used for?

This medicine is given by subcutaneous injection (shot just under the skin) to lower LDL (bad) cholesterol in people who:

• Inherited a gene that causes high levels of LDL (heterozygous or homozygous familial hypercholesterolemia).
• Have had a heart attack, stroke, TIA, or who have angina or peripheral artery disease caused by fatty deposits that buildup in blood vessels in the heart and make them narrower.

It is used when you cannot control your cholesterol levels by diet and exercise alone. This medicine is used along with a statin medicine.

This medicine may be used to treat other conditions as determined by your healthcare provider.

What should my healthcare provider know before I take this medicine?

Before taking this medicine, tell your healthcare provider if you have ever had an allergic reaction to any medicine, or to latex.

Pregnancy and breast-feeding: Tell your healthcare provider if you are pregnant, plan to become pregnant, or are breast-feeding. It is not known whether this medicine will harm an unborn baby. It is not known if this medicine passes into your breast milk. Do not breast-feed while you are taking this medicine without your healthcare provider's approval.

How do I use it?

Check the label on the medicine for directions about your specific dose. Carefully follow the instructions for using this medicine. Use this medicine exactly as directed by your healthcare provider for the length of time prescribed. Do not change your dosage or stop using this medicine without your healthcare provider's approval.

The shots are given either once every 2 weeks or once each month, depending on your condition. This medicine comes as a prefilled autoinjector or as a prefilled syringe. Both the autoinjector and syringe only contain 1 dose.

Check with your healthcare provider before using this medicine in children under age 13.

This medicine is given by injection under the skin in your upper arm, belly, or thigh. You may be able to give yourself these shots or have someone at home give them to you. Your healthcare provider will teach you how to use this medicine at home and give you detailed instructions on how to give these injections. The shot should not be given into an area where the skin is tender, bruised, red, or where you have scars or stretch marks. If you are not sure of how to give yourself the shots, ask your healthcare provider or pharmacist for help.

What if I miss a dose?

If you miss a dose, use it as soon as you remember if it’s within 7 days of your missed dose. If it is longer than 7 days from the missed dose, skip the missed dose. In either case, use your next dose on your regular schedule. Do not use double doses. If you are not sure of what to do if you miss a dose, or if you miss more than one dose, contact your healthcare provider.

What if I overdose?

Symptoms of an acute overdose have not been reported.

What should I watch out for?

A low-fat diet and regular exercise are important to reduce cholesterol. Follow your healthcare provider's advice.

You need regular lab tests to find out how this medicine is affecting you. Keep all your appointments for these tests.

If you need emergency care, surgery, lab tests, or dental work, tell the healthcare provider or dentist you are taking this medicine.

What are the possible side effects?

Along with its needed effects, your medicine may cause some unwanted side effects. Some side effects may be very serious. Some side effects may go away as your body adjusts to the medicine. Tell your healthcare provider if you have any side effects that continue or get worse.

Life-threatening (Report these to your healthcare provider right away. If you cannot reach your healthcare provider right away, get emergency medical care or call 911 for help.): Allergic reaction (hives; itching; rash; trouble breathing; tightness in your chest; swelling of your lips, tongue, and throat).

Serious (Report these to your healthcare provider right away.): Pain while urinating or urinating more often than usual; severe rash.

Other: Runny nose; sore throat; cough; back pain; diarrhea; redness, pain, or bruising at the injection site.

What products might interact with this medicine?

No significant drug interactions have been reported.

If you are not sure if your medicines might interact, ask your pharmacist or healthcare provider. Keep a list of all your medicines with you. List all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take. Be sure that you tell all healthcare providers who treat you about all the products you are taking.

How should I store this medicine?

Store this medicine in the refrigerator in the original container. Do not let it freeze. If you leave the medicine at room temperature, use it within 30 days. Keep the container tightly closed. Protect it from heat, high humidity, and bright light.

Do not use the autoinjector or prefilled syringe if it has been dropped on a hard surface.

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This advisory includes selected information only and may not include all side effects of this medicine or interactions with other medicines. Ask your healthcare provider or pharmacist for more information or if you have any questions.

Keep all medicines out of the reach of children.

Do not share medicines with other people.