Alirocumab, Injection

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KEY POINTS

• This medicine is given by injection to lower LDL in people with a certain kind of high cholesterol or fatty deposits in the blood vessels in the heart. 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; monoclonal antibody; cholesterol-lowering medicine

Generic and brand names: alirocumab, injection; Praluent

What is this medicine used for?

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

• Inherited a gene that causes high levels of LDL (heterozygous 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.

Pregnancy and breast-feeding: Tell your healthcare provider if you are pregnant, plan to become pregnant, are breast-feeding, or plan to breast-feed. It is not known if this medicine can harm an unborn baby. It is not known if this medicine passes into your breast milk. You and your healthcare provider should decide if you will take this medicine or breastfeed.

How do I use it?

The shots are given just under the skin, usually 1 time every 2 weeks. This medicine comes as a prefilled pen or as a prefilled syringe. Both the pen and the syringe contain just 1 dose. Your healthcare provider will determine which type and dosage is best for you.

Check with your healthcare provider before using this medicine in children under age 18.

These shots may be given by your healthcare provider. Sometimes you or someone at home can give them to you. Your healthcare provider will teach you how to use this medicine at home. Check the label on the medicine for directions about your specific dose. Carefully read and follow the instructions for use that come in the package of medicine. Be sure you know how and when to have shots. Do not stop using this medicine without your healthcare provider's approval.

Warm the prefilled pen or prefilled syringe at room temperature for 30 to 40 minutes after you take it out of the refrigerator before you use it. Use a different area for the shot each time, as directed by your healthcare provider. Do not give shots into skin that is tender, bruised, or 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?

You need regular checkups and blood tests to see how this medicine affects you. Keep all appointments.

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

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 normal; severe rash.

Other: Redness, itching, swelling, pain around the injection site; runny or stuffy nose; sore throat; muscle pain; diarrhea.

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. Do not use this medicine if it has been at room temperature for 24 hours or longer. Do not let it freeze. Protect it from heat, high humidity, and bright light.

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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.