alirocumab

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

Use only as directed. Tell your doctor if you use other medicines or have other medical conditions or allergies.

What is alirocumab?

Alirocumab is used in people with heart disease, to help lower the risk of heart attack, stroke, or needing to be hospitalized because of chest pain (unstable angina).

Alirocumab is also used to help lower blood levels of LDL cholesterol in people with inherited types of high cholesterol. Alirocumab is used together with a low-fat diet and sometimes in combination with a "statin" medication.

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

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

It is not known if alirocumab will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

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

How should I use alirocumab?

Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed.

Alirocumab is injected under the skin, usually once every 2 to 4 weeks. It may take up to 20 seconds to inject each dose.

Ask your doctor or pharmacist if you don't understand how to use an injection.

Do not shake this medicine. Prepare an injection only when you are ready to give it. Call your pharmacist if the medicine looks cloudy, has changed colors, or has particles in it.

Do not reuse a needle or syringe. Place them in a puncture-proof "sharps" container and dispose of it following state or local laws. Keep out of the reach of children and pets.

Throw away an injection pen after one use, even if there is still medicine left inside.

If you use alirocumab only once every 4 weeks, you will give yourself 2 separate injections at the same time. Use a new syringe or injection pen for each injection. Give each injection into a different place on your body.

You will need frequent blood tests.

Take the carton out of the refrigerator 30 to 40 minutes before injecting your dose, to let the medicine reach room temperature. Do not heat an injection pen, and do not leave it at room temperature for longer than 30 days.

What happens if I miss a dose?

Give an injection within 7 days after the missed dose. Then give the next injection 2 to 4 weeks after the missed dose was due, to put you back on your regular injection schedule.

If you are more than 7 days late for an injection:

• If you inject every 2 weeks, skip the missed dose and use your next dose at the regular time.
• If you inject every 4 weeks, start a new schedule based on the date you used the missed injection.

Do not use two doses at one time.

What happens if I overdose?

What should I avoid while using alirocumab?

What are the possible side effects of alirocumab?

Common side effects may include:

• redness, itching, soreness, or swelling where an injection was given;
• 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 alirocumab?

Other drugs may affect alirocumab, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all other medicines you use.

Where can I get more information?

Your pharmacist can provide more information about alirocumab.